Category Archives: Herd Immunity

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.

U.S. Hits Highest 1-Day Toll from Coronavirus With 3,054 Deaths, Hospitalizations and Answers to the Questions About the Vaccines

I have rewritten this post about 15 times but finally decided with the approval of the Pfizer vaccine for emergency use that I needed to answer a number of questions. So, here we go.

Vanessa Romo reported on the Covid Tracking Project and found that the coronavirus pandemic has pushed the U.S. past another dire milestone Wednesday, the highest daily death toll to date, even while the mortality rate has decreased as health experts learn more about the disease.

The Covid Tracking Project, which tracks state-level coronavirus data, reported 3,054 COVID-19 related deaths — a significant jump from the previous single-day record of 2,769 on May 7.

The spread of the disease has shattered another record with 106,688 COVID-19 patients in U.S. hospitals. And overall, states reported 1.8 million tests and 210,000 cases. According to the group, the spike represents more than a 10% increase in cases over the last 7 days.

Additionally, California nearly topped its single-day case record at 30,851. It is the second highest case count since December 6, the organization reported.

The staggering spike in fatalities and infections has overwhelmed hospitals and intensive care units across the nation, an increase attributed by many experts to people relaxing their precautions at Thanksgiving.

New Data Reveal Which Hospitals Are Dangerously Full. Is Yours?

Audrey Carlsen reported that Health care workers at United Memorial Medical Center in Houston face another full-throttle workday last week.

The federal government on Monday released detailed hospital-level data showing the toll COVID-19 is taking on health care facilities, including how many inpatient and ICU beds are available on a weekly basis.

Using an analysis from the University of Minnesota’s COVID-19 Hospitalization Tracking Project, NPR has created a tool that allows you to see how your local hospital and your county overall are faring. 

It focuses on one important metric — how many beds are filled with COVID-19 patients — and shows this for each hospital and on average for each county.

The ratio of COVID-19 hospitalizations to total beds gives a picture of how much strain a hospital is under. Though there’s not a clear threshold, it’s concerning when that rate rises above 10%, hospital capacity experts told NPR.

Anything above 20% represents “extreme stress” for the hospital, according to a framework developed by the Institute for Health Metrics and Evaluation at the University of Washington.

If that figure gets to near 50% or above, the stress on staff is immense. “It means the hospital is overloaded. It means other services in that hospital are being delayed. The hospital becomes a nightmare,” IHME’s Ali Mokdad told NPR.

At Hospitals, A Race to Save ‘Hundreds of Thousands’ Of Lives with New Vaccine

Sarah McCammon noted that lately, Jon Horton has been dreaming about freezers.

“I was opening the freezer and I was taking something out of the freezer and putting it in something else,” Horton said. “And it was just like — whew!”

And not just an ordinary freezer. Horton is pharmacy operations director at Sentara — a health care network based in Norfolk, Va.

Sentara officials are working out every detail of the logistics involved in rolling out the coronavirus vaccine from Pfizer, which has to be kept at nearly minus 100 degrees Fahrenheit or risk losing effectiveness.

“At a certain point, you’re just trying to figure out what needs to be done next,” Horton said during an interview with NPR at Sentara Norfolk General Hospital. “So, you’re focusing on this process, and as you open up that door, you learn a little more.”

As federal regulators prepare to meet Thursday to consider whether they’ll approve Pfizer’s brand-new coronavirus vaccine, employees like Horton are preparing to receive the vaccine at hospitals around the United States.

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The Sentara health system has four of the ultracold freezers that the vaccine requires, including one obtained through collaboration with a local medical school.

“We usually just deal with freezing temperatures, you know, a typical freezer,” said Tim Jennings, Sentara’s chief pharmacy officer. “That’s why we had to actually go out and acquire a special freezer for this.”

For sites that don’t, there’s dry ice. Jennings opens a big blue bin full of it, which resembles white “cheese doodles,” he notes.

There’s little room for error here: The vaccines must be monitored to make sure the temperature is stable each step of the way. And they’re in short supply right now; the first shipment from Pfizer is expected to include only about 72,000 doses for all of Virginia, a state of more than 8 million people.

Michelle Hood, chief operating officer at the American Hospital Association, said health care administrators across the country are gearing up for a major logistical undertaking.

“We’ve never done anything like this as a country or in the world, as significant as this exercise is,” Hood said. “And everything is new.”

The first vaccines will go mostly to front-line health care workers at the highest risk of exposure.

That’s where Mary Morin, a vice president in charge of employee vaccination at Sentara, comes in. She has a lot to think about as well.

“I did wake up last night and I’m going, ‘Oh, my God,’ ” Morin said.

Morin, whose background is as a registered nurse, has to turn Centers for Disease Control and Prevention guidelines about who should be first in line for the coronavirus vaccine into a real-life plan for her hospital workers.

“A front door to the hospital is the emergency department. You may have a security guard there. They’re patient facing. They’re forward facing,” she said. “So, it’s the staff — it isn’t just the nurses and the physicians.”

Unlike the flu shot, Sentara officials say, the coronavirus vaccine will be optional for staff. Large studies indicate the Pfizer vaccine is about 95% effective with few side effects. But it’s brand-new, and convincing people to take it may be a challenge.

The challenge ahead for hospital staff members like Jennings is making sure the vaccine is properly stored and administered to those who are willing and able to take the first doses. If the vaccine receives federal approval, officials say it could start being given to health care workers within days.

“We realize if we do this right, we could save thousands of lives,” Jennings said, “if not hundreds of thousands.”

The Covid-19 Vaccine: When Will It Be Available for You?

I was included in the set of clinical trials for the COVID-19 vaccine. But I was just notified that I was being “kicked out” due to the fact that the Committee wanted to make sure that I was vaccinated and not having the possibility of being given the placebo as per the trials due to the fact as a physician I am seeing cancer patients daily.

Vaccines, especially as one is already approved by the FDA and the other should be approved for emergency use this coming week.

I thought that I would review a number of questions that many have regarding the new vaccines.

First U.S. rollouts of doses could start in December, with health-care workers, older Americans likely to take priority

Peter Loftus and Betsy McKay reported that Pfizer Inc.  and its partner, BioNTech SE, have asked the U.S. Food and Drug Administration to authorize use of their coronavirus vaccine, and an FDA decision could come as soon as this weekend. Moderna Inc.  has made a similar request for its shot, and other vaccines could follow. The first rollouts could begin within days.

Here is what we know and don’t know about how, and when, the vaccine will get to you.

How will the Covid-19 vaccines be approved, and who decides who will get them?

The FDA will determine whether to authorize Covid-19 vaccines for use. An FDA advisory committee of outside experts voted Thursday in favor of Pfizer’s request for authorization of its vaccine. The FDA is expected to decide imminently.

The FDA has scheduled a Dec. 17 advisory committee meeting to consider Moderna’s request for authorization. A separate advisory committee to the U.S. Centers for Disease Control and Prevention has voted to recommend that health workers and residents of nursing homes and other long-term care facilities be first in line for the limited number of doses. The same committee will hold additional votes on which groups should be next in line. But governors can make the final call within their states.

How will the vaccines be distributed?

The federal government has a contract with McKesson Corp. to be a centralized distributor of Covid-19 vaccines, with the exception of Pfizer’s. Pfizer has set up its own distribution network. Federal health officials say initial doses would be shipped within 24 hours of any FDA authorization, and immunizations could begin within about 48 hours. The federal government also has partnerships with national pharmacy chains CVS and Walgreens to vaccinate residents and staff at long-term care facilities.

Some experts say it could take more than 48 hours for dosing to begin, as hospital workers and others get used to procedures for opening specialized, temperature-controlled boxes of vaccine vials and learn the risks and benefits of the shots.

“Many providers are going to need a few days to get it up and running, if not a week,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members run state, territorial and local vaccination programs.

What logistics are in place to deliver the vaccines?

McKesson, the centralized distributor for vaccines other than Pfizer’s, also will receive and package kits of medical supplies needed to administer the Covid-19 vaccine, such as needles and syringes and alcohol prep pads. It will send the kits and vials of the vaccine out to pharmacies, doctors’ offices and other facilities, at a minimum of 100 doses per order, based on order information supplied by the CDC.

Pfizer plans to use its own distribution centers and ship its vaccine in specially designed reusable containers that can keep thousands of doses at the ultracold temperatures required for it.

How many doses will be available at first?

The initial expected supply of Pfizer’s vaccine after authorization is about 6.4 million doses, according to Gen. Gustave Perna, chief operating officer of the U.S. government’s Operation Warp Speed initiative.

Of this, about 2.9 million doses will be shipped within 24 hours. A federal official said Wednesday that an additional 2.9 million doses would be held back and shipped about three weeks later for those initial vaccine recipients to get the second of the two-dose regimen. Another 500,000 doses from the initial supply would be held in reserve in case any problems arise, the official said. If Moderna’s vaccine is authorized, officials estimate the initial allocation will be about 12.5 million, which may also be sent in separate shipments to accommodate the second injection.

Including that initial supply, federal officials have estimated there would be enough doses to vaccinate 20 million Americans in December.

How many doses will be available next year?

Federal officials have estimated there could be enough to vaccinate about 30 million people in the U.S. in January and then about 50 million in February, with more in the months following. Globally, Pfizer expects to produce up to 1.3 billion doses in 2021 and Moderna expects up to 1 billion.

Who will get the first doses?

The first doses will likely go to health-care workers and residents of nursing homes and other long-term care facilities, which together number about 24 million. After that, the CDC vaccine advisory committee is considering recommending that essential workers such as teachers, police and food workers get vaccinated, followed by adults with underlying conditions that put the at high risk, and seniors age 65 and older.

The committee hasn’t completed its recommendation beyond the first phase, and decisions on which groups get vaccinated when could depend in part on the particular vaccine and what its data show about effectiveness among different age groups or health conditions.

Is there any debate about who should get vaccinated first?

Yes. Some health officials and experts believe health-care workers should be vaccinated first, while others are advocating for the most vulnerable—older Americans—to be first in line. And some state governors have singled out occupations such as teachers that should be at or near the top of the list. There is a similar debate about whether non-health-care essential workers such as teachers and police should be ahead of adults with high-risk medical conditions and people age 65 and over who aren’t in congregate settings.

When can the general public expect to have access?

Secretary of Health and Human Services Alex Azar said he expects there to be enough vaccine doses starting in the second quarter of 2021 so that anyone who wants a vaccine can get it. Other federal health officials have said in the spring or summer. The timeline could change if manufacturing doesn’t go as planned.

How will vaccine doses be allocated to U.S. states?

For the initial supplies, the federal government plans to allocate doses to states proportionally based on the size of their adult populations. It is unclear how long the federal government would stick with population-based proportions and how it would allocate supplies later.

How do states decide to distribute doses?

State, territorial and some local immunization programs, working with the CDC, have drawn up plans to distribute doses within their jurisdictions and to conduct vaccination campaigns. These plans include identifying facilities where vaccination campaigns can be conducted, enrolling them and ensuring the necessary equipment is in place to conduct them. States also have estimated their populations of high-priority groups like health-care workers.

Does the vaccine work the same way in all population groups?

Pfizer and Moderna haven’t yet provided full breakdowns of vaccine efficacy by age and race or ethnicity, but the companies have said efficacy was consistent across these groups.

Does everyone get the same dose regardless of age or other demographic?

Yes.

Coronavirus Daily Briefing and Health Weekly

How many people need to get vaccinated to stop the pandemic in the U.S.?

Moncef Slaoui, chief adviser to Operation Warp Speed, has said if 70% of the population were immunized, that level would achieve herd immunity, based on the approximately 95% effectiveness of both the Pfizer and Moderna vaccines.

A vaccine would need to be at least 80% effective, with about 75% of a population receiving it, to extinguish an epidemic without any other public-health measures, according to a study published in October in the American Journal of Preventive Medicine.

Reaching those levels of immunization would require educating millions of Americans about the safety and effectiveness of vaccines and confronting a strong antivaccine movement, said Peter Hotez, a vaccine scientist at the Baylor College of Medicine and an author of the paper. Those are steps the government hasn’t taken yet, he said. “To use a vaccine to eliminate this virus—it is a really high bar,” he said.

One open question is how effective the vaccines are at preventing people from transmitting the virus to others, Dr. Hotez said. Both vaccines were tested primarily for their effectiveness at preventing people from becoming ill. They are expected to be evaluated for effectiveness at preventing infection regardless of symptoms, but those data haven’t been released yet.

What is herd immunity?

Epidemiologists estimate that between 60% and 70% of a population needs to develop an immune response to the virus to reach “herd immunity,” a state in which enough people have either been infected or vaccinated to stop transmission of the virus. Some epidemiologists say herd immunity to Covid-19 might be achieved at a lower threshold of 50%.

When the vaccines are widely available, how will I get the shot?

Federal officials say they want to make getting a Covid-19 vaccine as easy as going to a pharmacy to get a flu shot. The government has formed partnerships with about 60% of U.S. pharmacies to administer Covid-19 vaccines to the broader population after high-priority groups are vaccinated. Manufacturers would ship doses to distributors to get them to hospitals, pharmacies, nursing homes and other administration sites, as determined by state and federal plans. Pfizer’s vaccine requires ultracold shipping and storage, while Moderna’s can be shipped at higher—though still freezing—temperatures. After thawing, doses can be kept in refrigerators for certain periods.

How many doses will I need?

Vaccines from Pfizer, Moderna and AstraZeneca PLC are given in two doses, three or four weeks apart. Federal and state officials are planning to issue reminders to people to come back for their second doses. A Johnson & Johnson vaccine is being tested as a single dose, but the company hasn’t yet reported how well that works.

How much does it cost? Will insurance cover it?

Both the Trump administration and President-elect Joe Biden have said the vaccine would be free of charge to all Americans, with administration fees billed to private or government insurance plans or to a special government relief fund for the uninsured.

Does it have to be a needle?

The vaccines closest to authorization are given as injections. Merck & Co. is exploring an oral formulation of a Covid-19 vaccine, but it isn’t expected to be available in the near term.

Should I get a vaccine if I’ve already been infected?

You can still benefit from the vaccine, the CDC says. Scientists don’t yet know how long someone is protected from getting sick again once they have had Covid-19. There is some evidence that natural immunity doesn’t last long.

How long does immunity last after vaccination?

The median follow-up period in the large clinical trials was only about two months after vaccination, so it isn’t yet known how long protection will last beyond that.

Will my child be able to get vaccinated? Has it been tested in children?

Children likely won’t get vaccinated until later because they are much less likely to have severe Covid-19 than adults. Pfizer has requested U.S. authorization of use of the vaccine in people 16 and older. Pfizer and Moderna have started to test the vaccine in children as young as 12, and other companies also plan to test their Covid-19 vaccines in children.

Can I stop wearing a mask after getting a COVID-19 vaccine?

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the US could reach herd immunity by May, based on the effectiveness of the Pfizer and Moderna vaccines if enough people are vaccinated

Can I stop wearing a mask after getting a COVID-19 vaccine?

No. For a couple reasons, masks and social distancing will still be recommended for some time after people are vaccinated.

To start, the first coronavirus vaccines require two shots; Pfizer’s second dose comes three weeks after the first and Moderna’s comes after four weeks. And the effect of vaccinations generally isn’t immediate.

People are expected to get some level of protection within a couple of weeks after the first shot. But full protection may not happen until a couple weeks after the second shot.

It’s also not yet known whether the Pfizer and Moderna vaccines protect people from infection entirely, or just from symptoms. That means vaccinated people might still be able to get infected and pass the virus on, although it would likely be at a much lower rate, said Deborah Fuller, a vaccine expert at the University of Washington.

And even once vaccine supplies start ramping up, getting hundreds of millions of shots into people’s arms is expected to take months.

Fuller also noted vaccine testing is just starting in children, who won’t be able to get shots until study data indicates they’re safe and effective for them as well.

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the country could reach herd immunity as early as May, based on the effectiveness of the Pfizer and Moderna vaccines. That’s assuming there are no problems meeting manufacturers’ supply estimates, and enough people step forward to be vaccinated.

FDA panel endorses Pfizer coronavirus vaccine for emergency use.

Thomas Barrabi reported that the U.S. Food and Drug Administration advisory panel voted Thursday to endorse the Pfizer-BioNTech coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country. And Friday it was official that the Pfizer vaccine is approved for emergency use.

Vaccine shipments would begin within hours of the FDA’s decision, which could come by as early as Friday, with the first vaccinations to follow soon afterward. Pfizer’s vaccine will be available in limited quantities, with initial doses earmarked for frontline health care workers and high-risk patients.

In November, Pfizer announced that its coronavirus vaccine was 95 percent effective and has not displayed any major side effects.

The advisory panel, comprised of outside experts, based its decision on data from clinical trials. Members were asked to vote on “whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older” based on the totality of available evidence.

Some committee members raised concerns about the wording of the question and whether trials have provided enough information regarding the vaccine’s effects on people aged 16 and 17 years old. The committee opted to vote on the question as it was originally worded.

Of the committee’s 23 members, 17 voted to recommend the vaccine and four voted against the recommendation. One member abstained in its endorse

Pfizer is one of several companies in the final stages of development. The FDA is expected to decide whether to approve a vaccine developed by Moderna for mass use later this month. Johnson & Johnson and AstraZeneca also have vaccines in the works.

More than 290,000 Americans have died from COVID-19 since the pandemic began. More than 15.4 million cases have been reported.

Convincing people to get COVID vaccine is vital — here’s how to do it

Dr. Austin Baldwin and Jasmin from Fox News makes us aware that the decision by the Food and Drug Administration Friday night to issue an emergency use authorization for Pfizer’s COVID-19 vaccine is a critical breakthrough in the battle against the disease that has infected more than 15.7 million Americans and killed nearly 300,000.

The FDA ruling that the Pfizer vaccine is safe and effective is just a first step in a massive rollout of the vaccine. Now the enormous task of distributing the vaccine around the nation begins.

But a crucial obstacle to widespread vaccinations will be public hesitancy to take the vaccine, driven by doubts, fears, and misinformation spreading throughout the nation and the world.

The same challenge will face other vaccines now awaiting approval in the U.S. and vaccines distributed globally. Gaining public acceptance for the Pfizer vaccine and other vaccines is vital, because we won’t end the worst global health crisis in a century until the majority of the world’s 7.7 billion people are vaccinated against COVID-19. The disease has infected more than 70 million people around the world and killed nearly 1.6 million.

Behavioral science will be as important to vaccine acceptance as basic science was to vaccine development. If government and health care leaders take the right approach to educating the public about the vaccines, we can create a pathway for the public to assess options and choose to get vaccinated. Given the accelerated development of the Pfizer vaccine and other vaccines not yet approved, convincing people that the vaccines are safe and effective is critical.

The World Health Organization identified vaccine hesitancy as a top global health threat in 2019 — just months before the COVID-19 outbreak. An Axios-Ipsos survey found that only half of Americans say they are likely to get a COVID-19 vaccine as soon as it is available. These numbers are even lower among African Americans, at just more than a quarter. Why?

Historically, minority communities have been suspicious of new health technologies and biomedical research due to past unethical experimentation on African Americans and Native Americans.

Given that African Americans are hardest hit by COVID-19, public health officials must respond to these concerns. Beliefs in vaccine conspiracies and rumors that the government is cutting corners in testing and development must also be addressed if we are to achieve herd immunity, the threshold of 70 percent of the population needed in order for person-to-person transmission to be largely eliminated.

As plans are developed to roll out the Pfizer vaccine and later other COVID-19 vaccines throughout the nation, public health officials and other health care leaders should consider three steps.

Transparency to build trust

Leaders at all levels of government and the health care community must be upfront that science is always evolving and that knowledge about the vaccines will continue to accumulate.

Communications should stress that the Pfizer vaccine and the Moderna vaccine (not yet approved) are 90 to 95% percent effective. It’s also important to emphasize that while the development, testing, and approval processes for vaccines have been accelerated, no steps were skipped.

When people are asked if they’re willing to get a vaccine that is “more than 90% effective” or one that has been “proven safe and effective,” willingness to be vaccinated increases to 65 to 70%.

Transparency also means being upfront about potential side effects of vaccines. These include possible arm soreness (as with most vaccines) and possible fatigue a day or two after vaccination. If people expect knowledge to evolve and believe public health leaders will be upfront, reports of new side effects are less likely to undermine confidence and trust.

 Active engagement with vaccine information

Communications about the vaccines should pose questions such as: “How will my family and I benefit from the vaccine?” or “If I don’t get a vaccine and then later get COVID-19, to what extent would I regret that decision?”

Such questions lead people to more actively engage with the information rather than simply being told that the vaccine is safe.

We took this approach when we developed an app and website to address parental hesitancy about the HPV vaccine among diverse populations. We are now working to adapt this approach to provide information on COVID-19 vaccines.

Interactive technology makes it more likely that people will become engaged in the decision to be vaccinated and be motivated to follow through to get the required second dose. 

Meeting different informational needs and styles of decision-making among people 

Some people will want detailed information to weigh the scientific evidence before being vaccinated against COVID-19. Others will want information mediated through a trusted source, like health care providers, faith-based leaders and public figures.

To accommodate different needs and maintain transparency, educational materials should provide information in a stepped manner. Basic information from trusted sources is presented first. This is followed by more detailed information using different media such as print, video and formats such as personal stories and graphics to explain numbers and risk.

Websites and apps that enable people to navigate to their level of desired information provide another level of empowerment. We found our app’s stepped approach led previously hesitant parents to be 2.5 times more likely to decide in favor of the HPV vaccine.

Our major investments in vaccine development and testing will fall short of achieving their potential impact unless the public takes the COVID-19 vaccines. We must work proactively to communicate better than ever before.

So, as I have said before about the flu vaccine, if it is offered to you, get the COVID-19 vaccine and be part of the solution to ending this Pandemic.

And wear the Damn MASKS, as Governor Hogan keeps telling us!

The conspiracy theorists are wrong: Doctors are not inflating America’s COVID-19 death toll for cash. What about Herd Immunity and Oh, those Ignorant College Students!

As the terrible fires continue to burn and Nancy Pelosi says that Mother Nature is angry with us and the political atmosphere is all about hate, I sometimes don’t know who to believe, especially when it comes to the media. Andrew Romano reported that earlier this week, Iowa Republican Sen. Joni Ernst became the first member of “the world’s greatest deliberative body” to embrace a false online conspiracy theory that seeks to minimize the danger of COVID-19 by claiming only a few thousand Americans have died from the virus — not the 185,000 reported by state and local health agencies and hospitals. 

Ernst, who described herself as “so skeptical” of the official death toll, even went so far as to echo the nonsense argument spread by QAnon and other right-wing conspiracy-mongers that medical providers who have risked their own lives and health to treat COVID-19 patients have been attributing non-COVID deaths to the virus to rake in extra cash from the federal government. 

“These health-care providers and others are reimbursed at a higher rate if COVID is tied to it, so what do you think they’re doing?” Ernst, who is facing a tight reelection race, said Monday at a campaign stop near Waterloo, Iowa, according to a report by the Waterloo-Cedar Falls Courier.

“They’re thinking there may be 10,000 or less deaths that were actually singularly COVID-19,” Ernst added in an interview with the paper. “I’m just really curious. It would be interesting to know that.”

Since Ernst is “really curious,” here are the facts.

Yes, Medicare pays hospitals more for treating COVID-19 patients — 20 percent more than its designated rate, to be exact. Incidentally, this additional payment was approved 96-0 in the U.S. Senate — including by Joni Ernst. The reason Ernst (and all of her Senate colleagues) voted for it is simple: It helped keep U.S. hospitals open and operating during a worldwide emergency.

“This is no scandal,” Joseph Antos, a scholar in health care at the conservative American Enterprise Institute, explained in a recent PolitiFact fact-check. “The 20 percent was added by Congress because hospitals have lost revenue from routine care and elective surgeries that they can’t provide during this crisis, and because the cost of providing even routine services to COVID patients has jumped.”

In other words, no one is getting rich by misclassifying COVID-19 deaths.

It’s also fair to say that fewer than 185,000 Americans have died “singularly,” as Ernst put it, from COVID-19. According to a recent update by the Centers for Disease Control and Prevention, 94 percent of patients whose primary cause of death was listed as COVID-19 were also judged to have comorbidities — secondary conditions like diabetes that often exacerbate the virus’s effects. For the remaining 6 percent, COVID-19 was the only cause listed in conjunction with their deaths.

On Sunday, President Trump retweeted a QAnon backer who falsely claimed this meant that only 6 percent of reported COVID-19 deaths — that is, 10,000 or so — were actually caused by the virus. Perhaps this “report” is what Ernst was referring to when she agreed Monday with an audience member who theorized that COVID-19 deaths had been overcounted. “I heard the same thing on the news,” she said.

Yet Twitter quickly removed the tweet for spreading false information, and for good reason.   

Despite all the innuendo, there’s nothing unusual about the way the government is counting coronavirus deaths, as we have previously explained. In any crisis — whether it’s a pandemic or a hurricane — people with preexisting conditions will die. The standard for attributing such deaths to the pandemic is to determine whether those people would have died when they did if the current crisis had never happened.

When it comes to the coronavirus, the data is clear: COVID-19 is much more likely to kill you if your system has already been compromised by some other ailment, such as asthma, HIV, diabetes mellitus, chronic lung disease or cardiovascular disease. But that doesn’t mean patients with those health problems would have died this week (or last week, or next month) no matter what. The vast majority of them probably wouldn’t have. COVID-19 was the cause of death — the disease that killed them now, and not later.

A closer look at the CDC data, meanwhile, reveals that many of the comorbidities listed by medical providers are complications caused by COVID-19 rather than chronic conditions that predated infection: heart failure, renal failure, respiratory failure, sepsis and so on.

Feverishly creating a baseless fiction from two threads of unrelated information — the additional Medicare payments and the CDC update about comorbidities — is a classic conspiracy-theorist move. But that doesn’t make it true.

“Let there not be any confusion,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday. “It’s not 9,000 deaths from COVID-19. It’s 180,000-plus deaths.”

“The point that the CDC was trying to make was that a certain percentage of [deaths] had nothing else but COVID,” Fauci continued. “That does not mean that someone who has hypertension or diabetes who dies of COVID didn’t die of COVID-19. They did.”

In reality, it’s more likely that the U.S. is undercounting rather than overcounting COVID-19 deaths. According to a recent New York Times analysis of CDC estimates, at least 200,000 more people than usual died in the U.S. between March and early August — meaning that the official COVID-19 death count, which hit 140,000 over the same period, is probably too low. 

In the Hawkeye State, COVID-19 had killed at least 1,125 as of Wednesday afternoon. Over the past week, the state has reported an average of 1,177 cases per day, an increase of 124 percent from the average two weeks earlier. Its positive testing rate has risen from 10 percent to 18.5 percent since then. 

So while Republican lawmakers such as Ernst seek to downplay the lethality of the virus, Theresa Greenfield, Iowa’s Democratic Senate candidate, seized on her opponent’s baseless claim to underscore the gravity of the situation in one of the only states in America where the pandemic is getting worse.    

“It’s appalling for you to say you’re ‘so skeptical’ of the toll this pandemic has on our families and communities across Iowa,” Greenfield tweeted Tuesday, addressing the senator. “We need leaders who will take this seriously.”

Why a herd immunity approach to COVID-19 could be a deadly disaster

Reporter Rebecca Corey noted that since the coronavirus pandemic began, herd immunity has been floated by some experts as a possible solution to the deadly virus that has so far killed over 865,000 people worldwide. 

Herd immunity is possible when enough people have contracted and become immune to a virus, providing community-wide protection by limiting the number of people who can spread it. And while the strategy is considered controversial and even downright dangerous by many public health experts, it is also reportedly gaining momentum in the White House.    

According to a report by the Washington Post, herd immunity is a strategy being pushed by Dr. Scott Atlas — a neuroradiologist with no background in infectious diseases or epidemiology who recently joined the White House as a pandemic adviser. 

Atlas denied that he had encouraged the White House to adopt a herd immunity strategy, and on Wednesday White House coronavirus task force coordinator Dr. Deborah Birx and top infectious disease expert Dr. Anthony Fauci dismissed the idea that herd immunity was under consideration. An administration official, however, told CNN that the policies being promoted by Atlas are indeed akin to a herd immunity approach.   

Ordinarily, herd immunity would be acquired through a majority of the population being vaccinated — not through immunity acquired by natural infection. 

“Normally, when we talk about herd immunity, we talk about how much of the population needs to be vaccinated,” World Health Organization (WHO) COVID-19 technical lead Dr. Maria Van Kerkhove said on Aug. 27. “If we think about herd immunity in a natural sense of just letting a virus run, it’s very dangerous because you would need a lot of people to be infected.” 

It’s still uncertain what percentage of a population would need to be immune to the virus in order to attain herd immunity. According to Johns Hopkins University, in general, the answer is 70 to 90 percent of a population, depending on how contagious the infection is. But a model published last month in the magazine Science found that the threshold needed for coronavirus herd immunity could be as low as 43 percent. 

Proponents of herd immunity have looked to emulate Sweden’s more hands-off approach; unlike most countries in Europe, the Nordic country opted out of a nationwide lockdown and kept most businesses open. 

But Sweden’s strategy didn’t entail a total return to normalcy. The Swedish government implemented a ban on gatherings of 50 people or more, and many Swedes voluntarily followed social distancing guidelines. 

Former FDA Commissioner Scott Gottlieb noted in an op-ed published on Aug. 30 that in addition to being much larger than Sweden (a country with a population the same size as North Carolina’s), the U.S. has a high rate of citizens with preexisting conditions, which can lead to a higher rate of COVID-19 complications; about 10 percent of Americans have diabetes, and 40 percent are considered obese. 

Moreover, Sweden’s pursuit of natural herd immunity doesn’t appear to be working. A study released in June by the country’s Health Agency showed that only 6 percent of Swedes had developed antibodies to the coronavirus — though a recent study from Sweden’s Karolinska Institute and Karolinska University Hospital suggests that immunity in Sweden may be higher than antibody tests indicate. 

The role of antibodies and how much of an impact they have on long-term immunity is still questionable. A U.K. study, which had not yet been peer-reviewed, found that antibodies may start to decline 20 to 30 days after the onset of COVID-19 symptoms. And a Chinese study found that antibody levels in patients who had recovered from COVID-19 fell sharply within two to three months after infection. 

Falling antibody counts may not necessarily mean waning immunity; other immune responses such as T-cells could also affect how long immunity lasts. But the case for natural herd immunity is made even more improbable by reports of coronavirus reinfections in Hong Kong, Europe and the U.S. If natural immunity is as short-lived as a few months, that wouldn’t be stable enough to provide community or nationwide protection.    

Yahoo News Medical Correspondent Dr. Dara Kass says waiting to reach the minimal number of infections needed for natural herd immunity to work would not only take longer than waiting for a vaccine (which could come before the end of the year, according to the CDC) but would also likely cost more lives. Even if only 40 percent of the U.S. population needed to contract and recover from COVID-19 to reach natural herd immunity, Kass argues, that would mean another 126 million more Americans would still need to be infected.  

“It’s taken us six months to get to 6 million infections,” Kass says. “What if we just said, let’s live life like normal? Let’s not wear masks, let’s not socially distance, let’s ride the subways and go to work. How fast could we get to 126 million infections? One year? Two years? Three years? We don’t know. But what we know is, the faster we infect people, the more people will die.” 

“We’ve seen so far 185,000 Americans die of this coronavirus with 6 million people infected,” Kass continues. “If we want to intentionally infect another 126 million Americans, that means that over 1 million more Americans would die of this virus before we infected enough people to get to any possible natural herd immunity.” 

According to a Gallup poll conducted in late July, 35 percent of Americans said they would not get a coronavirus vaccine even if it were FDA-approved and available to them at no cost. But Kass says a vaccine will likely be the key to any workable herd immunity strategy.

“The bottom line is, will herd immunity be the answer to this coronavirus pandemic? And the answer will be yes — but not natural herd immunity. We will get to herd immunity hopefully with the development of a safe, effective vaccine,” Kass says.  

“Until we have a safe and effective vaccine that is available to the hundreds of millions of Americans that still need to be exposed and recovered from this virus, we just need to continue to do the hard work, which means wear a mask, be socially distanced from people you don’t know, wash your hands multiple times a day and listen to the science.”

College Students Are Already Itching to Sue Frats Over COVID-19

So, is anyone surprised at the stupidity of college students returning to campus after this long imposed “lock-down?” Are you surprised at the number of positive COVID-19 tested students after all of their large parties?

Emily Shugerman reported that across the country, as college students return to campus with masks and hand sanitizer, fraternities and sororities are doing what they’ve always done: drinking and partying. 

At the University of Washington this summer, 137 students living in frat houses tested positive for the coronavirus after hosting raucous parties that violated their own internal guidelines. At the University of Alabama, students completed an entirely virtual rush process that ended with new members showing up in person to sorority houses, packing themselves together to take photos and then crowding the neighboring bars. The next week, the university announced more than 500 cases on campus.

For responsible students and their families, who could fall ill or have their classes canceled due to their classmates’ Greek Life antics, it all seems ripe for a lawsuit, right?

Not necessarily.

Two attorneys who specialize in litigation against frats told The Daily Beast they have received multiple inquiries from concerned students or parents wondering what their legal rights are when it comes to potential super-spreader events on their campus.

Attorney Douglas Fierberg said filing a lawsuit is absolutely an option, arguing that violating public health rules around coronavirus is no different than violating other safety rules, like a speed limit. 

“The violation of [safety rules] by someone with no excuse or justification renders them responsible for the harm that’s caused,” he told The Daily Beast. “That precedent has been around since the dawn of American jurisprudence.”

But David Bianchi, an attorney who helped draft Florida’s anti-hazing law, said it isn’t so simple. In order to win such a suit, the plaintiff would have to prove not only that the defendant acted negligently, but that the negligent behavior directly caused them harm. And in a pandemic—where the virus could be picked up anywhere from a frat house to a grocery store parking lot—that could be difficult to prove. 

“The defense lawyer will have a field day asking questions of the plaintiff about every single place they went for the seven days before the fraternity party, the seven days after the fraternity party, and they’re going to come up with a list of 50 places,” he said. “How do you prove that that’s not where they got it from?”

Bianchi said half a dozen parents called his office asking about the possibility of filing a lawsuit, and he told them not to bother.

“I call ’em like I see ’em, and I just don’t see it here,” he said.

Lawsuits against Greek organizations, for everything from wrongful death to sexual assault, are big business for personal injury attorneys. (In 2018, the parents of a freshman at Northern Illinois University won a historic $14 million settlement after their son died at a fraternity party.) 

And there’s no question that some are bracing for suits against fraternal organizations: Holmes Murphy, an independent insurance brokerage with a specialty in frats, wrote a blog post on how clients could avoid trouble.

“We’ve received many questions about whether or not a house corporation has a duty to do anything,” the post said. “This is a question that will ultimately be tested after a case and spread within a house occurs. There is certainly no shortage of lawsuits as a result of the pandemic. Ultimately, doing the right thing comes first. Start with the basics. That may be all you can do. But it is better than doing nothing.”

What’s hazier is the prospect for coronavirus lawsuits in general. Thousands of suits have been filed since the pandemic started—against schools, businesses, prisons, and pretty much anywhere else you can pick up a virus—but few have been decided. Some legislators have also pushed for laws giving businesses widespread legal immunity, in hopes of getting the economy back up and running. 

On college campuses, Fierberg said, legal actions may not happen right away—classes have only just started, and it takes time for someone to get infected, suffer a grievous injury, and find a lawyer. He predicted a rash of such suits in the next six months to a year.

“The time period that this is incubating is now,” he said. “What’s gonna happen in that experiment is yet to entirely show itself. If it comes out as Frankenstein then that’s one thing. If it comes out as something nice… well that’s a different thing.”

Why a Vaccine Won’t Be a Quick Fix for COVID-19

Medscape’s Brenda Goodman noted that nine months into the COVID-19 pandemic, we are all exhausted, stressed out, and looking for the exit, so hopes for a vaccine are high. Not only are we all stressed out but with the election only weeks away there is pressure to have a vaccine so that President Trump sees a bump in his numbers for re-election possibilities.

Numerous efforts are underway around the world to test, manufacture, and distribute billions of doses. A table maintained by the World Health Organization (WHO) lists 33 vaccines against SARS-CoV-2, the virus that causes COVID-19, currently being tested in people, with another 143 candidates in preclinical testing and I just reviewed an article which noted that there were actually 210 vaccines being studied.

The effort is so critical, the U.S. government is spending billions to make doses of vaccine that may be wasted if clinical trials don’t show them to be safe and effective. The goal of this massive operation, dubbed Warp Speed, is to deliver 300 million doses of safe and effective vaccines by January 2021.

As important as a vaccine will be, some experts are already trying to temper expectations for how much it will be able to do.

“We all hope to have a number of effective vaccines that can help prevent people from infection,” Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, said at an Aug. 3 news briefing. “However, there is no silver bullet at the moment, and there might never be.”

Barry Bloom, PhD, an expert in infectious diseases and immunology at the Harvard T.H. Chan School of Public Health, is even more direct: The idea that a vaccine will end the pandemic just isn’t realistic.

“That’s not going to happen,” he says. First, not enough people will get the vaccine. Second, for those who do take it, the vaccine may only offer partial protection from the virus.

“I am worried about incomplete availability, incomplete protection, unwillingness of a portion of a country to be vaccinated,” Bloom says.

At least at first, not enough people will get the vaccine for the world to achieve herd immunity, or community protection. Community protection robs the virus of the chance to spread easily. It occurs when enough people become immune, either because they’ve recovered from the infection or been vaccinated against it. This high level of immunity in a population cuts the chances that someone without immunity ― say an infant or someone who can’t be vaccinated for medical reasons ― will be exposed to the virus and get sick.

Typically, the herd immunity threshold for an infection is somewhere between 70% and 90% of the population. We don’t yet know where the threshold is for COVID-19 because there are still big unanswered questions about how our bodies respond to the virus or a vaccine against it: Do most people respond in a way that protects them in the future? If so, how long does that protection typically last?

Even at the low end of the typical range for community protection ― 70% ― we’re still far short of that mark.

Recent studies checking blood samples submitted to commercial labs suggest that 5% to 10% of the population has recovered from a COVID-19 infection in the U.S. That’s just an average. The real number varies widely across the U.S., ranging from a low of about 1% in San Francisco to a high of about 20% in New York City, according to CDC data. Most of the country is still in the 3%-5% range ― still a long way from community protection against the virus.

So, most of the immunity needed to reach a level that would provide community protection would have to come from a vaccine.

“It’s not just getting a vaccine. It’s using it and using it appropriately,” Bloom says. “Vaccines don’t prevent anything. Vaccination does.”

Getting enough doses to enough people will take a while, even after a vaccine becomes available, for several reasons.

When vaccines against COVID are first approved, supplies will be tight. Initially, there may be enough doses for 10 million to 15 million people in the U.S. The first shots will be reserved for the people who need them most.

Just this week, the National Academy of Sciences came up with a draft plan for how to fairly distribute the vaccine, which would unfold in four phases. Those phases will take time to execute.

The first phase recommends that the first doses go to health care workers and first responders, with the next batch going to people with health conditions that put them at highest risk of dying from COVID, and to seniors living in group homes. Those groups make up just 15% of the population, according to the report.

Phase two, which covers about 30% of the population, calls for vaccination of essential workers at “substantially high risk of exposure,” teachers, people with health conditions that put them at moderate risk from the disease, people living in close contact with others (like prisoners and those staying in homeless shelters), and seniors who weren’t covered in phase one.

The largest chunk of the population, including children, who can be infected but may show few signs of illness, aren’t a priority until phase three, which also includes other essential workers. Phase three accounts for about 40% of the population. The last phase, everyone else, makes up about 5%.

Among those who are eligible for vaccination, not everyone is likely to agree to get one.

A recent poll by Gallup found that 35% of Americans ― or about one in three ― don’t plan on getting a COVID-19 vaccine, even if it’s free. Among the two-thirds of Americans who say they will be immunized, a large number plan to wait. A recent survey by STAT found that 71% will wait at least 9 months to get their shots.

Those numbers align with a recent poll by WebMD, which found that 73% of readers said they would wait at least 3 months to get a vaccine when one becomes available.

“I don’t find that shocking. I would think for people who are rational, wouldn’t you want to see what the data are on safety and efficacy before you made a decision?” Bloom says. “I’m worried about the 25% who, no matter what happens, won’t take the vaccine. Those are the people who really worry me.”

Vaccine hesitancy ― fear of getting any vaccine ― is growing. The WHO recently listed it as one of the top threats to global health, pointing to the recent resurgence in measles. Many countries have recently seen large outbreaks of measles. These outbreaks have been caused by an increasing number of parents refusing to vaccinate their kids.

Experts are worried that vaccine hesitancy will play a large role in whether the U.S. and other countries reach herd immunity thresholds. The Gallup poll found Republicans are less likely to be vaccinated than Democrats, and nonwhite Americans ― the group being disproportionately affected by COVID-19 infections ― are less likely to be vaccinated than whites.

Bloom and others believe that right now, we should be working on a way to overcome vaccine hesitancy.

“Policymakers have to start focusing on this,” says Robert Litan, PhD, JD, a nonresident senior fellow at the Brookings Institute.

He thinks we shouldn’t try to overcome hesitancy by forcing people to take the vaccine. Instead, he wants the government to pay people to take it ― $1,000 each, or $4,000 for a family of four.

“That’s a lot of money,” especially now with the economy sagging and so many people out of work, Litan says. “I think a thousand dollars would get a lot of people to take the shot who would otherwise not take it.”

Litan ran the numbers, looking at various scenarios of how many people would take it and how effective the vaccine might be. He says he realized not enough people would be protected to fully reopen the country.

He says he’s not sure $1,000 is the right sum, but it should be generous because if people think the amount could go up, they will wait until it does, which would defeat the purpose of the incentive.

“I can’t think of anything else,” he says. “You either have carrots or sticks, and we can’t use sticks. It won’t work.” How Well Will It Work?

Getting enough people to take it is only one piece of the puzzle. We still don’t know how well any of the shots might work, or for how long that protection lasts.

Researchers have now confirmed at least four cases of COVID-19 reinfection, proving that the virus infected the same person twice.

We still don’t know how common reinfection is, but these cases suggest that some people may need a booster dose of vaccine before they’re fully protected against the virus, says Gregory Poland, MD, an expert in immunity and vaccine responses at the Mayo Clinic in Rochester, MN.

That’s similar to the way we dole out vaccines for seasonal flu, with people urged to get the shot every year, he says.

That’s another reason it could take a while to reach herd immunity.

It’s also not clear how effective a vaccine may be.

The FDA and WHO have said that a vaccine should be at least 50% more effective than a placebo to be approved. But that could mean that a shot merely decreases how bad an infection is but doesn’t stop it. That would be an important effect, Bloom says, but it could mean that even vaccinated people would continue to spread the infection.

“If it prevents disease, but doesn’t prevent growth in the upper respiratory tract, there is a possibility there will be a group of people who will be infected and not get sick because of the vaccine but still have the virus in their respiratory tract and be able to transit,” Bloom says. “That would not be the ideal for a vaccine, but it would protect against disease and death.”

He says the first studies will probably measure how sick vaccinated people get and whether or not they need to be hospitalized.

Longer studies will be required to see if vaccinated people are still able to pass the virus to others.

How effective any vaccine may be will also depend on age. In general, older adults ― the ones who most need protection against COVID-19 ― don’t respond as well to vaccines.

Our immune systems get weaker as we get older, a phenomenon called immunosenescence.

Seniors may need specially formulated vaccines ― with added ingredients, called adjuvants ― to get the same response to vaccines that a younger person might have.

Lastly, there’s the problem of reintroduction. As long as the virus continues to spread anywhere in the world, there’s a risk that it could reenter the U.S. and reignite infections here.

That’s what happens every year with measles. In most states, more than 90% of people are vaccinated against measles. The measles vaccine is one of the most effective ever made. It gives people substantial and long-lasting protection against a highly contagious virus that can stay in the air for long periods. You can catch it by walking through the same room an infected person was in hours before.

Every year, travelers come to the U.S. carrying measles. If they go to a crowded place, like a theme park, it increases the chances that initial infection will touch off many more. As vaccine hesitancy has increased in the U.S. and around the world, those imported cases have sparked outbreaks that have been harder and harder for public health officials to extinguish, raising the risk that the measles virus could become endemic again in countries like the U.S.

For the world to be rid of COVID-19, most of the world has to be vaccinated against it. There’s an effort underway ― called COVAX ― to pay for vaccinations for poorer countries. So far, 76 of the world’s wealthier countries have chipped in to fund the effort. The U.S. has not. The Trump administration says it won’t join because of the WHO’s involvement in the effort, a move that may place the plan in jeopardy.

For all these reasons, it will probably be necessary to continue to spread out, wear masks, and be vigilant with hand hygiene to protect yourself and others for the foreseeable future.

“For now, stopping outbreaks comes down to the basics of public health and disease control,” Tedros said.

We may get a vaccine, but we will still need to be able to test enough people for the virus, warn their contacts, and isolate those who are infectious to keep the epidemic under control, or, as Tedros has urged, “Do it all.”