Health & Fitness

Consultants say F.D.A. It ought to acquire extra security knowledge on Covid-19 vaccines

Vaccine experts on Thursday inundated Food and Drug Administration officials with a series of questions about guidelines for approving a coronavirus vaccine, urging the agency to wait longer for further safety data to be collected and whether an emergency approval could jeopardize the outcome the broader clinical trials.

The stakes, the experts said, couldn't be higher. While a vaccine is seen as critical to ending the pandemic, opinion polls have shown Americans are increasingly skeptical about the products and fear that the review process will be speeded up.

"In this particular case, public trust equals success," said Sheldon Toubman, the consumer representative on the advisory group. "Lack of trust means no success."

The meeting, which lasted all day and aired on YouTube, also included a presentation by a nonprofit group asking people their views on a coronavirus vaccine. Several people of color expressed concern about whether the vaccine had been tested in blacks, Latinos, or Native Americans.

Others said their skepticism had historical roots in the Tuskegee Syphilis Study, in which government scientists lied to black men and allowed them to go untreated for syphilis. "I firmly believe that this is another Tuskegee experiment," said one participant.

The panel of experts was not asked to rate a particular vaccine – none of the companies that have developed one has results from large clinical trials – but rather weigh up how the F.D.A. should review the candidates. The agency has announced that it will seek its opinion from the panel before approving an emergency coronavirus vaccine. The agency usually, but not always, follows the advice of its external experts.

Four companies are conducting late-stage clinical trials in the US, and some have estimated they will have preliminary data that could allow them to apply for emergency approval in certain high-risk groups by the end of November. One of the companies, Moderna, announced Thursday that it was the first company to fully register its 30,000-participant study.

Some of the experts felt the agency should ask companies to wait for more security data. They said the agency's current guidelines that require two months of safety data after a volunteer receives the last dose of a vaccine are not good enough. By collecting longer-term data, they could assess potential risks, e.g. B. whether immunity to the virus wanes after a few months or whether there are rare side effects.

The experts were also asked to provide their views on what should be done with the clinical trials when the F.D.A. to approve an emergency vaccine based on promising early data. Pfizer has stated that if an emergency vaccine is approved, it has an ethical obligation to offer the vaccine to people in the study who received a placebo in place of the actual vaccine. However, this would "unblind" the process by revealing who was in each group, which would jeopardize the overall results.

Many of the experts said the results of the clinical trials – which involved 30,000 to 60,000 people – were critical to understanding whether the vaccines work and can be safely delivered to millions and possibly billions of people.

"It seems to me that the continuation of the blinded phase is absolutely critical and therefore we should do everything possible to ensure that it continues," said Dr. Luigi Notarangelo, Head of the Laboratory of Clinical Immunology and Microbiology at the National Institute of Allergies and Infectious Diseases at the National Institutes of Health.

Some members said that if emergency vaccine use were restricted to a small group of high-risk people – such as nursing home residents or older adults – the studies should continue as most people in the placebo group would most likely not be in these risk groups.

Some F.D.A. Officials, including Marion Gruber, director of the Office for Vaccine Research and Review, addressed another possibility: Instead of an emergency permit, the agency could make the vaccine available through what is known as “extended access”. Such programs are typically used to administer experimental drugs to critically ill patients, but have been used with some vaccines.

By restricting access to the vaccine in this way, clinical trials could continue while people at extreme risk of dying from Covid-19 could be vaccinated, although no specifics were given.

However, a restricted access program could pose political risks. President Trump has urged vaccines to be widely available, boasting that they would be ready "immediately" as soon as positive news came in. However, senior federal health officials said that if the vaccines are successful, they are unlikely to be available to all Americans until well into next year.

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