Tag Archives: Masks

The Pandemic is Over

This is my prediction that by the end of February or maybe March, as more and more of the population gets infected. However, due to the confusion promoted by the news reporters, as well as social media and changes seen in most pandemics the population has become confused.
All of a sudden there is the push to use N95 and KN95 masks as the effective face protection.
But listen here, the use of N95 and KN95 masks were always the most effective, but the scientists were “silenced” and as long as you were wearing some sort of face masks or facial coverings “everyone” was satisfied. But listen carefully, the cloth and paper masks never were and protection from any virus. Remember that viruses are measured in microns, not inches or millimeters, etc.
Also, as Omicron takes over, we are seeing the effects and power of the portion of the vaccinated. Yes, they will get sick, but many will be asymptomatic and therefore will never be counted as infected. Which is my biggest problem with the Administration sending out millions of home self-tests. So, they are going to send out 500 million to a population of about 400 million people, which means that you can use the test once. Many times, the tests will be read as negative due to the timing of the infection and then what.
Also, with self-testing, if your tests are positive, who will report their positive tests? Therefore, will our future data on which we make decisions be accurate? Actually, No and we are already seeing this happen with all the home self-tests already being sold. And then the “sick” patients should self-quarantine, that if they are honest and care about those around them and those who matter to them, or just care about society.
This new variant/mutation is more contagious, and our population is exhausted. If you don’t believe me just review the New Year’s Eve celebration from Nashville or New York city. The crowds were huge and there were very few masks being worn!
Omicron not peaking nationally yet, surgeon general says. COVID-19 is sending mixed messages. The U.S. is recording over 800,000 cases a day for the first time since the beginning of the pandemic, and hospitalizations are also setting records.
But New York State recorded only about 48,000 cases on Friday, almost a 47% drop from the previous week’s case count, Gov. Kathy Hochul said Saturday.
“We are turning the corner on the winter surge, but we’re not through this yet,” the governor said in a statement.
Minnesota also saw declining intensive-care hospitalizations for COVID-19, and cases have been falling in Washington D.C. and other cities in the eastern half of the country.
But New York’s declining trend is not indicative of the national COVID-19 portrait, Surgeon General Vivek Murthy warned on Sunday.
“The entire country is not moving at the same pace,” he told CNN host Jake Tapper.
Oklahoma and Georgia both saw over a 100% rise in weekly COVID-19 cases, a USA TODAY analysis of Johns Hopkins University data shows, while Colorado saw a 90% increase.
“We shouldn’t expect a national peak in the next coming days,” he said. “The next feel weeks will be tough.”
Also in the news:
The United States has reported its 850,000+ deaths, Johns Hopkins University data shows. The U.S. averaged 1,776 reported deaths per day over the last week.
The Biden administration on Wednesday will launch a website where Americans can order up to four free COVID-19 testing kits per person.
U.S. Rep. David Trone of Maryland announced that he has tested positive for COVID-19. Trone said he has received a booster and is experiencing “only minor symptoms,” according to The Washington Post.
Navajo Nation President Jonathan Nez has signed an executive order requiring all government workers on the tribe’s vast reservation to receive a booster shot.
Today’s numbers: The U.S. has recorded more than 65 million confirmed COVID-19 cases and more than 850,000 deaths, according to Johns Hopkins University data. Global totals: More than 326 million cases and over 5.5 million deaths. More than 208 million Americans – 62.9% – are fully vaccinated, according to the Centers for Disease Control and Prevention.
What we’re reading: Omicron is closing daycare centers in droves. Parents are “just trying to stay afloat.” USA TODAY’s Alia Wong explains.
US now averaging 800,000 new cases each day and stated that the total deaths are now over 900,000.
The United States is reporting more than 800,000 cases a day for the first time, even amid signs that America’s omicron wave is slowing down. The country reported 5.65 million cases in the week ending Saturday, a USA TODAY analysis of Johns Hopkins University data shows. The rapid acceleration of case reports continues despite a shortage of tests. Still, in just the last week the country has reported more cases than it did in March, April, May and June 2021 – combined.
About 158,500 Americans were reported hospitalized on Saturday. Hospitals in 46 states report rising numbers of patients; 34 states report rising death rates.
Mike Stucka noted that we continue to push mask mandates, social distancing, vaccinations, and possible additional lockdowns.
With the majority of really sick hospitalized patients, actually about 72%, were non-vaccinated.
I just had a young lady with four children who notified me earlier in the week that because she had a few home self-tests she tested her sons with two of the boys just having sniffles or a minor sore throat. And three tested positive. And I believe that this is going to be the majority of COVID positive patients, that is minimal or no symptoms and therefore, not self-quarantining and therefore becoming super-spreaders.
COVID Vaccines Are a Scientific Feat, but ‘Prevention’ Is a Misnomer
— In public messaging, semantics matter
Rossi A. Hassad, PhD reported that especially since the advent of the COVID-19 Omicron variant, and the increasing incidence of infection and reinfection among those fully vaccinated and boosted, I have heard from a number of people whose concerns reflect the following sentiment, “You recommended the vaccine to prevent COVID-19, I took it, and this is what I got (infected).”
Undoubtedly, these COVID-19 vaccines are a gift of life and continue to be safe and effective. Nonetheless, this sentiment is understandable, and in my assessment, it signals an urgent need for more precise labeling and messaging about the COVID-19 vaccines from the FDA.
On Dec. 10, 2020, at the invitation of the FDA, I gave a brief oral presentation at the open public session of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine. I ended my remarks as follows:
“In conclusion, the potential benefits of this vaccine outweigh the identified risks. Therefore, I support the issuance of an EUA with the stipulation that the vaccine can protect against symptomatic disease. But at this time, it is not known if it prevents infection and transmission.”
The COVID-19 vaccine clinical trials and the resulting evidence show that the vaccines significantly reduce the risk of severe illness, hospitalization, and death. Nonetheless, in the labeling of the vaccines, and messaging to healthcare providers and the general public, the FDA specified that the Pfizer-BioNTech, Moderna, and Janssen vaccines are indicated for the “prevention of COVID-19” — this may have fostered an unrealistic expectation of absolute protection or immunity against COVID-19. By scientific convention, a vaccine is generally characterized as a primary prevention measure for a specific disease: that is, “you can be exposed to it without becoming infected.”
Over the summer, on Aug. 2, 2021, I emailed FDA’s Acting Commissioner Janet Woodcock, MD, regarding the word prevention, which the FDA has used to characterize the scope of protection provided by the three COVID-19 vaccines in use in the U.S. I noted that the word prevention in this context seems to be a misnomer and can contribute to public confusion and vaccine hesitancy. In particular, in light of the increasing number of breakthrough cases, the public may be inclined to believe that the COVID-19 vaccines are losing effectiveness. I also urged the FDA to provide clarification to the public in this regard. Woodcock responded the same day as follows:
“Thank you for writing. We will take your suggestions into account. I agree that the expected results of vaccination are confusing for most people. It is very likely that vaccination prevents acquisition of infection in some people but not all vaccinated people and that some get symptomatic infection and rarely, severe disease, and this may be related in part to their overall immune system response, the variant they were exposed to, and the actual amount of exposure and the time since their last vaccination, among other things.”
Notably, in September 2021, the CDC tempered its definition of vaccination to reflect that vaccines produce “protection from a specific disease,” rather than “immunity to a specific disease.” (In either case, immunity was defined on the same CDC page as “protection from an infectious disease.”)
Woodcock’s response continues to reflect the performance of the COVID-19 vaccines. Prevention of COVID-19 is not the intended primary benefit of these vaccines. In fact, Woodcock and Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently made the point that most people will get COVID eventually. These vaccines continue to significantly reduce the risk of severe illness, hospitalization, and death — and that’s an amazing scientific feat amidst a deadly pandemic. Attention to timely and effective messaging to healthcare providers and the general public should be a top priority for the FDA. Semantics matter.
(When) to Boost or Not to Boost, That Is the Question
— Countless complex questions remain
John P. Moore, PhD noted that for several months, America has been in the vaccine-booster phase of the COVID-19 pandemic. Various aspects of booster policy have been controversial and/or confusing, and the public response to the need for boosters has been mixed. But what is the best way to continue to provide the sensible majority who trust in the lifesaving COVID-19 vaccines with the best protection in the coming months to years? At times, it seems as if some folks believe “a dose a day keeps the doctor away.” And a meme is now circulating of a “Pfizer Loyalty Card,” offering a free pizza after dose nine. While droll, might that actually happen? (Dose nine, that is).
While the strong protective efficacy of the mRNA vaccines was certainly not predicted early on in the global vaccine program, a basic understanding of vaccine immunology allowed us to predict that protective antibody titers would inevitably wane over a 6-month period and could be restored with a booster dose.
The Early Booster Debates
In summer 2021, data from Israel triggered discussions among policymakers, scientists, and company executives about the need for boosters in the U.S. The vaccine booster concept wasn’t — or shouldn’t have been — inherently controversial, particularly for individuals at high risk for COVID-19 complications. However, there were doubts about the arguably premature timing of, and rationale for, a broadly based boosting program. Arguments were also raised about using those doses in under-vaccinated countries instead, both on moral grounds and to prevent the emergence of even more troubling variants (e.g., Omicron…). Other debates centered on whether the goal was to protect against mild infections (which vaccines typically don’t do) or severe disease and death. These discussions generally faded away once it became clear that protection against severe infections was diminishing significantly for older individuals, and that fully vaccinated people could still transmit their infections to others. In addition, anxious members of the vaccine-embracing public, including members of the media, put pressure on the Biden administration. A vaccine boost became something that Jane Public and Ronnie Reporter wanted, and, frankly, expected.
Americans can now be boosted 5 months after their initial two mRNA vaccine doses of Moderna or Pfizer. The far fewer recipients of the Johnson & Johnson (J&J) vaccine are also being boosted, most opting for an mRNA dose as that provides a stronger antibody response.
But what’s next? Already, Israel is rolling out a fourth Pfizer dose and is therefore well on the way to handing over a slice of pizza. Should we do the same here, and if so, when? In the hope that any policy decisions will be science-based, I will review some of the knowns and unknowns. Whatever knowledge I possess has been significantly boosted by helpful discussions with world-class immunologist colleagues.
Determining the Right Booster Schedule
Most agree that dose three (i.e., the first boost) should not be given too early. The period between the second and third dose is critical to the maturation of the immune response and establishment of immunological memory. As the quantity of antibodies in the blood declines, their quality increases, including their ability to counter variants. While there is no “magic moment” for dose three, the original CDC recommendation for a 6-month gap for both mRNA vaccines and the recent revisions to 5 months are both about right.
But what about dose four and onwards? Is there a point when it is certainly needed? Here, we don’t have hard data, although there are early indications from Israel that the antibody responses to Pfizer dose three are now dropping. That should not be a surprise, based in part on decades of experience with attempts at an HIV-1 vaccine. As but one illustrative example, an HIV-1 “spike protein” vaccine was given seven times to humans over a 30-month period. After the first two immunizations, every subsequent one triggered a rapid rise in antibody levels, followed by a gradual decline at a similar rate each time. The titer pattern over time looked like saw teeth. In the period between boosts, the antibody levels didn’t disappear, but the boosted peak levels weren’t much higher each time — there were ever diminishing returns to the potency of each booster dose.
Perhaps we will see something different with the SARS-CoV-2 spike protein, and maybe the mRNA delivery method will be the charm — but I wouldn’t bet the farm on a dramatically different outcome to our experiences with the HIV-1 spike protein. In other words, boosting is likely to increase protective antibody levels in the short term but probably won’t be truly sustained (T-cell responses, which help to prevent severe disease, also wane but more slowly). If the pandemic persists, fairly regular boosting may therefore be needed, akin to the annual flu vaccines.
However, this scenario also invites more questions about the intervals between doses: the HIV-1 vaccine study discussed above used a 6-month interval between the later doses, probably because prior experience showed that was when the boosted titers dropped back to near baseline. The Israelis, however, are now giving the fourth Pfizer vaccine dose about 4 months after the third. Is that too soon for comfort? Well, for sure, it should be no sooner than that…and most immunologists I talked to favor a longer interval. Given the cost and logistics, some important decisions will need to be made soon.
Our political and public health leaders have much to consider and will need to decide whether there is a need to sustain a high level of protection against SARS-CoV-2 infection and mild COVID-19.
Will We Keep Boosting…Forever?
What about the future? There is nothing inherently problematic with giving regular, sensibly spaced vaccine doses from an immunology perspective. Different COVID-19 vaccines can clearly be mixed when given sequentially. A recent HIV-1 vaccine study in monkeys involved nine doses of mRNAs, proteins, and protein-nanoparticles over a ~14-month period in a heroic attempt to broaden the neutralizing antibody response (the major obstacle to a successful HIV-1 vaccine). Next-generation, more potent COVID-19 vaccines may eventually play an important role. We’ll also need to explore alternative ways to deliver vaccines, whether based on immunology or emerging technology. What happens should be dictated by the trajectory of the pandemic, including the evolution of yet more variants. So far, despite vaccine manufacturers going ahead with their own plans, the case for variant-specific vaccines has been weak. Although, it’s possible the need for them may change in the coming months as Omicron continues to spread; and now what about the new variant, Deltacron?
Boosting J&J Vaccine Recipients
Additional complications are at play too: What’s the right approach to boosting J&J vaccine recipients? They can receive a second dose 2 months after the first, but in most cases that dosing interval is many months longer (and, as noted, most opted for an mRNA boost at that point). When should they receive a third dose? For the mRNA vaccines, the critical period for immunological quality improvements is the ~6-month interval between doses two and three (see above), but when does that happen for the J&J vaccine? In the long and rather random interval between doses one and two? After dose two? Or both? Could a third dose in the near future be too soon for comfort? Having more data would help.
Factoring in Natural Immunity
We also need to consider how to — or whether to — factor in immune responses induced by vaccine breakthrough infections, which are becoming increasingly common. Although breakthrough Omicron infections are generally not severe, the viral antigens will surely trigger a boosting effect in vaccine-primed immune systems — some members of the public are now embracing this idea. And we know that vaccinating previously infected people generates particularly strong immune responses (“hybrid immunity”). We can expect a lot of data on this topic in the next month or so, but for now we have to speculate.
But what happens when vaccination precedes infection? Should a two-dose vaccine recipient who is then Omicron-infected receive a further vaccine dose and, if so, when? Similarly, what happens if a triply vaccinated person becomes infected? Given how mutated the Omicron spike-protein is, an infection with this variant is likely to trigger the production of antibodies that have a lesser impact on new variants that more closely resemble the ones that circulated in 2020-2021. They would, however, be better poised to counter any variants that emerge from the Omicron lineage, as would Omicron-based vaccine boosters. In short, we need to determine how to factor in the combination of vaccination and infection history, and also how the pandemic may further evolve, to devise an optimal boosting approach. There are important scenarios that policymakers and serious immunologists must ponder soon. Otherwise, far-reaching decisions will be taken on the fly, which is never ideal.
The U.S. is blessed with an abundance of COVID-19 vaccines and world-class scientists. Our complex scenarios merit the most qualified experts to figure out the best paths forward. I, for one, look forward to reading what might emerge. I need that guidance to answer with greater confidence the questions I am frequently asked by friends, colleagues, and random members of the public. “Winging it” is becoming as tiresome as it is tiring.
Now that we have two antiviral medications that can be taken after a patient gets infected, I predict that all will change and that by the middle of February the pandemic will be declared over and be classified as an endemic. That will mean that we will be” instructed” to simply get our “up-dated shots” yearly with our updated flu vaccinations.
Infact, Moderna is already working on a combined vaccine to include updated influenza and COVID vaccines, which would be “offered” yearly.
So, can we get back to normal? Maybe! We still have to continue to assess the use of vaccines to those under the age of 5 years old. Once we have critically evaluated and cleared vaccines and antiviral medications for these young potential patients, we will have a safer healthcare system to “return to normal”.
As nations decide to live with the virus, some disease experts warn of surrendering too soon. The coronavirus isn’t going away, but that doesn’t mean resistance is futile, scientists say.
Joel Achenbach wrote that Nations around the planet are making a subtle but consequential pivot in their war against the coronavirus: Crushing the virus is no longer the strategy. Many countries are just hoping for a draw.
It’s a strategic retreat, signaled in overt and subtle ways from Washington to Madrid to Pretoria, South Africa, to Canberra, Australia. Notably, few countries today outside of China — which is still locking down cities — cling to a “zero-covid” strategy.
The phrase often heard now in the United States and many other nations is “live with the virus.” That new stance is applauded by some officials and scientists and welcomed by people exhausted with the hardships and disruptions of this global health emergency entering its third year.
But there are also disease experts who fear the pendulum will swing too far the other way. They worry that many world leaders are gambling on a relatively benign outcome from this omicron variant surge and sending messages that will lead people who are normally prudent to abandon the social distancing and mask-wearing known to limit the pathogen’s spread. Epidemiologists say the live-with-it strategy underestimates the dangers posed by omicron.
“This notion of learning to live with it, to me, has always meant a surrendering, a giving up,” World Health Organization epidemiologist Maria Van Kerkhove said.
Virologist Angela Rasmussen of the University of Saskatchewan likewise fears that people are relaxing sensible precautions prematurely: “I understand the temptation to say, ‘I give up, it’s too much.’ Two years is a lot. Everybody’s sick of it. I hate this. But it doesn’t mean actually the game is lost.”
The WHO officially declared a public health emergency of international concern on Jan. 30, 2020, when there were 7,711 confirmed cases of covid-19 and 170 deaths in China, and another 83 cases scattered across 18 other countries — and no deaths.
Two years later, the virus has killed more than 5.5 million people, and the pandemic is ongoing. But the global health emergency has evolved — reshaped by the tools deployed to combat it, including vaccines. The virus itself and the disease it causes are now so familiar, they have lost some of their early spookiness.
No national leader would ever say that it’s time to quit the struggle, but the tone of the contest has changed, with little talk of beating, crushing, defeating the virus. SARS-CoV-2 is part of the world now, a “pantropic” virus that can infect people, deer, minks, rats and all sorts of mammals.
Many nations continue to impose mask requirements, vaccination mandates and travel restrictions. But few leaders in democratic societies have the political capital to take harsh measures to suppress transmission. Even the arrival of the ultra-transmissible omicron variant did not throw the world back into winter 2021, when the paramount goal remained stopping viral spread at all costs — much less back to spring 2020, when people were told to stay home, wipe down their groceries and not touch their face.
Even officials in Australia, long a fortress nation that sought to suppress the virus at all costs, have chosen to ease some mandates in recent weeks.
Tennis superstar Novak Djokovic — shown at a training session Jan. 11 in Melbourne, Australia — has been in a pitched battle with health authorities because he lacks required coronavirus vaccination credentials. (AP)
The country has gained global headlines for its treatment of unvaccinated tennis champion Novak Djokovic, who flew in for the Australian Open and immediately ran afoul of the government’s virus protocols, spending the better part of a week in a detention hotel. On Friday, Australia’s immigration minister canceled the player’s visa a second time.
But the other national story in Australia is a debate over the relaxed restrictions. National and state leaders had an agreement that strict measures would end when vaccination reached 80 percent of the eligible population. That threshold was reached months ago, and now more than 90 percent of the eligible population is vaccinated. Masks are still required in some indoor settings, and there are capacity limits, but opposition leaders and some experts have decried what they call the “let it rip” strategy.
“The decision to remove restrictions just as Omicron surged has cost us dearly,” declared a report from an independent group of experts called OzSAGE. “The ‘let it rip’ strategy and defeatist narrative that ‘we are all going to get it’ ignores the stark lived reality of the vulnerable of our society.”
In South Africa, where officials first sounded the alarm about omicron, the government in December eased protocols, betting that previous encounters with the virus have given the population enough immunity to prevent significant levels of severe illness. The omicron wave there subsided quickly with modest hospitalizations, and scientists think one reason is that so many people — close to 80 percent — had previously been infected by earlier variants.
Omicron also appears to be less virulent — less likely to cause disease. This heavily mutated coronavirus variant stiff-arms the front-line defense of antibodies generated by vaccines and previous infection but does not seem to be adept at invading the lungs or escaping the deeper defenses of the immune system.
In the ideal scenario, omicron’s alarming wave of infections will spike quickly, leaving behind a residue of immunity that will keep a broad swath of the population less vulnerable to future infections. This would be the last major, globally disruptive wave of the pandemic. The virus would still be around but would no longer be in a special category apart from other routinely circulating and typically nonfatal viruses such as influenza.
There are other scenarios less attractive. Scientists are quick to point out that they don’t know how long omicron-induced immunity lasts. The virus keeps mutating. Slippery variants packing a more powerful punch could yet emerge, and virologists say that contrary to what has sometimes been conjectured, viruses do not inexorably evolve toward milder strains.
But humans change, too. Outside of locked-down China, most people are no longer immunologically naive to the coronavirus. Scientists believe that’s a factor in omicron’s relatively low severity for individual patients. In the long term, humans and viruses tend to reach something like a stalemate. Only one disease-causing virus, smallpox, has ever been eradicated.
In the short term, experts believe omicron is essentially unstoppable but of limited threat to individuals even as it causes societal chaos. Ali Mokdad, an epidemiologist at the University of Washington’s Institute for Health Metrics and Evaluation, said he believes that about half of the U.S. population will be infected with omicron during the next three months, with most cases asymptomatic.
“There’s no way to stop its spread — unless we do measures like China is doing, and you and I know very well that’s not possible in the United States,” Mokdad said.
‘New normal’
There is no unified global response to the pandemic. Despite calls to “follow the science,” scientific research cannot dictate the best policy for some of the stickiest issues — such as when to open schools to in-person learning, or who should be prioritized for vaccines, or whether people who have no symptoms should be regularly tested.
The national strategies typically reflect elements of a country’s culture, wealth, government structure, demographics and underlying health conditions. Also, geography: New Zealand has managed to record only a few dozen deaths from covid-19, one of the lowest per capita death tolls on the planet, by leveraging its isolation in the South Pacific.
Japan, Singapore and South Korea, nations with a long history of mask-wearing and aggressive measures to suppress epidemics, have managed to keep the virus largely in check without draconian lockdowns or major sacrifices to their economies.
Peru, hammered by the variants dubbed lambda and gamma before the delta and omicron waves arrived, has had the deadliest pandemic per capita, according to the Johns Hopkins University coronavirus tracking site. The nations of Eastern Europe, with older populations and high vaccine skepticism, are not far behind.
Countries have different and sometimes unreliable ways of documenting the pandemic, but some general trends are clear. Among the wealthiest nations, the United States — where the pandemic is thoroughly polarized, misinformation is rampant, and a significant fraction of the public has resisted vaccination — has had an unusually deadly pandemic. According to the Hopkins tracker, the United States ranks 21st in reported deaths per capita. Britain is not much better at 28th, while Canada is 82nd.
A group of doctors who advised President Biden during the presidential transition have urged a reset of the strategy to recognize the “new normal” of the virus, which has little chance of being eradicated and will probably continue to cause typically mild illness and require vaccination boosters at a frequency yet to be determined.
Biden took office nearly a year ago vowing to crush the pandemic, having won the presidency in part by emphasizing a more aggressive posture against the contagion than President Donald Trump. Biden’s administration pushed vaccination hard and saw millions of people a day roll up their sleeves during the spring. On July 4, after caseloads had dropped, he assembled a crowd on the South Lawn for a celebration of independence from the virus.
But the surge of infections and deaths from the delta variant proved that celebration to be premature, and the Centers for Disease Control and Prevention revised its guidelines, saying even those people fully vaccinated should resume wearing masks indoors. The delta wave began to subside in the fall, but then omicron, crammed with mutations that make it wildly more transmissible and evasive of immunity, erupted in late November.
Biden’s omicron strategy is not significantly different from what he employed against previous variants. On Dec. 2, he detailed his plans by first announcing what he would not do: “lockdowns.” He vowed to distribute 500 million rapid tests and doubled the number in recent days. His covid task force continues to emphasize the importance of vaccines, therapeutics and testing rather than restrictions on mobility and gatherings.
Fatalism and fatigue
The strategic shift toward the live-with-it strategy in many nations, including the United States, has often gone without formal acknowledgment from national leaders. Spain is one of the exceptions: Prime Minister Pedro Sánchez has said he wants the European Union to stop tracking covid as a separate disease and recognize that it is becoming an endemic pathogen.
Across the Pyrenees, French nightclubs closed as omicron swept through. Indoor masking is required, regardless of vaccination status. In bars, patrons are not allowed to consume alcohol while standing up. France, like Italy and many other European countries, has leaned heavily on vaccine passports.
French President Emmanuel Macron is blunt about his desire to make life uncomfortable for the unvaccinated by limiting their ability to go into public places. In a newspaper interview, he used graphic language that has been translated into English as “I really want to piss them off.”
Many global leaders, including those in the United States and Europe, have focused on vaccination as the key to mitigating the pandemic. The vaccines do lower the risk of severe illness. What they do not do as well is stop transmission and mild infection. The speed of omicron’s spread is the key factor in the equation that determines how much pressure it will put on hospitals — which are currently seeing record numbers of covid patients in the United States.
“If we just completely let everything go and allow the omicron epidemic to run its natural course, we’ll completely overrun our health system and be left in a situation potentially worse than what we experienced in early 2020,” said James Lawler, co-director of the University of Nebraska Medical Center’s Global Center for Health Security.
He is not seeing the precautions he saw early in the pandemic, when he was among the first disease experts to sound an alarm about the extreme transmissibility of the coronavirus. Earlier this week, he went to a grocery store and was virtually alone in wearing a mask. That’s the norm, he said, in Omaha.
“There’s not a mandate,” he said. “Across the entire experience of humanity, we should have learned by now the only way to get high levels of compliance like this is to make it mandatory. That’s what happened with seat belts.”
After Lawler made those comments, a county health commissioner imposed a mask mandate covering Omaha, but the Nebraska Attorney General filed a lawsuit to block it.
There is fatalism mixing with pandemic fatigue and, in some countries, science denial or ideological rejection of the restrictions and mandates that many public health experts consider to be common sense measures in a pandemic. And anecdotally, people may rationally feel the battle is lost, the virus has won.
Public health officials warn that this is a dangerous attitude. It’s true that for an individual, risk might be low. But when a virus spreads as quickly as omicron does, the equation suddenly spits out alarming results — millions of people sick at once, many of them with underlying conditions that have already put them on the edge of a cliff and vulnerable to a shove.
Rasmussen, the University of Saskatchewan virologist, is among the experts who think people have misunderstood the concept of endemicity — which is the point at which a virus continues to circulate at low levels but is not generating epidemic-level outbreaks. She fears some people hear the “endemic virus” talk as a sign that resistance is futile.
“People think that means we just give up,” she said. “They think ‘endemic’ means that we’re all going to get covid eventually. I’m hearing people say, ‘Why not just get it over with now, and I’ll be bulletproof?’ None of this is what endemicity means.”
Endemic COVID doesn’t mean it’s harmless or we give up, just that it’s part of life
Catherine Bennett discusses the eventual change in her article. We have experienced many bumps in the road since 2020 and one would have to be extremely brave to predict what the pandemic may throw at us next.
But in terms of the endgame, many experts believe COVID will eventually become an endemic disease. However, what this actually means is a source of considerable confusion. One of the main reasons for this is a misunderstanding of endemicity itself, and what COVID being an endemic disease would actually look like in the real world.
Let’s break it down. What does ‘epidemic’ actually mean? A disease is either epidemic or endemic. The most straightforward explanation of an epidemic disease is that it’s one in which the number of cases in the community is unusually large or unexpected. When this occurs, it signals a need for public health action to bring disease transmission under control.
In the case of a pandemic—a worldwide epidemic—this occurs on a much larger scale. Depending on the infectiousness and severity of the disease, it can represent a global public health emergency, as we’ve seen with COVID.
When you have the emergence of a completely new virus like SARS-CoV-2 that has the potential to cause severe illness while also being highly transmissible, the lack of any immunity among the population results in the drivers for disease spread being incredibly strong.
A disease being epidemic indicates there’s an imbalance between these drivers of disease spread and the factors limiting spread in the community. In short, it means the drivers for disease spread overpower the factors limiting spread. As such, the disease spreads like a raging bushfire. It’s explosive and hard to bring under control once it has seeded.
From epidemic to endemic
However, over time, the underlying forces driving an epidemic alter. As immunity begins to increase across the population—ideally in a controlled way by vaccination, but also by natural infection—the pathogen starts to run out of fuel and its ability to transmit falls. Pathogens can include a variety of microorganisms, such as viruses, bacteria and parasites. In this case, let’s assume we’re talking about a virus.
On top of immunity, we can also reduce a virus’ ability to spread by behavior changes, such as 1 / 3 limiting contact with others, mask wearing and improved hand hygiene. In addition to lowering the virus’ ability to transmit, immunity also reduces its ability to cause disease, meaning fewer people become really sick or die.
And finally, if we are lucky, over longer periods of time, the virus may also evolve to become intrinsically less severe. When will the COVID-19 pandemic end?
The net result of this is we move from an imbalance in terms of the forces driving disease to a steadier state of equilibrium. Instead of explosive and unpredictable disease spread, we reach a point where the presence of circulating disease represents a lower threat to the community than it did at the beginning of an epidemic.
Transmission becomes more predictable, but not necessarily constant—we may still see some waves, especially seasonally. But these are expected and manageable. In short, we start to live alongside the virus.
This is what we mean by an endemic disease. Examples of endemic diseases include the common cold, influenza and HIV/AIDS. Endemic doesn’t mean we drop our guard. The discussion around COVID becoming endemic becomes even more complicated by very different views about what this actually translates to in practice.
It’s important to emphasize it doesn’t mean we drop our guard, surrender to the virus or downgrade the threat the virus poses to individuals and the community. We remain vigilant and respond to surges in cases when they occur, doing what’s needed to keep transmission as low as possible.
Importantly, a disease being considered endemic doesn’t mean we consider it mild. It just means it remains a part of our lives, and therefore we still protect the vulnerable from severe illness, as we do with other diseases. It’s crucial we understand living with the virus isn’t the same thing as ignoring the virus. Instead, it represents an adjustment in the way in which we respond to the disease.
It’ll be a bumpy ride. It’s also important to highlight this transition may not necessarily be smooth and there will no doubt be challenges along the way. One of the main obstacles we’re going to face is the possible emergence of new variants and how these will impact the infectiousness and severity of the disease.
In order to reduce the likelihood of new variants emerging, it’s vital we really step up our rollout of vaccines globally to reduce virus transmission. To aid us in our transition to this next stage of the pandemic, we will, thankfully, be able to draw on many new weapons which are in the pipeline. This includes next-generation vaccines which will be more effective against the latest variants, or universal vaccines that cover all variants. We expect new vaccines will also be better at controlling transmission.
We’ll also have ever-improving treatments, and better infection prevention and control engineered for specific environments. The big question, of course is when will this transition to endemicity happen? Many experts, 2 / 3 believe huge strides will be made along this path in 2022.
It has been reported by the WHO that Omicron sub-variant has been found in 57 countries. A sub-variant of the highly contagious Omicron coronavirus strain, which some studies indicate could be even more infectious than the original version, has been detected in 57 countries, the WHO said Tuesday.
The fast-spreading and heavily mutated Omicron variant has rapidly become the dominant variant worldwide since it was first detected in southern Africa 10 weeks ago. In its weekly epidemiological update, the World Health Organization said that the variant, which accounts for over 93 percent of all coronavirus specimens collected in the past month, counts several sub-lineages: BA.1, BA.1.1, BA.2 and BA.3.
The BA.1 and BA.1.1—the first versions identified—still account for over 96 percent of all the Omicron sequences uploaded to the GISAID global science initiative, it said. But there has been a clear rise in cases involving BA.2, which counts several different mutations from the original including on the spike protein that dots the virus’s surface and is key to entering human cells.
“BA.2- designated sequences have been submitted to GISAID from 57 countries to date,” The WHO said, adding that in some countries, the sub-variant now accounted for over half of all Omicron sequences gathered. The UN health agency said little was known yet about the differences between the sub-variants, and called for studies into its characteristics, including its transmissibility, how good it is at dodging immune protections and its virulence. Several recent studies have hinted that BA.2 is more infectious than the original Omicron.
Maria Van Kerkhove, one of the WHO’s top experts on COVID, told reporters Tuesday that information about the sub-variant was very limited, but that some inital data indicated BA.2 had “a slight increase in growth rate over BA.1”
Omicron in general is known to cause less severe disease than previous coronavirus variants that have wreaked havoc, like Delta, and Van Kerkhove said there so far was “no indication that there is a change in severity” in the BA.2 sub-variant. She stressed though that regardless of the strain, COVID remained a dangerous disease and people should strive to avoid catching it. “We need people to be aware that this virus is continuing to circulate and its continuing to evolve,” she said. “It’s really important that we take measures to reduce our exposure to this virus, whichever variant is circulating.”
Merck to Deliver 3.1 million Treatment Courses of COVID Antiviral
Ralph Ellis reported that a little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.
Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said. “We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”
In June the U.S. government agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and in November agreed to buy an additional 1.4 billion courses for $1 billion.
The FDA granted emergency use authorization in late December to two antivirals for people who contract COVID: Merck’s molnupiravir and Paxlovid, which is produced by Pfizer. The drugs are designed for people with mild or moderate COVID who are more likely to become seriously ill — mainly people 65 and older or people who have chronic illnesses such as heart disease, lung disease, diabetes, obesity, or compromised immune systems.
Both antivirals require a five-day course of treatment. Merck’s is for adults ages 18 and older, and Pfizer’s for anyone age 12 and up. In clinical trials, molnupiravir reduced the risk of hospitalization or death in Covid patients by 30% but slashed the risk of dying by 90%, Davis said.
“The fact that molnupiravir does reduce the risk of death by 90%, we could have a meaningful impact in helping patients,” he said. Davis told CNBC that Merck sold $952 million in molnupiravir pills in the fourth quarter and is on track to rack up an extra $5 billion to $6 billion in sales in 2022.
Last week, Merck said laboratory studies showed molnupiravir was active against the Omicron variant. In December, Pfizer said preliminary lab studies also suggest the pill will hold up against the Omicron variant.
WHO official sees ‘plausible endgame’ to pandemic; Medicare to provide up to 8 free tests per month: COVID updates
John Bacon,Jorge L. Ortiz and Celina Tebor wrote in USA Today that the director of the World Health Organization’s Europe office said Thursday that coronavirus deaths are starting to plateau, and the continent faces a “plausible endgame” to the pandemic.
Dr. Hans Kluge said there is a “singular opportunity” for countries across Europe to take control of COVID-19 transmission as a result of three factors: high levels of immunization because of vaccination and natural infection, the virus’s tendency to spread less in warmer weather and the lower severity of the omicron variant. Data in the U.S. is similar to the data from Europe, providing similar hope.
“This period of higher protection should be seen as a cease-fire that could bring us enduring peace,” Kluge said.
At WHO’s Geneva headquarters, director-general Tedros Adhanom Ghebreyesus warned that the world as a whole is far from exiting the pandemic.
“We are concerned that a narrative has taken hold in some countries that because of vaccines, and because of omicron’s high transmissibility and lower severity, preventing transmission is no longer possible and no longer necessary,” Tedros said. “Nothing could be further from the truth.”
So, with the announcement that Pfizer has submitted their studies on 6 months to 5-year vaccine approval, the antivirals and the vaccine statistics, that the change to COVID-19 to be transitioned to the classification as an Endemic is right around the corner.
And lastly-
US Exiting ‘Full-Blown Pandemic Phase’ of COVID, Fauci Says
Carolyn Crist wrote the latest prediction from Dr. Fauci. The U.S. is heading in a positive direction in the pandemic as COVID-19 cases and hospitalizations decline, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.
Vaccination rates, treatments, and prior infections will make the coronavirus more manageable in 2022, Fauci told the Financial Times. Broad mandates and mitigation protocols will begin to be lifted.
“As we get out of the full-blown pandemic phase of COVID-19, which we are certainly heading out of, these decisions will increasingly be made on a local level rather than centrally decided or mandated,” he told the newspaper. “There will also be more people making their own decisions on how they want to deal with the virus.”
The U.S. is reporting an average of 240,000 new COVID-19 cases per day, according to the data tracker from The New York Times. That’s a 63% decline from the previous 2 weeks.
About 100,000 people are hospitalized due to COVID-19, according to the latest data from the U.S. Department of Health and Human Services. That’s also down 28% in the past 2 weeks.
At the same time, about 2,600 deaths are being reported each day, the newspaper reported, which is the highest level seen in the U.S. in a year.
Fauci said COVID-19 restrictions around the U.S. will end soon. He didn’t give a specific timeline but said it was likely to happen in 2022.
Some states have already begun to lift pandemic rules as COVID-19 cases subside. California, Connecticut, Delaware, Oregon, and New Jersey announced on Monday that they would lift mask mandates for schools and other public spaces throughout February and March. On Wednesday, New York Gov. Kathy Hochul dropped New York’s mask mandate as well.
At the same time, Fauci stressed that the coronavirus won’t be wiped out and people will have to learn to live with it. Health officials may soon reach an “equilibrium” where they don’t need to monitor infection levels as closely, he said.
“I hope we are looking at a time when we have enough people vaccinated and enough people with protection from previous infection that the COVID restrictions will soon be a thing of the past,” he said.
And I believe that we are just about there!

Delta Variant Now Accounts for 83% of US Cases and Back to Mask Wearing, Even for Those Vaccinated!

Carolyn Crist reported that the nation’s top health officials said Tuesday that the Delta variant of the coronavirus is racing through the country and now is responsible for 83% of all U.S. cases.

That’s a massive increase from a week ago, when Delta was seen as responsible for just more than half of new cases, CDC Director Rochelle Walensky, MD, told a Senate committee.

And listen to her carefully…is she actually suggesting a Federal Mandate to vaccinate everyone???

“The best way to prevent the spread of COVID-19 variants is to prevent the spread of disease, and vaccination is the most powerful tool we have,” she said.

Meanwhile, several states in the South are reporting a large increase in COVID-19 cases, particularly in areas with low vaccination rates, according to The Atlanta Journal-Constitution.

Arkansas, Florida, and Missouri are reporting full-fledged outbreaks, and neighboring states such as Alabama, Georgia, Louisiana, Mississippi, Tennessee, and Texas are following behind.

“4th wave is here,” Thomas Dobbs, MD, the state health officer for Mississippi, wrote on Twitter on Monday.

Dobbs posted a graph of hospitalizations in Mississippi, which showed numbers climbing dramatically in July after hitting a low in May and June.

“Very sad indeed,” he wrote. “Didn’t have to be this way.”

Mississippi reported more than 2,300 new COVID-19 cases over the weekend, which is the state’s largest 3-day increase in cases since February, according to The Associated Press. Mississippi has one of the lowest COVID-19 vaccination rates in the country.

Florida has become one of the country’s biggest COVID-19 hot spots, now accounting for a fifth of new infections in the U.S., according to NBC News.

In Jacksonville, UF Health broke its record for hospitalized COVID-19 patients, jumping from 86 patients on Sunday to 126 on Monday.

“We’re gaining cases at such a rapid rate, we don’t really know where it’s going to stop,” Chad Neilsen, the director of infection prevention at UF Health, told NBC News.

“We aren’t even thinking a couple of months,” he said. “We’re thinking what’s going to immediately happen in the next week.”

Hospitals in Arkansas and Missouri are also preparing for a surge of patients that could strain staff and resources again, according to NBC News. If hospitalizations triple in the next 2 weeks, as projected by the University of Arkansas for Medical Sciences (UAMS), it could feel like the chaotic period at the end of 2020.

“Right now, we’re managing OK, but we’re in surge mode,” Steppe Mette, MD, the CEO of the UAMS Medical Center, told NBC News.

“We’re putting patients in physical locations where we weren’t putting them normally because of that demand,” he said.

At Houston Methodist Hospital in Texas, COIVD-19 hospitalizations have increased by 70% during the last week, according to the Houston Chronicle . On Monday, the hospital had 184 COVID-19 patients, which is double the number it had on July 1.

The Delta variant accounts for about 85% of the cases, and the hospital recorded its first hospitalization with the Lambda variant, the Chronicle reported. The Lambda variant, which was first identified in Peru, has been spreading throughout South America and is now reaching the U.S.

The Delta variant has been “running rampant” among unvaccinated people in Texas, Marc Boom, MD, the CEO of Houston Methodist, wrote in an email to hospital staff. The variant will account for nearly all COVID-19 cases in the area within the coming weeks, he said.

“It is the variant of concern in Houston,” he said. “What we’re seeing now is that Delta is far more infectious.”

Public health officials are grappling with the best way to move forward as cases and hospitalizations continue to rise. Increasing vaccinations is key, but mandating or guilting people into getting a shot would likely backfire, NBC News reported.

“People have heard our messages ad nauseam, but to see patients struggling to breathe and wishing they got vaccinated, that may make a difference,” Mette told the news outlet.

“Those are real people who are getting real sick,” he said.

What Evidence Do We Need to Move Forward With COVID Boosters?

Dr. Vinay Prasad noted that a few weeks ago, on Monday, employees of Pfizer met with high level executives in the Biden administration to discuss the role of boosters — a.k.a. a third vaccination with an mRNA vaccine for SARS-CoV-2. Some have speculated that, as with the first two doses, the emergency use authorization pathway will again be used to market boosters. With the rise of the Delta variant and others, enthusiasm in the media and the Twitter commentariat for boosters is growing. However, there are certain criteria that must be met before we jump on the booster bandwagon. Some of these criteria apply at home, and others apply abroad. What does stand out is that more data, real data, and an evaluation of several factors at home and abroad will be key in moving forward.

Abroad

As a general rule, if your goal is to avoid variants — or mutated versions of a virus — you want the virus to replicate less. When it comes to variants, it doesn’t matter where the virus does the replicating. In a globally connected world, it is only a matter of time before an advantageous mutation finds its way to all parts of the world. As such, we in the U.S., are only as safe as the least safe place in the world.

What this means is that before we shift our manufacturing capacity to develop boosters for the current variants, we must make a real effort to ensure that the vaccines we do have get distributed to the greatest number of global citizens who will take them. I argued in April that, practically, this means that children in high income nations should be vaccinated after older citizens globally – this same logic extends to boosters.

Before we shift our manufacturing to booster production, we should make sure that we have manufactured adequate supplies of the original vaccine for all global citizens. Moreover, we need to put effort toward solving the last mile problem: how to deliver very cold mRNA vaccines to places in the world where it is difficult to deliver and keep things very cold. This is a technological problem well within our scope.

Efforts to manufacture and deliver vaccine boosters to already vaccinated individuals in high-income nations cannot take priority and must not interfere with efforts to vaccinate at-risk individuals around the world. In fact, it is in our best interest to vaccinate those at-risk first. If we pursue boosters in the U.S. without helping the rest of the world, then we might as well get ready for the fourth, fifth, and sixth boosters. We will watch rising death tolls around the world, while worrying that yet new variants may end up on our shores.

At Home

Here in the U.S., there are also metrics that need to be met before we contemplate widespread dosing of hundreds of millions of people with booster shots. Specifically: show me the data! I have no doubt that a third mRNA shot will lead to higher neutralizing antibody titers. For that matter, I would guess six shots would outperform three on that metric. But the burden of evidence to accept boosters is not simply a change in antibody titer — or even demonstration of improved titers for rare variants.

We must show that boosters improve clinical endpoints before we ask Americans to roll up their sleeves again. A large randomized trial of vaccinated individuals powered for reduction in symptomatic SARS-CoV-2 or (better yet) severe COVID-19 is needed to justify the harms and inconvenience of boosters. If such a trial simply cannot be powered, or takes a very long time, due to the sparsity of serious infection in the U.S., then the argument for emergency use authorization is inherently flawed. When there’s too little disease to run the definitive trial, you are, by definition, no longer in an emergency. One way to solve this problem might be to deliver boosters only in elderly individuals or those who are immunocompromised. Here, a trial measuring COVID-19 outcomes may be possible.

Alternatively, a case for boosters can be made if evidence shows that boosters alter the epidemic course for a nation or the globe. Here, too, antibody titers are insufficient. Moreover, ironically, clinical trials would have to be larger and more complex to demonstrate this. For these reasons, I think the burden is on vaccine manufacturers to show that severe COVID-19 outcomes are averted.

Finally, we need to consider the second order effects of boosters. Would we gain more if we took the effort that would go into boosters and instead used it to try to increase vaccination uptake by those who are reluctant to get their first and second dose? Is the mere fact that news outlets and companies report the possible need for boosters a disincentive to be vaccinated? A skeptical person may now no longer see SARS-CoV-2 vaccines as the path out of the pandemic, but a recurring, and possibly someday yearly obligation that they may prefer to avoid altogether. We can’t ignore the potential impact of discussing boosters on vaccine acceptance.

Boosters Without Data

If we accept boosters in the U.S. while the rest of the world remains unvaccinated, and if we authorize them based on inevitable improved laboratory titers without clinical outcomes, we run the risk of creating a medical industrial perpetual motion machine.

We will continue to breed new variants outside of our nation, which will lead to calls for yet more boosters, and we will continue to get new boosters without any evidence they are necessary (i.e., lower severe COVID-19 outcomes). Our arms will ache, our hearts will hurt, our wallets will be empty, and so too will our brains, as we will have abandoned all principles of evidence-based medicine.

Lambda variant of COVID-19 identified at Texas hospital. Is it worse than delta?

Ryan W. Miller reported that a Houston hospital has its first case of the lambda variant of the coronavirus, but public health experts say it remains too soon to tell whether the variant will rise to the same level of concern as the delta variant currently raging across unvaccinated communities in the U.S.

About 83% of COVID-19 cases in the U.S. are from the delta variant and the vast majority of hospitalizations are among unvaccinated people, according to the Centers for Disease Control and Prevention.

The lambda variant, on the other hand, has been identified in less than 700 cases in the U.S. However, the World Health Organization in June called lambda a “variant of interest,” meaning it has genetic changes that affect the virus’ characteristics and has caused significant community spread or clusters of COVID-19 in multiple countries.

Dr. S. Wesley Long, medical director of diagnostic biology at Houston Methodist, where the case was identified, said while lambda has some mutations that are similar to other variants that have raised concern, it does not appear to be nearly as transmissible as delta.

“I know there’s great interest in lambda, but I think people really need to be focused on delta,” Long said. “Most importantly, regardless of the variant, our best defense against all these variants is vaccination.

What is the lambda variant and how is it different from the delta variant?

The lambda variant is a specific strain of COVID-19 with specific mutations. It’s one of a handful of variants identified by the WHO as variants of concern or interest. Many other variants have arisen since the outbreak was first detected in late 2019 in central China.

“The natural trajectory of viruses is that they have a tendency to have mutations, and whenever we have a significant mutation that changes the virus … we get a new variant,” said Dr. Abhijit Duggal, a staff ICU physician and director for critical care research for the medical ICU at the Cleveland Clinic.

Some of the lambda mutations occur in its spike protein, which is the part of the virus that helps it penetrate cells in the human body and is also what the vaccines are targeting.

Mutations occurring there and in other parts of lambda are similar to those in variants of concern, like alpha and gamma, Long said. But even gamma, which never took hold in the U.S. to the same level as alpha or delta, has more concerning mutations than lambda, Long said.

Duggal said there hasn’t been anything specific with the lambda variant to spark concern about it becoming the dominant variant in the U.S., but “watchful waiting and being cautious is going to be the most important thing at this point.”

Where was the lambda variant first identified?

The lambda variant was first identified in Peru in December 2020. Since April, more than 80% of sequenced cases in the country have been identified as the lambda variant.

As of June, the WHO said it had identified the lambda variant in 29 countries. Argentina and Chile have also seen rising lambda cases, the WHO said.

However, the variant hasn’t spread nearly to the same level on a global scale as the delta variant. Lambda may have become so widespread in parts of South America largely because of a “founder effect,” Long said, wherein a few cases of the variant first took hold in a densely populated and geographically restricted area and slowly became the primary driver for the spread locally over time.

Long compared lambda to the gamma variant, which first was detected in Brazil and spread in similar ways.

Are COVID-19 vaccines effective against the lambda variant?

Studies have suggested the vaccines currently authorized for use in the U.S. are highly effective at preventing severe COVID-19 and death across multiple variants.

Duggal said while there is no reason to believe the vaccines will be ineffective against the lambda variant, more data is need to know exactly how effective it will be. The efficacy may lower some, but hospitalization may still be largely preventable in variant cases with vaccination, he said.

Remember ‘Nothing in this world is 100%’: Those fully vaccinated against COVID-19 can be infected, but serious illness is rare.

However, a new study posted online Tuesday found the Johnson & Johnson vaccine was not as effective at preventing symptomatic disease when faced with the delta and lambda variants. The study was not yet peer reviewed or published in a journal, but it aligned with studies of the AstraZeneca vaccine that conclude one dose of the vaccine is 33% effective against symptomatic disease of the delta variant.

Vaccines made by Pfizer-BioNTech and Moderna have shown to keep similar levels of effectiveness against several of the variants of concern. But, just announced, a new preprint study conducted by Pfizer-BioNTech found its vaccine efficacy could drop down to 84% within 6 months.

Getting vaccinated still remains the most important factor in stopping the virus’ deadly effects and slowing down new variants, Long said.

Mutations occur in the coronavirus as it spreads from person to person. Vaccination can help prevent symptomatic disease and decrease the spread in communities with high vaccinations rates, which can then prevent mutations from occurring and new variants from arising, Duggal added.

Delta’s threat: CDC reveals data on why masks are important for the vaccinated and unvaccinated

More on the Delta mutated variant, which is becoming a real problem for the un vaccinated portion of our population and why wearing masks are important for all. Adrianna Rodriquez reported that The Centers for Disease Control and Prevention has had a busy week. 

Only a few days after announcing updated mask guidelines, the agency on Friday released new scientific data on the delta variant that gives a snapshot of how the highly contagious strain triggered a wave of coronavirus cases. 

The much-anticipated report comes a day after a presentation compiled by a doctor with the agency was leaked to the media and detailed the dangers of the delta variant and how mask-wearing is essential to bring it under control.

In a briefing Tuesday, CDC director Dr. Rochelle Walensky said the new data spurred the agency to take immediate action by recommending fully vaccinated people to wear mask indoors in public settings where coronavirus transmission is high. 

“The delta variant is showing every day its willingness to outsmart us and be an opportunist in areas where we have not shown a fortified response against it,” she said earlier this week. “This new science is worrisome and unfortunately warrants an update to our recommendations.”

Here’s everything to know about the delta variant and how it impacts fully vaccinated people. 

‘Pivotal discovery’: What the new data says about delta variant, transmission 

Fully vaccinated people made up nearly three-quarters of COVID-19 infections that occurred in a Massachusetts town during and after Fourth of July festivities, according to a CDC study published Friday in the agency’s Mortality and Morbidity Weekly Report.

Out of 469 cases that were identified in Barnstable County, Massachusetts, from July 3 to 17, the agency found 74% occurred in fully vaccinated people. The CDC sequenced samples taken from 133 patients and discovered 90% were caused by the delta variant. 

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with delta can transmit the virus,” Walensky said in a statement sent to USA TODAY on Friday. “This finding is concerning and was a pivotal discovery leading to the CDC’s mask recommendation.”

Health officials continue to reiterate the majority of COVID-19 transmission occurs among the unvaccinated, not fully vaccinated people.

“Vaccinated individuals continue to represent a very small amount of transmission occurring around the country,” Walensky said. “We continue to estimate that the risk of breakthrough infection with symptoms upon exposure to the delta variant is reduced by sevenfold. The reduction is twentyfold for hospitalizations and death.” 

Four fully vaccinated people between the ages of 20 and 70 were hospitalized, two of whom had underlying medical conditions. No deaths were reported.  

The study found 79% of patients with breakthrough infection reported symptoms including cough, headache, sore throat, muscle pain, and fever. 

Remember also that: Breakthrough COVID-19 infections after vaccination can lead to long-haul symptoms, Israeli study shows.

Of the 346 breakthrough infections, 56% of people were vaccinated with the Pfizer-BioNTech vaccine, 38% with Moderna and 7% with Johnson & Johnson. As of Friday, over 190 million doses of the Pfizer vaccine has been administered in the U.S., nearly 140 million of Moderna and 13.3 million of Johnson & Johnson, according to the CDC.

Health experts say the reason why more breakthrough infections occurred in the mRNA vaccines compared to the Johnson & Johnson vaccine is because more people in the U.S. received the Pfizer-BioNTech and Moderna vaccines. 

“When you look at the data, it may concern some people that there appears to be a higher rate of breakthrough COVID infections in people fully vaccinated with the Pfizer vaccine, however, as a percentage of people who are fully vaccinated, more people have been vaccinated with the Pfizer vaccine,” said Dr. Teresa Murray Amato, chair of emergency medicine at Long Island Jewish Forest Hills in Queens, New York.

“It still appears that all three of the current vaccines with emergency use administration authorization in the United States are safe and effective against the delta variant of the COVID-19 virus,” she added. 

While study authors say evidence suggests fully vaccinated people exposed to the delta variant can contract and spread the virus, it is not sufficient to determine the vaccines’ effectiveness against the highly contagious strain. 

Delta substantially more contagious than other variants

Although the study didn’t specify if fully vaccinated people can transmit the virus to other fully vaccinated people, health experts say they should wear a mask and socially distance largely to protect those who haven’t been vaccinated or who have a weakened immune system and can’t get full protection from the vaccine. 

“The data makes a pretty compelling justification for why we need to go back to mask wearing and other public health measures,” said Dr. Charles Chiu, an infectious disease specialist at the University of California, San Francisco. “I do think it’s because of the delta variant.”

The delta variant is known to be substantially more contagious than other variants – as contagious though deadlier than chicken pox, according to the CDC presentation. Among common infectious diseases, only measles is more contagious.

People may also be infectious for longer with the delta variant, 18 days instead of 13, the presentation says.

Vaccines remain effective at preventing hospitalization and death from COVID-19, though they worked better against the original strain and the alpha variant than they do against delta, data finds.

What do the CDC mask guidelines say?

The CDC is urging fully vaccinated Americans to wear masks indoors in areas of high or substantial coronavirus transmission. 

They’re also recommending universal indoor masking for all teachers, staff, students and visitors inside schools from kindergarten to 12th grade, regardless of vaccination status. That aligns closely with guidelines from the American Academy of Pediatrics, which recommended this month that anyone older than 2 be required to wear a mask in school. 

The CDC and the AAP are still urging that children return to full-time in-person learning in the fall.

The goal behind the guidance may be to protect both the fully vaccinated and the unvaccinated, health experts say, especially vaccinated people who may be immunocompromised and children under 12 who aren’t yet eligible to get their shot.

But the reality is there’s hardly any transmission among fully vaccinated people to truly affect community spread, they say.

“It makes sense why they did it, but I don’t think it’s going to make a major difference in the large surge that we’re having,” said Dr. Ashish Jha, dean of the Brown University School of Public Health in Providence, Rhode Island. “The real issue still is unvaccinated people who are not going around masked up. I have no reason to think that this guidance will get unvaccinated, unmasked people putting on masks. And that’s what we really need.”

Is there a test for the delta variant?

A traditional PCR test alone cannot differentiate the delta variant from the original virus.

The delta variant has distinctive mutations that serve as biological markers that can only be detected through genome sequencing.

Many U.S. laboratories sequence a small – but nationally representative – number of positive samples for epidemiological purposes. According to the CDC, more than 175,000 sequences have been collected through the agency’s surveillance program since Dec. 20.

People who test positive for COVID-19 aren’t made aware if they were infected by the delta variant, even if their sample was sequenced.

“Our patients will not learn if they have a variant or not,” said Dr. Christina Wojewoda, chair of College of American Pathologists Microbiology Committee. “It is for epidemiology purposes only and currently, there is no medical use for that result.”

However, the CDC said more than 80% of sequenced samples have the delta variant, which means people sick with COVID-19 were most likely infected with the highly contagious strain. 

“It is safe to assume in most places, if you are infected now, it is likely delta,” Wojewoda said. 

‘A Few Mutations Away’: The Threat of a
Vaccine-Proof Variant

Damian McNamara noted something that concerns me if we don’t get control of the virus using the best weapon that we have, vaccinations. The Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus…[becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Walensky told reporters on Tuesday. 

A new, more elusive variant could be “just a few mutations away,” she said.

We are already reporting the lambda variant and I predict that next will be the gamma and then the kapa variant.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the Division of Medical Toxicology at Rutgers New Jersey Medical School in Newark, told Medscape Medical News.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta — that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Ray, vice-chair of medicine for data integrity and analytics and professor in the Division of Infectious Diseases at Johns Hopkins School of Medicine in Baltimore, Maryland.

“The problem is if the virus changes in such a way that the spike protein — which the antibodies from the vaccine are directed against — are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”

Technology to the Rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Nelson and Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Ray said.

Mutations are not the only concern!

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Ray said.

Protected, for Now

Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

Records have been set nearly every day lately in Tokyo, but not all of them have been by athletes competing in the Olympics.

Japan’s capital has exceeded 4,000 coronavirus infections for the first time — 4,058 cases, to be exact. That’s a record high and nearly four times as many cases were reported just a week ago.

Tokyo set new case records every day from Monday to Wednesday, experiencing just a slight dip on Thursday, when they totaled 3,300 — still one of the city’s highest daily counts on record.

So, those of you, your friends, associates who haven’t been vaccinated, your best protection is still getting vaccinated.

Just do it, get vaccinated!

Throw Away Your Mask After COVID Vaccination or Not, What about the Mutations and Infection after Vaccination?

As our national mortality statistics reach over 500,000 and a third vaccine has been approved by the FDA I thought that we should examine the use of masks, etc. after vaccinations. This is an important question especially considering the increasing findings of more viral mutants.

 Recently, a spirited discussion was sparked on social media: is it acceptable to relax masking 14 days after the second COVID-19 vaccine dose? Doctor Vinay Prasad and Doctor David Aronoff, in this post will discuss the advice as to whether to continue wearing masks as well as social distancing, etc. after one completes their vaccination.

Doctor Prasad starts off by noting that having spent some time thinking about the topic, and discussing with colleagues, I have reached two conclusions. First, it is a tradeoff with residual uncertainties, and reasonable people can disagree. But also, I favor the view that generally, 14 days after vaccination, we can relax some restrictions.

The caveats

It is important to be upfront with the caveats. Everything I say applies to average people in the community — I am not speaking about enhanced precautions in high-risk settings like nursing homes or medical centers. My argument is contingent on there being no “vaccine escape,” that is, no mutation in the coronavirus that markedly reduces vaccine efficacy. If that happens, may God help us. I am not sure we will make it.

Finally, my argument is appropriate for most places and most times, but if health systems are overwhelmed, e.g., as we saw in places like southern California or New York City, it might be reasonable to temporarily increase precautions. Additionally, my guiding principle does not apply to businesses, such as grocery stores or pharmacies, which can and will enforce their own policies.

Now, having said that: for most people, once you get 14 days out of your second dose of vaccine, I believe you can ease up on masking or another restriction, such as visiting a loved one for lunch or having more than one person visit a nursing home at the same time, or a small gathering of vaccinated people for dinner without masks.

The data

There are three lines of evidence that I wish to offer for my claim. First, consider the efficacy of the vaccine. The efficacy of the two mRNA vaccines is superb, offering 95% reduction in the rate of acquisition of symptomatic COVID-19 in randomized trials. That is a remarkable result. But the key statistic here is one step beyond the vaccine efficacy. If you get two doses of the vaccine, and if you remain asymptomatic 14 days after the second dose, what is the probability you will develop COVID-19? For Moderna, the answer is there is a 99.92% chance that you won’t. Only 12 cases occurred after this time in 14,550 actively vaccinated people in the trial, while the control arm experienced nearly 3.5% cumulative incidence. For Pfizer, only eight cases occurred amongst people who had completed a second dose and went 7 days without symptoms, again a 99.95% chance of not getting COVID if one remained asymptomatic a week after the second dose. In other words, if you get 14 days past the second dose, and feel fine, the likelihood you will get COVID-19 in these studies is very low. Some argue that in the real world — where folks are not as motivated as trial participants — the rate of SARS-CoV-2 acquisition might be higher, and thus relaxing rules riskier. But this logic cuts both ways: if people in the real world are less compliant, then the rules might be relaxed no matter what we say.

Next, consider the risk of spreading SARS-CoV-2 to others. That risk is in part driven by symptomatic infections which are exceedingly rare after second doses. Risk of spreading is diminished by the brisk immune response that occurs after symptomatic infection once someone is vaccinated. In the Moderna study, there were 30 cases of severe COVID overall and zero in the vaccination arm. Less symptomatic and less severe COVID will result in a lower propensity to propagate SARS-CoV-2. Moreover, studies of both recombinant antibody products speed viral clearance from airways. If the body is primed to manufacture anti-spike antibodies through vaccination, there is likely a similar rapid clearance and subsequent reduction in infectiousness occurs.

What about asymptomatic infection and so-called silent spread? In the Moderna trial, swabs taken from asymptomatic participants as they were receiving dose 2 showed a roughly 60% reduction in PCR positivity. It is likely that a second dose and longer asymptomatic period will result in greater reduction in PCR positivity. Preliminary data from AstraZeneca’s ChAdOx1 vaccine also showed reduced in asymptomatic PCR detection. In short, it is highly likely that receipt of vaccination and a 14-day asymptomatic period afterward results in both personal protection and reduced likelihood of ongoing viral propagation.

Third, what is the effect size of masks? More correctly — what is the effect size of masks 14 days after a vaccine with 95% efficacy? What is the effect of masks if PCR positivity is only 1 in 1,000 amongst asymptomatic people? I think we must confront a forgotten truth. Masks make sense not because we have perfect randomized controlled trial data showing they protect the wearer, or others, but based on bio-plausibility, and the precautionary principle, they were a reasonable public health measure to incorporate.

Authors of a 2020 update to the Cochrane review wrote, “Compared to no masks there was no reduction of influenza-like illness (ILI) cases (risk ratio 0.93, 95% CI 0.83-1.05) or influenza (risk ratio 0.84, 95% CI 0.61-1.17) for masks in the general population, nor in healthcare workers (risk ratio 0.37, 95% CI 0.05-2.50).” But the truth is none of these trials perfectly fits the moment. And we never did a cluster RCT of cloth masks — as they are used in the politically torn U.S. — to clarify the effect size with SARS-CoV-2.

The truth is I wear a cloth mask and I quite like it. But I have seen no data that can tell me the added benefit of masks 14 days after vaccination with 95% efficacy. It’s the biological equivalent of asking what happened before the Big Bang. If you ask, what is the evidence that it’s safe to stop wearing a mask, I say, what is the evidence that it’s still beneficial?

This same line of thinking applies to other restrictions that could be eased instead. What evidence supports restricting nursing home visitors, if all parties are vaccinated and masked? What evidence supports banning a small dinner, if everyone has had the vaccine? There is no evidence that supports these continued prohibitions.

Knowing these three facts allows us to put it all together. Is it reasonable to tell someone that, if they are asymptomatic 14 days after the second vaccine, they are highly unlikely to get COVID-19, and also less likely to spread the virus — both by having less severe disease, less asymptomatic carriage, clearing virus faster, stronger antibody responses, and fewer symptomatic cases? Absolutely, is my view.

It is then reasonable to say that the theoretical benefit of the mask may be so small that easing up on its use is fine. Alternatively, you might keep the mask, but ease up on something else, and, to be honest, most people might actually prefer a different concession. You might choose to see family instead, or have a gathering with your vaccinated friends. Getting vaccinated is like getting a stack of tickets at Chuck E. Cheese — you get to decide what to trade them in for!

The politics/sociology

Some contend my stance will undermine efforts to normalize masks, send mixed messages to the public. That’s possible, but it is also possible that my message empowers and excites people to get vaccinated, which is the only viable path out of the nightmare we find ourselves in. I think the less scientists manipulate their statements while trying to guess the response the better. I have tried to be fully transparent in my thinking on this topic. None of us knows the second or third order effects. If we distort the facts and bang on harder about prolonged mask use or other restrictions, will the world actually be better? Or will we provoke a deep backlash that has been brewing for some time? Do we risk losing some folks who might otherwise get vaccinated? I am not an incarnation of God, so I don’t know. I worry that the likes and retweets on social media encourage the fearful message rather than the correct one.

Public health experts have reminded me to talk about despair. We are all facing it, and when you clamp down on a society with restrictions, a free society can only bear it for so long. There must be a path out of it, and easing restrictions — particularly when the burden may outweigh the unproven, theoretical, and at best highly marginal benefit — is a great way to renew optimism. Folks who spend time doing boots on the ground public health share their view with me that this is a great place to start.

The last objection I want to discuss is that my policy is not the safest policy. It is not absolute safety. Indeed, I acknowledge this is true. But I disagree that wearing a mask is absolute safety. I disagree that only one nursing home visitor is the safest policy, and only having a picnic outside is safest. Only truly becoming a hermit is absolute safety. Lock yourself in home, and get all foodstuffs delivered. When you go out, always wear an N95, and do this even a year or two after vaccination. After all, who knows if the vaccine will wear off? None of us really wants absolute safety. We seek reasonable safety, and I will defend the proposition that is achieved merely by a prolonged asymptomatic period after second vaccination and after that something can be relaxed — and there are several options.

The end of COVID

COVID-19 will someday no longer be the topic of daily and breathless news coverage. The virus may always circulate, and some people may always get sick, but the real end will be when we stop thinking about it every moment of every day. That’s how this pandemic will end. Not with a bang, but a whimper.

People need to know that there is light at the end of the tunnel because there is.

Vaccination in the absence of viral escape is the way out of this. Once a person is a sufficient time and distance away from the second shot, and if they are feeling well, we can start to view them differently. They are less a vector for the transmission of a plague, and more a real person — with hopes and wants and desires and seeking connection. In such a moment, if they remove their mask to share a smile with me, I can promise you, I will lower my mask, and smile back.

And Opposing View-Now Is Not the Time to Relax COVID Restrictions

Doctor David Aronoff counters the argument with the facts that the COVID-19 pandemic has now raged on for more than a year. In the U.S., we have documented more than 24.5 million cases and 400,000 COVID-19-related deaths, with between 3,000 and 4,000 people dying each day. The CDC projects we will reach nearly 500,000 total deaths within the next month. COVID-19-related hospitalizations remain at an all-time high. America continues to suffer through a third wave of disease activity that has dwarfed the peaks of the Spring and Summer of 2020.

And, while COVID-19 is beating down on us, it could be worse, believe it or not. We have learned much about how the SARS-CoV-2 virus spreads, easily, through our breath from one person to another. Most nefarious has been the extent to which transmission occurs silently, moving from infected individuals who feel well, look well, and have no idea that they are infected. However, we know that maintaining our distance from others protects against transmission, as does the use of cloth face-coverings. It has been through social distancing and mask use that we have, in the absence of vaccination and herd immunity, been able to limit the damage done by this horrible infectious disease.

Clearly, vaccines against SARS-CoV-2 are the light at the end of the tunnel, assuming that viral mutations do not escape our vaccines sooner than we can put out the fire. With estimates that more than 60% of the population will need to have immune protection against SARS-CoV-2 to benefit from herd immunity, we have a long way to go. While less than 10% of the U.S. population has been formally diagnosed with COVID-19, a recent estimate suggested that by November of 2020 we were at about 15% of the U.S. population immune to the virus. And while that figure may now exceed 20%, this leaves more than 250 million Americans without immune protection, and falls short of the roughly 200 million people who might need to be immune for herd immunity to take hold.

Vinay Prasad, MD, MPH, has authored a thoughtful, evidence-based commentary, making a strong case for why we can relax some restrictions following successful immunization against SARS-CoV-2. He succinctly lays out an argument about why and how immunization, in the absence of vaccine-escaping virus mutants, will confer strong enough protection to render tight adherence to wearing masks and other restrictions unnecessary. And, while I think he has the right idea (I would love to see more people’s faces right now and share a meal with my friends), it is premature to suggest that now is that time. It is OK for us to hold differing opinions (that’s what we do). Two well-intentioned scientists can both look at the same data and reach different policy conclusions. So, let me focus on the case for keeping our masks on, even as we roll our sleeves up. The same logic holds for other restrictions.

First, given how active COVID-19 is right now we need to be doing everything in our power to slow its spread. Lives hang in the balance. I really like the Swiss Cheese model of pandemic defense, popularized by Australian virologist Ian Mackay, PhD, which demonstrates the concept that each measure we implement to interrupt the SARS-CoV-2 pandemic is imperfect yet when layered together they cooperatively reduce transmission risk.

Even immunization is not a perfect defense. Thus far, SARS-CoV-2 vaccination has not been shown to eliminate the risk that someone will get infected or pass the virus on to others. Studies published to date on the Moderna and Pfizer-BioNTech mRNA vaccines show clear protection against developing symptomatic COVID-19. But they also show that some vaccinated people still develop symptomatic disease. And, given what we know about the disease in non-immune people, symptomatic infections represent a fraction of total infections. This predicts that despite immunization some people will develop asymptomatic infection. Do I think that SARS-CoV-2 immunization will significantly protect people against both asymptomatic and symptomatic COVID-19? Yes. Do I think the risk to an individual will be zero following successful immunization? No. Stated differently, removing masks from vaccinated people (or relaxing social distancing) is likely to increase the risk for propagating COVID-19 compared to maintaining these restrictions. And, even if that incremental risk is small, why take it, given where we are with the disease now?

There will be a time when immune people can let their guards down, allowing even non-immune people to do the same (a benefit of herd immunity). But that time is not now.

The issue of wearing masks has been a contentious one, not helped by mixed messaging from leaders in the federal and state government. This has translated into story after story of difficulty convincing people of the public health benefit of wearing face-coverings. What we do not need are more people out and about in public spaces without masks, which sends the wrong message at the wrong time. We cannot know if an unmasked person is unvaccinated or simply an anti-masker. Why provide fuel for people to skirt mask policies based on stating they have been vaccinated, when they might not have been? And the same holds for hosting dinner parties or participating in other gatherings.

To safely advise people that once they are immunized, they can leave their masks at home and relax other infection control measures we need to record sustained decreases in disease activity, hospitalizations, and deaths, to the point where leading infectious disease and public health experts are comfortable recommending that we can de-escalate these interventions. We also need to ensure widespread vaccine uptake, particularly among Black, indigenous, and people of color, who have been disproportionately harmed by COVID-19. Recent data show that Black Americans, for example, are getting vaccinated at lower rates than white Americans.

We remain in the thick fog of a true healthcare emergency and need to be doing all we can, especially the simple things, to shut it down. Now is not the time to let up on masking, even for the relatively few who have been immunized. Abandoning mask-wearing and social distancing, even in immunized persons, is not the right thing to recommend, yet. We need masks on and sleeves up.

COVID-19 Variants: ‘The Virus Still Has Tricks Up Its Sleeve’

Now more on the counterpoint reported by Molly Walker who interviewed Dr. Warner Greene as followed: We are honored to be joined once again by Dr. Warner Greene. He’s senior investigator at Gladstone Institutes and a professor at University of California San Francisco. As we’ve discussed, COVID-19 variants are very much in the news. Can we go over what is the latest news about the variants, even today? What do we know about them and what’s the latest that’s been happening?

Variants are very much in the news. What we’re seeing is the slow but steady evolution of the coronavirus. There are now four major variants that are of concern. And, in fact, they call them variants of concern. The first recognized was the U.K. variant, recognized in the south of the United Kingdom. It has an increased transmission efficiency. And there are some reports that it may be somewhat more virulent, particularly in men over the age of 60.

Of even greater concern is the South African variant, which contains mutations that confer resistance to certain monoclonal antibodies, like one of the two monoclonal antibodies developed by Regeneron. The Eli Lily monoclonal antibody doesn’t seem to work against the South African variant and vaccine efficiency is also reduced with the South African variant.

Similarly, the Brazilian variant has basically the same set of mutations that are conferring antibody resistance, causing real concern. What it means for the vaccines, etc.: I think that both the South African and the Brazilian variants are a major concern. And it is possible that those variants as they spread, and they are in the United States now, we may need to revise the vaccines to account for these types of variants. That’s not clear yet, but better to be prepared, in case we do need to revise the vaccine.

And then there’s a fourth type of variant, which is just kind of emerging, less well-studied at this point, but out of California. So clearly there, the virus is searching for a lock and key mechanism trying to search for ways to allow itself to replicate better. We’re applying immune pressure. So, it’s mutating away from some of that immune pressure, and that’s why this antibody resistance is emerging.

So, what types of mutations does the SARS-CoV-2 virus have to go through to make it a variant?

Well, for example, the South African variant has 27 mutations, nine of which occur in the spike protein. The spike is the protein on the surface that binds to the ACE2 receptor and allows entry and fusion into the host cell. And, of course, that’s where most of the vaccines are focused, is on the spike. That’s where the monoclonal antibody therapeutics are focused, on the spike. And so the virus is looking for ways to avoid these types of immune pressures and it’s making mutations in its receptor binding domain and the internal domain that confer resistance to certain types of neutralizing antibodies.

Given that recent studies from Novavax and Johnson & Johnson last week found somewhat reduced clinical efficacy of vaccines against these variants, what type of booster modification is required for vaccines in order to better combat them with the mRNA and the viral vector vaccines? Is it different, is it the same?

I think the booster that, for example, Moderna and Pfizer are now working on is to take the genetic sequence of the variant and use that as the immunogen. So, there is a mutation at position 484 that is absolutely key for this loss of antibody protection. You would introduce an RNA that now has that same mutation at position 484 into the vaccine to create a vaccine that is really tailored to take that particular type of virus out. And that mutation is shared between the South African and the Brazilian variants.

And so it wouldn’t require a different type, depending on the type of vaccine, it would just be the same type of reformulation. It wouldn’t be mRNA, different than a viral vector, it would just be a different formula. It’s not anything to do with the type of vaccine. It still would be an mRNA-based vaccine. It would just contain a different RNA or more likely it will be a multi-valent vaccine that would be original virus, as well as a new virus.

It’s not clear exactly how that would be administered. It may be that we want to boost immunity against the old virus, as well as the new virus, so we would use a multi-valent approach in that case. But the mRNA vaccine platform is quite amenable to this type of updating. That’s a real advantage, much more so than the adenoviral vectors, the virus-delivered vaccines. It’s a more complicated process there.

If we could just look at the vaccines as we have them now against this wild-type strain, if for some reason we didn’t have any boosters, what type of progress could we make against the pandemic? Can we vaccinate our way out of the pandemic, even if we don’t have these boosters? Have these variants prevented that?

To be clear, these variants, the Brazilian and the South African variants, are only compromising the neutralizing antibody response against the coronavirus. The T-cell immune response presumably is fully intact and remains unevaluated. So it’s quite possible that these vaccines will stand up better than we expect or predict. Clearly the U.K. variant does not appear to be a threat, although the recent acquisition of the neutralizing mutation at 484 causes concern that the virus is evolving. Even the U.K. variant is evolving.

I would say that the one thing that is disturbing to me, or that causes me pause is the story in Manaus, Brazil. Manaus is in the Amazon basin, they had a huge outbreak in the spring. It was thought, as reported, that there would probably be herd immunity within the community up to about 75%. Then this variant comes in to the community and it’s just sweeping through, causing re-infection or what appears to be re-infection.

Now did the original immunity wane and these people were all sensitive? Is it just that the variant is able to avoid both the T-cell and the antibody response that was present in the herd in Manaus? That kind of real-time experiment is concerning in terms of the spread of this virus. And I think data like that and what’s going on in South Africa is what’s really prompting the vaccine companies to get prepared now. We don’t know the full dimensions of the problem, but better to overprepare at this point in time.

So, given what happened in Brazil, do you think that’s evidence of viral escape?

Certainly, the South African and Brazilian variants, the mutations they are acquiring in their spike protein are examples of escape from the antibody neutralization. These are mutating principal antibody-binding sites that are responsible for neutralization, so that these variants are emerging under the influence of immune pressure. It’s harder to get around the T-cell immunity though, because T-cell immunity differs from person to person based on the composition of our HLA genes and our immune response. And T-cells are really the major defense mechanism against viruses, so let’s hope that our T-cells fill in for any gaps that the antibodies might come up a little short on.

I’m not sure exactly what has happened in Manaus, whether there was really ever herd immunity, whether it’s waned, but I do know that the variant there is hitting hard. So, that’s a big question mark. I think Brazil holds the answers to a lot of the future of this pandemic. We need to understand precisely what is going on there.

What do we need to be studying in Brazil specifically? And what type of data would we need to be looking at and tracking, what types of real-world studies and epidemiological studies would you like to see out of what’s happening in Brazil to help us going forward?

I would like to know whether or not there was real herd immunity. Before this new variant began to spread, was there clear evidence of a good antibody response and retention of durable antibody responses against the original strain of “wild-type” virus. So, if, in fact, there was an intact immune response, and this virus was able to overwhelm that response, well that’s not good news, but if the response had waned or had never really developed fully, then that’s a less daunting problem.

Now on the positive side, you look at the Johnson & Johnson vaccine, it’s not the world’s best at preventing you from becoming infected with or developing minor respiratory symptoms. But even with the South African variant, this vaccine protects you from severe disease, having to go to hospital and dying. And frankly, that’s what we want from a vaccine. That is fantastic. You may have a runny nose or a mild upper respiratory tract infection, but you’re not going to develop life-threatening pneumonia and require hospitalization, intubation, etc. And I’d sign up for that type of vaccine any day.

All we have from the mRNA vaccines from Pfizer and Moderna are these kinds of in vitro and in lab studies that if you expose them to these variants, this is what they’ll do, but do we need some type of clinical efficacy? Would you say at this point that we don’t have evidence of clinical efficacy against the variants with these two vaccines that are currently being distributed?

Exactly. The mRNA vaccines are not being tested extensively in areas where the variants are prospering, but one of the trial sites for Johnson & Johnson was in South Africa. So, they were able to see how their vaccines stood up against that variant and it fared very well in terms of prevention of serious disease.

When do you think that we are going to get these types of studies? Is that something that we’re going to see as the vaccine trials kind of evolve, and are we going to be able to get that from the mRNA vaccines? Are we just going to not know what their clinical efficacy is until we get a booster, we’re just going to only have the lab evidence?

It’s likely that the virus is probably replicating at higher levels or more virus is replicating in terms of country here in the United States than almost anywhere else in the world, in terms of the breadth of cases that we’ve had, etc. We just simply do not have the genomic surveillance types of apparatus to necessarily detect these variants. For example, we’re just now detecting the California variants. There may be many variants in the United States. We do know that the Brazilian, as well as the South African, variants are in the United States, and it’s possible that there is community spread of these variants. So, we just have to really ramp up our sequencing efforts to really track what’s happening within our pandemic within the country and what types of viruses that we’re dealing with.

And it’s in that kind of setting as variants begin to hold sway. For example, it’s suggested that the U.K. variant will become dominant in the United States by March. So, our prediction is that the current vaccines will do very well against that variant. Now, if that variant is replaced by, for example, a South African variant, which is more immunologically daunting, well then, we’re going to have to see how the mRNA vaccines hold up against that. And it’s that kind of real-world information that’s going to inform whether or not we need to boost the immune system with a third shot.

Are the variants occurring in regions due to the similarities in the genome of the regional population, causing the viral RNA to mutate in a specific direction, and do antigen tests pick up variants?

No, the antigen tests will not pick up the variants. You really have to do the sequencing to find these mutations. So, it’s clear that the virus has a set of mutations and it’s trying different combinations. All the virus wants to do is to replicate better. The U.K. variant has one mutation in the receptor binding domain, which confers tighter binding to the ACE2 receptor and a higher level of transmission by 40% to 70%. And that’s the variant that may become dominant here in the United States by March. In contrast, the South African and the Brazilian variants, they not only have the same mutation that the U.K. variant does, they’ve added to it. They’ve added at least two additional mutations that really take out these neutralizing antibodies.

Now, did these two variants arise independently? Some would say yes. I don’t think that we know precisely because one person coming from South Africa carrying the virus could seed the virus in Brazil. So, we don’t know, but there are subtle differences. The virus is working toward a solution here for avoiding the antibodies.

Now, another question is, is the virus throwing everything at us right now that it’s got? Is this it and can we expect a pretty much static situation from here on out? And, you know, I don’t think so. I think the virus still has tricks up its sleeve, and will continue to evolve as we put additional immune pressures on it. So, that would be my guess, but we’re right at the cusp of the evolving science. And to think that where we were a year ago with no defense, no innate or no intrinsic immunity to this virus, and nothing really therapeutic or preventive. And now we’re in a situation where we have multiple, highly effective vaccines. It’s a true triumph of science.

Can you go into how else the virus could mutate? Is there any way that it could mutate that T-cell immunity that we have that would be compromised? Is that possible or is it just not that complex a virus?

Yeah, there may be the emergence of escape mutations that escape a cytotoxic T-cell, CD8 T-cell responses, or CD4 helper T-cell responses. We could certainly see that and it’s much harder to monitor for those types of immune reactions. So, certainly, like you get immune escape against antibodies, you can have immune escape against T-cell immunity as well.

California man tests positive for COVID-19 weeks after second jab: report

Edmund DeMarche reported that a California man said he was diagnosed with COVID-19 three weeks after he received his second dose of the vaccine, reports said.

CBS Los Angeles reported that Gary Micheal, who lives in Orange County’s Lake Forest, found out he had the virus after being tested for an unrelated health concern. His symptoms are relatively minor, the report said.

He received the Pfizer vaccine, the report said. Patch.com reported that he got his first dose on Dec. 28 and his second jab on Jan. 18.

Dr. Anthony Fauci, the country’s leading infectious-disease scientist, said the latest evidence indicates that the two vaccines being used in the U.S. — Pfizer’s and Moderna’s — are effective even against the new variants.

A doctor interviewed in the CBS report said that he was not surprised to hear about Michael’s diagnosis.

“I think I’ve heard of six or seven independent cases over the last three weeks of individuals that have been vaccinated with different timelines that have tested positive, and I think we’re going to continue to see that more and more,” Dr. Tirso del Junco Jr., chief medical officer of KPC Health, told the station.

Fauci has estimated that somewhere between 70% and 85% of the U.S. population needs to get inoculated to stop the pandemic that has killed close to 470,000 Americans.

And Now Four people in Oregon who received both doses of vaccine test positive for coronavirus

Minyvonne Burke reported that four people in Oregon have tested positive for the coronavirus after receiving both doses of the Covid-19 vaccine, health officials said.

There are two cases each in Yamhill and Lane counties, the state’s Health Authority said in a series of tweets on Friday. The cases are either mild or asymptomatic.

“We are working with our local and federal public health partners to investigate and determine case origin,” the agency said. “Genome sequencing is underway, and we expect results next week.”

The agency referred to the individuals who tested positive as “breakthrough cases,” meaning that they got sick with the virus at least 14 days after receiving both doses.

The Health Authority said more breakthrough cases could pop up.

“Clinical trials of both vaccines presently in use included breakthrough cases. In those cases, even though the participants got Covid, the vaccines reduced the severity of illness,” the agency said in a tweet.

“Based on what we know about vaccines for other diseases and early data from clinical trials, experts believe that getting a Covid-19 vaccine may also help keep you from getting seriously ill even if you do get the virus. … Getting as many Oregonians as possible vaccinated remains a critical objective to ending the pandemic.”

The agency’s announcement came the same day its health officer said there has been a decline of daily Covid-19 cases over the past several weeks. As of Friday, there were 149,576 cases in the state, according to the department’s count.

“These decreases are a testament to the actions all Oregonians are taking to slow the spread of Covid-19 and the sacrifices made – thank you,” health officer Dean Sidelinger said at a news conference Friday.

Another breakthrough case was reported in North Carolina, according to NBC affiliate WCNC-TV in Charlotte. The state’s Department of Health and Human Services told the outlet that the person had mild symptoms and did not need to be hospitalized.

The Centers for Disease Control and Prevention has said that quarantining is not necessary for fully vaccinated people within three months of having received their last doses as long as they do not develop any symptoms.

They do, however, still need to practice certain safety measures such as wearing face masks, social distancing, and avoiding crowds or poorly ventilated spaces.

“Fully vaccinated” means at least two weeks have passed since a person has completed their vaccination series and now we have the addition of the Johnson and Johnson vaccine, which is a single dose with less effectivity but about the same activity of our yearly flu vaccine.

So, as I have said before, continue to wear your masks, whether one, two, three or whatever the number of masks that we are going to be advised with future “scientific” evidence.