Category Archives: Pfizer vaccine

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.

Another New COVID Strain Is in the US; Will Present Vaccines Work with these New Strains, Pandemic Strategies Including New Migrants and What Happened to Merck’s Vaccine?

This has been an interesting few week and almost led me to close my office and retire. We had a patient come in the office and complete the questionnaire and “by-pass” our screening procedures, lying to us about his exposure to the COVID-19 virus. He just visited his brother the two days before the days office visit and lied to us, saying that he had no recent exposure, etc. However, a week later he called our office to allow notification that his COVID test was positive.

The thing that angered me and my staff more was that the patient waited a number of days to notify, besides lying to us about his exposure. This led us to close the office, cancel all patients until we could have a complete cleaning of the office and all get COVID tested.

Luckily, we all tested negative and all my staff and I had at least had our first vaccine doses. If we had tested positive, we would have to notify all the patients that were seen in the office between his visit and the day that we closed the office.

What an irresponsible set of actions and my fear is that this goes on in many situations because many of our patients, etc. are selfish and irresponsible and don’t care about anyone else except themselves…and they think the virus is all a lie, util one of their family members or close friends dies. How totally stupid and disgusting!! 

John Johnson wrote that the virus continues to mutate quickly. Anyone tracking the news is familiar with the new UK strain that is moving around the globe and threatens to become the dominant strain in the US soon. Now, health authorities in California have identified yet another strain that has popped up in about a dozen counties, reports the Los Angeles Times. Coverage on that and more:

  • California strain: The variant has been linked to large outbreaks in Santa Clara County and smaller outbreaks elsewhere. It’s still too early to say whether the new strain is more contagious or more lethal than the first forms of COVID that emerged, but studies on that are being prioritized. Bottom line: “This virus continues to mutate and adapt, and we cannot let down our guard,” says Dr. Sara Cody, Santa Clara County health officer.
  • A lament: In a New York Times op-ed, Ezra Klein runs through the coming COVID changes under the Biden administration. They include plans to get vaccinations organized on a mass scale, along with expanded testing and contract tracing. It’s all pretty basic stuff, he writes, which has him astonished that the Trump administration hasn’t done these things yet. “That it is possible for Joe Biden and his team to release a plan this straightforward is the most damning indictment of the Trump administration’s coronavirus response imaginable.”
  • Hopeful trend: US deaths are about to pass 400,000, but one medical expert spies a positive trend in the new data as well. “Over the last four days for the first time in months, we’ve seen a steady decline … a thousand per day fewer hospitalizations in the United States,” Dr. Jonathan Reiner of George Washington University tells CNN. “We’ve seen the same trend in new cases.” The next two months will likely be brutal, he adds, “but there is a ray of sunshine” as vaccinations continue.
  • Hopeful, II: In “The Morning” newsletter at the Times, David Leonhardt is tired of the “they’re only 95% effective” drumbeat, and he’s not alone. “It’s driving me a little bit crazy,” Dr. Ashish Jha of the Brown School of Public Health tells Leonhardt. Dr. Aaron Richterman of the University of Pennsylvania adds, “We’re underselling the vaccine.” As Leonhardt explains and doctors emphasize, the vaccine will save your life, even if you’re in that other 5%. To wit, of 32,000 people who got the Pfizer and Moderna vaccines in trials, only one person suffered a severe COVID case.

Migrant caravan demands Biden administration ‘honors its commitments’

Now, a real challenge for the new Biden administration. Adam Shaw noted that a migrant caravan moving from Honduras toward the U.S. border is calling on the incoming Biden administration to honor what it says are “commitments” to the migrants moving north, amid fears of a surge at the border when President-elect Joe Biden enters office.

More than 1,000 Honduran migrants moved into Guatemala on Friday without registering, The Associated Press reported. That is part of a larger caravan that left a Honduran city earlier in the day.

The outlet reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.

“We recognize the importance of the incoming Government of the United States having shown a strong commitment to migrants and asylum seekers, which presents an opportunity for the governments of Mexico and Central America to develop policies and a migration management that respect and promote the human rights of the population in mobility,” the statement said. ” We will advocate that the Biden government honors its commitments.” 

Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts migrants at risk. 

Biden has also promised a pathway to citizenship for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.

“A new United States Government is an opportunity to work with the Mexican Government to develop a cooperation plan with Central America to address the causes of migration, together with civil society organizations, as well as an opportunity to increase regional cooperation regarding the persons in need of protection, and to dismantle illegal and inhuman programs such as Remain in Mexico, the United States’ Asylum Cooperation Agreements with El Salvador, Guatemala and Honduras, as well as the Title 42 expulsions by the United States authorities,” it said, referring to the Centers for Disease Control (CDC) order that allows the U.S. to quickly remove migrants on public health grounds.

Biden officials, however, have been keen to send the message to migrants that it will not mean open borders overnight.

“Processing capacity at the border is not like a light that you can just switch on and off,” incoming Biden domestic policy adviser Susan Rice told Spanish wire service EFE. “Migrants and asylum seekers absolutely should not believe those in the region peddling the idea that the border will suddenly be fully open to process everyone on Day 1. It will not.” 

“Our priority is to reopen asylum processing at the border consistent with the capacity to do so safely and to protect public health, especially in the context of COVID-19,” she said. “This effort will begin immediately but it will take months to develop the capacity that we will need to reopen fully.”

It is unclear how far the migrants will get, and Guatemalan and Mexican governments have indicated they intend to turn them back. But the caravan comes amid fears that the new outlook on immigration and asylum from the Biden administration will fuel a surge at the border.

Acting Customs and Border Protection (CBP) Commissioner Mark Morgan said on “America’s News HQ” on Saturday that the caravan could include more than 5,000 migrants and blamed the tone from the incoming administration.

“We’re looking at two groups that are well over five thousand. And one of those groups have already gotten through the Guatemala border. And they’re on their way to El Rancho, which is about the located centrally in Guatemala,” he said. “It’s coming. It’s already started, just as we promised and anticipated it would with this rhetoric from the new administration on the border.”

President Trump warned this week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before” and that there were already signs of increased flows.

“They’re coming because they think that it’s a gravy train at the end,” he said. “It’s going to be a gravy train. Change the name from the caravans, which I think we came up with, to the gravy train because that’s what they’re looking for — looking for the gravy.”

Biden transition official tells migrant caravans: ‘Now is not the time’ to come to US

Yael Halon reported further on the migration noting that a migrant caravan moving from Honduras toward the U.S. border called on the incoming Biden administration to honor their “commitments” to the migrants moving north, citing the incoming administration’s vow to ease Trump’s restrictions on asylum.

But on Sunday, an unnamed Biden transition official said that migrants hoping to claim asylum in the U.S. during the first few weeks of the new administration “need to understand they’re not going to be able to come into the United States immediately,” NBC News reports. 

More than 1,000 Honduran migrants moved into Guatemala on Friday without registering as part of a larger caravan that left a Honduran city earlier in the day.

The Associated Press reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.

The Biden transition official, however, warned migrants against coming to the U.S. during the early days of the new administration, telling NBC that while “there’s help on the way,” now “is not the time to make the journey.” 

“The situation at the border isn’t going to be transformed overnight,” the official told the outlet.

“We have to provide a message that health and hope is on the way, but coming right now does not make sense for their own safety…while we put into place processes that they may be able to access in the future,” the official said.

President-elect Joe Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their political asylum hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts them at risk. 

Biden has also promised a pathway to legal permanent residency for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.

President Trump warned last week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before,” claiming that there were already signs of increased flows.

AMA President: Biden Team Must Create National Pandemic Strategy

Ken Terry stated that now that the campaign is over, that the incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, said Susan R. Bailey, MD, president of the American Medical Association (AMA), in a speech delivered today at the National Press Club in Washington, DC.

Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.

“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Bailey emphasized.

She called on the Biden administration, which takes over next week, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”

In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”

Biden Vaccine Distribution Policy

In a question-and-answer period following her speech, however, Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Tuesday, the Trump administration announced that it plans to do the same thing.

“We’re a little bit concerned about the announcement that [the Department of Health & Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Bailey said. “We don’t have adequate data to tell us that one dose is sufficient — we don’t think it is — and how long you can wait for the second dose without losing the benefits of the first dose.”

She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline healthcare workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”

Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.

Bolstering Public Health

In her speech, Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the US has a public health crisis:

  • Restore trust in science and science-based decision making. Make sure that scientific institutions like the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
  • Ensure that the health system provides all Americans with affordable access to comprehensive healthcare. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
  • Work to remove healthcare inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA policy statement that recognized racism as a public health threat.
  • Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
  • Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised Biden for his promise that the US will rejoin the World Health Organization.

At several points in her presentation, Bailey rejected political interference with science and healthcare. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.

Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”

Asked when she thought that life might get back to normal again in the US, Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”

Merck Ends Development of Two Potential COVID-19 Vaccines

Tom Murphy, AP Health Writer, pointed out that the drug maker, Merck, said Monday that it will focus instead on studying two possible treatments for the virus that also have yet to be approved by regulators. The company said its potential vaccines were well tolerated by patients, but they generated an inferior immune system response compared with other vaccines.

Merck was developing one of the potential vaccines with France’s Pasteur Institute based on an existing measles vaccine. The French institute said it will keep working on two other vaccine projects using different methods.

Merck entered the race to fight COVID-19 later than other top drug makers.

It said last fall that it had started early-stage research in volunteers on potential vaccines that require only one dose. Vaccines developed by Pfizer and Moderna were already in late-stage research at that point.

The Food and Drug Administration allowed emergency use of both the Pfizer and Moderna vaccines late last year. Each requires two shots.

Five potential vaccines have reached late-stage testing in the United States, the final phase before a drug maker seeks approval from regulators. Results from a single-dose candidate developed by Johnson & Johnson are expected soon.

Since vaccinations began in December, nearly 22 million doses have been delivered to people nationwide, according to the Centers for Disease Control and Prevention. Nearly 6% of the population has received at least one dose.

A total of 3.2 million people, or 1% of the population, have received both doses required for those vaccines.

More than 419,000 people in the United States and 2 million globally have died due to the coronavirus, according to Johns Hopkins University.

The government is paying Merck & Co. about $356 million to fast-track production of one of its potential treatments under Operation Warp Speed, a push to develop COVID-19 vaccines and treatments. The money will allow the Kenilworth, New Jersey, company to deliver up to 100,000 doses by June 30, if the FDA clears the treatment for emergency use.

The treatment, known as MK-7110, has the potential to minimize the damaging effects of an overactive immune response to COVID-19. This immune response can complicate the life-saving efforts of doctors and nurses.

Merck said early results from a late-stage study of that drug showed a more than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate or severe COVID-19. The company expects full results from that study in the first quarter.

Merck’s other potential treatment is an oral antiviral drug.

Merck said it will focus COVID-19 research and manufacturing efforts on two investigational medicines: MK-7110 and MK-4482, which it now calls molnupiravir. Molnupiravir, which is being developed in collaboration with Ridgeback Bio, is an oral antiviral being studied in both hospital and outpatient settings. If these oral antiviral drugs are effective this will be a real advancement in the treatment of COVID-19. Merck said a phase 2/3 trial of the drug is set to finish in May, but initial efficacy results are due in the first quarter and will be made public if clinically meaningful. 

Merck said results from a phase 3 study of MK-7110, an immune modulator being studied as a treatment for patients hospitalized with severe COVID-19, are expected in the first quarter. In December, the company announced a deal to supply MK-7110 to the U.S. government for up to about $356 million. (Reporting by Deena Beasley Editing by Shri Navaratnam)

Moderna Study: Vaccine Effective vs COVID Variants

With the weekly announcement of new mutant strains of the COVID virus we are all wondering whether the vaccine that are being administered will be effective against the new strains. Carolyn Crist noted that as mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.

Moderna, whose two-dose vaccine has been authorized for use in the U.S. since Dec. 18, said Monday that it is now investigating whether a third dose of the vaccine will work to prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.

“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stephane Bancel said in a statement.

Moderna on Monday also said its COVID-19 vaccine could protect against the U.K. strain but that it is less effective against the strain identified in South Africa.

Pfizer and BioNTech, whose vaccine were also authorized in December, announced last week that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the coronavirus variant first identified in the United Kingdom.

“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.

“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”

There were at least 195 confirmed cases of patients infected with the U.K. variant in the U.S. as of Friday, according to the CDC. No cases from the South African variant have been confirmed in the U.S. To try and prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.

The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.

That means about 1 in 13 people in the U.S. have contracted the virus, or about 7.6% of the population.

“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.

After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year. Following a major surge throughout January, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.

Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Sunday, about 111,000 patients were hospitalized, which is the lowest since mid-December.

The U.S. has also reported nearly 420,000 deaths. As recently as last week, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily deaths.

The University of Washington’s Institute for Health Metrics and Evaluation released a new projection last week that said new cases would decline steadily in coming weeks. New COVID-19 cases have fallen about 21% in the last 2 weeks, according to an analysis by The New York Times.

“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.

At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.

“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Rivers told the newspaper.

So, next, when we get vaccinated do we need to wear masks and continue social distancing?

We will explore that set of questions next.

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!