Mar­i­on Gru­ber

Two of the FDA’s most se­nior vac­cine lead­ers are ex­it­ing from their po­si­tions, rais­ing fresh ques­tions about the Biden ad­min­is­tra­tion and the way that it’s side­lined the FDA.

Mar­i­on Gru­ber, di­rec­tor of the FDA’s Of­fice of Vac­cines Re­search & Re­view and 32-year vet­er­an of the agency, will leave at the end of Oc­to­ber, and OVRR deputy di­rec­tor Phil Krause, who’s been at FDA for more than a decade, will leave in No­vem­ber. The news, first re­port­ed by Bio­Cen­tu­ry, is a mas­sive blow to con­fi­dence in the agency’s abil­i­ty to reg­u­late vac­cines.

The bomb­shell an­nounce­ment comes at a par­tic­u­lar­ly cru­cial mo­ment, as boost­ers and chil­dren’s shots are be­ing weighed by the reg­u­la­tor. The de­par­tures al­so come as the ad­min­is­tra­tion has re­cent­ly jumped ahead of the FDA’s re­views of boost­er shots, an­nounc­ing that they might be avail­able by the week of Sept. 20.

A for­mer se­nior FDA leader told End­points that they’re de­part­ing be­cause they’re frus­trat­ed that CDC and their ACIP com­mit­tee are in­volved in de­ci­sions that they think should be up to the FDA. The for­mer FDAer al­so said he’s heard they’re up­set with CBER di­rec­tor Pe­ter Marks for not in­sist­ing that those de­ci­sions should be kept in­side FDA. What fi­nal­ly did it for them was the White House get­ting ahead of FDA on boost­er shots.

FDA’s for­mer act­ing chief sci­en­tist Lu­ciana Bo­rio added on Twit­ter, “FDA is los­ing two gi­ants who helped bring us many safe and ef­fec­tive vac­cines over decades of pub­lic ser­vice.”

“These two are the lead­ers for Bi­o­log­ic (vac­cine) re­view in the US. They have a great team, but these two are the true lead­ers of CBER. A huge glob­al loss if they both leave,” For­mer BAR­DA di­rec­tor Rick Bright wrote, weigh­ing in on the news. “Dr. Gru­ber is much more than the Di­rec­tor. She is a glob­al leader. Vi­sion­ary mas­ter­mind be­hind glob­al clin­i­cal reg­u­la­to­ry sci­ence for flu, Ebo­la, Mers, Zi­ka, Sars-cov-2, many oth­ers.”

Phil Krause

In a let­ter from Marks to staff, he ex­plained:

Janet Wood­cock told End­points that she wish­es Gru­ber and Krause well and thanks them for their sig­nif­i­cant ser­vice.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

Contract manufacturer Abzena has permanently laid off 66 employees at one of its San Diego sites, marking the latest in a string of layoffs spanning the biotech industry.

The layoffs took effect on Jan. 11 at the company’s 8810 Rehco Road site, according to a WARN notice filed with the Employment Development Department of California.

Abzena does have another location in the San Diego area, where the manufacturer invested $60 million and added 50,000 square feet in 2020. Endpoints News reached out to Abzena but has not received a response as of press time.