Category: Corona Virus Vaccine

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A Covid-19 vaccine, amazingly, is close. Why am I so worried? – STAT – STAT

July 31, 2020

A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a having a vaccine to fight it. Moderna and the National Institutes of Health recently announced the start of a Phase 3 clinical trial, joining several others in a constructive rivalry that could save millions of lives.

Its a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of historys greatest scientific achievements.

Im optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a bit of angst. Behind the proud declarations, many science and medical professionals have been whispering concerns. These whispers have escalated into a murmur. Its time to cry them loudly:

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Hey, Food and Drug Administration: Dont be rash! Premature approval of a sub-standard Covid-19 vaccine could have dire implications, and not just for this pandemic. It could harm public health for years, if not generations, to come.

Unfortunately, elements now in place make such a disastrous outcome not only possible but in fact quite likely. Specifically, the FDA and its staff of chronically overworked and underappreciated regulators will face enormous public and political pressure to approve a vaccine. Whether or not one worries about an October surprise aimed at the upcoming election, regulators will be pressed hard. Some will stand firm. Some may resign in protest. But others could break and allow a bad vaccine to be released.

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What makes a bad vaccine? Insufficient protection against the disease it is designed for, unwanted side effects, or some combination of the two. If an approved Covid-19 vaccine turns out to be ineffective, this could unintentionally promote wider spread of the disease by individuals who presume they were protected from it. Likewise, a negative experience with one vaccine might discourage the use of other vaccines that are far more safe and effective, whether they are for Covid-19 or other vaccine-preventable diseases.

Some things take time. Under normal circumstances, ensuring that a vaccines effects are safe and durable requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient, making sustained investigation all the more necessary. A merely short-term effect could encourage vaccinated individuals to resume risky behaviors, which would all but guarantee that the epidemic endures. And if unintended side effects turn out to include, for instance, chronic inflammatory or autoimmune disease, a bad vaccine could impart lifelong damage.

But wait, theres worse! A bad Covid-19 vaccine could further undermine confidence in the many safe, reliable vaccines already in our public health arsenal. Vaccine skepticism and anti-science bias, propagated by B-list celebrities and Russian troll farms, have been gaining strength all year. Combined with disappointing Covid-19 outcomes, such malign forces could facilitate the reemergence of once-vanquished foes polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus that once killed multitudes of children each year.

These are enormous risks. Placing all of our bets on a small set of untried vaccine technologies would be gobsmackingly foolish. Yet this is exactly what we are now doing. Most of the high-profile names capturing headlines are pursuing comparatively minor variations on a theme of genetic vaccines (those delivered via DNA or RNA). If one approach happens to work, the odds are higher the others will work as well. Disappointing results from one candidate, though, might presage failure across the board.

Rather than investing in a balanced portfolio of vaccines with different approaches not to mention different therapies, devices, and diagnostics for treating Covid-19 too many observers, too many companies, and too many governmental officials seem to be narrowly focused on hopes for a savior vaccine. Were that savior to fail, our national morale, already low, could plummet even further.

Dont get me wrong. I, along with millions of Americans, want a Covid-19 vaccine. But we deserve one thats been proven to be safe and effective.

Its not too late to take a deep breath and devise a strategy to balance short- and long-term goals, including vaccination, improved diagnostics, and existing and novel treatments. We must support the FDA and hope that its scientists and physicians retain the strength and conviction to resist approving a substandard vaccine.

For encouragement, we should look to Frances Oldham Kelsey, a veritable patron saint of the FDA. In 1960, during her first month working for the agency, Kelsey was asked to approve a sedative called Kevadon, which had the potential to generate billions in revenue. Despite enormous pressure, Kelsey spotted a risk for toxicity and dug in her heels. She refused to rubber stamp the approval. Her actions saved the lives of countless babies. Kevadon, better known as thalidomide, proved to be one of the most dangerous and disfiguring drugs in history.

Kelsey passed away in 2015 at the age of 101. We must pray that her spirit inspires a new generation of FDA leaders with the courage to say, No.

Michael S. Kinch is associate vice chancellor, professor of biochemistry and molecular biophysics, and director of the Centers for Research Innovation in Biotechnology and Drug Discovery at Washington University in St. Louis. He is the author of Between Hope and Fear: A History of Vaccines and Human Immunity (Pegasus Books, 2018) and two other books.

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A Covid-19 vaccine, amazingly, is close. Why am I so worried? - STAT - STAT

FDA says it would clear a coronavirus vaccine so long as it’s safe and at least 50% effective – CNBC

July 31, 2020

Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn testifies before the House Committee on Energy and Commerce on the Trump Administration's Response to the COVID-19 Pandemic, on Capitol Hill in Washington, DC, June 23, 2020.

Kevin Dietsch | Pool via Reuters

The Food and Drug Administration would authorize a coronavirus vaccine so long as it is safe and at least 50% effective, the agency's commissioner, Dr. Stephen Hahn, said Thursday.

"We all want a vaccine tomorrow. That's unrealistic. And we all want a vaccine that's 100% effective. Again, unrealistic," Hahn said in an interview with Dr.Howard Bauchner of the Journal of the American Medical Association. "But we said 50%, and the reason was because we felt that that was a reasonable floor given the pandemic."

He added that the minimum requirement of 50% effectiveness also helped give vaccine manufacturers guidance on how to design their clinical trials. Moderna and Pfizer, sent their vaccine candidates to phase three trials earlier this week, aiming to enroll about 30,000 participants to prove the vaccines are both safe and effective in a large population.

Hopefully, Hahn said, the vaccine or vaccines that end up getting authorized will prove to be more than 50% effective, but it's possible that the U.S. could end up with a vaccine that, on average,reduces a person's risk of a Covid-19 infection by just 50%.

"We really felt strongly that that had to be the floor," he said, adding that it's "been batted around among medical groups." "But for the most part, I think, infectious disease experts have agreed that that's a reasonable floor, of course hoping that the actual effectiveness will be higher."

Dr. Anthony Fauci has said he hopes the vaccine will have an efficacy rate of at least 60%, meaning on average the vaccine reduces a person's risk of a Covid-19 infection by 60%.

"Obviously, we would like to see it much, much higher. But 60% is the standard that you do for the cutoff. That's not unusual," he said Monday."I would like to see the highest percentage that we could possibly get."

Hahn added on Thursday that if a vaccine isn't safe, the FDA will not authorize it, regardless of how effective it appears to be.

"If we get to 50% but it's not safe, to me, it's not a vaccine that we can authorize," he said. "We're going to be very, very, very carefully looking at those safety data and we're going to be transparent, Howard, about what we've seen."

He said the FDA is using new strategies and technology to streamline data collection from clinical trial participants in order to more quickly and frequently collect data on safety. The FDA will also continue to monitor the safety of the vaccines after they are authorized and administered to the public, he said.

"We cannot have a situation where people lose trust in the FDA and in the clinical trial process," he said. "That would be a mistake for all of us."

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FDA says it would clear a coronavirus vaccine so long as it's safe and at least 50% effective - CNBC

Coronavirus Live News: World Updates – The New York Times

July 31, 2020

The American people got ripped off, and Donald Trump and his team got taken to the cleaners, said Rep. Raja Krishnamoorthi, Democrat of Illinois and the chairman of the panels economic and consumer policy subcommittee. The Trump administrations mishandling of ventilator procurement for the nations stockpile cost the American people dearly during the worst public health crisis of our generation.

The report faulted Peter Navarro, Mr. Trumps top trade adviser, and Jared Kushner, his son-in-law and senior adviser, for negotiating a deal to acquire ventilators quickly in which the panel said they paid almost five times the price per device than under a previous contract with the same vendor.

The Trump negotiators appeared gullible and conceded to Philips on all significant matters, including price, the report said, referring to Philips North America Corporation, which had a federal contract to supply ventilators to the national stockpile. The documents show that the administration accepted Philips first offer without even trying to negotiate a lower price.

The committee launched an investigation in April to determine why the country was without much-needed ventilators during the initial months of the coronavirus pandemic.

In January, Philips approached the Trump administration about speeding up the long-delayed delivery of ventilators it had agreed to supply, but the administration failed to respond to for six weeks, the panel found. When it did, the report said, rather than insist on the delivery of the devices by the deadlines in its original contract, officials led by Mr. Navarro and Mr. Kushner negotiated a new deal at an inflated rate.

Reporting was contributed by Liz Alderman, Luke Broadwater, Julia Calderone, Kate Conger, Robert Gebeloff, Michael Levenson, Giulia McDonnell Nieto del Rio, Eshe Nelson, Richard A. Oppel Jr., Richard C. Paddock, Elian Peltier, Matt Phillips, Austin Ramzy, Motoko Rich, Eliza Shapiro, Megan Specia, Eileen Sullivan, Katie Thomas, Neil Vigdor, Mihir Zaveri.

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Coronavirus Live News: World Updates - The New York Times

Vaccine distribution will be joint venture between CDC and Pentagon – POLITICO

July 31, 2020

We believe weve actually combined the best of both, the official said. A second senior administration official stressed the agencies would be working as one team to distribute hundreds of millions of doses if any of the vaccines in development are approved in the coming months.

Private companies are also likely to join the effort. The first official said the government is bringing in people to integrate CDC IT capabilities with some new applications that were going to need that the CDC never had.

The background: The Pentagon will be guiding not just distribution logistics but also manufacturing and kitting, the process of safely packaging a vaccine with its necessary equipment such as syringes and needles.

The DoD is handling all of those logistics that is where their comparative advantage is, said the first senior official. And the CDC, some of their IT systems, relationships with the states following post-vaccination will belong to them.

Pentagon chief spokesperson Jonathan Hoffman told reporters earlier in the day that distribution would be a collaborative process between the private sector and the military.

Operation Warp Speed, the government's coronavirus vaccine and drug accelerator, is examining how do we take advantage of the commercial capability of the private sector to handle things like distribution, and where will either DoD step in to help manage that process, or if necessary, will DoD be required to step in and actually physically deliver items itself, Hoffman said.

The debate: The comments come just one day after McClatchy reported that neither the White House nor Warp Speed officials had formally asked the Pentagon to help with vaccine distribution. While the White House said Defense is ready to assist, an HHS official told McClatchy Wednesday that their involvement would be the exception, not the norm.

State and local government groups have already raised concerns about Pentagon involvement and using new methods in coronavirus vaccine distribution. The CDC already leads and maintains a highly effective system of vaccine ordering and distribution, groups including the Association of State and Territorial Health Officials wrote in June. With time of the essence we strongly recommend against designing new and untested systems of vaccine distribution.

The state and local officials also questioned whether military involvement in vaccine administration would undermine already shaky public confidence in vaccines.

Whats next: Senior health officials told reporters that they are in constant discussion about first-priority populations for receiving possible coronavirus vaccines, including the elderly and medically vulnerable, but that those plans will depend on which candidates are ready first.

Two vaccines entered the final stage of human trials this month and several more are readying for the sweeping phase three stage. Results are expected later this year or early 2021. In the meantime, an expert committee has been convened by the National Academies of Science to discuss a distribution framework.

Lara Seligman and Rachel Roubein contributed to this report.

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Vaccine distribution will be joint venture between CDC and Pentagon - POLITICO

Covid-19 Tests Are in Short Supply. Should You Still Get One? – The New York Times

July 31, 2020

What is a conscientious person who already wears a mask and maintains social distance to do?

Yes, said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison.

One of the most important things to keep in mind when discussing public health is the fact that this is fundamentally a community issue, not merely an individual health concern, she said. We are all in this together. What I do affects everyone around me, and what they do affects me.

If public health experts want people to be tested, they should comply, especially if the goal is to gather critical information about how many people are infected at a given point, Professor Charo said.

Epidemiologists can use the data to determine how fast the virus is spreading and which measures are working, she said.

Taking a test, like wearing a mask, shows a desire to be a part of the solution, said Dr. K. C. Rondello, an epidemiologist at Adelphi University in Garden City, N.Y.

The virus has been difficult to control in large part because many infected people without symptoms have unknowingly spread it, he said.

More testing will help identify these hidden cases, Dr. Rondello said.

But Candace L. Upton, a professor of philosophy at the University of Denver, said people should not feel duty bound to get a test. It can even be argued that it is morally wrong to go in for a test if you have no symptoms and are not at a high risk, she said.

Until there is no longer a shortage of test kits, it is morally unjustified to test patients for Covid-19 solely for the purpose of collecting data, Professor Upton said. Because of the deficit, labs shouldnt be offering them to people who are just curious.

The priority should remain testing only those with symptoms or compromised immune systems, and essential workers and older people, she said.

Professor Upton added that testing should be done selectively even in locations where tests are readily available and where results can be delivered quickly.

The whole system is unfair, she said. And so to take advantage of surpluses in certain places in the market is to add to the injustice to people who didnt have availability in the first place.

The national failure to coordinate testing efforts shouldnt cause people with no symptoms to feel conflicted about being tested for the coronavirus, said Dr. Andrew Diamond, chief medical officer at One Medical in San Francisco, a membership-based primary care practice with offices around the country.

Updated July 27, 2020

If there is a way for you to get tested that does not clearly and directly impair someone who is a priority, then you should get tested for sure, he said.

Molly Wallace, 24, who grew up on Marthas Vineyard, was tested after she moved back to the island from Boston in March.

She was furloughed from her job as a medical assistant and began volunteering at a testing site, Test MV, at Marthas Vineyard Regional High School, where she went to school.

Ms. Wallace said that she had never had coronavirus symptoms but that she had still felt obligated to be tested. I dont want to be the person to bring Covid here, she said.

All residents and visitors to the island are encouraged to be tested at Test MV, where volunteers distribute free kits of self-administered nasal swabs, said Ms. Wallace, who is now the sites outreach coordinator.

People typically get their results within 72 hours, or more quickly if they test positive for the virus, Ms. Wallace said. That is a stark contrast to states like New York and Arizona, where lines for tests have sometimes stretched around blocks and the turnaround time for results has been days, if not weeks.

Wearing a mask should feel obligatory, Dr. Diamond said, but taking a test should not.

If tests were widely available and turnaround times for results were much faster, people would have a stronger sense of obligation to get tested, he said.

Under the current circumstance, I would say its much more important to continue to do what youre doing, Dr. Diamond said. That is, wear a mask, keep six feet away from people and stay home as much as possible, he said.

Dr. Diamond added, The behavior is really the thing thats going to make the biggest difference.

Remy Tumin contributed reporting.

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Covid-19 Tests Are in Short Supply. Should You Still Get One? - The New York Times

Pfizer executive targets end of year for COVID-19 vaccine – KHOU.com

July 31, 2020

Pfizer also announced it had started a study of its vaccine candidate in the U.S. and elsewhere. That study aimed to recruit 30,000 people.

ANDOVER, Mass. Editor's Note: The video above is from July 22, 2020.

An executive at a Massachusetts facility helping create a potential vaccine for the coronavirus said Thursday that the company hopes to have the treatment ready by the end of the year.

We have the potential, subject to technical success and regulatory authorization, to manufacture up to 100 million vaccine doses by the end of this year and up to 1.3 billion doses by the end of 2021, said Meg Ruesch, research and development leader at Pfizer Inc.'s Andover, Massachusetts, facility.

The vaccine candidate, a collaboration between Pfizer and BioNTech, introduces into the body the genetic instructions for the cell to make a specific protein in this case a SARS-CoV-2 protein which is intended to stumulate an immune response, she said.

The data on the trials has been encouraging, she said at a news conference with Gov. Charlie Baker.

She also put to rest concerns that the vaccine process is being rushed.

We don't cut any quality corners, she said.

The Trump administration last week announced that it would pay Pfizer nearly $2 billion for December delivery of 100 million doses of their COVID-19 vaccine under development.

Pfizer earlier this week announced it had started a study of its vaccine candidate in the U.S. and elsewhere. That study aimed to recruit 30,000 people.

A vaccine or a treatment is critical to breaking the cycle of this insidious virus, and helping us all return to something more like regular normal" the Republican governor said.

Baker, expressing concern about clusters of new confirmed cases of COVID-19 associated with private parties, warned residents not to relax when it comes to mask wearing and social distancing.

To all our residents, I cant express this enough, don't be careless or complacent," he said.

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Pfizer executive targets end of year for COVID-19 vaccine - KHOU.com

US invests another $2.1 billion into a potential COVID-19 vaccine – NewsWest9.com

July 31, 2020

The United States will pay up to $2.1 billion for 100 million experimental COVID-19 vaccines from pharma giants GlaxoSmithKline and Sanofi Pasteur.

LONDON, UK Pharma giants GlaxoSmithKline and Sanofi Pasteur have announced they will supply 100 million doses of its experimental COVID-19 vaccine to the United States as governments buy up supplies in hopes something will work.

The United States will pay up to $2.1 billion for development including clinical trials, manufacturing, scale-up and delivery of its vaccine,'' the companies said in a statement. Sanofi will get the bulk of the funds.

The U.S. government has a further option for the supply of an additional 500 million doses longer term as part of its Operation Warp Speed program.

The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year, U.S. Health and Human Services Secretary Alex Azar said in a statement. Todays investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.

Earlier this week the British government signed a deal for 60 million doses of a potential coronavirus vaccine that could start to be rolled out in the first half of next year.

Britains GSK and Frances Sanofis vaccine prospect is based on the existing DNA-based technology that is used to produce Sanofis seasonal flu vaccine. It is one of several vaccines in development.

The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone, said Thomas Triomphe, executive vice president of Sanofi Pasteur.

The companies said discussions are ongoing with the European Commission.

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US invests another $2.1 billion into a potential COVID-19 vaccine - NewsWest9.com

Experimental COVID-19 vaccine protects upper and lower airways in nonhuman primates – National Institutes of Health

July 29, 2020

Media Advisory

Tuesday, July 28, 2020

Two doses of an experimental vaccine to prevent coronavirus disease 2019 (COVID-19) induced robust immune responses and rapidly controlled the coronavirus in the upper and lower airways of rhesus macaques exposed to SARS-CoV-2, report scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19.

The candidate vaccine, mRNA-1273, was co-developed by scientists at the NIAID Vaccine Research Center and at Moderna, Inc., Cambridge, Massachusetts. The animal study results published online today in the New England Journal of Medicine complement recently reported interim results from an NIAID-sponsored Phase 1 clinical trial of mRNA-1273. The candidate mRNA-1273 vaccine is manufactured by Moderna.

In this study, three groups of eight rhesus macaques received two injections of 10 or 100 micrograms (g) of mRNA-1273 or a placebo. Injections were spaced 28 days apart. Vaccinated macaques produced high levels of neutralizing antibodies directed at the surface spike protein used by SARS-CoV-2 to attach to and enter cells. Notably, say the investigators, animals receiving the 10-g or 100-g dose vaccine candidate produced neutralizing antibodies in the blood at levels well above those found in people who recovered from COVID-19.

The experimental vaccine also induced Th1 T-cell responses but not Th2 responses. Induction of Th2 responses has been associated with a phenomenon called vaccine-associated enhancement of respiratory disease (VAERD). Vaccine-induced Th1 responses have not been associated with VAERD for other respiratory diseases. In addition, the experimental vaccine induced T follicular helper T-cell responses that may have contributed to the robust antibody response.

Four weeks after the second injection, all the macaques were exposed to SARS-CoV-2 via both the nose and the lungs. Remarkably, after two days, no replicating virus was detectable in the lungs of seven out of eight of the macaques in both vaccinated groups, while all eight placebo-injected animals continued to have replicating virus in the lung. Moreover, none of the eight macaques vaccinated with 100 g of mRNA-1273 had detectable virus in their noses two days after virus exposure. This is the first time an experimental COVID-19 vaccine tested in nonhuman primates has been shown to produce such rapid viral control in the upper airway, the investigators note. A COVID-19 vaccine that reduces viral replication in the lungs would limit disease in the individual, while reducing shedding in the upper airway would potentially lessen transmission of SARS-CoV-2 and consequently reduce the spread of disease, they add.

KS Corbett et al. Evaluation of the mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates. New England Journal of Medicine DOI: 10.1056/NEJMoa2024671 (2020).

NIAID Director Anthony S. Fauci, M.D., Barney S. Graham, M.D., Ph.D., deputy director, VRC, NIAID, and Robert Seder, M.D., chief, Cellular Immunity Section, VRC, NIAID, are available to discuss this paper.

NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Experimental COVID-19 vaccine protects upper and lower airways in nonhuman primates - National Institutes of Health

Coronavirus Vaccine Put To Final Test In Thousands Of Volunteers – WBEZ

July 29, 2020

The worlds biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government one of several candidates in the final stretch of the global vaccine race.

Theres still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc., will really protect.

The needed proof: Volunteers wont know if theyre getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.

Unfortunately for the United States of America, we have plenty of infections right now to get that answer, NIHs Dr. Anthony Fauci recently told The Associated Press.

Moderna said the vaccination was done in Savannah, Georgia, the first site to get underway among more than seven dozen trial sites scattered around the country.

Several other vaccines made by China and by Britains Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.

But the U.S. requires its own tests of any vaccine that might be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate each one with 30,000 newly recruited volunteers.

The massive studies arent just to test if the shots work theyre needed to check each potential vaccines safety. And following the same study rules will let scientists eventually compare all the shots.

Next up in August, the final study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer.

Thats a stunning number of people needed to roll up their sleeves for science. But in recent weeks, more than 150,000 Americans filled out an online registry signaling interest, said Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites.

These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population, Corey told a vaccine meeting last week. He stressed that its especially important to ensure enough Black and Hispanic participants as those populations are hard-hit by COVID-19.

It normally takes years to create a new vaccine from scratch, but scientists are setting speed records this time around, spurred by knowledge that vaccination is the worlds best hope against the pandemic. The coronavirus wasnt even known to exist before late December, and vaccine makers sprang into action Jan. 10 when China shared the virus genetic sequence.

Just 65 days later in March, the NIH-made vaccine was tested in people. The first recipient is encouraging others to volunteer now.

We all feel so helpless right now. Theres very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that Im doing something, Jennifer Haller of Seattle told the AP. Be prepared for a lot of questions from your friends and family about how its going, and a lot of thank-yous.

That first-stage study that included Haller and 44 others showed the shots revved up volunteers immune systems in ways scientists expect will be protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results.

If everything goes right with the final studies, it still will take months for the first data to trickle in from the Moderna test, followed by the Oxford one.

Governments around the world are trying to stockpile millions of doses of those leading candidates so if and when regulators approve one or more vaccines, immunizations can begin immediately. But the first available doses will be rationed, presumably reserved for people at highest risk from the virus.

Were optimistic, cautiously optimistic that the vaccine will work and that toward the end of the year there will be data to prove it, Dr. Stephen Hoge, president of Massachusetts-based Moderna, told a House subcommittee last week.

Until then, Haller, the volunteer vaccinated back in March, wears a mask in public and takes the same distancing precautions advised for everyone while hoping that one of the shots in the pipeline pans out.

I dont know what the chances are that this is the exact right vaccine. But thank goodness that there are so many others out there battling this right now, she said.

AP photographer Ted Warren in Seattle contributed to this report.

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Coronavirus Vaccine Put To Final Test In Thousands Of Volunteers - WBEZ

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