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Top FDA official takes over vaccine office as agency weighs COVID-19 shots for kids

Peter Marks, one of the Food and Drug Administration’s top-ranking officials, has taken over the agency’s vaccine review office just as the regulator begins considering whether to clear coronavirus shots for children.

In a letter sent to agency staff, Marks, the director of the agency’s Center for Biologics Evaluation and Research, said he assumed management of the review team on Monday, taking over for veteran FDA staffers Marion Gruber and Phil Krause.

The development, first reported by BioCentury, was set in motion last month, when Marks disclosed that both Gruber and Krause — the head and deputy director, respectively, of the FDA’s vaccine review office — planned to leave the agency later this year.

At the time, Marks said he would serve as the office’s acting director during a search for permanent replacements for Gruber and Krause. That has now occurred, with Marks indicating in an email that the move will enable Gruber and Krause “to have time to transition before their departure.” Gruber will retire next month, while Krause will leave the FDA in November.

“This will facilitate a smooth transition and ensure that the important vaccine work the team is undertaking to end this devastating pandemic can continue to move forward seamlessly,” an FDA spokesperson said in an email to BioPharma Dive.

The FDA hasn’t said why Gruber and Krause chose to depart just as it considers weighty decisions around booster shots and authorization of vaccines for young kids.

But the two have publicly split with the Biden administration over boosters, joining top scientists at the World Health Organization to argue in a recent paper against clearance of additional doses for the general public. The White House had pushed for broad authorization of boosters for all adults, but was forced to narrow its plans after scientific deliberations at the FDA and Centers for Disease Control and Prevention didn’t support that approach yet.

Both Gruber and Krause were involved in the recent meeting of an FDA advisory committee to discuss a third Pfizer dose, with Gruber pushing members of the panel to vote on broad use. The advisers overwhelmingly opposed recommending another shot to the general public, before supporting a more targeted clearance.

The FDA ultimately authorized boosters for the elderly, those at high risk of severe disease, and people who are at frequent risk of exposure because of their job — a group that includes millions of Americans but not everyone over 16, as Pfizer had requested.

Other difficult vaccine decisions lie ahead, which an agency spokesperson cited as a reason for Marks to take over before Gruber and Krause step aside. The agency could soon decide how to handle boosters for recipients of Moderna and Johnson & Johnson’s shots, as well as whether to clear vaccinations for children.

Each topic comes with its own issues to tackle. FDA panelists, for instance, were concerned that authorizing boosters in younger adults might expose more people to the risk of a type of heart inflammation associated in very rare cases with Pfizer’s vaccine, particularly in men under 40.

Safety is an important factor in the coming review of Pfizer’s vaccine for children between 5 to 11 years of age as well. Kids don’t experience COVID-19’s worst health outcomes as often as adults, but pediatric infections and hospitalizations spiked as the delta variant spread throughout the U.S.

Pfizer said the immune response spurred by its shot in a late-stage study of kids was similar to what was reported for 16- to 25-year-olds. The safety profile was also comparable, though the company hasn’t yet reported specifics or published detailed study results.

The drugmaker submitted data from that trial on Tuesday and expects to formally request an emergency use authorization in the coming weeks. That review, which reportedly could conclude before Halloween, will now be led by Marks.

“During the next days and weeks, I will be working very closely with the… team to ensure that the important public health work of the organization continues to move forward,” Marks wrote.

BioCentury reported two reviewers in the vaccine office resigned following Marks’ transition. An FDA spokesperson did not share any further information when asked by BioPharma Dive.