Dr. Marion Gruber, director of the Office of Vaccines Research and Review at the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), and Dr. Philip Krause, her deputy, have announced that they will step down from their roles in October and November respectively.
Endpoints News, a biotech industry news website, reported that a former senior FDA leader said that the two scientists have been frustrated by the Centers for Disease Control (CDC) and their ACIP committee in recent times. However, the decision which broke the camel’s back in their departure was the recent White House correspondence on vaccine boosters, as they announced a date for launching the booster rollout that jumped ahead of the FDA’s guidance.
CBER director Dr Peter Marks praised both of them in an internal email shared across many news websites, including Endpoint News and CNN. Of Dr. Gruber’s departure, he said that it “is a huge loss for CBER and FDA.” Marks also congratulated Dr Krause “for his incredible contribution to public health over the course of his impressive career in the U.S. Public Health System and with CBER.”
The FDA has also announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the Pfizer/BioNTech vaccine booster application. The meeting will take place on September 17, just days before the White House's proposed date for the beginning of the vaccine booster rollout.
“The process for authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making,” Marks said in a statement. “Should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions.”
Early last month, Director General of the World Health Organization (WHO) Dr Tedros Adhanom Ghebreyesus asked rich countries, who have already vaccinated most of their populations, to not begin widespread booster distribution while most of the poorest countries in the world have yet to receive substantial doses of the vaccine.
Many rich countries have pledged hundreds of millions of vaccines for the Global South. However, those doses will come from future production and not those currently kept in stock in these countries. This means the vaccines aren't currently being distributed even though they could prevent disease, death, and the emergence of more variants.