How The FDA Plans To Guarantee Safety Of A COVID-19 Vaccine, New Standards For Emergency Use Considered

The Food and Drug Administration is considering tougher standards for any coronavirus vaccine to boost public confidence amid growing skepticism over the agency’s independence from political pressure. The standards, which are closer to what is required for full approval, could be announced as early as this week.

The Washington Post reported the changes to the FDA’s emergency use authorization will make it difficult for any vaccine to be rolled out before Election Day as President Trump has suggested. Public health experts have worried the administration could pressure the FDA into a premature decision, bringing a vaccine’s safety and efficacy into question.

A Pew Research Center poll indicated just half of Americans are certain or fairly certain they will take the vaccine when it becomes available, with 24% saying they definitely will not.

The FDA has granted emergency use authorization of a vaccine only once before: in 2005 when it OK’d a vaccine for anthrax for military personnel.

Public doubt has been growing as a result of administration efforts to undercut the statements of its own scientists and blunders by the Centers for Disease Control and Prevention, which bungled the early rollout of testing, succumbed to White House pressure in posting coronavirus guidelines and most recently took down information on the aerosol spread of the virus, saying it was an unfinished draft that should not have been made public.

Trump last week contradicted CDC Director Robert Redfield, who testified before a Senate panel that a vaccine would not be widely available until at least the second quarter of 2021. Trump insisted one would be available in a matter of weeks.

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an FDA adviser, said the process virtually guarantees an emergency use order cannot be issued before December.

The Post, quoting sources familiar with the situation, said the revised guidelines call for manufacturers to follow test subjects for two months after they receive a second dose of vaccine and to look for at least five severe cases of COVID-19 among subjects who received a placebo. The FDA also wants evidence the vaccine works in older people.

The FDA said earlier to win approval, a vaccine will have to show it is 50% more effective than a placebo.

Moderna and Pfizer began their 30,000-subject phase 3 clinical trials July 27. The second dose of vaccine is delivered 21 to 28 days after the first. Pfizer said its data may be ready for review by late October. Moderna said its data won’t be ready until later than that.

Trials of AstraZeneca’s vaccine candidate have resumed in the U.K. but remain halted in the U.S. after a test subject developed a neurological problem.

“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,” Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the Post. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.”

The FDA has been criticized for the emergency authorizations issued for hydroxychloroquine and convalescent plasma. The emergency approval for the anti-malaria drug was revoked because it caused heart problems in some COVID-19 patients and was shown to be ineffective in treating the disease. Last month, FDA Commissioner Stephen Hahn exaggerated the benefits of the plasma treatment.

There currently are 40 vaccines undergoing human trials and dozens more in development. Vaccines normally take years to develop. Work on a coronavirus vaccine began in January although some of the research was based on earlier efforts to develop a vaccine for SARS.