September 17, 2021
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
Today, you are asked to discuss whether the data presented by the Sponsor support the safety and effectiveness of a booster dose of their COVID-19 vaccine, and if so, for whom.
I will focus on the safety sample data discussed in the FDA’s briefing document. The total safety sample is very small — only 329 patients. Even more important, the sample is not representative of the people who will want the booster. There are safety data on only 12 patients ages 65 and over, even though people over 65 are considered a priority group for a booster due to weaker immunity. Twelve people over 65 is much too small to draw conclusions about safety and is obviously not large enough to have any confidence in the claim that adverse events from booster doses are less common in those 65 and over.
In addition, there are zero patients ages 16 and 17, and safety for this population is being extrapolated based on safety for those 18 and over. Data should be collected for any population that the boosters would be approved for, rather than extrapolating pediatric safety from adult safety data.
Unfortunately, the size of the sample is not the only problem with the safety data. A median of 2.6 months is not enough time for assessing the safety of the booster. In addition, we agree with the FDA that it is unknown whether there will be an increased risk of myocarditis, pericarditis or other adverse reactions after a booster dose.
We all know that COVID can be deadly, but the efficacy of a booster compared to no booster is not well established, since the placebo control group is missing in addition to uncontrolled variables that could influence the diagnosis of COVID for those with boosters and those vaccinated without boosters. Assurance that the benefits outweigh the risks should be gathered before approving booster vaccines. Otherwise, potential risks may become obvious only after large numbers of the general population have received boosters, and the benefits of boosters may be much less than expected.
FDA decisions should be based on proof of the safety and effectiveness of a medical product before the product is widely distributed. To approve a booster without adequate safety or efficacy data undermines the integrity of the FDA.
It is unfortunate that the White House announced the need for and availability of boosters prior to FDA’s assessment of the data. We know numerous people who have already received booster doses, by merely asking their doctors or local pharmacies for a third dose. We all want to get the COVID-19 pandemic under control and protect as many people as possible, which is exactly why it is so important to carefully and scientifically assess the safety and effectiveness of COVID-19 booster vaccines. The data provided for this meeting do not allow us to draw confident conclusions, and a premature decision will make it impossible to do the research necessary to draw scientific conclusions.