Tag Archives: Pfizer

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.

Amid a public health crisis, Americans’ views on health care policy haven’t changed, survey says; And What will Biden do to Healthcare?

Rebecca Morin reported that over the past several weeks, the majority of Americans have had to alter their lives due to the coronavirus pandemic.

Face masks have become part of most people’s daily wardrobe. Social distancing restrictions are still being ordered in many of the states. And millions have lost their jobs, as well as their health insurance. 

Now that Joe Biden has been declared the next president, we need to consider what I have been saying, that if we have learned nothing else, a form of universal affordable health care is a necessity.

Despite the changes, the majority of Americans’ long-held beliefs surrounding health care haven’t changed, according to a new survey.

About half of Americans – 51% – said they agree that government-run health insurance should be provided to all Americans, according to a survey from the Democracy Fund + UCLA Nationscape Project. That’s just a 1 percentage point less than in February.

“The events themselves have not driven people to some radical new conclusions about whether the government should be providing certain types of services,” said Robert Griffin, research director for the Democracy Fund Voter Study Group. “These are not attitudes that have suddenly changed overnight in response to political events that have occurred.”

The new survey comes amid a public health crisis, where most of the United States was closed down for more than a month to help limit the spread of the coronavirus. Over the past couple of months, more than 36 million people have sought jobless benefits. The Labor Department said Thursday that about 3 million Americans filed initial unemployment benefit claims last week.

Are lockdowns being relaxed in my state? Here’s how America is reopening amid the coronavirus pandemic.

Half the states across the nation have also begun loosening social distancing restrictions over the past several weeks. Experts show that the curve showing the rate of new cases may be flattening, but they are estimating at least 60,000 more people will die from coronavirus by August. 

The Democracy Fund + UCLA Nationscape Project is a large-scale study of the American electorate. Throughout the 2020 election cycle, the researchers aim to conduct 500,000 interviews about policies and the presidential candidates. This survey was conducted between April 29 and May 6, with 6,366 Americans surveyed. There is a margin of error of plus or minus 2.1 percentage points.

Another policy view that hasn’t seen a lot of change? Subsidizing health insurance for lower-income people who are not receiving Medicare or Medicaid.

Sixty-three percent of Americans said that they agree with that – a 2 percentage-point drop from February. 

However, a majority of Americans believe there should be more short-term aid for those in need during the coronavirus pandemic, according to an analysis on Nationscape Insights, a project of Democracy Fund, UCLA, and USA TODAY. 

Pandemic protocols: Safety measures vary from the White House to the Supreme Court

Griffin noted that during the pandemic, Americans are “much more flexible in terms of thinking about what types of policies they might consider,” even if their attitudes about basic policies haven’t shifted much.

Seventy-nine percent of Americans strongly or somewhat support increasing spending on health insurance and food aid for the poor during the coronavirus pandemic. When broken down between Democrats and Republicans, the majority of both also support to increase spending.

The coronavirus pandemic also hasn’t affected long-standing political norms for Republicans and Democrats, according to the survey.

Sixty-nine percent of Democrats said they agree with providing government-run health insurance to all Americans. In February, that number was at 68%. In terms of agreeing on subsidizing health insurance for lower income people who are not receiving Medicare or Medicaid, Democrats are at 78%, a 2-percentage point drop from February.

For Republicans, the numbers don’t change drastically either. Thirty percent of Republicans agree to providing government-run health insurance to all Americans, compared with 33% in February. There was also a three-point drop from February to May among Republicans when asked if they agree on subsidizing health insurance for lower income people who are not receiving Medicare or Medicaid, from 53% to 50%. 

Biden Wants to Lower Medicare Eligibility Age To 60, But Hospitals Push Back

Phil Galewitz reported that President-elect Joe Biden’s plan to lower the eligibility age for Medicare is popular among voters but is expected to face strong opposition on Capitol Hill.

Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60. Is this the first step to Medicare-for-All?

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals — a powerful political force — are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals are on average half what commercial or employer-sponsored insurance plans pay.

“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.

“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a Kaiser Family Foundation tracking poll from January 2019. (Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.)

Although opposition from the hospital industry is expected to be fierce, it is not the only obstacle to Biden’s plan.

Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to pay hospitals and nursing homes fully for inpatient care for Medicare beneficiaries.

It’s also unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act (if the Supreme Court strikes down part or all of the law in a current case), expanding Obamacare subsidies and lowering drug costs.

Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, but full benefits depend on the year you were born, ranging from age 66 to 67.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out of pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.

“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and their workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”

Biden has room on health care, though limited by Congress

Biden’s proposals for a public health insurance option and empowering Medicare to negotiate prescription drug prices seem out of reach

President-elect Joe Biden is unlikely to get sweeping health care changes through a closely divided Congress, but there’s a menu of narrower actions he can choose from to make a tangible difference on affordability and coverage for millions of people.

With the balance of power in the Senate hinging on a couple of Georgia races headed to a runoff, and Democrats losing seats in the House, Biden’s proposals for a public health insurance option and empowering Medicare to negotiate prescription drug prices seem out of reach. Those would be tough fights even if Democrats controlled Congress with votes to spare.

But there’s bipartisan interest in prescription drug legislation to limit what Medicare recipients with high costs are asked to pay, and to restrain price increases generally. Biden also could nudge legislation to curb surprise medical bills over the finish line.

Moreover, millions of people already eligible for subsidized coverage through “Obamacare” remain uninsured. A determined effort to sign them up might make a difference, particularly in a pandemic. And just like the Trump administration, Biden is expected to aggressively wield the rule-making powers of the executive branch to address health insurance coverage and prescription drug costs.

With COVID-19 surging across the country, Biden’s top health care priority is whipping the federal government’s response into shape. In his victory speech Saturday, he pledged to “spare no effort, or commitment, to turn this pandemic around.” He appointed a pandemic task force to develop “an action blueprint” that could be put into place on Inauguration Day.

On broader health policy issues, Biden has signaled he will stick with his robust campaign platform, which called for covering all Americans by building on the Affordable Care Act, adding a new public insurance option modeled on Medicare and lowering the eligibility age for Medicare.

“We’re going to work quickly with the Congress to dramatically ramp up health care protections, get Americans universal coverage, lower health care costs, as soon as humanly possible,” the president-elect said earlier this week.

Progressives who drive the Democratic Party’s health care agenda say Biden must try as hard as he can to deliver, no matter if Sen. Mitch McConnell, R-Ky., remains majority leader of the Senate.

“I would vote for anything that improves health care for the American public, but what we need to do is push boldly and clearly for progressive policies,” said Rep. Ro Khanna, D-Calif., first vice chair of the Congressional Progressive Caucus.

Khanna says he’d like to see a President Biden calling out McConnell in public. “Right at the State of the Union, he should say, ‘One person potentially stands in the way of this, and that is Mitch McConnell,’” said Khanna.

Not in the real world, Republicans say.

They say the only way Democrats could get a big health care bill through is to first win the two Senate seats in Georgia and then rely on a special budget procedure that would allow them to pass legislation in the Senate on a simple majority vote. Either that or change Senate rules to abolish the filibuster. None of that can be done with a snap of one’s fingers.

“I put the odds of large-scale comprehensive health care reform at almost zero,” said Brendan Buck, who served as a top adviser to former House Speaker Paul Ryan, R-Wis.

Biden’s to-do list on health care begins with new hires and a rewrite of Trump administration policies.

Democrats have a deep talent pool he can tap for top jobs. Among the leading contenders for health secretary is former Surgeon General Vivek Murthy, who is a co-chair of Biden’s coronavirus task force. North Carolina state health secretary Dr. Mandy Cohen, another Obama administration alum, is also being promoted.

The rewrite project involves rescinding regulations and policies put in place by the Trump administration that allowed states to impose work requirements on Medicaid recipients, barred family planning clinics from referring women for abortions, made it easier to market bare-bones health insurance and made other changes.

But Biden can also use the government’s rule-making powers proactively. Prescription drugs is one area. The Trump administration was unable to finalize a plan to rely on lower overseas prices to limit what Medicare pays for some drugs. It’s a concept that Democrats support and that Biden may be able to put into practice.

On Capitol Hill, there doesn’t seem to be a clear path.

A Republican advocate for action to curb prescription drug costs, Sen. Chuck Grassley of Iowa, is expected to take on a new role in the next Congress, with less direct influence over health care issues.

A factor that may work in Biden’s favor is that many Republicans want to change the subject on health care. Exhaustion has set in over the party’s decade long campaign to overturn the Affordable Care Act, which has left the main pillars of former President Barack Obama’s health law standing, while knocking off some parts.

Though not ready to embrace the ACA, “Republicans have tired of banging their heads against the wall in an effort to get rid of it,” said Buck.

Brian Blase, a former Trump White House health care adviser, says he thinks there is potential on prescription drugs.

“Biden, I think, will be pragmatic in this area,” Blase said.

He expects a Biden administration to wield its rule-making powers aggressively, looking at international prices to try to limit U.S. prescription drug costs.

Coronavirus relief legislation could provide an early vehicle for some broader health care changes.

Former Health and Human Services Secretary Kathleen Sebelius, who oversaw the rollout of the ACA under Obama, says it’s not a question of all or nothing.

“Will it be as much progress as if we had had a big Senate win?” she asked.

It may not look that way.

“But can he make progress? I think he can.”

What You Need to Know About the ‘90% Effective’ COVID-19 Vaccine

There is promise—but there are also questions.

Marty Munson noted that on  Monday, a COVID-19 vaccine made by the drug company Pfizer in conjunction with BioNTech made headlines. An early analysis released by the drug maker suggested that the vaccine could be more than 90 percent effective in preventing COVID-19.

No doubt it’s promising news—in fact, a CNN report says that Anthony Fauci, M.D., the nation’s top infectious diseases expert, texted CNN and called it “extraordinarily good news.”

The early analysis is of a trial that involved nearly 44,000 subjects; half receiving a placebo and the other half receiving a two-dose regimen of the new vaccine. The report says that 94 people got COVID-19. It’s not clear how many of those received a placebo and not the vaccine, but it would have to be most of them for the reports to claim more than 90 percent efficacy.

The excitement among scientists and the financial sector isn’t just about the robustness of the results. This vaccine uses a new technology, known as mRNA, a gene-based drug technology that has never been used in a vaccine before. So, the potential success of this drug is also a huge success for science. The Wall Street Journal quotes Professor John Bell, a UK health-policy advisor involved in the Oxford-AstraZeneca vaccine as saying, “the most important message is that you can make a vaccine against this critter.”

What it means so far

The news is encouraging, but the vaccine is not a panacea yet. The New York Times pointed out on Tuesday that “independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last.”

Data hasn’t been released on whether any people in the trial developed milder forms of COVID-19, what kind of side effects are associated with it, and how long protection might last. A few more considerations that moderate enthusiasm for the results: The results were released by the company, not in a medical journal, and the trial hasn’t concluded, so the numbers may change, The New York Times report points out.

If the company does receive emergency authorization of the vaccine after it collects the required amount of safety data, there are still questions and concerns about whether it is effective in all populations, how much vaccine the company can produce and how quickly, who would get it first, how it will be transported and delivered and whether people will accept the vaccine and get it when it’s offered.

What else to know

The news is promising and especially with the latest information regarding the Moderna vaccine, but there’s more data to come out, and many more problems need to be solved before a vaccine is a reality for most Americans. The pandemic is far from over, and this news doesn’t change that yet. So for now, at a time when there have been about 110,000 COVID-19 cases a day surging in the U.S., it’s still important to wear masks and continue to use social distancing measures and common sense. It seems that we are all forgetting common sense.

So, as my favorite candidate for the presidency. Governor Larry Hogan, says-Wear the damn masks and…get your flu shots!!!!

Also, I have included a cartoon from Rick Kollinger who has suffered a setback in his fight with his cancer. But after my visit with him, and my harassment he has attempted to draw a few more cartoons for me and his fans. Thank you Rick and please get better!


 [r1]

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

It is truly amazing how out of touch the GOP and, I believe President Trump is, on health care, especially “after” or during this COVID pandemic. Consider the amount of monies spent on caring for the millions of patients diagnosed with COVID-19. One must remember that due to the EMTALA Act, which ensures public access to emergency services regardless of ability to pay. Think of all the COVID testing and ICU care that has been provided for all that needed it. This experience, etc. should convince, even the clueless that we need a type of universal health care policy.

They, the GOP and the President, promised us all that they would create, provide a wonderful healthcare for all, better than Obamacare. But have they? No!

And now is the time to produce a well-designed alternative, or consider Obamacare as a well thought out program, except for the lack of financial sustainability. And guess what happened after I had a phone call with a member of the Trump administration. He asked me what I thought Trump’s chances of winning re-election. I responded that I thought he had about a 20% chance of getting re-elected. He pressed me as what I thought that would increase his chances. My response was to finally reveal their, the GOP/Trump’s

, plan and I suggested that they should adopt the Affordable Care Act but outline a plan to sustainably finance the healthcare plan.

My suggestion- embrace the Affordable Care Act as a good starting point and use a federal sales tax to finance it instead of putting the onus on the young healthy workers.

 At a hearing on the coronavirus response, Senator Dick Durbin asked the Trump administration’s top health officials about the president’s comments touting a plan to replace the Affordable Care Act, also known as Obamacare. They said they did not know about such a plan.

And a Republican victory in Supreme Court battle could mean millions lose health insurance in the middle of a pandemic.

John T. Bennett noted that Ruth Bader Ginsburg, Barack Obama, Donald Trump and Mitch McConnell could soon be forever linked if the late Supreme Court justice’s death leads to the termination of the 44th president’s signature domestic policy achievement: the Affordable Care Act

All sides in the coming battle royal over how to proceed with filling the high court seat she left behind are posturing and pressuring, floating strategic possibilities and offering creative versions of history and precedent. Most Republicans in the Senate want to hold a simple-majority floor vote on a nominee Mr. Trump says he will announce as soon as this week before the end of the calendar year. Democrats say they are hypocrites because the blocked a Barack Obama high court pick during his final year.

It appears Democrats have only extreme options as viable tactics from preventing confirmation hearings and a floor vote before this unprecedented year is up. Speaker Nancy Pelosi on Sunday refused to rule bringing articles of impeachment against the president or even William Barr, his attorney general whom the Democrats say has improperly used his office to help Mr. Trump’s friends and use federal law enforcement unjustly against US citizens.

Unless Ms Pelosi pulls that politically dangerous lever, the maneuvering of the next few weeks most likely will end after Congress returns after the 3 November election with a high court with a 6-3 conservative bend. Analysts already are warning that conservatives appear months away from being able to partially criminalize abortion and also take down the 2011 Affordable Care Act, also known as Obama care.

Democrats have sounded off since Ms. Ginsburg’s death to warn that millions of Americans could soon lose their health insurance, especially those with pre-existing conditions. Last year, 8.5m people signed up for coverage using the Affordable Care Act, according to the Congressional Budget Office.

“Healthcare in this country hangs in the balance,” Joe Biden, who is the Democratic nominee for president and was vice president when Mr. Obama signed the health plan now linked to his name into law, said on Sunday.

Mr. Biden accused Republicans of playing a “game” by rushing the process to replace Ms. Ginsburg on the court because they are “trying to strip healthcare away from tens of millions of families.”

Doing so, he warned, would “strip away their peace of mind” because insurance providers would no longer be required to give some Americans policies. Should a 6-3 court decide to uphold a lower court’s ruling that the 2011 health law be taken down, those companies would “drop coverage completely for folks with pre-existing conditions,” Mr. Biden warned in remarks from Philadelphia.

“If Donald Trump has his way, the complications from Covid-19 … would become the next deniable pre-existing condition for millions of Americans.” That means they would lose their health insurance and be forced to either pay for care out of their pocket or use credit lines. Both could force millions into medical bankruptcy or otherwise create dire financial hardships.

Mr. Trump about a month ago promised to release a new healthcare plan that, if ever passed by both chambers of Congress and signed into law, would replace Obamacare.

So far, however, he has yet to unveil that alleged plan.

Trump Press Secretary Kayleigh McEnany told reporters last week that the White House’s Domestic Policy Council is leading the work on the plan. But when pressed for more details, she chose to pick a fight with a CNN reporter.

“I’m not going to give you a readout of what our healthcare plan looks like and who’s working on it,” Ms. McEnany said. “If you want to know, if you want to know, come work here at the White House.”

When pressed, Ms. McEnany said “stakeholders here in the White House” are working on a plan the president has promised for several years. “And, as I told you, our Domestic Policy Council and others in the White House are working on a healthcare plan,” she insisted, describing it as “the president’s vision for the next five years.”

The president frequently mentions healthcare during his rowdy campaign rallies, but only in general terms. He promises a sweeping plan that will bring costs down across the board and also protect those with pre-existing conditions. But he mostly brings it up to hammer Mr. Obama and Mr. Biden for pushing a flawed law that he has been forced to tinker with to make it function better for consumers.

Broad brush

His top spokeswoman echoed those broad strokes during a briefing on Wednesday. “In aggregate, it’s going to be a very comprehensive strategy, one where we’re saving healthcare while Democrats are trying to take healthcare away,” she told reporters. “We’re making healthcare better and cheaper, guaranteeing protections for people with preexisting conditions, stopping surprise medical billing, increasing transparency, defending the right to keep your doctor and your plan, fighting lobbyists and special interests, and making healthier and making, finding cures to diseases.”

If there is a substantive plan that would protect millions with pre-existing conditions and others affected by Covid-19, it would have made a fine backbone of Mr. Trump’s August Republican National Committee address in which he accepted his party’s presidential nomination for a second time. But healthcare was not the major focus, even though it ranks in the top two issues – along with the economy – in just about every poll that asks voters to rank their priorities in deciding between Mr. Trump and Mr. Biden.

If there is a coming White House healthcare plan that would protect those with pre-existing conditions and prevent millions from losing coverage as the coronavirus pandemic is ongoing, the president is not using his campaign rallies at regional airport hangars to describe or promote it.

“We will strongly protect Medicare and Social Security and we will always protect patients with pre-existing conditions,” said at a campaign stop Saturday evening in Fayetteville, North Carolina, before pivoting to a completely unrelated topic: “America will land the first woman on the moon, and the United States will be the first nation to land an astronaut on Mars.”

The push to install a conservative to replace the liberal Ms. Ginsburg and the lack of any expectation Mr. Trump has a tangible plan has given Democrats a new election-year talking point less than two months before all votes must be cast.

“Whoever President Trump nominates will strike down the Affordable Care Act,” Hawaii Democratic Senator Mazie Hirono told MSNBC on Sunday. “It will throw millions of people off of healthcare, won’t protect people with pre-existing conditions. It will be disastrous. That’s why they want to rush this.”

 About 1 In 5 Households in U.S. Cities Miss Needed Medical Care During Pandemic

Patti Neighmond noted that when 28-year-old Katie Kinsey moved from Washington, D.C., to Los Angeles in early March, she didn’t expect the pandemic would affect her directly, at least not right away. But that’s exactly what happened.

She was still settling in and didn’t have a primary care doctor when she got sick with symptoms of what she feared was COVID-19.

“I had a sore throat and a debilitating cough,” she says, “and when I say debilitating, I mean I couldn’t talk without coughing.” She couldn’t lie down at night without coughing. She just wasn’t getting enough air into her lungs, she says.

Kinsey, who works as a federal consultant in nuclear defense technology, found herself coughing through phone meetings. And then things got worse. Her energy took a dive, and she felt achy all over, “so I was taking naps during the day.” She never got a fever but worried about the coronavirus and accelerated her effort to find a doctor.

No luck.

She called nearly a dozen doctors listed on her insurance card, but all were booked. “Some said they were flooded with patients and couldn’t take new patients. Others gave no explanation, and just said they were sorry and could put me on a waiting list.” All the waiting lists were two to three months’ long.

Eventually Kinsey went to an urgent care clinic, got an X-ray and a diagnosis of severe bronchitis — not COVID-19. Antibiotics helped her get better. But she says she might have avoided “months of illness and lost days of work” had she been able to see a doctor sooner. She was sick for three months.

Kinsey’s experience is just one way the pandemic has delayed medical care for Americans in the last several months. A poll of households in the four largest U.S. cities by NPR, the Robert Wood Johnson Foundation and Harvard’s T.H. Chan School of Public Health finds roughly one in every five have had at least one member who was unable to get medical care or who has had to delay care for a serious medical problem during the pandemic (ranging from 19% of households in New York City to 27% in Houston).

We had people come in with heart attacks after having chest pain for three or four days, or stroke patients who had significant loss of function for several days, if not a week.

There were multiple reasons given. Many people reported, like Kinsey, that they could not find a doctor to see them as hospitals around the U.S. delayed or canceled certain medical procedures to focus resources on treating COVID-19.

Other patients avoided critically important medical care because of fears they would catch the coronavirus while in a hospital or medical office.

“One thing we didn’t expect from COVID was that we were going to drop 60% of our volume,” says Ryan Stanton, an emergency physician in Lexington, Ky., and member of the board of directors of the American College of Emergency Physicians.

“We had people come in with heart attacks after having chest pain for three or four days,” Stanton says, “or stroke patients who had significant loss of function for several days, if not a week. And I’d ask them why they hadn’t come in, and they would say almost universally they were afraid of COVID.”

Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”

He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”

The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).

Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.

“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “

By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”

He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.

“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”

Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.

In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.

“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.

“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.

“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”

In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.

“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.

Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”

And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.

For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.

Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”

Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.

As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.

“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.

Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.

His muscles got so tight that his feet would uncontrollably curl.

“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”

Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.

‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines

Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”

Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.

The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.

“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”

The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.

However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”

Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.

Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.

Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects

Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.

The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.

Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.

Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects

Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.

What’s the worst that could happen if we give an untested vaccine to millions of people?

We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.

If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.

“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”

One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.

If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.

What happened with the last vaccine rush?

On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”

How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.

By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.

What else can go wrong when vaccines are rushed

“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.

One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.

We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.

All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.

“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.

An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.

Other issues with inadequately tested vaccines

Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)

If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”

“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.

So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.

And finally, don’t forget to get your Flu vaccine, now!