On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. The advisory committee was tasked with discussing Pfizer’s supplemental application for administration of this third dose for individuals aged 16 and older, and for individuals aged 65 and older or have a high risk of contracting COVID-19.
Regarding the first inquiry, the eighteen-person advisory panel voted 16-2 “NO” for the question of whether the safety and effectiveness data supported approval of the booster vaccine at least six months after completion of the primary series for individuals aged 16 and older.
Regarding the second inquiry, the eighteen-person advisory panel unanimously voted “YES” for the question of whether the known and potential benefits outweigh the known and potential risks of a Pfizer booster dose six months after receipt of the primary series of vaccines for individuals 65 years of age and older, and for individuals at high risk of severe COVID-19. The second faction of individuals identified in that vote—individuals at high risk of experiencing a severe COVID-19 reaction—include only those persons eligible for the vaccine aged sixteen and older. Likewise, the panel was polled on whether healthcare workers or others at high risk for occupational exposure should be included in the category of “individuals at high risk of severe COVID-19.” All eighteen panelists voted “YES” as well.
Trailing this news from the FDA, Pfizer announced on September 20, 2021, that studies from a clinical trial indicate its COVID-19 vaccine is safe for children aged 5 through 11. Pfizer concluded “the vaccine was safe, well tolerated and showed robust neutralizing antibody responses” for that demographic. The study utilized smaller doses of the vaccine, which were administered twenty-one days apart. Pfizer’s Chairman and CEO explained that pediatric cases of COVID-19 have risen by about 240% in the United States, which is the basis of the company seeking authorization from the FDA for this age demographic. At this time, Pfizer has not submitted its application for authorization related to children aged 5 through 11; however it “plan[s] to submit them to the FDA and other regulators with urgency.”
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.