Critics also cite the Food and Drug Administration’s emergency-use authorization of hydroxychloroquine and chloroquine as a covid-19 treatment in March as the president heavily promoted it — and despite lack of evidence. That authorization was revoked Monday after studies showed no clear benefit from the antimalarial drugs. In a memo explaining the reversal, the FDA said it had received almost 400 reports of adverse events about the drugs, including 109 serious cardiac episodes.
“This will be a huge issue … when we have the first application for a vaccine and people will wonder and worry, ‘Is the FDA using science and evidence here, or is it trying to meet some political timeline?’” said Ashish Jha, director of the Harvard Global Health Institute. “I think the FDA has lost a lot of credibility the last few months.”
Unlike a rare cancer treatment or a drug for a debilitating disease, vaccines are given to healthy people, so there is little tolerance for side effects or risks, vaccine experts say. Another concern is that those who have been immunized may return to behaviors that put them at risk, only to have a vaccine turn out to be ineffective.
Trump administration officials insist the process will be driven by science.
“Under no circumstances will we allow political pressure to affect our decision-making and, importantly, that has not occurred on my watch,” said FDA Commissioner Stephen Hahn, who has denied the White House influenced the agency’s emergency authorization of antimalarial drugs.
“Any new vaccine must be thoroughly tested to ensure it is safe and effective, and that is why Operation Warp Speed is being led by expert scientists focused on saving lives,” said White House spokesman Judd Deere.
Trump has eschewed the advice of many scientists throughout his presidency, but now he finds himself reliant on an extraordinary scientific experiment to end a global pandemic. Even as he spends far less time dealing with the coronavirus crisis, the president has convened several meetings on vaccines in recent weeks, telling officials to move faster on making a vaccine available.
If a vaccine were approved as early as the fall, it would most likely come in the form of a so-called emergency-use authorization issued by the FDA. Such authorizations require a lower level of evidence of effectiveness than formal approvals. They may be issued if the agency believes a product “may be effective” to prevent or treat a serious or threatening disease, and that its “known and potential benefits” outweigh the risks.
National Institutes of Health Director Francis Collins said delivering an emergency-use authorization by the fall is one of the administration’s “stretch goals.”
“We have for the most part been focused on the stretch goals and trying to inspire everyone” to do things that previously did not seem possible, Collins said in an interview. “Hopefully at least having an EUA for one or more of [the vaccines] by sometime in the fall — that is a stretch goal, and even beyond belief. It has my knuckles white.”
An emergency-use authorization might allow a vaccine to be distributed to certain high-risk groups. Two senior administration officials said groups that are likely to be prioritized are the elderly, those with preexisting conditions and front-line essential workers, such as those in health care and food safety.
It remains unclear, however, just how broad or narrow such an authorization could be, and the number of people who would be eligible to receive it under those circumstances.