DETROIT – The Food and Drug Administration vaccine advisory panel will have a critical meeting Friday, Sept. 17.
The group of outside experts will discuss whether or not to recommend a third dose of the Pfizer vaccine as a booster.
The FDA’s briefing material and Pfizer’s submission have already been made public, so there’s an idea of what people can expect Friday.
There is a lot riding on the outcome of the meeting since the White House has already promised booster doses to the general public. However, that decision is not a slam dunk and there’s a lot of data to be considered.
The data that favors booster doses is plentiful -- especially in light of an Israeli study recently published in the New England Journal of Medicine and part of the submission to the FDA.
The study found among people who are over 60 and received their initial two doses five months earlier, rates of confirmed COVID and severe illness were substantially lower among those who received a booster dose of the Pfizer vaccine.
Other data from Israel and the United States suggest that immunity decreases over time. One Analysis found people vaccinated in January 2021 were more than twice as likely to be infected with a breakthrough case than those vaccinated in April 2021. The study suggests the drop in protection over that time could be overcome with a booster.
In addition to the effectiveness of a potential booster, the FDA committee will also need to consider safety. While the data being presented to the FDA panel doesn’t raise any significant safety considerations, the main thing of note was a slightly increased rate of lymph node swelling with the booster. Although the sample size was small, no serious adverse effects were seen.
There are other consideration in play though. A recent article published in The Lancet that was co-authored by two FDA scientists questioned the need for boosters at the time -- especially given that so much of the rest of the world remains unvaccinated.
The FDA does not have to follow the advice of its advisory panel, but it generally does.
The CDC’s advisory panel is scheduled to meet Wednesday and Thursday to discuss boosters -- two days after the White House had hoped to begin distributing the third doses.
Everything about COVID-19 is new and new data is constantly being generated. Depending on a person’s interpretation of the data, reasonable people can come to different conclusions. Hopefully, we can come together to an absolute truth, but the steps along the way are messy and all we can do is make the best judgements with the data we have at the time.
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