FDA names new head to vaccine review office

The Food and Drug Administration has appointed a new vaccine review head, naming the top scientist at a global public health non-profit to replace Marion Gruber, who retired last year amid her opposition to Biden administration efforts to quickly roll out COVID-19 vaccine boosters.

David Kaslow, chief science officer for PATH, will become the director of the Office of Vaccines Research and Review on Oct. 11. He takes over for Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, who has served as acting director of the vaccine review office since Gruber left on Oct. 31, 2021.

Kaslow has a long background in vaccine research, development and distribution. Before joining PATH, he led vaccines and infectious disease at Merck & Co.’s research laboratories for nearly six years and was an advisor to PATH’s Malaria Vaccine Initiative and the Bill & Melinda Gates Foundation. Earlier in his career, Kaslow worked in malaria vaccine development at the National Institute of Allergies and Infectious Diseases, where he studied the proteins involved in malaria parasite transmission to mosquitos.

Even though the vaccine review office has worked through some of the knottiest problems of the COVID-19 pandemic, Kaslow will still have a full agenda as he takes the reins. While the COVID-19 vaccines from Moderna and Pfizer have gained full approval, the boosters are still under emergency use authorization. If COVID-19 becomes a seasonal disease and people need regular boosters as with influenza, the vaccine office will need to work out the details of how to execute a full approval of a shot that changes as the virus evolves.

Meanwhile, the office is also likely to be reviewing upcoming submissions for the first shots to protect against respiratory syncytial virus, as drugmakers GSK, Johnson & Johnson, Pfizer and Moderna are advancing candidates.

Gruber’s retirement from the agency was accompanied by the departure of her deputy Phil Krause in November 2021. Shortly after the departures were announced, both were listed as co-authors of an article published in The Lancet that then argued against broad rollout of COVID-19 vaccine boosters, at a time when the Biden administration was preparing to begin a booster campaign.

An FDA spokesperson didn’t respond to emailed questions about whether Krause has been replaced.

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