1. FDA Flip-flops on Moderna's mRNA flu vaccine application
On Feb. 10, Moderna announced that the FDA had refused to file its application for an mRNA flu vaccine. The director of the Center for Biologics Evaluation and Research, which regulates vaccines, overruled the CBER career staff and refused to file the application because Moderna did not use the approved high-dose flu vaccine as the comparator to the investigational vaccine for study participants 65 and older. The study instead compared the new product to standard-dose flu vaccine, which is also labeled for this population.
While people may debate the optimal design for the study, FDA had agreed to the standard-dose comparator before Moderna conducted the study. It is unusual for FDA to refuse to file an application, much less for such an order to be signed by the CBER director. This is an action typically reserved for applications that are missing key information or have serious data integrity issues.
One week later, after intense media coverage and intervention from the White House, FDA reversed its decision and agreed to review the application. Moderna agreed to seek accelerated approval for patients over age 65 (rather than standard approval) and, if approved, to further study the vaccine in this population.
On Mar. 7, FDA Commissioner Makary announced that the CBER Director would be leaving FDA at the end of April.
Editor’s note: The FDA's approach to this vaccine, which might be charitably be described as haphazard, adds to the regulatory uncertainty facing vaccine manufacturers, which will undermine investment in new and better vaccines.
2. More changes to the membership of CDC's vaccine advisory committee
Sec. Kennedy added two new members to the CDC's Advisory Committee on Immunization Practices (ACIP). One of them, Angelina Farella, is a member of America’s Frontline Doctors, a group that came to prominence during the pandemic for making ivermectin more available to the public.
The ACIP meeting that was originally scheduled for February has been rescheduled for March. According to the Federal Register Notice announcing the meeting, the committee will include discussions of Covid vaccine injuries and long Covid. Traditionally, ACIP would get updates on outbreaks, including measles outbreaks, and would review epidemiology, vaccine effectiveness, and uptake data for the respiratory virus season. The current ACIP is not currently scheduled to discuss any of these items.
In late February, the American College of Obstetricians and Gynecologists, along with the American Academy of Pediatrics, withdrew as a liaison organization from the ACIP. The organization's President said, “The recent reconstitution of the committee; the removal of ACOG experts from ACIP workgroups; and HHS’ unilateral changes to vaccine recommendations, which bypassed established scientific and clinical processes, represent a fundamental departure from the scientific rigor and impartiality that have been the hallmark of this committee for 60 years.”
Editor’s note: The statement from ACOG exemplifies the growing chasm between ACIP and medical professional societies.
3. Guinea-Bissau hepatitis B vaccine study
We previously covered an unethical Hepatitis B vaccine trial in Guinea-Bissau that the CDC planned to fund. Since then, a number of other irregularities around the study approval process within the CDC have come to light.
Unusual aspects of the approval include:
- The CDC approved the grant in ten days, far shorter than the typical months-long process, bypassing the CDC’s internal subject matter experts and resting with two political appointees in the office of the director.
- The ethics committee in Guinea-Bissau that purportedly approved the study was not in compliance with various US standards, including not having enough committee members. No ethics committee at CDC or at the University of Southern Denmark, the institution where the researchers proposing the study are based, reviewed the study.
- The name on the approval letter from the ethics committee was of a member of the committee who had resigned three years previously.
- There were direct communications, which appear to have expedited the review process, between the researchers proposing the study and Lyn Redwood, a prominent anti-vaccine advocate who was recently hired by CDC. (We noted her hiring in a previous Straight Shot.)
These findings led the World Health Organization to issue a statement outlining “significant concerns” with the study.
Editor’s note: The more information that comes to light on the CDC's funding of this proposed study, the worse it appears.
