Regulators and experts address awkward vaccine research issues

Washington-US regulators determine the fate of COVID-19 vaccine Taking an extraordinary step: Ask outside scientists if their standards are high enough.

The Food and Drug Administration may have to decide whether to allow first use by the end of the year vaccine Against the virus. On Thursday, the Federal Advisory Board closes the decision-making process and discusses whether the guidelines set by the FDA for vaccine developers are rigorous enough.

At a meeting of the Milken Institute on Wednesday, FDA Commissioner Steven Hahn pledged, “We will not cut corners and use only science and data to make that decision.”

The exact amount of data his institution needs to ensure that the vaccine is safe and effective is an important question for advisors. Even bigger problem: If the FDA permits emergency use of the vaccine before the final trial is over, it destroys the possibility of learning how well that shot (and perhaps the competitors still being studied) works. Do you?

“We can’t overlook the fact that it’s our social interest to see these exams complete,” said Dr. Luciana Borio, a former FDA Deputy Chief Scientist who oversees the advisor’s debate. It was.

In addition, multiple vaccines are being studied-shots made with different techniques, each with its own strengths and weaknesses.

“The first vaccine is not always the best vaccine,” warned Dr. M. Miles Brown, a former FDA scientist at Georgetown University School of Medicine. If you are not allowed to end your trial, it can be difficult or impossible to know for sure.

This is an important moment in the FDA’s 114-year history. Governments are spending billions of dollars competing for vaccines through a research process that usually takes years, the FDA is facing unprecedented pressure from the Trump administration, and politics could overturn science. It fuels public skepticism.

The interest is so high that the FDA broadcasts the conference on YouTube. Some important issues that the Commission discusses are:

How much proof do you need?

The FDA requires manufacturers to conduct a study of at least 30,000 people to prove whether the vaccine protects and how safe it is. These studies should include a sufficient number of people at the highest risk of COVID-19: the elderly, minorities, and those with underlying health problems.

The FDA has made it clear that the vaccine must be at least 50% effective. The study is designed to run for two years, but companies may get enough evidence that the shot is protective-at least for some people-stop the trial early and be broader. We ask for a so-called “emergency permit” for vaccination.

Despite opposition from the White House, the FDA told vaccine makers earlier this month not to ask for a quicker review until they tracked at least half of their trial participants for two months. With other vaccines, it is the length of time that the major side effects occur.

The director of the non-profit ECRI Institute, which reviews the medical technology of hospitals and insurance companies, said that was not enough. In a comment submitted to the Advisory Committee, ECRI Dr. Marcus Shabaker said the FDA should require six months of follow-up.

“Doing less than that would simply be too risky, and the consequences could be serious,” he wrote. “Weak vaccines that lose public confidence can poison wells for epidemic control over the years.”

Do emergencies use DERAIL’s complete answer about vaccines?

Participants who take dummy shots are usually provided with the real thing when the study is completed due to evidence that the vaccine is working.

However, Borio warned that if the FDA allowed emergency use of the COVID-19 vaccine, it would not be the same as completely demonstrating that the shot would work.

And if participants in the placebo group were immediately provided with actual shots, researchers may not be able to get answers for all high-risk groups in the study-or how long vaccine protection will last. You may not be able to know, the process is expected to take more months.

However, Pfizer, which is developing one of the leading candidates with Germany’s BioNTech, warns research participants who have obtained a placebo and grants access to the vaccine if an emergency license is granted. There is an ethical obligation, “he told the FDA. The company wants the FDA to investigate “other scientifically and statistically appropriate methods” to determine long-term safety and efficacy.

Pfizer’s stance can face repulsion. The Infectious Diseases Society of America argues that FDA panelists “provide a compelling case” of how vaccine developers will complete trials if the FDA permits early approval of the vaccine. Should be “.

Clearing vaccines based on premature or defective data “may cause more harm” by “further undermining public confidence in all vaccines,” the group said.

This is an unprecedented dilemma. The FDA previously allowed the emergency use of only one vaccine, a decade-old vaccine approved in 2005 to prevent anthrax poisoning.

This time, there are multiple COVID-19 vaccines in the pipeline. Pfizer’s competitor Johnson & Johnson said that if a patient decides to drop out instead looking for the first clear shot, the early FDA clearance of one vaccine will be “complete” in another ongoing trial. I warned that it could “endanger my sexuality.”

The company asked regulators to explain the options available to ensure that all ongoing COVID-19 vaccine trials are completed.

What about long-term safety monitoring?

Even a study of 30,000 people cannot find side effects that affect only 1 in 100,000 people. Therefore, the government plans additional scrutiny of all COVID-19 vaccines to reach the market.

Initially, the dose given only to certain high-risk people is limited-and those early recipients receive daily text messages during the first week after vaccination, followed by weekly text messages for up to 6 weeks. Receive and ask how they feel.

The FDA also checks electronic health records and claims databases for warning signs.

“A large-scale follow-up that has never been done must take place here,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s Vaccine and Biologics Center.

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at Howard Hughes Medical Institute. AP is solely responsible for all content.