At FDA, Rifts Grow Over Booster Shots As Leadership Tug Of War Plays On

Roll Call: FDA’s Internal Turmoil Could Impact Boosters, Shots For Kids 
Signs of internal turmoil at the Food and Drug Administration are raising concerns among former agency officials as widely anticipated deadlines on COVID-19 boosters and vaccines for children near. A high-stakes debate about whether the booster shots are necessary recently led to upheaval at the FDA’s Office of Vaccines Research and Review, namely the sudden sidelining of that office’s two most experienced regulators. The drama comes amid a critical month for U.S. vaccine policymaking. FDA documents on COVID-19 boosters for Moderna and Johnson & Johnson recipients are expected to become public ahead of meetings of the FDA’s independent advisers on vaccines next week. (Kopp, 10/6)

Politico: Top Covid Experts Privately Urge Biden Admin To Scale Back Booster Campaign
A vocal contingent of prominent doctors and scientists is pressing the Biden administration to scrap its plans to provide booster shots to all previously vaccinated adults, according to five people familiar with the matter. Several of these outside experts, including some who advised President Joe Biden’s transition team, objected to the administration’s approach during a private, off-the-record call last week with federal health officials. Current U.S. data on vaccine performance does not justify using boosters widely to reduce the risk of breakthrough infections and slow the virus’ spread, the experts said. (Banco and Cancryn, 10/6)

Bloomberg: FDA Reviewing Data On Mixing And Matching Covid Booster Shots, Fauci Says
Data that may show the safety and effectiveness of mixing and matching boosters of different Covid-19 shots are under review by U.S. regulators, presidential adviser Anthony Fauci said. A study of adults who received booster doses of different Covid-19 vaccines than their original shots has been completed, Fauci said in an interview on Bloomberg Television’s “Balance of Power with David Westin,” and the data have been presented to the U.S. Food and Drug Administration. The National Institutes of Health study looked at the safety, immunogenicity and efficacy of mixing and matching of the three U.S. authorized vaccines for booster purposes. (Rutherford, 10/6)

Will the FDA soon have a new leader? —

Politico: Biden Closes In On Pick To Lead Food And Drug Administration 
The Biden administration is closing in on a nominee to lead the Food and Drug Administration, four people familiar with the process told POLITICO. The White House was nearing a final pick anyway, but National Institutes of Health Director Francis Collins' Tuesday announcement that he would step down accelerated the timeline, according to one person with knowledge of the matter. (Cancryn, Owermohle, Lim and Gardner, 10/6)

And the search is on to replace Dr. Francis Collins at the NIH —

Stat: Here's Who Might Replace Francis Collins As NIH Director
Almost as soon as Francis Collins announced that he’ll soon step down as director of the National Institutes of Health, lists of potential candidates began circulating through the capital. Among the most prominent candidates singled out during conversations with current and former NIH officials and outside research advocates are a number of science heavyweights. Four of the six sources immediately named Jennifer Doudna, the biochemist best known for her Nobel prize-winning research on the gene-editing technology CRISPR. (Facher, 10/7)

Politico: Biden’s New Health Challenge: Find Another Francis Collins
National Institutes of Health Director Francis Collins was that rare Washington figure whose clout transcended presidential administrations and frequent power shifts in Congress — more so during a public health crisis. Now, the Biden administration needs to find a Collins clone. (Owermohle and Wilson, 10/5)

KHN: Collins’ Skillful Piloting Helped NIH Steer Clear Of Political Minefields 
It’s remarkable that the reputation of the National Institutes of Health has remained mostly intact through the covid-19 pandemic, even as other federal science agencies, including the Food and Drug Administration and Centers for Disease Control and Prevention, have come under partisan fire. That is in no small part due to NIH’s soft-spoken but politically astute director, Dr. Francis Collins. The motorcycle-riding, guitar-playing Collins announced Tuesday he will step down by the end of the year from his job as chief of the research agency, having served more than a dozen years under three presidents. (Rovner, 10/6)