Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

9 min readNov 22, 2020

“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible. A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”

The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer, industry, and sometimes a patient representative. Additional experts with specific expertise may be added for individual meetings as needed.

Although the VRBPAC members provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorize the vaccine for emergency use are made by the FDA. In terms of timing of the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.

The week of Nov. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted. These comments will be reviewed by the FDA.

The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This is what you have to think about the real adequacy of these immunizations.

What do the companies mean when they say their vaccines are 95% effective?

The fundamental logic behind today’s vaccine trials was worked out by statisticians more than a century ago. Researchers vaccinate some people and give a placebo to others. They then wait for participants to get sick and look at how many of the illnesses came from each group.

In the case of Pfizer, for example, the company recruited 43,661 volunteers and waited for 170 people to come down with symptoms of COVID-19 and then get a positive test. Out of these 170, 162 had received a placebo shot, and just eight had received the real vaccine.

From these numbers, Pfizer’s researchers calculated the fraction of volunteers in each group who got sick. Both fractions were small, but the fraction of unvaccinated volunteers who got sick was much bigger than the fraction of vaccinated ones. The scientists then determined the relative difference between those two fractions. Scientists express that difference with a value they call efficacy. If there’s no difference between the vaccine and placebo groups, the efficacy is zero. If none of the sick people had been vaccinated, the efficacy is 100%.

A 95% efficacy is certainly compelling evidence that a vaccine works well. But that number doesn’t tell you what your chances are of becoming sick if you get vaccinated. And on its own, it also doesn’t say how well the vaccine will bring down COVID-19 across the United States.

What’s the difference between efficacy and effectiveness?

Efficacy and effectiveness are related to each other, but they’re not the same thing. And vaccine experts say it’s crucial not to mix them up. Efficacy is just a measurement made during a clinical trial. “Effectiveness is how well the vaccine works out in the real world,” said Naor Bar-Zeev, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

It’s possible that the effectiveness of coronavirus vaccines will match their impressive efficacy in clinical trials. But if previous vaccines are any guide, effectiveness may prove somewhat lower.

The mismatch comes about because the people who join clinical trials are not a perfect reflection of the population at large. Out in the real world, people may have a host of chronic health problems that could interfere with a vaccine’s protection, for example.

The Centers for Disease Control and Prevention has a long history of following the effectiveness of vaccines after they are approved. On Thursday, the agency posted information on its website about its plans to study the effectiveness of coronavirus vaccines. It will find opportunities to compare the health of vaccinated people to others in their communities who have not received a vaccine.

What exactly are these vaccines effective at doing?

The clinical trials run by Pfizer and other companies were specifically designed to see whether vaccines protect people from getting sick from COVID-19. If volunteers developed symptoms like a fever or cough, they were then tested for the coronavirus.

But there’s abundant evidence that people can get infected with the coronavirus without ever showing symptoms. And so it’s possible that a number of people who got vaccinated in the clinical trials got infected, too, without ever realizing it. If those cases indeed exist, none of them are reflected in the 95% efficacy rate.

People who are asymptomatic can still spread the virus to others. Some studies suggest that they produce fewer viruses, making them less of a threat than infected people who go on to develop symptoms. But if people get vaccinated and then stop wearing masks and taking other safety measures, their chances of spreading the coronavirus to others could increase.

“You could get this paradoxical situation of things getting worse,” said Bar-Zeev.

Will these vaccines put a dent in the epidemic?

Vaccines don’t protect only the people who get them. Because they slow the spread of the virus, they can, over time, also drive down new infection rates and protect society as a whole.

Scientists call this broad form of effectiveness a vaccine’s impact. The smallpox vaccine had the greatest impact of all, driving the virus into oblivion in the 1970s. But even a vaccine with extremely high efficacy in clinical trials will have a small impact if only a few people end up getting it.

“Vaccines don’t save lives,” said A. David Paltiel, a professor at the Yale School of Public Health. “Vaccination programs save lives.”

On Thursday, Paltiel and his colleagues published a study in the journal Health Affairs in which they simulated the coming rollout of coronavirus vaccines. They modeled vaccines with efficacy rates ranging from high to low but also considered how quickly and widely a vaccine could be distributed as the pandemic continues to rage.

The results, Paltiel said, were heartbreaking. He and his colleagues found that when it comes to cutting down on infections, hospitalizations and deaths, the deployment mattered just as much as the efficacy. The study left Paltiel worried that the United States has not done enough to prepare for the massive distribution of the vaccine in the months to come.

“Time is really running out,” he warned. “Infrastructure is going to contribute at least as much, if not more, than the vaccine itself to the success of the program.”

This article originally appeared in The New York Times.

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

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