Category: Covid-19 Vaccine

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Johnson & Johnson gears up for 60000-person COVID-19 vaccine trial, the industry’s biggest yet – FiercePharma

August 22, 2020

With several COVID-19 vaccines already in phase 3 trials and investigators aiming to enroll tens of thousands of participants, Johnson & Johnson is prepping the largest study yet.

Thedrugmakeris planning to enroll a whopping 60,000 participants in a phase 3 trial set to begin next month, according to the governments clinical trialdatabase.

Thats twice theenrollment rival vaccine makersModernaand Pfizer are planning for their own phase 3 tests. Pfizer has already enrolledmore than11,000 people, according to aThursdayupdate. And Moderna signed up 8,374 participantsin the first three weeksof its own trial, CNNreportedearlier this week. But officials wereconcerned about a dearth of minorities enrolled in the Moderna trial, CNN reports.

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RELATED:Johnson & Johnson to start human testing of COVID-19 vaccine next week

Aside from those companies, AstraZeneca's vaccine is also in phase 3 testing in the U.K., Brazil and South Africa. The company has enrolled about 8,000 participants in the U.K.out of an expected 10,000,a spokesman told Politico on August 13. Investigatorshavevaccinated about 3,000 people in Brazil and 900 people in South Africa.

As for J&J, investigators plan totest the companys vaccine,Ad26.COV2.S, against placebo to see whetherthe candidate can reduce moderate to severe COVID-19. J&J expects the study to start around September 5.

These companies represent theCOVID-19 frontrunners, but many other players are involved in the hunt for a COVID-19 vaccine, including Novavax and a partnership between Sanofi and GlaxoSmithKline. Novavax isprepping a 30,000-person phase 3 trial for this fall.

RELATED:Busy AstraZeneca inks yet another big COVID-19 vaccine deal, this time with EU

As the vaccines move forward,governments around the world have been negotiating supply deals to be ready if the candidates succeed. The U.S. has inked agreements for 800 million doses, and Europe is in advanced discussions with several companiesafter signing a pact for 400 million doses with AstraZeneca.

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Johnson & Johnson gears up for 60000-person COVID-19 vaccine trial, the industry's biggest yet - FiercePharma

A coronavirus vaccine that is safe, effective: How do we get there? – Chicago Tribune

August 22, 2020

Despite all the urgency, scientific advances and funding, there are many hurdles. In addition to the difficulty of creating and evaluating vaccines at an accelerated pace, countries must figure out how to manufacture, store and distribute hundreds of millions of doses as well as convince enough people to be vaccinated to halt the spread of the disease.

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A coronavirus vaccine that is safe, effective: How do we get there? - Chicago Tribune

When It’s Ready, Who Gets The COVID-19 Vaccine First? – Vermont Public Radio

August 22, 2020

When a vaccine becomes available for COVID-19, who gets it first?

Thats the latest question VPRs people-powered journalism project, Brave Little State, has set out to answer. It was asked by a Vermonter named Roger Stone. And no, hes not that Roger Stone. Although this Roger Stone says he did used to get phone calls for the other guy, when they both lived in Manhattan.

Anyway, this Roger Stone is retired from the advertising industry.

Oh, quite retired, he tells me. I'm 79 years old, and right there in the prime age group for having some bad things happen to you if you happen to contract COVID.

Stone lives in in Bondville, a tiny village in the small town of Winhall. And he says theres no Instacart where he lives. No for-profit delivery services. Not for food, not for meds. And, he says, policymakers havent done much to help older folks like him stay safe at home.

So when he heard the feds were starting to discuss how a vaccine shouldbe distributed? Stone tuned in.

And realized that it's really a question, he says. It's just like, not a slam dunk that the old people would get a high priority right behind health care workers and essential workers.

That had him worried. Worried enough to write in to Brave Little State:

What's on my mind is how the state is going to set priorities for the vaccines when they become available," Stone says. How is this going to be settled out? Is there a committee? Is there a governor? How does that work?

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Alrighty. Lets get up to speed on the global effort to get a vaccine for COVID-19 to folks like you and me.

According to a handy guide published by the New York Times, a number of teams began work on vaccines about eight months ago, in January. After testing on mice and monkeys, the first safety trials began in a small group of humans in March.

As of mid-August, there are more than 165 vaccines in various stages of development. About 30 are in human trials. Eight are in Phase 3 trials, being tested on tens of thousands of people for safety and effectiveness. Two have already been approved for limited use.

More from VPR: Confused About Antibodies? Let Our Comic (Featuring Many Llamas) Explain

And the federal government has been funding mass production of a number of vaccines. Optimists say one or more vaccines could be available to the public by the end of the year.

Others say sometime next year is more realistic. Thats really TBD. But whenever it is available, there probably wont be enough for everyone, not right away. As for who will get access first? Roger Stone, and other older Vermonters ? They arent the only ones who wanna know.

Heidi Hopper, who works as a paraeducator in South Burlingtons elementary schools, hopes to get vaccinated sooner rather than later.

I last year was diagnosed with non-Hodgkins Lymphoma, she says. Im hoping that I would be on that list coming from cancer, and working in schools.

And although her treatment went well, and she is now one year cancer free, chemotherapy damages the immune system. This semester, while Hoppers colleagues plan to be back in schools teaching in person, shell work from home.

I would love to be back in school with people, Hopper says. You know, I'm a people-person, so it will be very hard for me if I don't get the vaccine and I'm home.

Neither Hopper nor Stone think they should be first in line. In fact, almost everyone I talked to agreed those vaccines should be reserved for frontline health care workers.

But after that if there really is a shortage who is next? Other essential workers? Vermonts elders? People with suppressed immune systems? What about people of color? In Vermont, Black people have gotten COVID-19 at 11 times the rate of white people.

Giving priority to high-risk populations in this case would involve looking at racially diverse communities, based on the very worrying racial disparity that we have.

More from VPR: Race, COVID-19 And Health Disparities In Vermont

Maria Mercedes Avila is an associate professor of pediatrics and the health equity liaison at the Larner College of Medicine at UVM. She joins a chorus of medical professionals who say some racial minorities should also get priority access.

Children under nine who tested positive for COVID-19, of those children, 68% are children who are racially diverse, Avila says. That's a very alarming statistic for the second whitest state in the country.

Indeed. So many groups have valid reasons to want to be near the front of the COVID-vaccine line.

Christine Finley, the immunization program manager at Vermonts Health Department, is pretty familiar with the vaccine distribution process. Shes one of 31 liaisons to the Centers for Disease Controls standing Committee on Immunization Practices -- or ACIP. Its the group that writes federal guidelines for vaccines.

Finley represents immunization managers across the country, alongside the American Academy of Pediatrics, Academy of Family Physicians, the Association of State and Territorial Health Officers, U.S. Department of Veteran Affairs, Indian Health Service and more.

Those liaisons and 15 voting members -- almost all are doctors -- break out into more than dozen work groups to look at all aspects of vaccines: their safety, their efficacy, who should get it, when. The committee then writes and votes on vaccine guidance, which it sends to the CDC.

And that's the guidance that is expected to be followed by all health care providers, Finley says.

So is any of this process different for COVID-19? Short answer: Yes.

Everything's different for COVID, Finley says with a laugh.

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For one, Finleys group has been meeting monthly, online, rather than the usual three times a year in Atlanta.And, she says, the information is coming from vaccine researchers with a speed thats all together new.

But most different is that this time, theres a second group doing similar work at the National Academies of Science, Engineering and Medicine. They are focusing especially on issues of equity.

And somehow, by October, Finley says, these two groups hope to issue federal guidance.

After that, whenever the vaccine is available, the federal government will pay for and distribute it to each jurisdiction based on population size and other factors. Thats according to the CDC.

Once that happens, itll be up to people like Christine Finley to figure out how to get the right number of doses to the people at the top of the list.

Whoever those people are, many will likely be getting vaccine doses from UVM Medical Center, Vermonts largest medical provider and the largest employer in the state.

Among those employees is Tim Lahey, a vaccine researcher and the medical centers director of ethics. He says hospital leadership has asked the state to convene stakeholders to discuss vaccine access.

I know that conversations about the fair distribution of the vaccine are already starting, he says.

I wondered about the motivation whether UVM Medical Center was being very attentive to health care workers safety, or if it was more about them having to deal with the public, and therefore wanting some guidance?

Laheys answer: Yes.

He says hospitals dont have to deal with scarcity that often. And there will a lot of scrutiny around vaccine distribution. Hospital officials dont want to be the only ones involved.

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Lahey, of course, is trained in medical ethics -- he understands as well as anyone the challenges facing the committee members writing the vaccine guidance. And, in his mind, vaccines are different from organ transplants or ventilators. He says you cant just think about who is most at risk of dying.

Because if we found out that you can't contain the epidemic without vaccinating people in their 20s and 30s who are perfectly healthy, then we have to prioritize those people, because the point is to save lives, he tells me.

And then Lahey brings up another complicating factor, which actually works against older people like Roger Stone and immunocompromised people like Heidi Hopper:

Almost all vaccines have less effective responses from people who are immune compromised and elderly, Lahey says. So you get into this interesting conundrum where elderly people need protection from influenza the most. They need protection from COVID-19 the most. But they're also less likely to have a great response to the vaccine. And so the ideal population-level response probably is a combination of giving it to people who are most at high risk and giving it to people who are most likely to respond.

This was news to me. And this concept of prioritizing at the population level, rather than the individual? Lahey says its one reason certain racial minorities should get prioritized for vaccine.

He says thats different, however, when youre talking about ventilators.At 2 a.m. when two people are vying for one ventilator, you really cant know which of those people has suffered more injustice.

Vaccination is different. We know that race is a marker of risk of severe COVID-19, Lahey says.And we want to distribute the vaccine preferentially to people who are most at risk so that we can save the most lives possible. And vaccination is a population-level intervention.

Ideally, he says, there will be enough vaccine for everyone to access ASAP. That is still a possibility. But if there isnt, its not really up to UVM Medical Center to decide who gets priority. Its up to the CDC and the National Academies of Science, and their committees who are in the midst of eternal video conferences, hashing all this out.

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Not everybody wants to go first

But wait. All of this concern about who gets the vaccine first? Its premise is an assumption. One I didnt think much about until I talked to Linda Goodman.

I have a rare blood cancer called Waldenstrom's, it's a non-Hodgkin's lymphoma, she tells me.

Goodman is in the same support group as Heidi Hopper, the cancer survivor who works in elementary schools. Only Goodman is not gunning to be first in line for a COVID-19 vaccine.

Its an interesting question that you ask, Goodman says. The question is, who is it safe for, more than who should have priority? And when the vaccine came out, I would not get it initially until it'd been out for X period of time, so I knew what the side effects would be.

Goodman was open to the vaccine until she heard a segment on a SiriusXM radio station called Doctor Radio. Thats where she learned that even though the vaccines are going through the traditional Phase 3 30,000 person clinical trials, very rare side effects, or those affecting very small segments of the population, may not be understood until hundreds of thousands of people have received the vaccine.

And because of her cancer, Goodman says -- she doesnt want to go first. Plus, she says, shes lucky.

I have this amazing home that looks out into many, many acres, including water, she said.

And Goodman has a husband who does the shopping, and keeps her company. Shes willing to be cloistered away.

But what she brought up this fear that the vaccine wont be safe? Its more prevalent than I had understood. And its more prevalent than doctors and public health officials like Christine Finleywould like.

They named the whole piece about the vaccine on the federal level, Operation Warp Speed, Finley says. I don't think there could be a worse name that you could name something.

She adds: Because I think that it just says, Oh, gosh, they're really rushing it. And it misses what's going on. In the trials that they're doing, the standard is that you want 30,000 people in those trials. They are going to have 30,000 people. They are not cutting the size of the population that is going to be in the trials.

Finlay also notes that in a poll done by the Associated Press and University of Chicago, only half of American adults said they would definitely get a COVID-19 vaccine when it comes out.

We need to do better than that if we want to achieve herd immunity, Finley says.

As a liaison to the CDC working group, Finley is watching the sausage get made. And, she says, its made her confident the vaccine will be safe.

In the meantime, she and the committees figuring all this out are left with two contradictory but equally important mandates: Figure out how to save the most lives with a small amount of vaccine, and then convince people to come and get it.

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Thanks to Roger Stone for the great question.

If you have a question about COVID in Vermont, or anything else, ask it at bravelittlestate.org. While youre there you can sign up for our newsletter, and vote on the question you want us to tackle next. Were on Instagram and Twitter @bravestatevt.

This episode was produced by Emily Corwin, with editing from Mark Davis.

Brave Little State is a production of Vermont Public Radio. Our digital producer is Elodie Reed, and we have engineering support from Chris Albertine. Ty Gibbons composed our theme music; other music by Blue Dot Sessions.

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When It's Ready, Who Gets The COVID-19 Vaccine First? - Vermont Public Radio

How will the WHO ensure everyone has access to a COVID-19 vaccine? – World Economic Forum

August 22, 2020

The World Health Organization (WHO) on Tuesday urged countries to join a global pact aimed at ensuring less wealthy countries have access to COVID-19 vaccines, warning about the risks from so-called vaccine nationalism. Here is a look at the WHOs plan and the approaches by wealthier nations.

COVAX is working to ensure fair access to COVID-19 vaccines.

Image: Reuters/Dado Ruvic/Illustration

What is the WHOs vaccine program?

The COVAX global vaccines facility is a program designed to pool funds from wealthier countries and nonprofits to develop a COVID-19 vaccine and distribute it equitably around the world. Its aim is to deliver 2 billion doses of effective, approved COVID-19 vaccines by the end of 2021.

The details of the program are still being hashed out ahead of an Aug. 31 deadline for nations to join. It is led by the WHO, along with the Gavi vaccine alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI).

COVAX is part of a broader program, called the Access to COVID-19 Tools (ACT) Accelerator, that works to ensure that vaccines, treatments, diagnostic tests and other healthcare resources are broadly available to combat the pandemic.

What are the wealthier nations doing?

They have focused on securing vaccines for their own citizens, striking deals for the first doses even as data has yet to prove the vaccines to be effective.

Governments including United States, the United Kingdom, Japan, and the European Union have spent tens of billions of dollars on deals with vaccine makers such as Pfizer Inc (PFE.N), Johnson & Johnson (JNJ.N), AstraZeneca Plc (AZN.L) and others. The United States alone has committed nearly $11 billion for development, testing, manufacture and stockpiling of hundreds of millions of doses.

Russia and China are also working on vaccines and have already begun vaccinating some of their citizens.

What kind of resources are being brought to bear?

The ACT Accelerator is financed by a variety of nonprofits and governments. It is aiming to raise about $31 billion.

So far, the COVAX facility has attracted interest from 92 poorer countries hoping for voluntary donations and 80 wealthier countries, a number little changed from a month ago, that would finance the scheme, according to the WHO.

What is the WHO's concern?

The WHO has expressed concern that wealthier countries hoarding vaccines for their own citizens could impede efforts to end the pandemic.

We need to prevent vaccine nationalism, WHO chief Tedros Adhanom Ghebreyesus said during a Tuesday virtual briefing. Sharing finite supplies strategically and globally is actually in each countrys national interest.

WHO leaders have said that developing a coordinated global distribution system for COVID-19 vaccines that prioritize those at greatest risk of getting sick, such as healthcare workers, would help curb the spread of coronavirus worldwide.

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How will the WHO ensure everyone has access to a COVID-19 vaccine? - World Economic Forum

Is the Race for a COVID-19 Vaccine Moving Too Fast? – Vogue

August 22, 2020

Im a vaccine lover. I got the shingles vaccine as soon as a colleague had a gruesome experience with an itchy, painful rash. But the prospect of a vaccine for COVID-19 has been scaring me. On the positive side, scientists are dropping everything and rushing to create a vaccine; whoever succeeds will be the worlds savior. On the other hand, the word rushing is a little unsettling.

How do you know its safe? How do you know you should get it? Globally, 31 vaccines are in human trials, and many more candidates are being studied. Russia has already approved a vaccine but it skipped the phase where it is subjected to large-scale testing, raising skepticism in the global medical community.

A surprising number of Americans have expressed concerns about this process to polltakers, with as much as half the population saying they might not take a vaccine, either because theyre against vaccines in general or because they dont trust Trumps government and worry he will pressure the FDA to approve vaccines quickly for political reasons.

So, whats worse: risking the vaccine, or risking the illness and its potentially debilitating long-term repercussions (not to mention death)?

For guidance, I turned to James R. Baker Jr., a professor at the University of Michigan who researches immunology. He holds 50 patents, has testified before Congress many times, founded four companies, and served as global head of vaccines for the big drug company Merck. He also writes the very informative blog, Pandemic Pondering.

Here is a condensed, edited version of a conversation that surprised me in its bluntness.

Q: Will there be multiple vaccines, and will we get to choose which ones seem best for us?

A: Even if one is approved, work will continue on others. The early vaccine candidates are being developed predominantly in younger, healthier people with an age cutoff of 55.

Q: What do you mean? Theres an age cutoff?

A: They are not testing them in older people. And that is a huge problem. Basically the people that really need this vaccine are over 50.

Q: Why are so many companies not testing older people?

A: The real reason they want to test younger people is they know they will respond better and they are more likely to get an immune response that will lead to approval.

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Is the Race for a COVID-19 Vaccine Moving Too Fast? - Vogue

Analyst tips first wave of COVID-19 vaccines to generate $20b – BioPharma-Reporter.com

August 22, 2020

The scale of the unmet need created by COVID-19 has been clear for months. With the virus killing people and throttling economies around the world, governments have been desperate for a vaccine. What has been less clear is the magnitude of the near-term commercial opportunity.

That has begun to change as the US government has published details of its contracts with many of the leading developers of COVID-19 vaccines. Armed with that information, Gal calculated the near-term financial opportunity in a note to investors.

Gal thinks the initial wave of vaccinations needed to start bringing the virus under control may generate revenues of around $20 billion. The estimate assumes the US will pay a slight premium to other developed markets.

What happens beyond 2021 is less clear. At this stage, it is unclear how long immunity conferred by the vaccines will last. If annual booster shots are needed, vaccine manufacturers could continue to generate sizable sales for years to come, particularly if they are able to charge governments prices that more accurately reflect the value of their products after the pandemic ends.

For now, the focus is on showing the vaccines work and scaling up manufacturing to quickly meet the current pent-up demand. Based on company disclosures, Gal expects vaccine manufacturers to have enough capacity to meet demand in the developed world.

Gal modeled that AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer, and Sanofi, the six big vaccine developers covered in the analysis, have capacity to supply more than 5 billion doses.

How soon those products get to governments depends on when the vaccines get regulatory approval and the speed at which manufacturing ramps up.

Gals model has three vaccine developers Pfizer, Moderna, and AstraZeneca shipping products this year. Those companies are predicted to ship enough products to vaccinate 158 million people by the end of the year.

The big vaccination push will come early in 2021. Gal predicts J&J, Novavax and Sanofi will start shipping vaccines in the first quarter. With the first three vaccine manufacturers to market continuing to ship products, Gal predicts the authorization of the new candidates will give countries the capacity to immunize 709 million people by the end of March.

If accurate, the forecast suggests developed countries could have enough vaccines to immunize their populations by the end of the first quarter. There are around 1.1 billion people in the US, Canada, the UK, the European Union, Japan and Korea, the developed markets Gal expects to buy up most of the first vaccines.

That forecast is underpinned by the expectation that manufacturers, particularly J&J and Sanofi, will make big volumes of vaccines before winning approval. Gal expects J&J and Sanofi to each distribute enough vaccines to immunize 100 million people in their first month on the market.

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Analyst tips first wave of COVID-19 vaccines to generate $20b - BioPharma-Reporter.com

Yale and Yale New Haven Hospital begin Phase 3 trial of COVID-19 vaccine – Yale News

August 22, 2020

Yale School of Medicine and Yale New Haven Hospital today announced the start of Phase 3 of the Pfizer vaccine trial at the hospital. This groundbreaking study is intended to be one of several vaccine trials to be undertaken in the hopes of finding the most scientifically validated vaccine in the shortest amount of time.

The study is a collaboration between BioNTech SE and Pfizer using modified RNA. This is a novel way to create a vaccine for use in humans. Rather than using the part or whole of the actual virus in an inactive form to create immunity, this vaccine candidate uses a genetic code (modified RNA) to make the body generate proteins that resemble the SARS CoV-2 virus spike protein, thereby causing development of antibodies against it. Antibodies against the spike protein, a projection from the COVID virus that allows it to attack cells and infect a person, may block the infection from taking hold if the body comes in contact with the virus. In Phases 1 and 2 of the trial, this novel vaccine has proven safe and effective in generating an appropriate immune response. This third phase hopes to show that it can prevent infection.

I am very excited that Yale New Haven Hospital and the Yale Center for Clinical Investigation (YCCI) are undertaking this novel vaccine trial, said Principal Investigator Dr. Onyema E. Ogbuagu, YNHH Infectious Disease physician and associate professor of Medicine at Yale School of Medicine. The earlier trial phases have been very encouraging showing that when injected, the vaccine is tolerated well and generates the appropriate immune response that has the potential to protect humans from COVID-19.

The YCCI Cultural Ambassadors program is playing a large role in educating the public on clinical trials, building on past success to address cultural and operational issues to encourage a diverse and underserved patient population to participate. The Cultural Ambassador program is a partnership between YCCI, the Connecticut AME Zion Churches, and Junta for Progressive Action. Created 10 years ago, this group has had great success in engaging populations of color in clinical research. When we started talking about clinical trials in our community, people of color represented only 3%6% of the participants in clinical trials, said the Rev. Elvin Clayton, pastor, Walters Memorial AME Zion Church. Now we see between 30%-50% participation, and in some trials, over 80%.

The Cultural Ambassadors are now sharing information about the Pfizer COVID vaccine trial with the goal of ensuring that the final vaccine will be effective for everyone, regardless of their cultural or ethnic background. Our community has been disproportionately impacted by COVID-19, said the Rev. Dr. Leroy Perry, pastor of St. Stephens AME Zion Church. We will be working harder than ever to ensure that the underserved community has access to this clinical trial and when ready, the vaccine will be made affordable to those who are disproportionately affected.

The trial is a randomized placebo-controlled trial which means that of the planned nearly 30,000 enrollees, half will receive the vaccine and half will receive a placebo. If success is seen early on in the trial, all participants will be given the vaccine and all enrollees will be followed for two years. All participants must be healthy, willing to comply with scheduled visits and be between the ages of 18 and 85 years. To learn more about the trial or to sign up to participate, visit the Clinical Trials at Yale website.

This vaccine trial is yet another example of the importance of academic medical centers, said Dr. Thomas Balcezak, executive vice president and chief clinical officer, Yale New Haven Health. Our partnership with the Yale School of Medicine and YCCI creates opportunity to bring cutting-edge care and therapeutics to our community.

This vaccine is being developed at a record rate due to the rapid proliferation of COVID-19 around the globe. But despite the pace, there will be no sacrifice to safety, which is forefront in the minds of the research team, YNHH and YCCI. Prior to COVID-19, the fastest development of a vaccine was to inoculate against the mumps, which took four years.

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Yale and Yale New Haven Hospital begin Phase 3 trial of COVID-19 vaccine - Yale News

COVID-19 vaccine trials need diverse volunteers to ensure safety, effectiveness and public buy-in – USA TODAY

August 20, 2020

Approving a vaccine in the U.S. usually takes years, but COVID-19 vaccines are moving through in record time. What does that mean? USA TODAY

BOSTON Dianne Wilkerson wants Black Bostonians to volunteer for trials testing potential COVID-19 vaccines.

She understands why they're hesitant.Black Americans have a long history of being treated poorly by the medical establishment; many faced discrimination in medical care themselves.

Still, if they don'tparticipate in the trials meant to establish vaccine safety and effectiveness, they'll never know whether the vaccines will work for them.

"The risks for not being involved are so great," said Wilkerson, a founding member of Boston's Black COVID-19 Coalition.

About 25% of the city's populationis Black, yet Blacks have made up more than 35% of those infected and killed by COVID-19.

Nationally, the figures are even worse.Just over 80 Black Americans have died of COVID-19 out of every 100,000, compared with 46 Latino Americans and 36 white Americans, according to the American Public Media Research Lab.

The first two large-scale vaccine trials began nationwide in late July, and at least three more will start before early fall. Each one will need 30,000 volunteers, half of whom will get an active vaccine and half a placebo.

Federal officials including the heads of the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention have called for these trials to include a large number of people of color.

This May 4, 2020 photo from the University of Maryland School of Medicine, the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection.(Photo: AP)

"We must make sure there is appropriate diversity in the clinical trials," FDA Commissioner Dr. Stephen Hahn said in an recent interview with the editor of the scientific journal JAMA.

Even if everyone's immune system reacts the same way to the virus, differences in care and underlying health may mean people of color respond differently to infection, Hahn said:"We need to make sure those folks are in these trials so that we understand what the immunological effects are, but also the clinical effects."

In addition to racial and ethnic diversity, most of the trials also are looking for people over 65. Older immune systems don't work as well as they used to, and older people have been disproportionately sickened and killed by the virus that causes COVID-19.

Early trials haven't been diverse.

In the two small clinical trials that have published their results, one in The New England Journal of Medicine, one in The Lancet, only eight of 1,100 participants were Black.In both studies, participant age averaged in the mid-30s.

It's not for lack of enthusiasm in the trials. More than 300,000 people have already expressed interest in volunteering to participate.

The Fred Hutchinson Cancer Centerin Seattle, which is managing a registry of volunteers, is not breaking them down by demographic group. But Hahn said 19% of those who had volunteered so far were Black and nearly the same percentage were Latino.

And although 300,000 sounds like a lot of volunteers, it's not nearly enough, said Claire Hudson, a spokesperson for the center.

"Its important to note that we need millions of interested volunteers to join the online registry," coronaviruspreventionnetwork.org, she said via email.

Not all the people who express interest in volunteering will make it into one of the trials, Dr. FrancisCollins, director of the National Institutes of Health,explained at a teleconference announcing the start of the first trial.Some volunteers might not live near testing sites, for instance.

"The more the better," Collins said of volunteers. "This is going to be a big American opportunity for people to come on board as our partners to try to take part in what has been a historic effort to bring to an end the worst pandemic our world has seen in over 100 years."

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

Dr. Barbara Pahud has a plan:If not enough people of color will come to major medical centers to volunteer for clinical trials, she'll bring the clinical trials to them.

As a medical student in Mexico, Pahud was given a cooler of shots to deliver to the community. Now, she's has outfitted a van that she plans to park perhaps at a health center or church to take vaccine trials where Americans of color spend their time.

Pahud, research director of pediatric infectious diseases at Childrens Mercy Kansas City, said she's also making an effort to hire people who speak Spanish, and to have all printed material available in two languages.

"The usual stuff that should always be done is actually being done this time, which is fantastic," she said.

Dr. Barbara Pahud, MD, MPH and Research Director of Pediatric Infectious Diseases at Childrens Mercy Kansas City.(Photo: Children's Mercy Kansas City)

Researchers and community members will both need to take a risk.

"If we really want to do research that reflects the community that we live in, that is being impacted by this disease, we (researchers)need to change our mindset," Pahud said. On the flip side, "communities need to understand that if they want to benefit from the vaccine, they need to let their people volunteer, or we won't be able to know if the vaccine works in their population."

Others are making similar efforts.

At the University of Colorado, Thomas Campbell said his medical practice has used its electronic medical records to identify and reach out to everyone at high risk for COVID-19.

"I've already had over 100 people email me personally and said 'sign me up,'" said Campbell, also aninfectious disease physician at UCHealth.

Pfizer, which has launched its own 30,000-person trial, is locating its trials in diverse communities, including some with large Hispanic and Black populations, spokesperson Sharon Castillo said.

"We're making sure that the demographics of our trial population reflects the demographics of the states and communities that have been most impacted," she said.

Pfizer also is working with partners, such as grassroots organizations and local and Spanish media, to raise awareness and encourage participation. And the company is reducing barriers to participation, Castillo said, by printing materials in five languages.

"We're learning a lot on how to go above and beyond to make sure minorities are represented," she said, promising that Pfizer would continue this approach in all its clinical trials going forward.

Butgood intentions may not be enough.

Wilkerson said a recent meeting with officials at Brigham and Women's Hospital did not end where she wanted it to.

The hospital has reached out to Black leaders, including Wilkerson, for help in encouraging minority participation in these trials. Hospital officials said that meeting and others with local people of color have gone well.

But Wilkerson said a few listening sessions and dropping flyers at local communities centers won't be enough to redress decades of mistrust, or to get Black Bostonians to participate.

"We have an opportunity to reset how (hospitals)relate to Black and brown people," she said, adding that her group plans to seize that opportunity:"We intend to get their attention."

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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COVID-19 vaccine trials need diverse volunteers to ensure safety, effectiveness and public buy-in - USA TODAY

COVID-19 vaccine won’t be mandatory in US, says Fauci – Yahoo News

August 20, 2020

Anthony Fauci, the United States' top infectious diseases official, said Wednesday the government wouldn't make any future COVID-19 vaccine obligatory for the general public -- though local jurisdictions could make it mandatory for some groups, like children.

"You don't want to mandate and try and force anyone to take a vaccine. We've never done that," said Fauci, a member of the White House coronavirus task force, during a video talk organized by George Washington University.

"You can mandate for certain groups of people like health workers, but for the general population you can't" he added, citing the example of the National Institutes of Health, where health workers can't treat patients without a flu shot.

Australia's Prime Minister Scott Morrison hours earlier announced that coronavirus vaccines, once approved, would be mandatory for everyone in his country, barring medical exemptions.

But the United States' decentralized system of government, and anti-vaccine sentiments that have been building for decades, had in any case made a program of mandatory immunization unlikely.

"It would be unenforceable and not appropriate," said Fauci.

This however doesn't prevent states from making a vaccine mandatory for children to attend school, as is already the case for certain diseases such as measles, though some are exempt for medical or religious reasons.

At any rate, the administration of President Donald Trump has pre-ordered hundreds of millions of vaccine doses from six companies, and these will be distributed for free.

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COVID-19 vaccine won't be mandatory in US, says Fauci - Yahoo News

Woman talks about her experience participating in COVID-19 vaccine trial in Chesterfield – KMOV.com

August 20, 2020

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Woman talks about her experience participating in COVID-19 vaccine trial in Chesterfield - KMOV.com

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