On Tuesday, October 26, 2021, the FDA’s Vaccines and Related Biological Products Advisory Committee members voted to approve vaccinations for children aged 5 through 11. Specifically, the panel addressed the following question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer . . . Vaccine when administered as a 2-dose series . . . outweigh its risks for use in children 5-11 years of age?” The members agreed that the apparent risks associated with vaccinating persons in that age group were outweighed by the benefits of the same.
Pfizer sponsored a report for this meeting that found COVID-19 was among the top ten leading causes of death for children aged 5 through 14 between January and May 2021 in the United States. The vaccine proposed for children aged 5 through 11 is of a lower dose and administered three weeks apart. The panel discussed the benefits and risks of this vaccine for eight hours, including fielding questions and comments from the public. Ultimately, seventeen members voted in favor of approving the vaccine; one member abstained from voting.
This approval from the advisory committee does not mean children are approved to receive the vaccine; rather, the FDA is taking the committee’s vote under consideration. Likewise, the CDC is slated to discuss the same topic next week, November 2-3, 2021.
Norton Rose Fulbright lawyers will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.