Vaccine

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Sanofi, GSK to supply vaccine doses to WHO-backed alliance

PARIS (Reuters) – French drugmaker Sanofi and Britain’s GlaxoSmithKline will supply 200 million doses of their COVID-19 candidate vaccine to a global inoculation scheme backed by the World Health Organization.

There is no internationally-approved treatment against COVID-19, which has killed more than 1.16 million people, and the two companies’ vaccine is still undergoing phase 1 and 2 trials, from which first results are expected by late November or early December.

They said on Wednesday they had signed a statement of intent with vaccine alliance GAVI, which is coordinating the global scheme, known as COVAX.

COVAX, which aims to deliver 2 billion vaccine doses around the world by the end of 2021, has already sealed agreements this year with AstraZeneca and Novavax.

It aims to discourage national governments from hoarding COVID-19 vaccines and to focus vaccinating the most high-risk people first in every country.

More than 180 nations including China have joined the plan but some, including the United States, have opted to stick with their own supply deals.

Sanofi and GSK signed a $2.1 billion deal with Washington during the summer to supply it with more than 100 million doses of the same vaccine, which they hope to present for regulatory approval next year.

The companies also have similar agreements with the European Union, Britain and Canada.

Their candidate vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.

Sanofi is also working on another vaccine project with U.S. company Translate Bio that will use a technology known as messenger RNA (mRNA) which instructs cells in the body to make coronavirus proteins that then produce an immune response.

Clinical trials for this project are expected to start in the fourth quarter.

COVAX is co-led by GAVI, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI).

(Reporting by Vishwadha Chander in Bengaluru, Matthias Blamont in Paris; Editing by Shounak Dasgupta and John Stonestreet)

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Tennessee mulling independent review on COVID-19 vaccine

NASHVILLE, Tenn. (AP) — Tennessee is considering independently reviewing the safety and efficacy of a coronavirus vaccine once it is eventually approved by the federal government before distributing it to the public, Health Commissioner Lisa Piercey said Wednesday.

“It’s not off the table,” Piercey told reporters during the state’s weekly COVID-19 briefing.

Last week, Piercey announced the state had submitted its draft distribution plan for a coronavirus vaccine to the federal government. However, she has since warned that the plan will likely be amended as state officials learn more about when the state will start receiving the vaccine and how many doses are initially provided.

California was the first state to announce that it would hold off on distributing any COVID-19 vaccines until it had independently reviewed them. A handful of other states have since joined in that pact, including Nevada, Oregon and Washington. Meanwhile, New York Gov. Andrew Cuomo has appointed a similar independent group to review the quality of the vaccine.

Supporters of such independent reviews argue that doing so adds an extra layer of assurance to people interested in the vaccine. However, others counter that doing so could politicize the vaccine process.

Piercey said she didn’t “have a clear answer” when asked if an independent review could cause more alarm over the vaccine’s safety, but instead stressed “when we get to that bridge we’ll cross it but it’s definitely on our minds.”


Earlier this year, Gov. Bill Lee declined to say whether he would be vaccinated against COVID-19 when a vaccine becomes available. Instead, he said he’d determine if it’s “safe and effective and talk to my doctor.”

Tennessee is expected to get 2% of the national vaccine allocation, but the exact number is unclear. It’s also unknown when a COVID-19 vaccine will be available for distribution to the states.

Under the current draft plan, Tennessee will distribute the majority of the vaccines throughout its 95 counties based on population. Ten percent of the vaccines will be set aside as a reserve.

The health agency is seeking hospitals, pharmacies, clinics and other partners capable of storing and administering the vaccine. First responders will be the state’s top priority in receiving the vaccine during the initial distribution phases, with health care workers being the next top priority.

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Sanofi, GSK to provide 200 million Covid vaccine doses to WHO immunization program

A health worker wearing a protective mask works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S.

Eva Marie Uzcategui | Bloomberg | Getty Images

European drugmakers Sanofi and GlaxoSmithKline will provide 200 million doses of their Covid-19 vaccine to the World Health Organization’s global immunization partnership COVAX, which seeks to ensure coronavirus vaccines are distributed equitably across the world, the companies announced Wednesday.

Global health organizations including the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations and the WHO are leading the COVAX effort, which is focused on first vaccinating the most high-risk people in every country. The deal is contingent on the vaccine winning regulatory approval, the companies said in a statement.

The initiative aims to deliver 2 billion doses of the vaccine by the end of 2021, though it’s now competing for scarce doses of promising vaccines with some wealthy countries like the United States that didn’t join the COVAX facility and procured hundreds of millions of doses on their own.

“Since we started working on the development of COVID-19 vaccines, GSK has pledged to make them available to people around the world,” Roger Connor, president of GSK Vaccines, said in a statement. He added that “this has the potential to be a significant contribution to the global fight against COVID-19.”

More than 180 countries have so far joined COVAX, the companies said. WHO says at least 78 higher-income countries, including China and the United Kingdom have signed on.

The WHO has previously acknowledged that there won’t be enough vaccine doses for everyone in the world once one candidate is authorized for use. The UN health agency has published allocation principles that countries can use to craft a plan for who would first receive the immunization when the country receives doses.

The WHO says it intends for all countries to receive enough doses to vaccinate 20% of their population, excluding countries that request fewer doses than that, before any country receives more doses.

Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, said their provision of doses demonstrates the company’s “commitment to global health and ensures our COVID-19 vaccines are affordable and accessible to those most at risk, everywhere in the world.”

Sanofi and GSK’s vaccine is further behind in clinical development than some of the front-runners like Pfizer, Moderna and AstraZeneca, which are all in late-stage trials. Sanofi and GSK said they anticipate results from their phase two trial in early December and will then launch a large phase three trial. The companies plan to request regulatory approval for the vaccine, if the data supports it, in the first half of 2021.

WHO Director-General Tedros Adhanom Ghebreyesus has previously said he’s less concerned with acquiring doses of the first available vaccine and more concerned with acquiring a large amount of doses of all vaccines.

“The first vaccine to be approved may not be the best,” he said last month. “The more shots on

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Highly anticipated COVID-19 vaccine data from Pfizer unlikely to come before Election Day: CEO

ABC News Corona Virus Health and Science

“This will not be a Democratic vaccine or Republican vaccine.”

Pfizer executives said in a third-quarter investor presentation on Tuesday they have not seen the first interim efficacy data yet. The Data Monitoring Committee, an independent group of experts monitoring the clinical studies and the data collection, “has not conducted any interim efficacy analyses to date,” according to Pfizer.

The slight delay from an earlier prediction of data by the end of October means results will likely not be known by Election Day, despite claims by President Donald Trump for months that a vaccine is “weeks away.”

The Data Monitoring Committee has thresholds for review that are triggered when a certain number of trial volunteers become sick with COVID-19. The first interim analysis is scheduled to happen when 32 people develop COVID-19, according to Pfizer’s extensive clinical trial protocol.

Bourla said, however, the company is still on track for a November application for authorization, if the vaccine shows to be effective and, just as importantly, safe.

Pfizer CEO Albert Bourla had previously said the company “may know whether or not our vaccine is effective by the end of October.”

Once there are 32 volunteers infected with COVID-19, Pfizer will analyze how many of them received the vaccine and how many received a placebo. If more than 76.9% of the grouping is in the placebo group, Pfizer will consider the vaccine efficacious.

Once an independent review board releases information on the trials, the company will need a week to review it internally, Bourla said.

Pfizer plans to release the interim data if it is negative (worse than 11.8%) or positive (better than 76.9%) for efficacy. If the data is somewhere in between, Pfizer will wait for more conclusive results, Bourla said.

“In case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know,” he explained to investors, adding that the company “reached the last mile here and we expect these things will start coming soon, so let’s all have patience.”

He said he is “cautiously optimistic” the vaccine will work based on earlier studies.

PHOTO: Medical syringes stand in front of the Pfizer company logo, Oct. 12, 2020.

Medical syringes stand in front of the Pfizer company logo, Oct. 12, 2020.

Pfizer said it expects efficacy and safety data will be available in November, and if it is, it will apply for emergency use authorization.

Pfizer’s vaccine candidate was also developed with the German biotech firm BioNTech. There are 150 clinical trial sites around the world.

More than 42,000 participants have been enrolled and nearly 36,000 have received a second dose of the vaccine. Expanding the number of participants has allowed trials to include additional populations, among them children between 12 and 18 and people with preexisting conditions.

When

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The Health 202: Hundreds of millions of coronavirus vaccine doses will be ready in early 2021, officials say

“We are on the brink of seeing the fruits of our labor,” said Gen. Gustave Perna, chief operating officer for Operation Warp Speed, the initiative created by the administration to get a safe vaccine approved and distributed as quickly as possible.

The administration is working on two parallel tracks to get a vaccine approved and ready to distribute.

Perna said he, along with Warp Speed chief Moncef Slaoui, recently visited the Tennessee offices of McKesson, the major vaccine distributor that has contracted with the government to head up distribution of eventual coronavirus vaccines.

“At the end of the day I chose [McKesson] because they know how to do it,” Perna said.

Once the Food and Drug Administration approves a coronavirus vaccine for emergency use — expected to happen in late November or early December if trials continue going well — McKesson will partner with FedEx and UPS, along with a number of pharmacies and grocery stores including Walmart, CVS, Walgreens and Kroger, to get the doses shipped around the country, Perna said.

The Defense Department is closely involved in the effort, prompting concerns that an agency not accustomed to delivering vaccines might be charged with the critical task. Perna insisted, however, that the department is helping with logistics and program support — not distribution.

“There will not be this vision some people have of army trucks driving through the street delivering vaccine,” he told listeners on the online forum. “This is not feasible nor the proper way to do this.”

States also have a role to play. They’ve all submitted to the federal government plans for distributing a vaccine, with varying standards for who should get a vaccine first and how quickly the process should move.

New Jersey, for example, wants to administer the vaccine 70 percent of non-pregnant adults within six months. Nebraska laid out two initial phases of vaccine distribution in which the vaccine first goes to medical staff and later to the elderly and people with underlying conditions.

The vaccine news couldn’t come at a more critical time as cases of the novel coronavirus are surging across the country – and public health officials warn things could deteriorate further over the winter. Trump, however, continues to insist the country is “rounding the corner” in the disease as the election approaches next Tuesday, and his chief of staff said this weekend that the virus could only be controlled through a vaccine and therapeutics.

The process is moving with unprecedented speed, but there are plenty of challenges.

For one thing, vaccines require cold storage. Medical professionals distributing a vaccine will also need equipment including needles, syringes, alcohol, pads, bandages and masks.

And government officials say it’s critical to track who is getting the vaccine and where. Five of the six vaccines being developed as part of Warp Speed — excluding the vaccine being developed by Johnson & Johnson — require two doses. People who receive a first dose will need to be given the same vaccine in their second

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Is Northwest Biotheraputics a Buy Ahead of Its Brain Tumor Vaccine Clinical Data Release?

When it comes to winning biotech stocks this year, coronavirus vaccine developers automatically come to many investors’ minds. However, one of the top-performing stocks in the sector is Northwest Biotherapeutics (OTC:NWBO), which focuses on immunotherapies that treat cancer, and has returned a staggering 408% since January.

The main reason why investors are so excited about Northwest Biotherapeutics’ prospects is that the company’s 14-year-long phase 3 clinical trial to evaluate its one and only immunotherapy candidate, DCVax-L, as a treatment for glioblastoma, has concluded. Should you consider buying the stock in anticipation of the data release? Let’s find out together. 

3-D illustration of a dendritic cell.

Image source: Getty Images.

Treatment background

Glioblastoma is a deadly form of brain cancer prevalent in up to 15% of people with brain tumors. Even after patients receive standard of care (SOC) treatments consisting of surgery, chemotherapy, and radiotherapy, their median survival time comes down to just 15.5 months in historical studies. DCVax-L is an experimental immunotherapy that seeks to stimulate patients’ own immune systems to fight cancer growth. 

The potential biologic has been in phase 3 clinical trials since December 2006. In the study, all glioblastoma patients receive SOC treatments, while a random portion also receives DCVax-L via upper arm injections. A key trial endpoint requires at least 233 patient deaths out of a total of 331 participants enrolled to calculate a survival benefit for DCVax-L, if any. The company completed its study on July 24, and the data is currently being reviewed by statisticians. In the meantime, speculations on the results have ranged from wildly enthusiastic to pessimistic from excited investors and short-sellers. 

The bullish case

The bullish case for Northwest Biotherapeutics stock is straightforward: The DCVax-L clinical trial was supposed to wrap up as early as November 2016, but had to keep going because the projected number of deaths had not occurred by then.

Around the time when the trial was enrolling, only 3% of glioblastoma patients who received SOC survived over five years. Due to extremely low survival rates for patients who receive SOC treatments, bullish investors argue that there is no other logical explanation for the clinical study going into overtime than DCVax-L keeping patients alive longer than expected. 

The bearish case

The bearish case is a lot more complicated.

Clinical trials investigating experimental biologics for deadly diseases with a lack of therapeutic options usually have pre-planned interim analyses. DCVax-L’s phase 3 trial had two such analyses built into the study.

The analysis is conducted by an independent data-monitoring committee (DMC) that can recommend that the trial stop early if an experimental therapy demonstrates statistically meaningful efficacy against SOC treatments. This way, the biologic can quickly advance to the approval stage in order to save more lives.

Northwest Biotherapeutics’ DMC carried out two interim analyses on the DCVax-L study in 2017 and 2018 (more on this later). Both times, however, the company published the DMC’s findings as blinded, and the trial continued. Unfortunately, that doesn’t make any sense at all in the context of

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These teens, tweens are some of the Covid-19 vaccine trial’s youngest volunteers

When Abhinav, an Ohio seventh grader, learned that a Covid-19 vaccine trial near his hometown was enrolling children, he wanted to participate. But there was one aspect of the study that had him worried.

“I was mostly a bit nervous about the blood draws, because I had one about five years ago, and it wasn’t so comfortable,” Abhinav, 12, said.

Nonetheless, he decided to enlist in the trial, which is run by Pfizer Inc.

“I think that it could really benefit the world, and I think it could also help scientists know more about the coronavirus,” said Abhinav, whose family asked that their last name not be used to protect their privacy.

Abhinav received his first injection at Cincinnati Children’s Hospital Medical Center last Thursday, making him among the youngest participants in the world to take part in a Covid-19 vaccine trial. His father, Sharat, a bone marrow transplant physician, had already been in the trial himself, and encouraged Abhinav to sign up after experiencing no ill effects other than a fever that lasted for a day or two.

“I’m happy that he’s doing his bit for science,” Sharat said of his son. “With the Pfizer study, no major side effects have been reported so far, so that made me comfortable with enrolling Abhinav as well.”

Earlier this month, Pfizer became the first pharmaceutical company in the United States to receive approval from the Food and Drug Administration to test its vaccine on children as young as 12. The kids who have signed up say they are proud to be participating — and say they feel safe doing so.

“They were talking about symptoms, and they were just fatigue, low-grade fever, headache. I was thinking, ‘I hope I don’t have anything like that because I don’t want it to mess with school or work,’” Katelyn Evans, 16, of Green Township, Ohio, said. “But I wasn’t thinking about my permanent health for a short-term inconvenience.”

Katelyn Evans, 16, receives a Covid-19 vaccine during a trial at Cincinnati Children's Hospital Medical Center on Oct. 14. (Cincinnati Children's Hospital Medical Center)
Katelyn Evans, 16, receives a Covid-19 vaccine during a trial at Cincinnati Children’s Hospital Medical Center on Oct. 14. (Cincinnati Children’s Hospital Medical Center)

Like most of the other coronavirus vaccine trials, Pfizer’s involves getting two shots. Participants are given the shots three weeks apart and then have their health monitored for two years by researchers. The participants do not know whether they are receiving a placebo injection or an actual Covid-19 vaccine.

Either way, the youngest trial volunteers say they have confidence in the vaccines that are being developed — putting them at odds with many adults across the country.

Manufactured during a highly politicized pandemic in a matter of months versus the years or decades that a vaccine typically takes, the Covid-19 vaccines have prompted growing skepticism. A survey in October from Stat News and the Harris Poll found that only 58 percent of the American public would get a vaccine when it becomes available, down from 69 percent of those polled in August.

But researchers say the vaccines they are testing

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The next vaccine challenge: Nationalism

Instead of a coordinated global effort among governments to prepare the world to produce and distribute a vaccine, the pandemic has set off a wave of “me first” health care nationalism. Early in the pandemic, nations scrambled to bring production “home” and to secure enough doses of a still-hypothetical vaccine for their own citizens first. From export controls on critical health care supplies to closing borders to the movement of people, many measures governments took to protect their own citizens have also made it more difficult to orchestrate a global response, according to a new episode of POLITICO’s Global Translations podcast released Wednesday.

Governments have been looking for national solutions even though there is no “wholly domestic supply chain for any product” in the vaccine race, Jim Robinson, a former executive from the pharmaceutical giant Merck, told the podcast.

Robinson is now working with a handful of international organizations racing to fill in gaps in the global vaccine supply chain — and in global leadership — to ensure the world gets access to the vaccine. “Unfortunately, this is not a global effort to find a global solution,” he said.

Robinson leads the manufacturing strategy for Covid at the Coalition for Epidemic Preparedness Innovations, an international organization that works with the World Health Organization and GAVI, the Vaccine Alliance. Their partnership created COVAX, a voluntary multilateral effort to ensure equitable access to the vaccine around the world; 156 countries are now eligible to buy vaccines from COVAX. COVAX member countries get access to purchase vaccines from a portfolio of potential candidates and access to globally sourced supplies. The idea is to ensure it will be accessible to rich and poor countries alike.

Under the Trump administration, the United States, like Russia, has stayed out of COVAX. It is forging ahead on its own with Operation Warp Speed, a collaboration between the Department of Health and Human Services and the Pentagon to develop, manufacture and distribute a vaccine. It has partnered with several leading pharmaceutical companies, and a half dozen vaccine candidates are already in advanced clinical trials.

Anthony Fauci, the U.S. government’s top infectious disease expert, said the massive logistics and sourcing challenge is why the U.S. government turned to a four-star Army general, Gustave Perna, to serve as chief operating officer of the effort. “The purpose of getting someone of the experience and talent of Gen. Perna was precisely to assure that we can get [that] done,” Fauci said in an interview airing in the podcast.

Many countries around the world either don’t have the infrastructure to manufacture a vaccine in-house or don’t have access to necessary supplies, said Robinson. “Our goal is to really fill in the gaps for the global vaccine ecosystem to help create capacity for the rest of the world.”

The COVAX initiative is helping governments fumble toward cooperation. Initially, China, like the United States, stayed out of the coalition, preferring a nationalist approach to vaccine development. But earlier

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U.S. Vaccine Allocation Planner for COVID-19 Launched by Ariadne Labs and Surgo Foundation

Data-driven tool will help state and county decisionmakers operationalize phased vaccine distribution to priority populations in communities across the United States

When COVID-19 vaccines become available in the United States, there won’t be enough to vaccinate everyone right away, and states will need to allocate them to their highest priority populations. A new tool provides state and county decisionmakers the region-specific data they will need to distribute vaccines to different populations based on available vaccine doses, priority populations, and vulnerable communities.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201027006116/en/

Visit the COVID-19 Vaccine Allocation Planner at https://covid19vaccineallocation.org/. (Graphic: Business Wire)

The Vaccine Allocation Planner for COVID-19 was jointly developed by Ariadne Labs, a joint center for health systems innovation at Brigham and Women’s Hospital and Harvard T.H. Chan School of Public Health; and Surgo Foundation, a nonprofit focused on solving health and social problems with precision.

The National Academies of Sciences, Engineering, and Medicine (NASEM) recently launched a set of vaccine allocation guidelines for the United States, identifying 13 high-priority populations to be vaccinated in phases:

  • Phase 1A includes high-risk workers in health facilities and first responders.

  • Phase 1B includes people with significant comorbid conditions and people living in congregate care settings.

  • Phase 2 includes critical workers in other high-risk settings (public transit, grocery stores, etc.); teachers and school staff; people with moderate comorbid conditions; all older adults; people in homeless shelters or group homes; and incarcerated people or staff who work in jails.

  • Phase 3 includes young adults; children; and the remaining critical workers.

  • Phase 4 includes anyone residing in the United States who didn’t have access to vaccines in prior phases.

The Vaccine Allocation Planner for COVID-19 helps state and county decisionmakers operationalize the NASEM guidelines, allowing users to obtain size estimates of the high-priority populations in their immediate regions and weight purely by this criteria, while also considering other factors like community vulnerability. It also helps users estimate the number of vaccine doses available; and the percentage of vaccine coverage achievable under various scenarios.

“State and local leaders are going to need to make decisions about how to distribute their allotted COVID-19 vaccine doses, and there are many permutations those decisions could take,” said Dr. Sema Sgaier, Executive Director of Surgo Foundation and adjunct assistant professor at Harvard T.H. Chan School of Public Health. “Our tool gives them the concrete, localized data they will need to estimate with precision and maximize the public health impact of the coronavirus vaccine, while at the same time prioritizing vulnerable populations.”

“In the midst of the pandemic, we will face a scarce supply of the COVID-19 vaccines. Nations, states and local municipalities are planning for effective vaccine distribution,” said Dr. Rebecca Weintraub, Director of Vaccine Delivery at Ariadne Labs and Associate Physician, Division of Global Health Equity at Brigham and Women’s Hospital in Boston. “Unfortunately, too often scarce resources go to the most privileged. We built this tool for leaders with the data they will

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General plans campaign to deliver coronavirus vaccine quickly

The Pentagon general spearheading President Trump’s drive to ensure a coronavirus vaccine gets to the American people in record time said Tuesday that Operation Warp Speed can only work if there is full buy-in from the public when the vaccine becomes available.

Army Gen. Gustave Perna, a military logistics specialist who got a shoutout from Mr. Trump himself at last week’s presidential debate, described his mission at a session organized by the conservative Heritage Foundation was “our world’s best scientists and doctors working beside the world’s best military with the support of American industry and academia.”

“It’s the collective effort that will ensure we’re successful. I’m proud to be a part of it,” Gen. Perna said.

Operation Warp Speed is pushing ahead in the face of an at times angry political debate over the government’s handling of the virus crisis and whether the urgency of the mission will affect the safety of the process.

Thousands of volunteers will be needed after pharmaceutical giants AstraZeneca and Johnson & Johnson announced this week they were restarting U.S. clinical trials on their coronavirus vaccine candidates following a temporary stand-down over possible safety issues. Officials at Operation Warp Speed — a public-private partnership to develop therapeutics and ultimately a vaccine for COVID-19 — said locating a large number of volunteers for the trials is absolutely crucial.

In the past, about 5,000 to 8,000 people agreed to take part in clinical trials, Dr. Matthew Hepburn, head of program’s vaccine development, told the Heritage gathering.

“Our standard has been 30,000 volunteers for our clinical trials. We want to gather as much safety information as we possibly can,” Dr. Hepburn said Tuesday. “We want to know if [the vaccine candidates] work. The more people you enroll, the sooner you’re going to be able to evaluate the effectiveness.”

Dr. Hepburn said biotech firm Moderna has already completed its Phase 3 clinical trials with more than 30,000 volunteers enrolled in the testing. The New York-based pharmaceutical company Pfizer has signed up more than 40,000 people to take part in currently ongoing testing.

“That shows me that over 60,000 Americans have decided to say, ‘I will volunteer. I don’t know if I’m going to receive the vaccine or if I receive a placebo. But I’m going to do my part,’” Dr. Hepburn said. “We’re very proud of the spirit of volunteerism that we see in America.”

Medical researchers will be keeping in contact with those who received the initial COVID-19 vaccine candidates.

“The people that are vaccinated in the clinical trial now, our intention is to follow them for up to two years so we can get a better idea on that critically important question of duration of protection,” Dr. Hepburn said.

Past campaigns against viruses such as smallpox, polio and the measles made it possible for researchers to move more quickly to the coronavirus finish line, officials said.

“These efforts have gone on for decades. We stand on the shoulder of giants,” Dr. Hepburn said. “There was massive progress

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