New Coronavirus Booster Immunization Guidelines Set by FDA for Healthy Adults Under 65
The FDA plans to require a new clinical trial before approving the annual COVID-19 booster shot for healthy Americans under 65.
Dr. Vinay Prasad, the controversial head of the U.S. Food and Drug Administration’s vaccine and biologics division, will retire from the agency at the end of April.
FDA Commissioner Dr. Marty McCulley posted about his departure on social media platform
The news was first reported by the Wall Street Journal.
Mr. Makary said a successor would be named before Mr. Prasad’s retirement.
Before joining the hospital, Prasad, an oncologist, was an outspoken critic of U.S. drug and vaccine policies, particularly those related to the novel coronavirus. His tenure included a series of high-profile controversies over product reviews of vaccines, including Moderna MRNA.O’s coronavirus vaccine, gene therapy drugs and other rare disease drugs.
He was appointed director of the FDA’s Center for Biologics Evaluation and Research last May. Shortly after, he resigned, citing issues with his treatment of muscular dystrophy, and returned to the role just a few weeks later.
Most recently, Prasad’s division at the FDA engaged in a back-and-forth battle with Dutch pharmaceutical company UniQure over disagreements over the future direction of the company’s Huntington’s disease gene therapy.
U.S. drug regulators have asked for new research to support approval of the company’s gene therapy for rare brain disorders, but the company and patient advocates have argued that the FDA’s request is too lengthy and burdens patients.
Pharmaceutical company stocks rise
The U.S. Department of Health and Human Services, which oversees the FDA, accused the company of misleading the public about what regulators are looking for.
UniQure’s U.S.-listed shares rose 57% in after-hours trading following the news of Prasad’s departure.
A Feb. 24 Wall Street Journal op-ed said the FDA had gutted several rare disease drugs under the Prasad administration, contradicting McCurry’s stated goal of flexible review of these treatments and calling into question the health regulator’s control.
The article cited the latest denial of Disc Medicine IRON.O treatments, which received Secretary’s National Priority Vouchers, a program launched by McCurry to fast-track breakthrough treatments.
Disk said the agency concluded that the trial did not show a clear link between biological improvement and clinical benefit.
Disc’s stock price rose about 10% in post-market trading.
Prasad’s resignation is the latest personnel change at the Department of Health, which recently replaced National Institutes of Health Director Jay Bhattacharyya to head the U.S. Centers for Disease Control and Prevention following the resignation of Jim O’Neill.
(Reporting by Kristi Santosh and Kamal Choudhury in Bengaluru; Michael Arman in New York; Editing by Shriraj Kalvira, Shinjini Ganguly and Caroline Huemer)
