— Data should be from completed phase III trials, not interim results, group says
A group of clinicians and researchers has petitioned the FDA to delay fully approving any COVID-19 vaccines before clinical trials have been completed, calling the notion of approval to stimulate vaccination rates “backward logic.”
The group, led by Linda Wastila, BSPharm, MSPH, PhD, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, includes 27 petitioners, including 16 experts outside the U.S., primarily based in Europe.
“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point,” they wrote in a blog post published in The BMJ.
“If the FDA listens to us, they won’t give serious consideration to approving a COVID-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed phase III trials — not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These phase III trials are not simply efficacy studies; they also are necessary and important safety studies,” the group wrote.
Full approval is not necessary to address public health, they argued, because the emergency use authorizations that the FDA has already issued for three vaccines are substantial enough to provide adequate vaccine access.
However, full approval may convince more people to get vaccinated, the group tacitly acknowledged. “While approval might lead to increased public confidence in COVID-19 vaccines, as well as provide legal support for employer-instituted vaccine mandates, to approve a medical product for these reasons is outside FDA’s regulatory purview. Approval decisions must be driven by the safety and efficacy data,” they wrote in the blog post.
The group also asked the FDA to hold off approval until the agency:
- Confirms there is substantial evidence that clinical effectiveness outweighs harms among special populations
- Requires a “thorough” safety analysis of spike proteins produced in situ after vaccine administration, including studies on spike proteins’ “full biodistribution, pharmacokinetics, and tissue-specific toxicities”
- Completes vaccine biodistribution studies “from administration site and safety implications of mRNA translation in distant tissues”
- Comprehensively investigates all severe adverse reactions reported after vaccination
- Examines the safety of people taking more than two doses
- Includes gene delivery and therapy experts in its Vaccines and Related Biological Products Advisory Committee
- Enforces “stringent conflict of interest requirements to ensure individuals involved in data analysis and decision making” related to Biologics License Applications lack such conflicts with the vaccine manufacturers
The group submitted their petition June 1, calling on FDA to provide an answer by June 11 in part “to allow Petitioners the opportunity to seek emergency judicial relief should the instant Petition be denied,” they stated. Group members also plan to lobby Congress, according to an email from the group to MedPage Today.
“Approving a COVID-19 vaccine now risks setting a precedent of lowered standards for future vaccine approvals. The ‘FDA approved’ seal must represent a high bar — and premature licensure of a COVID-19 vaccine could seriously damage public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure,” they wrote in the blog post.
One of the petitioners, Joseph Ladapo, MD, PhD, of UCLA’s David Geffen School of Medicine, was among the physicians with America’s Frontline Doctors publicly praising hydroxychloroquine to treat COVID-19 last summer. Ladapo has written at least two editorials critical of the vaccines for the Wall Street Journal this year. However, while the America’s Frontline Doctors group is still in operation and fiercely opposes the vaccines, MedPage Today could not find any clear affiliation between the group and Ladapo since last summer.
Fellow petitioner Donald W. Light, PhD, is a professor at Rowan University School of Osteopathic Medicine in Stratford, New Jersey; Rowan was one of the first medical schools to embrace the vaccines in the U.S., back in December 2020.