Ex-Surgeon General: People ‘Are Dying’ Because FDA Hasn’t Fully Approved A Covid-19 Vaccine - Forbes

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Topline

Former U.S. Surgeon General Jerome Adams on Tuesday pressed the Food and Drug Administration (FDA) for an update on when a Covid-19 vaccine may be approved, arguing that the wait—which is normal for approvals of this kind—is jeopardizing American lives.

Key Facts

“U.S. citizens are dying” and “variants are rising” while we await an update from the FDA and White House on when it will fully approve a Covid-19 vaccine, Adams, who served as surgeon general under former President Donald Trump, tweeted.

The “quickest path” to herd immunity in many U.S. communities is “organizational vaccine mandates, but lack of FDA licensure leaves schools, colleges, businesses in a legal quandary,” Adams argued.

Key Background

Pfizer and BioNTech, Moderna and Johnson & Johnson’s Covid-19 vaccines have been granted emergency authorization by the FDA, not full approval. For a treatment to receive emergency use authorization, its “potential benefits” must “outweigh the known and potential risks of the vaccine.” All three Covid-19 vaccines underwent extensive testing before being approved, and researchers so far have identified minimal side effects. Pfizer applied for full approval with the FDA on May 7, while Moderna did the same on June 1. Johnson & Johnson, which was granted emergency approval later than Moderna and Pfizer, has yet to apply for full authorization.

Big Number

12. That’s the number of months the FDA takes to fully approve a vaccine, according to Yale School of Medicine researchers. Along with reviewing at least six months of follow-up data from clinical trials, researchers typically inspect the manufacturing facilities.

Crucial Quote

Asked about when the FDA might grant full approval at a news briefing earlier this month, Dr. Anthony Fauci responded: “We don’t want to get ahead of the FDA. They have their process where they need to cross all the t’s and dot all the i’s.”

Surprising Fact

Emergency Use Authorization is a relatively new mechanism for the FDA. The first EUA was issued in 2009 during the swine flu pandemic.

What To Watch For

Adams and some other health experts argue full approval will slash the share of unvaccinated Americans because it will decrease vaccine hesitancy and allow employers to more easily mandate vaccines. In May, the Equal Employment Opportunity Commission (EEOC) said employers can require their workers to receive a Covid-19 shot, but some companies are worried about lawsuits. Last week, the U.S. Army said it will likely require all soldiers to be vaccinated by September if a Covid shot is granted full approval. Polling shows about one third of unvaccinated Americans are waiting for full FDA approval before getting a shot.