Today was the FDA vaccine advisory committee meeting to provide feedback to the FDA regarding the Pfizer-BioNtech COVID-19 vaccine. I don’t think anyone will be surprised by the outcome, especially since the pre-meeting package written by the FDA was extremely favorable regarding the safety profile and the very high efficacy rates seen in the study.
The question posed to the committee was: “Based on the totality of the scientific evidence available, do the benefits of the Pfizer-BioNtech COVID 19 vaccine outweigh its risks for use in individuals 16 years of age and older?” The vote was 17 yes, 4 no, and 1 abstain.
The issues that seemed to trigger the no and abstain votes appear to be related to the recommendation for approval of the vaccine in 16 and 17 years of age. Some of the pediatricians on the panel felt that, since patients in that age group would likely be last in the priority line to receive the vaccine (unless they had condition that put them at greater risk), there would be time to review additional data available on the 16- and 17-year-old patients by the time they moved to the front of the line. In addition, they said that there was data available on the age group to date was quite thin and that that age group of children has few cases and those patients usually do very well without intervention.
Others, however, noted that the safety data was robust for the vaccine in general and that including the 16- and 17-year-old patients in the recommended population would help prevent them from not only getting the disease but also from potentially spreading the virus.
The committee vote is not binding on the FDA but there was no indication that the committee members did not believe the vaccine was safe and effective. There was no second vote with the language changed regarding the 16- and 17-year-old patients, which I believe the no and abstain voters were hoping for.
