New York health officials will review any COVID-19 vaccine approved by the Trump administration, Gov. Andrew Cuomo (D) said Thursday, citing his distrust of the federal government.
“Frankly, I’m not going to trust the federal government’s opinion, and I wouldn’t recommend to New Yorkers based on the federal government’s opinion,” Cuomo said at a press conference.
The Food & Drug Administration (FDA), a part of the federal government, reviews vaccines for safety and efficacy, but its independence has come into question after a series of decisions made by the agency, in addition to remarks made by President Trump that have fed fears that the development of a vaccine could be politicized.
No drug manufacturer has asked the FDA yet to approve a potential COVID-19 vaccine, but several candidates are in the final stages of clinical trials.
FDA Commissioner Stephen Hahn, who was appointed by Trump, has repeatedly said any COVID-19 vaccines will be held to the highest standards dictated by science, not politics.
But Trump has undermined that message repeatedly, questioning the FDA’s plans to issue tougher standards for the emergency authorization of a coronavirus vaccine. The changes would require a median of two months of safety data on participants in the trials to ensure there is enough time to identify side effects.
“We’re looking at that. That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” Trump said at a White House press briefing Wednesday.
Trump went on to assert that the standards would cause unnecessary delay in the delivery of a possible vaccine. Multiple companies are currently in clinical trials for vaccine candidates.
“Why would [companies] have to be adding great length to the process? We want to have people not get sick. The vaccine is very important,” Trump said, adding, “I think that was a political move more than anything else.”
Concerns about political influence in the vaccine approval process follow the FDA’s decisions to approve emergency use authorizations for two potential COVID-19 drugs despite limited data showing their effectiveness.
The FDA initially approved the emergency use of hydroxychloroquine — an antimalarial drug touted by Trump and his allies — as a potential COVID-19 treatment, before pulling it after studies showed it was ineffective and might cause harm in some patients.
The FDA later issued an emergency approval for convalescent plasma as a COVID-19 treatment, even though National Institutes of Health Director Francis Collins and Anthony Fauci, the nation’s top infectious disease doctor, warned there was not enough data showing its effectiveness.
Career FDA officials took the unusual step of writing a USA Today editorial earlier this month vowing to make decisions “guided by the best evidence.”