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Cohan: The coronavirus booster shot plan has been a rollercoaster

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Cohan: The coronavirus booster shot plan has been a rollercoaster

The debate over coronavirus booster shots has heated up in recent weeks and is finally hitting a crescendo.

But before getting into the many details of Friday’s FDA panel meeting, during which members voted to authorize booster shots for people 65-plus and high-risk patients, let’s take a step back to last month.

The Biden administration on Aug. 18 announced a plan to begin offering booster shots to all Americans starting on Sept. 20, and patients would become eligible eight months after their second shot.

While President Biden did acknowledge that plan was contingent upon U.S. Food and Drug Administration and Centers For Disease Control and Prevention approval, the announcement surprised some public health experts as being a bit premature, which it clearly was.

In addition, some health groups such as the World Health Organization had asked countries to pause booster rollout to be able to share vaccine doses with the countries that need it most.

The plan caused concern among members of the Vaccines and Related Biological Products Advisory Committee, a panel tasked with voting whether to clear vaccines for use in the public before the decision gets passed to a CDC committee.

Dr. Marion Gruber and Dr. Phil Krause, both VRBPAC members, wrote an opinion piece in the medical journal Lancet, saying, “Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently.”

Krause and Gruber plan to step down from the FDA within the next two months, which Gruber acknowledged during Friday’s meeting. She said it would likely be her last advisory committee meeting as an FDA official and thanked committee members.

The booster issues continued to mount during the marathon meeting. Members were tasked to vote on whether to recommend approval of a Pfizer booster dose for everyone 16 and older at least six months after their second dose.

Key data that Pfizer reps relied on from Israel was picked apart by members, as they found out Israel uses a different definition of severe coronavirus than here in the U.S., and current data from the country might be skewed due to the recent high holidays. Israel has already rolled out booster shots.

Krause pointed out that much of the data presented was not peer-reviewed nor reviewed by the FDA.

Members noted how there is absolutely no data on boosters in kids 16 and 17 years old. The safety database of only 300 people was too small, some members said, and overall, the country’s top researchers asked for more data, which CDC officials said would become available soon, but not now.

With many questions left unanswered throughout the course of the nine hour meeting, members overwhelmingly voted against the measure.

VRBPAC member Dr. Melinda Wharton said, “Recommending a third dose for younger people is just not something I’d be comfortable with at this point.”

They went back to the drawing board though, and crafted a new policy question that asked about offering boosters to those 65-plus, high-risk patients and possibly health care workers under emergency use authorization, not full FDA approval.

The vote was a unanimous yes.

The system is clearly working well, and Americans should have confidence in that.

The Advisory Committee on Immunization Practices will debate the booster question this week before a plan is ultimately signed by the CDC director and boosters make their way into the public.

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