COVID Vaccines

FDA Approves Covid Booster for 65+ and Older

The US Food and Drug Administration (FDA) vaccine advisers met last Friday and voted unanimously to recommend emergency use authorization of ‘a booster dose of Pfizer’s vaccine to people 65 and older and those at high risk of severe Covid-19 six months after they get their first two shots’.

The advisory panel reportedly rejected by a vote of 16-2 “a broader application to approve booster doses of Pfizer’s vaccines for everyone 16 and older six months after they are fully vaccinated”.

I think this should demonstrate to the public that the members of this committee are independent of the FDA, and that in fact we do bring our voices to the table when we are asked to serve on this committee.

Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University (source: CNN Health)

The panel members were reportedly concerned on the amount and quality of data available to weigh the booster’s long-term effectiveness and its safety in young people.

Pfizer’s head of vaccine research & development, Kathrin Jansen said in a statement, the company “will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population.”

According to CNN Health, some of the advisers — a group of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts — have reportedly expressed that ‘the process was rushed, and several members said during the meeting they wanted to see more data’.

Dr Paul Offit of the Children’s Hospital of Philadelphia reportedly said “While I would probably support a three-dose recommendation for those over 60 or 65, I really have trouble supporting this as written for anyone of greater than or equal to 16,”

Pfizer representatives reportedly told the FDA panel that “maintaining high vaccine effectiveness is integral to containing the pandemic, positing that more instances of severe disease and hospitalization are likely in the U.S. if the country doesn’t begin administering boosters to get ahead of the curve. The company argues that the effectiveness of its vaccine wanes over time, and that the rise of the Delta variant is not a major consideration in decisions on boosters.”

According to the FDA briefing documents “that Pfizer’s vaccine — as well as vaccines made by Moderna and Johnson & Johnson — still provide strong protection against severe disease, hospitalization and death, even if antibodies do wane over time”.

Coronavirus-19 vaccination watch

According to the US Centers for Disease Control and Prevention (CDC) COVID vaccination tracker page (as of September 19, 9 a.m.) 466,561,785 doses have been distributed and 385,586,012 doses administered. According MDH COVID-19 Response vaccine data (as of September 15) a total of 6,329,527 doses of Covid-19 (Pfizer & Moderna) vaccines have been administered in Minnesota. According to the MDH latest tally (as of September 17) the confirmed COVID-19 cases in Minnesota are 681,613 (out of 12,005,921 tested) with 7,983 deaths.