Peter Marks will serve as acting director of the Office of Vaccines Research and Review at the U.S. FDA following the resignation of two top officials at the agency.
Sarah Silbiger/Getty Images
Peter Marks has been tapped to serve as acting director of the Office of Vaccines Research and Review at the U.S. Food and Drug Administration (FDA) following the resignation of two top officials at the agency who questioned the Biden administration’s plan for COVID-19 booster shots.
Marion Gruber and Philip Krause, who oversaw the FDA’s vaccines authorization division, announced their retirements at the beginning of September. The resignation came a few weeks before the two joined in publishing a paper in The Lancet that argued against evidence supporting the booster shot program. The report said there is insufficient evidence supporting the White House plan to give additional jabs of the COVID-19 vaccines to the general adult population.
“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” the paper reads.
Earlier this month, the FDA authorized a booster for the vaccine developed by Pfizer and BioNTech. The shot was authorized for people over the age of 65 and people who are considered at high risk for severe disease from COVID and front-line health care workers. The shot was authorized to be administered six months after the second dose.
Members of the FDA’s Vaccines and Related Biological Products Advisory Committee opposed the administration of a booster shot to all people ages 16 and above who received the Pfizer vaccine. They unanimously supported the administration of a booster to the class of patients for which the booster was authorized.
Gruber will leave the FDA at the end of October and Krause intends to go in November.
The FDA appointed Marks to take over, at least temporarily in order to prepare the office for the retirement of Gruber and Krause, a spokesperson for the agency told The Hill. Marks will step into the role as Pfizer and BioNTech move closer to seeking authorization of their vaccine for juveniles ages 5 to 15.
Moderna, who has also received authorization for its vaccine, is also expected to seek Emergency Use Authorization for this same population. Additionally, some second-generation vaccines are likely to come before the FDA seeking EUA.
The FDA is not the only health agency with a pandemic-related turnover. Henry Walke, who has helmed the COVID-19 response at the U.S. Centers for Disease Control and Prevention (CDC) is also stepping down, according to Politico. Citing “sources familiar with the matter,” Walke will be replaced by Barbara Mahon, the deputy chief of the agency’s enteric-disease branch. While Walke is stepping away from the COVID-19 response unit, he will remain at the agency as director of the CDC’s Division of Preparedness and Emerging Infections.
“He is not leaving the agency, just passing the torch on the response after serving as the Incident Manager for more than a year,” a CDC spokesperson said in a statement. “Shifts in response personnel and leadership are normal.”
