Some FDA Employees Push Back on White House and Pfizer over COVID Booster Shots

Posted on 09/13/2021

As Israel sees opportunity with a fourth COVID shot (second booster), a group of scientists that includes two senior U.S. Food and Drug Administration (FDA) officials and the World Health Organization, are pushing back against Pfizer Inc. and the Biden administration on the need for the U.S. to have more COVID boosters. The study group unveiled research that the emergency-use authorized COVID vaccines in the U.S. remain highly effective against severe disease and hospitalization by the delta variant (Indian variant). The opinion piece is published in The Lancet.

The White House has begun planning for COVID boosters later this month. In September 2021, two top officials from the Food and Drug Administration submitted their resignations over frustration with the Biden administration’s handling of the COVID-19 vaccine’s booster shots. Dr. Marion Gruber—director of the FDA’s Office of Vaccines Research and Review who’s been with the agency for 32 years and her deputy, Dr. Philip Krause, had submitted their resignation notices.

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Scott Gottlieb, a Pfizer board member and former FDA Commissioner, told CBS’ Face the Nation recently that the drug company is expecting to have data on its COVID vaccines in young children before the end of September 2021. Reported by Israeli media, Pfizer Chief Scientific Officer Philip Dormitzer made comments to a Zoom gathering of academics in September 2021 saying, “Early in the pandemic we established a relationship with the Israeli Ministry of Health where they used exclusively the Pfizer vaccine and then monitored it very closely.” He added, “so we had a sort of laboratory where we could see the effect.”

He added that Israel “immunized a very high proportion of the population very early — so it’s been a way that we can almost look ahead: What we see happening in Israel happens again in the US a couple months later.”

Israel was an early adopter in the COVID mRNA vaccinations after inking a deal with Pfizer to receive a large number of vaccine doses before many other countries. However, the country still faces rising COVID rates, compared to some neighboring countries of similar size. BNT162b2 is the Pfizer-BioNTech COVID-19 Vaccine that is under U.S. emergency use authorization. Year to July 4, 2021, Pfizer had made revenues of US$ 11.3 billion from BNT162b2 with US$ 4,072 billion coming from the U.S. Essentially 33.7% of Pfizer’s revenue is linked to the COVID shots. The next revenue generating drug from Pfizer, Year to July 4, 2021 made US$ 2.524 billion. According to SEC documents, the impact of BNT162b2, which includes a charge for the 50% gross profit split with BioNTech and royalty expenses.

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