Tag Archives: 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.

Pandemic fears are boosting demand for trustworthy news; And What Have We Learned from Sweden’s Experience?

During these last few months of the pandemic one of my concerns is the lack consistent reliable data with which the media pundits of all sorts deliver their predictions and many times with false knowledge and predictions. Question, what is the correct social distancing length? Studies keep on changing! One of the key features of the web is its ability to turn regular people into citizen journalists. The cost of publishing text on the web is almost nil. The barriers to entry in the media industry are low, too. And many readers are not picky about where their news comes from: the stories that go viral can come from amateur scribes or veteran ones, media startups or established outfits. But this is not always the case. New research suggests that when a crisis hits, readers turn to reliable sources.

In 2018 Paul Resnick and James Park, two researchers at the University of Michigan, devised a pair of tools for measuring the popularity of English-language news stories on Facebook and Twitter. The first, dubbed the “Mainstream Quotient”, measured the proportion of highly-shared links that came from mainstream news sources, such as the New York Times, the BBC and, yes, The Economist. The second, the “Iffy Quotient”, measured the share originating from less trustworthy sources, based on ratings provided by NewsGuard, a company that tracks misinformation published online.

Both indices have shifted significantly during the pandemic. Beginning in February, when the coronavirus started to spread outside China, traffic to traditional media outlets and news sites surged, whereas dodgier sites attracted fewer readers. The Mainstream Quotient rose steadily during this period, a phenomenon Messrs Resnick and Park call a “flight to quality”. The Iffy Quotient, meanwhile, tumbled. The drop was particularly steep during March, when many countries instituted lockdown measures (see chart).

The researchers argue that consumers seek out reliable news sources during times of uncertainty, in the same way that fearful investors turn to gold. Whether these patterns will last remain unclear. The Iffy Quotient has already started to creep back up, for both Facebook and Twitter. And recent efforts by social-media platforms to crack down on fake news may prove only temporary. Once the pandemic subsides, demand for unreliable news may return to pre-covid levels. For now, at least, the flight to quality has taken off.

Pandemic Spike in Telehealth Levels Off

Crystal Phend of MedPage pointed out that Telehealth’s early bonanza during the pandemic has given way to persistently elevated use in primary care, a Department of Health and Human Services (HHS) report showed.

Analysis of Medicare fee-for-service (FFS) data showed an increase in Medicare primary care visits from 0.1% of all primary care in February to 43.5% in April, representing an increase from about 2,000 to 1.28 million telehealth visits per week.

Meanwhile, there was a “precipitous” drop in in-person visits for primary care in mid-March as COVID-19 took hold in the U.S., then a rise from mid-April through May, according to the report from the Office of the Assistant Secretary for Planning and Evaluation.

Use of telehealth in primary care “declined somewhat but appears to have leveled off at a persistent and significant level by the beginning of June,” the report noted. It still accounted for 22.7% of Medicare beneficiaries’ primary care visits as of June 3rd.

Overall, weekly primary care visit rates have not yet returned to pre-pandemic levels.

“Based on early experience with Medicare primary care telehealth at the start of the COVID-19 public health emergency, there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services — when many beneficiaries and providers were concerned with transmission of COVID-19,” the authors noted. “The stable and sustained use of telehealth after in-person primary care visits started to resume in mid-April suggests there may be continued demand for telehealth in Medicare, even after the pandemic ends.”

The findings overall match those from healthcare provider databases suggesting a 60% to 70% drop in health care office visits, partially offset by telehealth visits, with the start of the pandemic. Drug market research firm IQVIA has reported from physician surveys that about 9% of patient interactions were via telehealth prior to the pandemic but 51% during the shutdown, with expectation of a 21% rate after the pandemic, the HHS report noted.

There have been calls for Medicare to make the loosened rules around telemedicine permanent, and some legislative movement in that direction, but private insurers have signaled the opposite.

Fred Pelzman, MD, an internal medicine physician at Weill Cornell Medicine in New York City (and MedPage Today columnist), said an informal survey of his patients indicated they would be willing to do up to 50% of their care via video tools.

“We went from a handful of video visits in our practice to several thousand over the course of the months,” he said. “It’s a great way to take care of people, kept a lot of people safe, we think. What has happened is that as we started to open our practice back up again and offer appointments, the floodgates have opened and patients are declining video visits.”

Those patients opting for in-person visits tend to be older, braving what feels like a quiet time in the pandemic for the state to take care of necessary visits, he noted. “I think ultimately that we’ll plateau. It will probably come down a little more.”

The study included Medicare FFS Part B claims from January through May 2020 for primary care services along with preliminary Medicare Part B primary care claims data up to June 3. Primary care services included evaluation and management, preventive services, and advance care planning.

Telehealth usage increased most in urban counties early in the pandemic and saw smaller declines in May compared with rural counties across the country. Among cities, Boston had the greatest proportion of primary care visits by telehealth (73.1%) and Phoenix the lowest (37%).

Notably, the rate “was not strongly associated with differences in COVID-19 severity across cities as measured by rate of hospitalizations per thousand Medicare FFS beneficiaries,” the report pointed out.

I read an article predicting that telehealth visits are the future of medicine. This is truly worrisome due to the many incorrect diagnoses as well as poor control of chronic diseases that I have seen coming through my office alone. Physical diagnosis is made by looking at the patient, listening to the patient, hearing what the patient is really saying, touching the patient and using the different diagnostic tools such stethoscopes, ophthalmoscopes, otoscopes, percussion hammers, etc. to make the correct diagnoses and to follow our patients. How is that done virtually? The only ones benefitting the most from these virtually visits are the practices and the electronic medical record companies selling the practices additional software to utilize telehealth. And patients are finding that not all telehealth “visits” are paid for by their insurance companies.

How Did Sweden Flatten Its Curve Without a Lockdown?

One expert credits a “good-enough strategy”; others worry that it won’t last. Who is correct?

Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage reported that

Despite never implementing a full-scale lockdown, Sweden has managed to flatten its curve, prompting its health leadership to claim victory — but others question the cost of the strategy, as the country has a far higher death toll than its Scandinavian neighbors.

In late July, Sweden’s 7-day moving average of new cases was about 200, down from a peak of around 1,140 in mid-June. Its daily death totals have been in the single digits for two weeks, well below its mid-April peak of 115 deaths in a single day.

However, on a per-capita basis, Sweden far outpaces its Scandinavian neighbors in COVID deaths, with 567 deaths per million people compared with Denmark’s 106 deaths per million, Finland’s 59 deaths per million, and Norway’s 47 deaths per million. The Swedish figure is closer to Italy’s 581 deaths per million.

While the positive trends have led Anders Tegnell, PhD, chief epidemiologist at the Swedish Public Health Agency and architect of Sweden’s coronavirus strategy, to state that the “Swedish strategy is working,” others have criticized the approach, including two dozen Swedish academics who published a recent USA Today editorial.

“In Sweden, the strategy has led to death, grief, and suffering,” they wrote. “On top of that, there are no indications that the Swedish economy has fared better than in many other countries. At the moment, we have set an example for the rest of the world on how not to deal with a deadly infectious disease.”

The Swedish Public Health Agency has not openly stated that herd immunity was its goal, though many suspect that this was the intention. Tegnell told reporters last week he thought the recent trends indicated that immunity was now widespread in the country. But with rates of antibody positivity around 10%, that seems impossible. (Officials at the agency did not respond to MedPage Today‘s request for comment.)

So how has Sweden managed to get its outbreak under control?

Behavior Change

While Sweden didn’t officially lock down, many in the country have described a locked-down “feeling” that has eased in the summer months.

At the start of the outbreak, only high schools and universities closed; daycare and elementary schools have been open. Businesses have also remained open, but typically at reduced hours, and restaurants have functioned at reduced capacity.

Swedes have been asked to keep their distance in public, refrain from non-essential travel, and work from home when possible. Gatherings of more than 50 people are also banned. People age 70 and over are advised to stay away from others as much as possible.

Masks were never required and aren’t commonly worn.

This response hasn’t changed over time, through the June surge and into today’s decline, so there’s no definitive explanation for the flattening, though, and experts have several theories.

“Swedes in general have changed their behavior to a great extent during the pandemic and the practice of social distancing as well as physical distancing in public places and at work has been widespread,” said Maria Furberg, MD, PhD, an infectious diseases expert at Umea University Hospital in northeastern Sweden.

“During the months of March to early June, all shops were practically empty, people stopped dining with friends, and families stopped seeing even their closest relatives,” Furberg told MedPage Today. “A lock-down could not have been more effective. Handwashing, excessive use of hand sanitizers, and staying home at the first sign of a cold became the new normal very quickly.”

Mozhu Ding, PhD, an epidemiologist at the famed Karolinska Institute, said the decline is “likely to be a combination of measures taken by individuals, businesses and a widespread information campaign launched by the government.”

“Even without a strict lockdown order, many businesses allowed employees to work from home, and universities are offering distance courses to the students,” Ding told MedPage Today. “Individuals are also taking personal hygiene more seriously, as items like hand sanitizers and single-use gloves are often sold out in pharmacies and grocery stores.”

Immunity

Experts told MedPage Today there weren’t clear data to prove Tegnell’s assertion of widespread immunity in Sweden.

Furberg said there is likely “some sort of unspecific immunity that protects parts of the population from contracting COVID-19” but it’s not necessarily secondary to SARS-CoV-2 exposure.

For instance, a study by the Karolinska Institute and Karolinska University Hospital recently found that about 30% of people with mild or asymptomatic COVID showed T-cell-mediated immunity to the virus, even though they tested negative for antibodies.

“This figure is [more than] twice as high as the previous antibody tests, meaning that the public immunity to COVID-19 is probably much higher than what antibody studies have suggested,” Ding told MedPage Today. “This is of course very good news from a public health perspective, as it shows that people with negative antibody test results could still be immune to the virus at a cellular level.”

Indeed, T-cell immunity is coming into focus as a potentially important factor in COVID infection. A paper published in Nature in mid-July found that among 37 healthy people who had no history of either the first or current SARS virus, more than half had T cells that recognized one or more of the SARS-CoV-2 proteins.

Another 36 people who had mild-to-severe COVID-19 were all found to have T-cell responses to several SARS-CoV-2 proteins, and another 23 people who had SARS-CoV-1 (the virus responsible for the SARS outbreak in 2003) all had lasting memory T cells — even 17 years later — that also recognized parts of SARS-CoV-2.

It could be that T cell immunity is the result of a previous infection with common cold coronaviruses, but this hasn’t yet been established; nor is it certain that T cell immunity is driving Sweden’s decline in COVID cases.

Path Forward

Summertime is another factor that may account for the decline, which began around late June — not directly because of the weather, but social factors related to it.

Swedes are “outdoors more, and students are not at school,” said Anne Spurkland, MD, a professor of immunology at the University of Oslo in Norway.

Also, “perhaps Sweden has finally gotten better control over the disastrous spread of the virus in nursing homes which to some extent can explain their relatively high death rates,” Spurkland told MedPage Today. About half of Sweden’s 5,730 deaths occurred among those in elder care homes.

Norway is still requiring that Swedes quarantine for 10 days when coming into Norway, and Denmark has not fully reopened its borders to its neighbor yet either.

That doesn’t bode well for the Swedish economy. If the goal of avoiding a lockdown was to spare economic woe, its success has been limited.

According to Business Insider, “international tourism and trade are decimated. … Sweden’s National Institute of Economic Research predicts Sweden’s GDP will fall 5.4% in 2020, after predicting a 1% rise [in] December 2019. It also expects unemployment to rise around three percentage points, to 9.6%, between the end of 2019 and the end of 2021.”

Spurkland said it’s still “too early yet to conclude whether the Swedish approach was the wisest over all,” as it remains to be seen whether Norway and other countries that did lock down will avoid a second wave of infections in the fall.

Yet she cautions that choosing to take on a higher case load may have health consequences far beyond the immediate infection.

“What we have learned these months is that COVID-19 is not only about death, it is also about ill health,” Spurkland said. “Quite a number of people going through the infection have long-term symptoms, that may be stopping them from resuming their daily life. We do not know yet how large a proportion of those who get the virus will fall into this category, but it is certainly a concern.”

“So, when deciding on taking a herd immunity approach to handle a totally new virus we do not know anything about,” she said, “the Swedish government has also unknowingly put the general population at risk for much long-term ill-health caused by the virus.”

Furberg doesn’t see it that way: “I am very proud of the way Swedes have adapted to the restrictions and regulations and I believe the Public Health Agency of Sweden has picked a good-enough strategy for our country.”

What Americans Need to Understand About the Swedish Coronavirus Experiment

Sweden made headlines for never shutting down. Here’s what’s really happening there.

Matthew Zeitlin pointed out that Tooutsiders, life in Stockholm, Sweden, appears perfectly normal: Walk down a cobblestone street, and you may see two friends sitting at a cafe enjoying the spring air or a group of kids kicking a soccer ball in the park. Cars and bicyclists may zip by; a family may walk past you on their afternoon stroll.

Whereas most of the Western world has been in lockdown for weeks, Sweden has opted to forgo any sort of shelter-in-place policy in response to the coronavirus and instead allow businesses and parks to stay open and groups of under 50 to gather.

That’s not to say the country hasn’t been proactive at all. The policy in effect in Sweden is similar to what had been implemented in much of the United States before shelter-in-place orders were issued — and the one that will soon be in place in states that reopen. The Swedish government has recommended that people wash their hands frequently, maintain social distance, work from home if they can, and those who are elderly or more susceptible to Covid-19 stay home. The government recommended that universities switch to online teaching; they quickly followed course. Social distance is required by law in restaurants, and bar service is banned. The government changed its sick leave rules to encourage anyone who is feeling symptoms to stay home. “Instead of saying ‘close down all of society,’ we have looked at society and closed down… aspects of society,” where the disease is most likely to spread, Anders Tegnell, the epidemiologist at Sweden’s Public Health Agency in charge of recommending policy to the government, told The Daily Show. “I think that’s had a great effect.”

Sweden may not be so much an alternative, as a glimpse of the future.

Sweden’s approach has been hailed by critics of American and European pandemic policies as a less restrictive — and less economically devastating — alternative to state or national shutdowns, but it’s also been lambasted by others as an unnecessarily risky strategy that has led Sweden to have the highest Covid-19 death toll among the Nordic nations. As more and more areas of the United States reopen, Sweden may not be so much an alternative as a glimpse of the future.

As of Sunday afternoon, the country had 25,921 confirmed cases and3,220deaths, according to the Johns Hopkins Coronavirus Resource Center. These are much higher figures than those of the country’s neighbors, but lower than those in some other wealthy Western European countries on both an overall and population-adjusted basis. Sweden also has suffered problems familiar to residents of countries that have had more severe outbreaks and stricter policies. Nursing homes have been hard hit, and Tegnell described Sweden’s failure to protect nursing home residents as its greatest shortcoming so far. Immigrant and ethnic minority communities also have suffered, due in part to their larger households. Just over half of all households in Sweden in 2016 consisted of only one person, while immigrants were substantially more likely than native-born residents to live in overcrowded conditions or multigenerational household.

Even with the less aggressive containment measures, the economic effects of the virus have been severe for the country. Sweden’s National Institute for Economic Research projected that gross domestic product would contract by 7% in 2020 and the unemployment rate would rise to just over 10%. The large fall in consumer and business confidence, the institute said in a release, point “to a rapid and severe downturn, not least in large parts of the service sector.”

“The economy will shrink both due to a drop in exports and is already contracting due to lower consumption. But the underlying causes differ: The export sector is mostly affected by the international situation, whereas the drop in consumption is directly related to the government’s recommendation of social distancing,” said Lina Maria Ellegård, an economist at Lund University.

In the first three months of the year, the Swedish economy contracted by less than 1% — less than the United States’ fall — but the production of both goods and services declined in March. The car industry — one of Sweden’s major export sectors — along with real estate, hospitality, and restaurants led the way.

That’s because even without lockdowns or orders, the behavior of Swedes still changed — to an extent. According to data collected by Google and Apple, Swedes have cut back on their travel to places like stores and restaurants and decreased their use of transit-like buses substantially, though not as dramatically as their Nordic neighbors in Denmark. Still, travel over the Easter holiday fell by 90%, Tegnell said on The Daily Show.

Multiple experts in Sweden I spoke to agreed that because a recommendation made by Swedish leadership is culturally viewed as more of a demand, the freedoms allowed have not resulted in free-for-alls. “There’s a basic misconception that there’s one big huge after-ski party,” said Lars Trägårdh, a Swedish historian. “That’s not true.”

Sweden’s voluntary restrictions policy is made possible by the high levels of trust throughout Swedish society. “We have a lot of social trust and a lot of trust in the institutions, and the institutions have confidence in the citizens,” said Trägårdh. “That’s why we decided to have this voluntary approach as opposed to one that’s more hardcore.”

The photos circulating online don’t fully represent the broader reality on the ground either. “I’ve seen pictures in the newspapers and news media of what looks to be crowded restaurants in Stockholm. What I’ve seen is mostly pretty sparse restaurants. Every other table is empty, and there’s very little business,” said Bo Becker, an economist at the Stockholm School of Economics. “Life doesn’t go on as usual, but maybe the lockdown is less severe than in other countries.”

But even if Sweden’s policy of allowing businesses to open and people to move out and about is not that different from some policies American states have or will soon implement, there’s been one major difference: the schools. Schools for children up to age 15 have remained open, all the way down to daycares and preschool. “That makes a world of difference,” Trägårdh told me. “It’s a gender issue.”

Sweden has one of the highest rates of female participation in the labor force for rich countries. Forcing young children to stay home would put many mothers in a bind or even knock them out of the workforce entirely.

“Closing down schools works well if you are in a well-to-do, middle-class family that has a house and a garden and can afford to have one person staying at home,” Trägårdh said. “That may not look like a doable proposition if you are a single parent or do not make a lot of money.”

Shutting down daycare and schools could increase risk as well, Erik Angner, a philosopher and economist at Stockholm University, explained, by leading working parents to turn to their own parents for help. “If you close daycares, then either one parent has to stop working or grandma or grandpa shows up,” he said. But since the elderly are most at risk, it was even more important to keep schools and daycares open

As other countries work through their peak infections, they will have to figure out how to reach a new status quo where the disease’s spread is still slow but restrictions can be lightened. “Now that everybody else is starting to shift toward opening up, people are talking about Sweden,” said Trägårdh. “Other Nordics are realizing you can’t keep schools closed forever. We’re in the long run here. It’s not a 60-meter race, it’s more like a marathon.”

While Sweden has a higher death rate than its Nordic neighbors and other wealthy European nations like Germany, it has been lower than rates in the Netherlands, France, and the United Kingdom. According to the Financial Times’ figures, Sweden has seen an 18% jump in excess deaths since the start of the outbreak, while Denmark has seen a 5% rise. Excess deaths in England and Wales are up 37%.

“The data out of Finland, Norway, and Denmark looks much better,” said Angner. “But everything will hinge on what will happen next.”

There’s some evidence that Sweden has managed to take the heaviest blow from the virus already — about a fourth or fifth of the population of Stockholm may have been infected, which would put the infection rate at a level similar to that found in New York City, which has had many more deaths and been under a near-total lockdown for almost two months. On Tuesday, health officials in Stockholm said the number of new deaths linked to Covid-19 was slowly decreasing from one week to the next.

The Swedish example carries both optimistic and pessimistic tidings for the United States as it embraces a partial, scattered reopening cheered on by the White House. It suggests that, even without punitive mandates, people can and will take measures to keep themselves safe from the disease. But even though people are protecting themselves without formal orders, the economy will be only slightly better off than it was under lockdown. Meanwhile, the American push to reopen is being driven by distrust of the government combined with the absence of robust safety-net programs to stem the economic bleeding. In the American context, Sweden’s example may be no example at all.

As a paper that was just accepted for publication, written by this author and two coauthors, we need reliable data to evaluate our progress as well as our failures to predict, based on appropriate statistical models and in order to lead us all in the correct path for future strategies for this pandemic and future crises.