The agency also is looking for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people, as a sign the vaccine works.
These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable for any vaccine to be authorized before the election. The agency has previously said any vaccine would have to be 50 percent more effective than a placebo.
“It’s hard to imagine how an EUA could possibly occur before December,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines. The guidance is just one way of trying to shore up confidence in the agency. FDA allies, intent on building trust, are also spotlighting agency career scientists, noting that the one overseeing the vaccine-approval process has threatened to quit if he is pressured to greenlight a vaccine before he is convinced it is safe and effective. But, administration critics note, such efforts are undercut on an almost daily basis by overly rosy and contradictory comments by Trump and continued revelations about administration actions to strong-arm government scientists and regulators, and curb their independence.In addition, the FDA guidance is unlikely to satisfy some critics, who say the agency should not use an emergency authorization for a vaccine at all. “Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.” The FDA career staff itself is trying to reassure the public. In a highly unusual move, Peter Marks, the head of the center that oversees vaccine regulation, and seven other senior career officials vowed in a column to maintain “independence to ensure the best possible outcomes for public health.” The agency also has pledged to take any vaccine data to its panel of outside advisers, called the Vaccine and Related Biological Products Advisory Committee, before making decisions. The agency has scheduled a public meeting of the panel for Oct. 22 and said others sessions can be held as needed, depending on when data is available. But some FDA watchers say those steps are not enough and that the agency should forswear use of an emergency authorization for a vaccine and instead require a full approval. “If we don’t get this right, we’ll see a deep corrosion of trust over the long term — and that will be the darkest legacy for a post-covid world,” said Lawrence Gostin, a public health expert at Georgetown University’s law school.
Eric Topol, founder and director of Scripps Research Translational Institute, opposes using an emergency authorization in the next several weeks or months. “We are not in a high-trust mode, and the last thing you want to do is take a short cut and put everything at risk,” he said.
He said the agency should not consider such an authorization until at least early next year to ensure it has adequate safety data.