FDA Advisory Committee Meeting on EUA for Moderna COVID-19 Vaccine Booster Today

Today I’m watching the FDA meeting on extending the Emergency Use Authorization (EUA) for Moderna COVID-19 Vaccine Booster application. Right now, I’m in-between presentations and I’ll be updating later this afternoon. I’m skipping the Open Public Hearing.

I’m wondering if the question to vote on will get changed like it did last month for the Pfizer booster. So far, today’s question is:

“10/14 Voting Question:

Question 1) Do available data support the safety and effectiveness of Moderna COVID-19 Vaccine for use under EUA as a booster dose (50 mcg mRNA-1273) at least 6 months after completion of a primary series in the following populations:

• Individuals 65 years of age and older,

• Individuals 18 through 64 years of age at high risk of severe COVID-19, and

• Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

Dr. Arnold Monto is in fine form and has already starting limiting the number of questions participants can ask. But we’re ahead of schedule and he’s very pleased overall.

My wife, Sena, finally got her Pfizer booster this morning. It has been kind of complicated for her to schedule and she went through a telephone algorithm about a half dozen times. She showed up on the day scheduled a couple of days ago and the pharmacy manager cancelled it, saying it was too early for the 6-month mark (by 2 days) following her 2nd primary series dose. This morning he apologized for being the “Vaccine Nazi.”

My Moderna booster depends on what happens today, and after the CDC advisory committee makes its decision at their meeting next week Oct 20-21. If approved, I’d get half the dose I received during my primary series (50 mcg instead of 100 mcg)—provided I don’t run into the Vaccine Nazi.

Anyway, this morning’s meeting went fairly well; only 2 people forgot to unmute their microphones. The Israeli researchers gave a presentation on their updated booster program that impressed committee members, who called the data “compelling.” As I recall, last month, some people raised questions about their definition of COVID-19 disease severity, making it hard to judge how applicable their data results would be in the United States. This morning, they clarified that the disease severity criteria actually came from the NIH (slide 15).

Update around 2:15 PM today: The committee upvoted the question above unanimously.

Tomorrow the committee will take up the issues of J&J boosters and heterologous vaccinations.

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