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Two FDA officials resigning over politicized vaccine approval process

The top two officials of the Food and Drug Administration’s Vaccines Research and Review Division are resigning. Marion Gruber has been with the agency for 32 years, and the head of the pivotal board for over a decade. Her deputy, Phil Krause, is leaving in November. Becker’s Hospital Review is reporting that the two are citing political pressure to approve a booster regimen and children’s use of the COVID-19 vaccines as the primary reason for their decision.

The announcement comes as a potential HIV vaccine was pulled from the approval process by Johnson and Johnson and the Bill and Melinda Gates Foundation due to its failure to prevent infection. In that study, efficacy was found to be only 25 percent, which researchers say can be chalked up to random chance. The vaccine relied on similar technology as that being used in the COVID-19 variety, according to ABC News.

Recent data from Israel and the United States suggest the Pfizer/BioNtech vaccine is effective around 40 percent of the time against the Delta variant. The decision is sure to bring up questions about why one treatment is being held to a significantly higher standard than the other.

The vaccines will be approved inevitably, as there are a lot of major public health players who have become deeply financially invested in the decision. The last two FDA commissioners have joined firms that directly profit from vaccine adoption. Dr. Steven Hahn took a position at Flagship Pioneering earlier this year. The venture capital firm provided seed funding for Moderna as far back as 2009 and remains one of the company’s biggest investors. Moderna stock has jumped 20-fold since the beginning of the pandemic thanks to the vaccine, the only product the company has ever brought to market in its 12-year history. Scott Gottlieb is on the Board of Directors for Pfizer. That company has recognized over $10 billion in profits from the COVID-19 vaccine alone, making it the best drug introduction in history as governments guaranteed purchases and provided most of the marketing and advertising. Gottlieb tweeted about the potentially forced retirements of Gruber and Krause Tuesday.

Commenting on the tweet has been disabled. Gottlieb’s remarks invite worries over the future impartiality of the Vaccine Review division.

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