The FDA's panel of experts said its COVID-19 vaccine approval rules aren't strict enough, and could lead to vaccines being rushed out

Kate Duffy
·2 min read
vaccine trial
A volunteer receives an injection from a medical worker. REUTERS/Siphiwe Sibeko
  • The Food and Drug Administration's (FDA) panel of experts questioned the safety standards of the agency's COVID-19 vaccine approval at an advisory meeting Thursday.

  • Independent experts in the FDA's vaccine advisory board said they were concerned about a vaccine being rushed out, and later proving unsafe or ineffective, per Bloomberg.

  • The FDA requires a two-month follow-up after a final vaccine dose before emergency approval of a vaccine. This is too short, the experts said.

  • "What we're being asked to do is to build this plane as we fly it," said Archana Chatterjee, dean of Chicago Medical School.

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The Food and Drug Administration's (FDA) panel of experts questioned the safety and efficacy of its own rules around emergency COVID-19 vaccine approval at an advisory meeting Thursday.

The FDA's vaccine advisory board, made up of external experts in infectious diseases, met Thursday to discuss the agency's standards for a coronavirus vaccine.

Many the panel members voiced concerns about a vaccine being rushed out, and later proving unsafe or ineffective against coronavirus.

This could ultimately undermine public confidence in COVID-19 vaccines for years to come, they said.

The first test of these rules could come in late November, when Pfizer has said it plans to submit its vaccine for emergency approval.

In particular, experts on the panel were worried about the FDA's rule that manufacturers must wait two months after giving a final dose to patients before applying for approval. This is not long enough, the experts said.

Amanda Cohn, chief medical officer at the National Center for Immunization and Respiratory Diseases, said in the meeting: "Very rarely do we look at [vaccine efficacy] so shortly after completing a series."

Diana Zuckerman of the National Center for Health Research said the vaccine trials "have serious design flaws." They are too focused around treating mild infections, and may not show whether the vaccines treat severe strains of the virus, she said.

Read more: The top 5 takeaways from the first meeting of the FDA's expert vaccine group, including plans for vetting, distributing, and tracking COVID-19 vaccines

Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center, said the trials "haven't gone far enough" in terms of safety.

Archana Chatterjee, advisory panel member and dean of Chicago Medical School, told the committee the public are concerned about the safety of coronavirus vaccines, adding: "What we're being asked to do is to build this plane as we fly it."

The meeting came just before the FDA approved Gilead Sciences' antiviral drug remdesivir to treat coronavirus patients.

Remdesivir, which was used to treat President Donald Trump's coronavirus infection, is the only antiviral drug approved to treat COVID-19 patients. 

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