Category: Covid-19 Vaccine

Topline

The government is reportedly set to announce this week that Medicare and Medicaid will cover the out-of-pocket costs for Covid-19 vaccines that have received emergency use authorization from the Food and Drug Administration, as well as permit greater flexibility for patients seeking Covid-19 treatment, Politico reports.

Medicaid and Medicare will reportedly cover Covid-19 vaccines

The new regulations, which have been under development for weeks, are likely to be announced on Tuesday or Wednesday by the Centers for Medicare and Medicaid Services, Politico reports, citing four sources with knowledge of the matter.

Current policies dont cover the costs of vaccines that have received emergency use authorization, which allow unproven medicines to be used in an emergency.

The changes would mean patients could receive a Covid-19 vaccine at no cost.

Two producers of leading candidates, Pfizer and Moderna, have said they plan to apply for emergency use authorization by the end of 2020.

Given the speed and circumstances behind the race to develop a Covid-19 vaccine, any successful candidate will very likely be approved on an emergency basis first. The reported changes to Medicaid and Medicare will help ensure the high levels of vaccination required to tackle the pandemic.

Medicare and Medicaid to cover early Covid vaccine (Politico)

Pfizer Reportedly Manufactures Several Hundred Thousand Covid-19 Vaccines Anticipating November Regulatory Approval (Forbes)

Pfizer Will Seek Emergency Approval For Covid-19 Vaccine In November, After Election (Forbes)

Full coverage and live updates on the Coronavirus

View post:

Report: Covid-19 Vaccine Will Be Covered By Medicaid, Medicare - Forbes

TribLIVE's Daily and Weekly email newsletters deliver the news you want and information you need, right to your inbox.

Theres a good chance that a coronavirus vaccine could be available by late 2020 or early 2021.

Developing an effective vaccine that fast would be a remarkable scientific achievement. It would also provide the first real hope of taming a new, deadly virus that has upended all aspects of American life if people are willing to take it. Many may not be.

Polls show decreasing support for getting vaccinated as battles between science and politics have weakened trust in government agencies that evaluate and recommend vaccines. Enthusiasm for a vaccine is particularly low among Black Americans, a group that has been especially hard hit by covid-19. Republicans are less likely to seek a vaccine than Democrats. Polling from STAT and The Harris Poll found that the percentage of Americans who said they would get a vaccine as soon as possible dropped from 69% in mid-August to 58% in early October. Several other polls have found that only about half of Americans now want a covid-19 shot.

Because of politicization around vaccines, leaders of unions representing about 2 million health care workers announced Tuesday that they will not receive or administer a new coronavirus vaccine without additional assurance from independent experts that the approval process has not been tainted.

While support could easily grow once a vaccine is approved, the polling is worrisome because broad vaccination is the best way to block the virus. The alternative herd immunity after most people have been infected would lead to far more suffering and death, experts say.

The issue is so important that a committee of the National Academies of Sciences, Engineering, and Medicine that was asked to set priorities for allocating early, scarce vaccine doses included chapters in its report earlier this month on the possibility that demand would be too low. The group emphasized the importance of evidence-based communication about vaccines so they actually are used.

This raises an important question: What does the the science of communication say about how to discuss a new vaccine for a new disease with a wary public?

People who study medical communication said any vaccine approved soon will face unprecedented challenges. While many Americans question the motives of pharmaceutical companies, people have in the past largely accepted guidance from the Food and Drug Administration and the Centers for Disease Control and Prevention, said Kathleen Hall Jamieson, director of the University of Pennsylvanias Annenberg Public Policy Center. Both agencies have lost considerable luster this year due to allegations of politically motivated influence from the Trump administration.

Science has become another voice in the room and not the voice, said Rupali Limaye, director of behavioral and implementation research at Johns Hopkins University.

Confusion and distrust will make it harder to convince the public to try a new product, especially when some already had concerns about vaccines. Plus, some of the vaccines now in trials are very different from those in the past.

This is a whole new ball game, said Alison Buttenheim, a public health researcher at Penn Nursing who studies behavioral aspects of infectious disease prevention, including vaccine acceptance. Anyone who says we know what messaging will work here is not correct.

It did not help that the president, eager for a win on coronavirus, predicted a vaccine could be available before Election Day, raising the specter of an emergency authorization timed for political impact. It was an unlikely claim when he made it, and the FDA later changed its rules to make that timetable unworkable.

Multiple communications experts said that the very name of the governments vaccine development effort, Operation Warp Speed, was a mistake. People want a vaccine as soon as possible, but they want to be sure it works, and they want it to be safe. Theres an association between breakneck speed and mistakes that will now have to be addressed.

The top priority will be restoring faith in the science of vaccine development. Assuming the first vaccine is indeed safe and effective, this will require exceptional transparency about the testing process. How many people got the shots? How long were they monitored for side effects? How well did the vaccine protect them?

Communications experts said it matters greatly who promotes the vaccine. People believe a trusted messenger. During the vice presidential debate this month, Sen. Kamala Harris illustrated how this works. If the public health professionals, if Dr. (Anthony) Fauci, if the doctors tell us that we should take it, Ill be the first in line to take it absolutely, she said in response to a question. But if Donald Trump tells us that we should take it, Im not taking it. Of course, in politically fractured America, some people might take the opposite approach.

The important lesson is that people want to know that someone they respect recommends the vaccine. This could be a national political figure, but people are most likely to respond to local leaders, especially family doctors and local nurses, communications experts said. They may also listen to ministers, family members and celebrities. For those who, like Harris, trust science and Dr. Fauci, it could be a scientist. Philip Massey, a health communications expert at Drexel Universitys Dornsife School of Public Health, said public health officials should be talking with groups like Black Lives Matter activists about vaccines.

The message itself needs to vary with each groups concerns. How does the vaccine work for people over 65? Was it tested in large enough numbers of Black people to address the fears of a group that has historic reasons to be wary of medical research?

Its not going to be one message that works for everybody, Buttenheim said.

Some people will want numbers, and Baruch Fischhoff, a psychologist who studies risk assessment at Carnegie Mellon University, believes most of us can understand them if theyre presented properly. He believes public health officials should be laying the groundwork for that communication now. He would begin by explaining how many people were in the trial and how long they were followed. Some percentage of participants had serious side effects. A company may say that a vaccine is 60% effective, but what does that mean? It could be that 30% of participants were totally protected and 30% had milder symptoms, while the vaccine had no effect on the rest. People should see those numbers, said Fischhoff, who, like Buttenheim, was on the Academies of Sciences vaccine committee.

Once that foundation is laid, Fischhoff said, people will be more receptive to campaigns asking them to get the vaccine.

Dominique Brossard, chair of the department of life sciences communication at the University of Wisconsin-Madison, thinks its best to keep messages simple and include links to more detailed data for people who want to go deep. If numbers must be used, make them concrete. Most people, for example, cant visualize what 223,000 deaths the current national death toll means. They might understand it better if they knew thats the population of Brossards town: Madison.

Most research on vaccine communication has centered on children and parents reluctant to vaccinate, Brossard said. Theres much less evidence about adult vaccines. She thinks attitudes toward flu shots some people get them every year and some never do will likely spill over onto a coronavirus vaccine. People underestimate the risks of covid-19 most likely because they dont personally know anyone who has been seriously ill. Public health officials, she said, need to tell stories that emphasize both the short and long term impact of covid-19.

She added that messages need to be short, emotionally appealing and consistent.

Massey said any vaccine campaign will need to address the 3 Cs: Confidence in the vaccine, Complacency about the disease and Convenience of getting the vaccine. He hopes that giving the vaccine first to frontline workers, who have been pandemic heroes, may sway others.

Jamieson thinks it likely will be helpful to compare the risks of the vaccine with the much greater risks of covid-19.

Buttenheim said some people may respond to pleas to help their communities even if they are not personally worried about the disease. Overall, the message should be simple: This is safe. This is effective. This is the norm. This is what everybody is doing, and this is what people I admire are doing. Messaging about where and when to get vaccines needs to be equally straightforward.

Limaye says its not helpful to argue against misperceptions. Instead, pivot to the severity of the disease and the persons susceptibility to it. If theyre not worried about themselves, maybe they would get a shot to protect an older relative.

Some people may be deep into conspiracy theories or social media information bubbles. Jamieson said the only hope is to expose them to frequent positive messages about vaccines, because familiarity increases the perception of accuracy.

But Buttenheim said, There are some people were not going to be able to persuade. It is what it is.

Categories:Coronavirus | Health | News | Top Stories

TribLIVE's Daily and Weekly email newsletters deliver the news you want and information you need, right to your inbox.

Read more:

Once a covid-19 vaccine is here, there will be a new challenge: convincing people it's safe - TribLIVE

Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

This transcript has been edited for clarity.

Eric J. Topol, MD: Hello. This is Eric Topol for Medscape. It's a great privilege to have a one-on one conversation with my friend Paul Offit, MD, who is my go-to for vaccines. And this is an important time for vaccines. So, welcome, Paul.

Paul A. Offit, MD: Thank you, Eric.

Topol: We had convened recently to discuss vaccines. And then just last week there was a really important 9-hour meeting of the Vaccines and Related Biological Products Advisory Committee. Certainly, Paul, you were one of the key players there. Can you give us your overall sense of this long meeting, which was of intense public interest?

Offit: I think it was good that it was open, because what the public got to see was a look behind the curtain. What we struggled with is that typically for vaccines, one does large phase 3 trials, in which tens of thousands of people get the vaccine or don't get the vaccine. The data are evaluated and submitted as a biological license application (BLA) to the US Food and Drug Administration (FDA) for licensure.

But that's not this process. This process is not going to be a licensure process. These aren't going to be licensed vaccines. They're essentially going to be permitted for use through an emergency use authorization (EUA), which is frankly no different from any investigational drug. But that is odd because it's going to be given to most Americans.

I think from the public standpoint, when they hear EUA, they think hydroxychloroquine. Hydroxychloroquine was approved through an EUA, but it didn't work to treat or prevent the disease, and 10% of people who got it had cardiac toxicities. Or they think of convalescent plasma, also a product which has never been shown to work.

So the fear and it's a reasonable fear, it's an understandable fear is that the FDA, up to this point regarding these EUAs, really has not done its job. They have not stood between pharmaceutical companies and the American public to make sure that we get products that are safe and effective. They haven't. And therefore, the public is suspicious of this process.

What you saw in the advisory meeting last week, I thought, was an attempt to understand practically what the differences were going to be between doing it this way, with these unlicensed products, and doing it the way we always do. Because the fact of the matter is, these are large, prospective, placebo-controlled trials. The Johnson & Johnson trial is a 60,000-person trial. Pfizer's is 44,000. Moderna's is 30,000. That's a typical trial size for a biological license application. For example, the HPV vaccine was a 30,000-person trial. Our vaccine, the rotavirus vaccine, was a 70,000-person trial; pneumococcal vaccine was 35,000. So the size of these trials is typical. So why not do it through a biological license application? Why not do it the way we've always done it?

The answer is several-fold. Most important, I think the FDA would never license a product that was tested with a shorter period of time. I think that's the biggest. We're not going to know anything, really, about not just long-term efficacy, but even relatively short-term efficacy; we'll know that there's efficacy for months but not necessarily for a year. Whereas the HPV trial was a 7-year study and the rotavirus vaccine was a 4-year study. Usually it's several years. So this is unprecedented in terms of length of follow-up for efficacy and also, arguably more important, safety. We'll have a couple months of safety data after the last dose, which would pick up something like Guillain-Barr syndrome, as we saw with a flu vaccine. But you do worry about vaccine-induced pathology. And at least Stanley Perlman, MD, PhD, who was on the advisory meeting conference call, is a coronavirus immunologist. He wanted at least 4 months. So that's the struggle.

On the other hand, 225,000 people [in the United States] are dead from this virus within a year. As you move forward with these kinds of trials, you go from phase 1 to phase 2 to phase 3, you just try to reduce uncertainty. That's the goal. How much uncertainty do you need to reduce? Do we need to wait, for example, to see what the 1-year follow-up is, knowing that during that time hundreds of thousands of people may die? Should we wait 2 years, which William Haseltine, PhD, actually reasons: Why don't we wait 2 years and get all the data as we would do for a typical vaccine? The answer is because with the rotavirus trials, 60 children died per year; that's a little different from this.

Topol: Bill Haseltine was arguing during the advisory committee that we should wait 2 years for a vaccine?

Offit: No; it was just in a recent media interview.

Topol: Oh, okay. I didn't think he was weighing in on the committee. He's said some unusual things when I listen to his segments.

One of the reasons that an EUA is appropriate is, as you're putting it, the context of this pandemic, which is unlike the other vaccines that you reviewed. But another is that it takes many months to prepare a product BLA, right? They can be 10,000 pages. This is a much more expeditious route. Are there other reasons besides those two?

Offit: There's one other reason that was subtly stated on one of the slides presented by Jerry Weir, PhD, from the FDA, in regard to supervision regarding manufacturing. When the FDA licenses the product, they don't just license the product; they also license the process and they license the building. That is a rigorous process. I noticed that for our vaccine, the rotavirus vaccine, RotaTeq, was a 1-year process. You have to validate everything. You have to validate the computers; you have to validate how you're cleaning out the vats; you have to validate how you're putting the cells on a monolayer. However you're making the product, you have to validate every step of that. I think that in that slide that he showed, there was one word in there that made me think that this is a little looser than normal, which is the word "generally." It's going to be generally acceptable.

I asked somebody from the FDA to explain this to me, because when I looked at his slides, I thought, It doesn't look like it's any different in terms of what the FDA calls CMC, chemistry manufacturing control. It looked like it was no different from normal, which didn't make sense because I couldn't imagine how it could be that fast doing it the normal way. So there are some subtle differences there. But again, I wish we wouldn't call it an EUA. I wish we had another name for it.

Topol: Actually, that's an important point you brought up, because there is this pathway, expanded access, which could be used. What do you think about that?

Offit: Marion Gruber, PhD, who is at the FDA, talked about that as another way to think about this. And I think that makes sense. One of the fears she has, and I think we all have, is that Pfizer had stated that if they show that their vaccine meets a standard for efficacy, 50% or 60%, then they would then give the vaccine to the placebo group. She made the point in a couple of slides that they are under no obligation to do that that under an emergency use authorization, you don't have to do that because, frankly, it's still investigational. It's an investigational product. Because the minute you give the vaccine to participants in the placebo group and it could extend to other placebo-controlled trials then you've lost data. Let's suppose that this vaccine is 60% effective. There may be vaccines out there that are 80% effective, 90% effective. But if you stop doing placebo-controlled trials, you're not going to know that. That's the tension in all of this.

Topol: This is one of the most important points of all: Once a company says their vaccine works and they file for an EUA, there is this ethical dilemma. I spoke to the Pfizer group, Kathrin Jansen and her colleagues, and their plan was, "We'll go ahead and file for an EUA. And we don't necessarily have to cross over our placebo participants, at least early on, because we certainly want to follow them." But there is an ethical dilemma. On the one hand, you're claiming some signal of efficacy; and on the other, you're denying the participants access to that efficacy. So it's a very fine line, right?

Offit: Yes. And there's not a clear answer to this. You could argue that if you're a 70-year-old person and you were in the placebo group in the hopes that you were in the vaccine group and now you find out that the vaccine is 60% effective or whatever, you can see how that person could reasonably say, "I think I should get this vaccine. I'm at higher risk. If I get this virus, I have a 10% chance of dying. I want this vaccine."

Topol: Yet here's this monstrous effort of having 60,000 people in a trial, but the follow-up can be basically lost if there's crossover. So it's like a domino effect. If one of these vaccines clicks and says, "We've got it" and it looks like Pfizer and Moderna are leading at the moment then there could be a rippling effect on all the programs, right?

Offit: Yes, because, ethically, can you give a placebo to somebody who's at risk someone, say, who is obese or has diabetes or is older?

Topol: Clearly we're going to need lots of vaccines here. And as you alluded to, hopefully with incrementally increasing efficacy, even perhaps with a second generation of vaccines among these 200 different candidates. But is it a problem that people will ultimately take multiple vaccines along the way?

Offit: First, I think the only way we can immunize the whole population is with multiple vaccines. Second, I think it's going to depend on the vaccine. So let's suppose you received a replication-defective simian adenovirus or replication-defective human adenovirus vaccine. And then there was a different sort of replication-defective virus that looked much better, but it was also an adenovirus. There may be enough cross-reactivity where you wouldn't benefit from the second vaccine. But otherwise, for the most part, I think you would be able to have a second vaccine and benefit from it. For example, look at the shingles vaccines. Zostavax was given to people. Then Shingrix came along and it's a significantly better vaccine. And you can now get that even if you got Zostavax.

Topol: That brings up a topic that I think is really interesting that a lot of people don't appreciate outside of your specialty: the concept of superhuman immune response with vaccines. We've seen now some 30 or so well-documented reinfections with SARS-CoV-2 around the world with genomics to prove that the strain was different in the initial and subsequent infections, separated by months. And it wasn't the genomics of the virus evolving that was accounted for that; it truly was a reinfection. Now, of course, that's a small group among 40 millionplus infections. (The number is probably larger than 30, but many people don't have genomics to conclusively show that it's a reinfection.) The point being is that some people don't have an adequate immune response. We also know that from neutralizing antibody studies days after infection. There are some precedents whereby the vaccine could actually perform better than the typical human response. Can you take us through that? Because that's a key concept. I like to be optimistic and I'm hoping that the vaccines will be better than human responses. What do you think?

Offit: There's certainly historical precedent for vaccines being better than natural infection. The HPV vaccine induces a higher neutralizing antibody response than does natural infection significantly higher. If you're infected with tetanus, you actually need to be vaccinated because the quantity of the tetanus toxin, so-called tetanospasmin, that causes symptoms is actually subimmunogenic. So you get symptoms without developing an immune response.

Similarly for children less than 2 years of age, by conjugating polysaccharides like the Haemophilus influenzae type B (HIB) polysaccharide or the pneumococcal polysaccharide to a harmless protein, you induce a T celldependent B-cell response. If you had just given the polysaccharide, which is basically what you're doing when you get naturally infected, that response doesn't happen. So actually those vaccines are better than natural infections. If you as a 6-month-old got a HIB infection, you still would benefit from getting a vaccine. Same thing with pneumococcus. So there are examples of that.

I think where that might happen here is that there were two papers in Science that looked at the capacity of this virus, SARS-CoV-2, to induce antibodies directed against interferon. In other words, it induces you to have an immune response against your own immune system. That's why people were worried at some level about convalescent plasma as having those kinds of antibodies, which could be immune-suppressive. I think this is a weird virus. Anybody who's been watching this for the past year should not make any predictions about what's about to happen because it's been so surprising. But I think you're right; I think we may be able to get a vaccine that is better than natural infection, because when you're naturally infected with the virus, it reproduces itself 10 times, 100 times, 1000 times. When you're given a purified protein or you're given a messenger RNA, which encodes just one protein of the virus, that doesn't happen. So we'll learn. I think we're going to learn as we go here. And I'm sure that some of this knowledge is going to be painful over the next couple years.

Topol: Do you think any of the different types of vaccines, whether it's genetic or protein, attenuated viral vectors, lend themselves to a more potent immune response or is it hard to know?

Offit: Well, technically, as a member of the FDA Vaccine Advisory Committee, I have to sign a form that says I never publicly expressed a preference for a vaccine, but I'll try and say it more generally.

If you were older, for example, over 65, and you look at the sort of Shingrix-Zostavax experience, Shingrix has two powerful adjuvants. One is based on this so-called QS-21, a saponin of the soapbark tree. The other is monophosphoryl lipid A from Salmonella minnesota. The purified protein product used in the SARS-CoV-2 Novavax vaccine actually has one of those adjuvants. So you wonder whether this so-called QS-21like adjuvant would induce a better immune response. Similarly, I think the Sanofi-GSK collaborative vaccine also has a powerful adjuvant, a squalene-based adjuvant called AS03. As you get older, your immune system gets more and more senescent, so the powerful adjuvants may make a difference, as it did in Shingrix. But who knows? Let's see.

Topol: When we're in despair, we try to find the bright side of things. And the fact that there are these notable examples of vaccine programs that turned out to be better than what humans can mount as an immune response is really great to know. I don't think that's actually out there in the medical community very much yet.

Now for an update on another topic that we discussed previously. There are two points. You really brought this home and today Tony Fauci and Andrea Lerner and colleagues published in JAMA on this that just because we're starting on vaccines, we still have a long way to go. We still need to be wearing masks. The point being that you could be an asymptomatic carrier. You could be vaccinated so you don't get infected, but you still can harbor the virus in your nasal mucosa. Isn't that right?

Offit: There are many reasons to believe that natural infection with SARS-CoV-2 does appear to protect against moderate to severe disease associated with reinfection. Although there have been cases that people get a moderate to severe infection, get better, and then get a second moderate to severe infection. That is not typical. So it's unlike, say, strep throat, which you can get again and again, unmodified; or gonorrhea, which you can get again and again, unmodified. Those are examples where natural infection does not appear to protect against disease associated with rechallenge. That's not true here because what we're hearing is not that. What we're hearing typically is that someone got an infection and then later found out they had a mild form of the infection and was asymptomatic. That's the usual sort. And that's what you'd expect with this kind of virus. There were human challenge studies done in the early 1990s with human coronaviruses that found that you did get protection for a year, and the protection was generally against moderate to severe disease. Good. That's what you want. Knowing that natural infection appears to protect means that you can make a vaccine that can, in theory, induce an immune response similar to natural infection and therefore protect. So all good news.

But I do think that what you say is exactly right. Let's say you get a vaccine that is 75% effective at protecting against moderate to severe disease, which we'd all be happy with. That's still 1 out of 4 people and you don't know who that is who could still get moderate to severe disease.

Also, I think the vaccine will not be as good at preventing asymptomatic shedding or mild disease, because that's what the animal model studies teach us. The animal model studies teach us that you can prevent pneumonia, but you don't seem to prevent upper respiratory tract shedding. So you need to wear a mask.

That's what keeps me up at night: that a vaccine will be oversold as being a magical powder that we sprinkle over the United States and make all of this go away.

That's what worries me the most. People ask me what keeps me up at night. That's what keeps me up at night: that a vaccine will be oversold as being a magical powder that we sprinkle over the United States and make all of this go away. And people are going to say, "You know, I'm tired of the mask, I'm tired of social distancing." They throw it all away, engage in high-risk activity. And we take a step back.

Topol: I think that point is central. You emphasized that before but I wanted to get to it again, because I think a lot of people think the vaccine comes and the masks go, and we're looking at likely all of 2021 with masks. If you just judge the timeline where vaccines will ramp up and get to a large portion of people...

Topol: That brings me to how to promote public trust. You've spent your career on vaccines and dealt with the resistance the anti-vaxxers and all kinds of stuff. You've written books about this. If we were smart right now, and if you were to design a way to nurture public trust so that when the vaccines are approved and they have the data, we would get a high population-level immunity what would we do right now to foster trust?

Offit: Right now, what we can do is be transparent with the process. I like that the FDA Vaccine Advisory Committee meeting was televised and anybody could log in and watch it. So they see people who are arguing about how this should work. There was a press conference after that meeting. One of the reporters said, "You know, it looks so contentious. Everybody seems so skeptical about the vaccine." That's what you want. You want everybody sitting around that table to be skeptical about this product. You want them to stand in the way in front of the American public and protect America. You want them to say, "I will approve this vaccine when I would get it, when my parents would get it. Would my children get it?" That's what you want to hear from those people. That's the way it works at the Advisory Committee for Immunization Practices (ACIP); I was a voting member there, too.

I think once the vaccine is in hand and you have some evidence that it works and it's safe, then you have to be able to tell people what you know and what you don't know. You know that it's effective for X length of time. You know that it's X percentage effective. You know that it's safe in this many people for this length of time. And here are all of the programs that are in place to continue to monitor safety, to continue to monitor for efficacy. Here's how we're going to continue to look at this. And then as it starts to roll out, 100,000 people have gotten it. A million people have gotten it. Ten million people have gotten it. And then you feel more and more safe. Maurice Hilleman, who I consider to be the father of modern vaccines, said it best: "I never breathe a sigh of relief until the first 3 million doses are out there." That's always true. So you never really quite know. Always just trying to reduce uncertainty, but you never eliminate uncertainty. You never know everything. The question is, when do you know enough to say that the benefits of this likely, very likely, outweigh the risk (and what is largely theoretical risk)?

Topol: If you were to guess, from what we know of the family of coronaviruses and as good as we can get with vaccines, do you think we'll be able to go longer than a year without people getting booster shots over time?

Offit: Yes. I'm willing to make any prediction as long as you don't hold me to it.

It's a single-stranded RNA virus. It certainly mutates like any single-stranded RNA virus. But both measles and flu are single-stranded RNA viruses. Flu mutates so much from one year to the next or, frankly, from one minute to the next that natural infection or immunization one year doesn't protect you the next year. I don't think that's going to be the case with this virus, although there have been people who've gotten two infections and there are genetic differences. The question is, and it hasn't really been answered yet, are there serotype differences or are these genetic differences, functional differences, that make the virus a different serotype or more virulent or less virulent or more contagious or less contagious? And that's the important question not whether there are genetic differences; of course there are genetic differences.

Topol: So far this has been such a slowly evolving virus, except for the one mutation, the D614G mutation, that has become dominant. And even then, it's debated whether it is truly more pathogenic. I guess that that point of stable virus is good. But a concern is that it's hard enough to have people get, initially, a second dose of the shot, and then to have them come back every year to maintain a population immunity would be even harder. I think the other point that's worth noting is that if the vaccine has 60% efficacy vs 80% or 90%, then the proportion of the population that needs to be immunized is markedly different, right?

Offit: Yes, marginally. There is a formula for this. There are a few caveats, but if you had a vaccine that is 75% effective, you would need to vaccinate about two thirds of the American population to stop spread. But there are other things going on. First of all, 75% effective probably doesn't mean 75% effective against shedding.

But on the other hand, you do have some population immunity now. And also, hopefully people will continue to wear a mask despite the bad example that's being set by the administration.

Topol: No kidding about that. And how one can be anti-masking and pro-vaccine at the same time, just doesn't compute very well.

Offit: I was on service last week, and we take care of children who either have COVID-19 or are suspected of having COVID-19. If, when I walk into the room of someone who is suspected of having COVID, you gave me three choices: I can either stand 6 feet away (but if I don't stand 6 feet away I have to stand, say, within 2 feet of the person); I can wear a mask; or get a vaccine that's 75% effective. What would I choose? I choose standing 6 feet away first. Social distancing is the most powerful. Second, I would choose the mask. I think the mask, if worn correctly and the right mask I'm not talking about an N95 respirator, but a good surgical mask that is well fitting that's going to be more than 75% effective. The vaccine will be third, which is really the opposite of what the administration's pushing.

Topol: That probably is one of the most important things to emphasize. In a little way, [CDC Director Robert] Redfield made those comments during a congressional testimony and people said, "What? You'd rather have a mask than a vaccine?" But you articulated that somewhat better, which is not at all surprising to me, by the way.

What are your residual concerns at this time? We're going to see data from these trials, likely a couple of them, before year end. Fortunately, it's not going to be before the election in 8 days. It's going to be after. That got fixed, fortunately, by the FDA. That team developed a spine in the midst of all this. But perhaps we will see a couple of trials with readouts, and then we have a recommendation plan of phases of who should get vaccinated kind of a staged process. What are your concerns about that going forward.

Offit: I worry about the interim analysis with small numbers that Pfizer or Moderna will say, "Look, we've had 35 cases of illness and we're going to now report that. We have 25 or 30 cases in the placebo group, and four or five or 10 in the vaccine group."

I only hope that they don't submit for an EUA with small numbers. I really hope we get to 150, which is what the NIH group that was put together by Francis Collins had asked for. I think that's a minimum of what you need to at least feel comfortable that you have so-called tight confidence intervals for your efficacy.

Obviously, the worst thing you would do is put a vaccine out there that's unsafe. But if you put a vaccine out there that's ineffective, you are going to lose the trust of what is already a fragile confidence by the American public. You don't get a second chance to make a first impression. We need vaccines as our way out of this. And we can't screw that up. I do worry that the pressure to get something out there quickly, with small numbers, would put us, the FDA Vaccine Advisory Committee, in a position of having to say, "You just don't have enough data yet," even knowing that people are dying of this virus.

Topol: You've now brought up two key points about the first couple of trials. Not only can they affect the rippling of all the programs of vaccines by declaring efficacy and making it hard for people who are deemed at higher risk to stay on a placebo arm, but there's also this issue of incomplete ascertainment of what is really happening. And that would really be a problem.

When these companies have their data, will your group be reassembled to adjudicate that?

Offit: Yes.

Topol: And that will be a public hearing as well, right?

Offit: Both FDA and CDC advisory committees are always open to the public.

Topol: Even though Pfizer's trial is outside of Operation Warp Speed, they'll be reviewed by NIH as well?

Offit: Here's how it will work. The FDA vaccine advisory committee has already been asked to agree to three dates to meet in November and three dates to meet in December, in anticipation that there probably is going to be a situation where we need to review data. But all the FDA does is essentially permit the companies to sell or in this case, distribute the vaccine. But that's not the recommendation. It's the CDC that recommends vaccines through the ACIP. So the ACIP is going to independently review data and then make a recommendation.

Our hospital, like many hospitals, will wait for a recommendation from the ACIP. Usually insurance companies wait for the recommendation.

I think the ACIP really is the key group.

Offit: What worries me in all this is that after the hydroxychloroquine and convalescent plasma experiences, it's not just that the public has gotten skittish about what's going on at the FDA. I think that professionals have too. So now you have at least five states that are going to form their own vaccine advisory committees. The National Medical Association, which is a group that represents African American physicians, has said the same thing: "We're going to get our own group of vaccine advisors. We don't trust the government." Which is to say that "we don't trust the FDA to protect us." If we've gotten to the point in America where we don't trust the FDA, we're in some trouble.

Topol: This is yet another essential point, because earlier we talked about how to promote trust. And what you've reviewed right from the top of our discussion today is that because of the precedent with hydroxychloroquine, which had no evidence basis, and then the convalescent plasma, with no evidence basis... And in the midst of that, a widening EUA for remdesivir, which had very little evidence, and now a full approval for remdesivir, which again has mixed results, including this recent WHO Solidarity Trial. How can the FDA approve it when you have a trial that negates the efficacy? So there is a trust lost in the FDA. But it seems, Paul, as though, in recent weeks, the FDA has gotten stronger. That is, it stood up to the pressure of Trump and the administration and Azar and the Department of Health and Human Services (HHS). Is that a sign that things are turning in the right direction?

Offit: Yes, most definitely. I think when Commissioner Hahn stood up and said, "No, we are getting 2 months of safety data after the last dose," which is a reasonable and minimal requirement, and typical, frankly, for vaccines that clearly would have put the timeline beyond November 3rd, Election Day, which clearly aggravated others. But he wrote it down. He submitted it in written form to us to consider. And the administration backed away. And I think it did make the administration angry.

I think it may have made others who were higher up in HHS angry. But the fact of the matter is, Stephen Hahn stood up for the American public when he did that. So, good for him. And by turning to the FDA vaccine advisory committee, we're not government employees. We're academics. We will give our opinion. We're used to being in academic medicine. We're used to people ignoring our opinion all the time. But we can at least give an unvarnished, clear opinion about what we think about this, that that's what we'll do. We'll be honest about what we think of this. If we do that and that's in a public meeting, and then there's any attempt to try to go around what we've done, it would just backfire.

Topol: It's really great to hear your point on this. These are the most important clinical trials, as far as I can tell, in history, because we are in such a horrible predicament. We've dug this humongous hole in terms of how we're going to dig out when we have 83,000 cases a day for a couple of days in a row, and it's still on the rise. We're also seeing hospitalizations rise, and now deaths are increasing again. So we need a remedy. This is it. And we need to get it right. We've talked about all the things that could go off track if it's prematurely, or not properly, given the green light. So this has been a great discussion.

I hope that these other vulcanization of reviews in California, New York, and other states will start to get behind the FDA, that they'll realize that you and your colleagues and these different external groups that are reviewing the data, as well as internal at FDA, are doing it right.

We need to understand that this has gotten on course now in terms of the review process. That's really great. We needed that because we didn't have that last time we met. It was all up in the air as to what was going to happen, whether Trump was going to waive his vaccine approval as an election tool or not. I feel a lot better.

It's great to hear your views, Paul. Thanks for being with us. This has been a great conversation again. I think we have to have you back after your next review. There's no better way to understand what's going on than to get your expertise, your frank comments. Thank you so much for helping us at Medscape, and our community, get up to speed.

Offit: My pleasure. Thank you.

Eric J. Topol, MD, the editor-in-chief of Medscape, is one of the top 10 most cited researchers in medicine and frequently writes about technology in healthcare, including in his latest book, Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again.

Paul A. Offit, MD, is the director of the Vaccine Education Center at Children's Hospital of Philadelphia and the Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania. An internationally recognized expert in virology and immunology, he has published more than 150 papers in medical and scientific journals and is the co-inventor of the rotavirus vaccine RotaTeq.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube

More:

For COVID-19 Vaccines, ACIP Will Be a Critical Gatekeeper - Medscape

We attempted to send a notification to your email address but we were unable to verify that you provided a valid email address. Please click here to update your email address if you wish to receive notifications. Otherwise, you may click here to disable notifications and hide this message.

See the original post here:

Health commissioner: COVID-19 vaccine coming in late 2020, early 2021 - The Gazette

New Jersey will aim to have 70% of its adult population vaccinated within a six-month period once a COVID-19 vaccine is approved and available, state officials announced Monday.

To reach that lofty goal, about 81,000 of the Garden States nine million residents would have to be vaccinated each day for five days a week, state Health Commissioner Judith Persichilli said during a virtual coronavirus briefing in which officials laid out the first draft of New Jerseys vaccination plan.

Thats about 3,200 people a day five days every week in each of the states 21 counties, Persichilli added.

By comparison, about 50% of New Jerseys population receives the flu vaccine, and a little more than 70% of those are children, she said.

A coronavirus vaccine is not expected to be mandatory, officials said. But Gov. Phil Murphy stressed weve got to make sure vaccine compliance is high."

The comments came as the state publicly unveiled a 182-page vaccination plan that it submitted to the federal Centers for Disease Control on Oct. 16. Under the plan, front-line healthcare workers, people over 65, and those with underlying conditions would be the first to receive initial doses.

Murphy stressed this is a work in progress that could change. But he insisted New Jersey is prepared for whenever a vaccine is set to be distributed, likely in the coming months.

I am proud today to be able to say these four words: We will be ready," he said.

But officials said whether the state reaches its vaccination goals will depend on building trust among residents. Murphy said a big challenge will be cutting through anti-vaccine noise and convincing people the vaccine will be safe.

We cannot let the online rumors and social-media-driven conspiracy theories jeopardize our ability to build statewide immunity against this deadly virus, the governor said. We know from public polling that there is already growing skepticism of a vaccine and in the face of this virus, that skepticism could prove to be as deadly as the virus itself."

Murphy emphasized that New Jersey will not simply rush forward on a vaccine and will instead be methodical and deliberate" to make sure its safe.

If we, based on all the experts, conclude beyond any reasonable doubt that this is safe and efficacious and it can be scaled and delivered in the proper way, we need folks to do their part," he said. We will not put anything on the street that we cant say all those things about.

Murphy also stressed that New Jersey will need federal help to fund the undertaking.

Let me be clear: If we do not receive any additional funds, achieving a 70% vaccination rate will take many years, if it happens at all, he said.

President Donald Trump has repeatedly said a vaccine is imminent in the United States, though an exact timeline remains uncertain.

Dr. Anthony Fauci, the White Houses top infectious disease expert, told the BBC on Sunday that experts will know by early December whether a potential vaccine is safe and effective, but it likely wont be available in a widespread fashion until next year.

The amount of doses that will be available in December will not certainly be enough to vaccinate everybody," Fauci said. "Youll have to wait several months into 2021.

Four companies are in late-stage clinical trials in the United States: AstraZeneca, Johnson & Johnson, Moderna, and Pfizer.

The U.S. Food and Drug Administration could issue emergency authorizations for one or more of those vaccines by the first quarter of 2021, Persichilli said.

The federal government will likely make limited quantities at first, the state health commissioner said. Its unclear how many doses New Jersey would get.

Persichilli said its then up to the state to determine who will receive the initial allotments. The state plans to work with local health departments to dole out the doses.

Under New Jerseys plan, the first batches likely be reserved for healthcare workers who have potential exposure to the virus and those who are at higher risk. That includes people 65 and older, those with pre-existing medical conditions, people who live in group settings such as prisons and psychiatric hospitals, and essential workers who cant practice social distancing such as law enforcement personnel, food packaging and distribution workers, teachers and school staff, and child-care workers.

Officials said a big goal is making sure the vaccine is given out equitably, regardless of race or social status.

We will work to quickly move across population segments and deliver vaccines into the communities that were hardest hit, not just those that are easiest to reach, Murphy said.

The announcement came a week after New York laid out its vaccination plan.

New Jersey has been among the American states hit hardest by the virus. COVID-19 has killed more than 16,000 residents in nearly eight months.

Like many parts of the country, New Jersey has also been dealing with spikes in new cases and hospitalizations in recent weeks. On Monday, state officials announced 1,223 more cases and seven additional deaths, while hospitalizations reached a nearly four-month high.

Thank you for relying on us to provide the journalism you can trust. Please consider supporting NJ.com with a subscription.

Brent Johnson may be reached at bjohnson@njadvancemedia.com.

The rest is here:

N.J. wants 70% of adults to get COVID-19 vaccine in 6 months once its available - NJ.com

What has been accelerated is providing funding, resources, cutting through some of the administrative processes that normally draw out a developmental process for a vaccine. Because this is an emergency situation and we are in a global pandemic, they are moving on all fronts in that regard.

Go here to see the original:

Fact or Fiction: COVID-19 vaccine- speedy but safe? - Live 5 News WCSC

Several clinics across Iowa are still looking for vaccine trial volunteers.

Dr. Anthony Fauci says a coronavirus vaccine could be given to some of the most vulnerable individuals by the end of 2020.

In the meantime, thousands of people across the United States are participating in those closely-watched trials.

One of them, Ashley Vanorny, is a University of Iowa alum.

"As a former psychology student at the University of Iowa, I know what it's like to recruit patients," Vanorny told Local 5. "So because of that I've always decided that as many as I qualify for, I will do."

Vanorny is participating in the Pfizer study out of the University of Iowa, and says she got two doses at the beginning of the trial.

Researchers don't tell her if she got the real vaccine or a placebo.

But Vanorny thinks she might have received the real thing.

"I did have a different reaction. I had the injection at the beginning of the morning, and then by the end of that evening, I got chills and a mild moderate headache," Vanorny said. "But it was a risk I was willing to take, and I believe a good and necessary risk."

Throughout the trial, Vanorny logs her progress using a special app.

"It's really slick," Vanorny said. "It's just an app and then after that you are checking in once a week until your next appointment."

Vanorny is happy she's participating in something that could save millions of lives.

"For me, it's painless. And for me, I think it's important that as many people as possible that you participate in things like this if you're able," Vanorny said.

If you want to participate in coronavirus treatment trials or vaccine trials, several clinics across the state are looking for volunteers.

Continued here:

What is it like to participate in a COVID-19 vaccine trial? - Local 5 - weareiowa.com

A health worker injects a woman during clinical trials for a COVID-19 vaccine last month in Hollywood, Fla. Eva Marie Uzcategui/Bloomberg via Getty Images hide caption

A health worker injects a woman during clinical trials for a COVID-19 vaccine last month in Hollywood, Fla.

The Food and Drug Administration is preparing for the eventual rollout of one or more COVID-19 vaccines by identifying the concerns that some people have about taking such a vaccine.

At a meeting Thursday of experts advising the FDA on COVID-19 vaccines, the concerns of front-line workers and people of color were read aloud verbatim, highlighting the crucial project of communicating the safety and effectiveness of a vaccine in an environment of deep political distrust.

Those concerns were gathered at a series of listening sessions organized by the Reagan-Udall Foundation, a nonprofit that aims to advance the work of the FDA.

Susan Winckler, the foundation's CEO, noted that its study was rather narrow, with a focus on the role of the FDA in vaccine review and approval.

Nonetheless, participants in the sessions voiced a range of concerns:

The listening sessions focused on two groups. One was front-line workers in service, retail and health care settings. The second focused on people who are often underrepresented and are at increased risk for COVID-19: Black, Hispanic and Indigenous/Native American communities.

Eight such sessions have been conducted so far, and a few more are slated for the coming weeks. The foundation said its goal is to understand the perceptions that may lead Americans to feel hesitant about receiving a COVID-19 vaccine and to use that information to craft messaging that addresses those concerns.

Winckler noted that the participants' concerns often shared certain themes: concerns about the speed of the process, distrust of government and government agencies, distrust of the health care system, and concern that politics and economics will be prioritized over science.

People of color also voiced worries that the vaccine won't work for minority populations. Among their statements:

Participants also expressed fears based on past experiences. One person expressed a worry that "this is another Tuskegee experiment."

Vaccine hesitancy was a frequent topic at Thursday's FDA meeting recognition that the introduction of COVID-19 vaccines will be a nationwide communications effort as much as a scientific one.

The FDA meeting was one effort to demonstrate that the vaccine development process in the U.S. is safe and is being handled with great care and transparency.

Marion Gruber, director of the FDA's Office of Vaccines Research and Review, said that development of a vaccine is happening as quickly as it can but no faster.

"Vaccine development can be expedited," she said. "However, I want to stress that it cannot and must not be rushed."

Read the original post:

Doubts About COVID-19 Vaccine Among People Of Color ...

(Photo by Alex Edelman-Pool/Getty Images)

Pool | Getty Images News | Getty Images

LONDON Hopes are rising that a Covid-19 vaccine could be approved by the end of the year, with drugmakers and research centers scrambling to help bring an end to the pandemic.

Dozens of candidate vaccines are in clinical evaluation, according to the World Health Organization, with some already conducting late-stage tests before seeking formal approval.

The outcome of the trials is being closely monitored around the world.

The U.S.'s leading expert on infectious disease believes it will only be a matter of weeks before the findings of a potential vaccine will be known.

"We will know whether a vaccine is safe and effective by the end of November, the beginning of December," White House coronavirus advisor Dr. Anthony Fauci said in a BBC interview on Sunday.

"The question is: Once you have a safe and effective vaccine, or more than one, how can you get it to the people who need it as quickly as possible?"

Fauci said a vaccine deemed safe and effective would be rolled out according to a set prioritization, with individuals such as health care workers and those in a higher risk category likely to receive the first doses. He said it would be "several months into 2021" before a vaccine becomes more widely available.

The development of a vaccine, Fauci warned, would not replace the need for public health measures to help protect people from the disease for some time.

To date, more than 43 million people have contracted the coronavirus worldwide, with 1.15 million related deaths, according to data compiled by Johns Hopkins University.

The race for a Covid vaccine has seen governments step in to try to help the process along by providing funds to allow companies to scale up manufacturing even before drugs have been approved.

Leo Varadkar, Ireland's deputy prime minister, has said he is hopeful an inoculation against the coronavirus could be approved before the end of the year.

"I'm increasingly optimistic, as is government, that we will see a vaccine approved in the next couple of months and that in the first half or first quarter of next year it'll be possible to start vaccinating those most at risk," Varadkar, who is a qualified doctor, told RTE radio on Sunday.

A Rehab Support worker checks on patient notes as the first patients are admitted to the NHS Seacole Centre at Headley Court, Surrey, a disused military hospital, which has been converted during the coronavirus pandemic.

Victoria Jones | PA Images via Getty Images

Not all public health experts share the same level of optimism about the development of a Covid vaccine before year-end, however.

The Mail on Sunday reported plans had been drawn up for frontline National Health Service staff to receive a coronavirus vaccine within weeks, citing an email sent by an NHS Trust chief to his staff.

In response to the report, U.K. Health Minister Matt Hancock said on Monday that it was not the government's expectation for NHS staff to receive access to a potential vaccine this year.

He did rule out the possibility of a Covid vaccine being delivered to hospital staff in 2020 but said the bulk of the rollout would likely take place in the first half of next year.

The U.K.'s chief scientific advisor, Patrick Vallance, has said he doesn't believe a Covid vaccine will be available for widespread use in the community until at least the spring.

He also told the National Security Strategy Committee in London last week that the coronavirus was likely to become as endemic as the annual flu.

This means the infection rate of the coronavirus, like other coronaviruses, will eventually stabilize at a constant level so that the virus becomes present in communities at all times.

Vallance said creating a vaccine from scratch took approximately 10 years on average. The fastest vaccine ever developed was for mumps, and it took more than four years.

Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020.

Dado Ruvic | Reuters

Separately, Dr. David Heymann, who led the WHO's infectious disease unit during the SARS epidemic in 2002-2003, believes some governments may be over-reliant on the development of a vaccine at a time when effective communication, diagnostic testing and outbreak containment activities are all critically important tools.

"The difficulty right now is that in many countries, they are looking forward to a vaccine which may or may not come, which may or may not be effective in the short or long term, and they are looking at possible therapeutic (options) which could solve many of the problems," Heymann said during a webinar for think tank Chatham House last week.

"But, that's not a good way to proceed at present. We have to learn to live with the pandemic."

View post:

Hopes are rising for a potential Covid vaccine and Fauci says findings will be known by early December - CNBC

AstraZeneca and Johnson & Johnson will restart trials of their vaccine candidates against coronavirus disease 2019 (COVID-19); the United States hits a record high 2-day total of COVID-19 infections; strategies can help ease stress amid the coming election.

After halting clinical trials to investigate safety concerns of their respective vaccine candidates against coronavirus disease 2019 (COVID-19), both AstraZeneca and Johnson & Johnson (J&J) announced plans to restart their studies. As reported by STAT, the trial by AstraZeneca had been stopped on September 6 after a study participant developed neurological symptoms, with an independent monitoring committee then determining the vaccine candidate was safe for the trial to resume. J&J, which had halted its trial on October 11, could begin enrolling patients as early as next week.

According to Reuters, the past 2 days have exhibited the highest ever number of new COVID-19 cases in the United States during that time frame, with 79,852 new cases reported on Saturday and a record of 84,244 cases on Friday. Notably, 29 states have set records for increases in new cases, including Ohio, Michigan, North Carolina, Pennsylvania, and Wisconsin. North Dakota has been indicated as the hardest hit state based on a recent analysis of new cases per capita.

With Election Day approaching, an article by NPR spotlights the prevalence of stress and how to cope with it. According to a survey from the American Psychological Association, 77% of Americans reported being worried about the countrys future and a further 71% of participants reported this time as the lowest point in the history of the United States. In highlighting how to cope with the added stress of the election, several strategies were noted, including preparing mentally for delayed results, doubling down on stress-reducing habits like sleep and exercise, and looking for signs of hope.

See original here:

What We're Reading: COVID-19 Vaccine Trials to Restart; Record 2-Day Infections; Stress-Reducing Strategies - AJMC.com Managed Markets Network