Steep Vaccine Hurdles Overcome White House Block

WASHINGTON (CN) — The Food and Drug Administration will not consider emergency approval of any coronavirus vaccine that developers have not monitored for at least two months after testing in human trials, the agency said Tuesday, all but ensuring there will be no vaccine before Election Day.

Coming shortly after a reported blockade by the Trump administration, the criteria were announced ahead of what will be an Oct. 22 meeting of the Vaccines and Related Biological Products Advisory Committee.

“The vaccines are coming momentarily,” Trump said in a video tweeted Monday night upon checking out of the hospital where he was treated this weekend for Covid-19.

Administration officials speaking anonymously to the Times said the president's understanding about vaccine steadiness came from talks with pharmaceutical industry officials. Politico reported Tuesday that the White House rescinded its block to approve the new guidelines.

Lee Riley, a professor of epidemiology at the University of California, Berkeley, said the FDA’s guidelines are in line with the course of action public health experts would recommend.

“They seem to be quite aware of potential complications,” Riley said Tuesday in an interview. “They seem to be really relying on science to make the guidelines, which is encouraging.”

Higher criteria for emergency vaccine authorization increases the vaccine’s threshold of safety, Riley added. He said the guidelines indicate the FDA’s commitment to acting carefully, despite the Trump administration’s pressure to lower standards. 

Safeguarding against the possibility that a rushed vaccine will allow more serious cases to develop, the FDA said that drugs will qualify for emergency authorization only when administered in trials where at least five cases of severe Covid-19 infections occurred.

“Vaccines are complex biological products, and an EUA for a Covid-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the document states, using the abbreviation for emergency use authorization.

To ensure the vaccine’s quality and consistency, the FDA said it also require adequate manufacturing information, "and a determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.”

As noted in its 38-page briefing document, the FDA proclaimed that Covid-19 vaccines will be safe and effective, with “as much transparency as possible to the American public, while adhering to applicable confidentiality requirements.”

Last week, Pfizer CEO Albert Bourla said in a note that the company remains committed to the “ambitious” goal of having vaccine data ready to submit to the FDA “in October.” Moderna’s CEO Stéphane Bancel, by comparison, indicated the pharmaceutical giant will not seek authorization before the election.

Follow @@lexandrajones

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit