In a July 9 memo, the director of the FDA’s Center for Biologics Evaluation and Research contended there was not enough evidence that the benefits of Moderna’s COVID-19 vaccine Spikevax outweighed its risks in healthy children.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, played a direct role in approving Modern’a COVID-19 vaccine, Spikevax, for children, with a narrower label than expected.
In a memo released July 9, Prasad noted that he felt “differently about certain aspects” of the FDA reviewers’ conclusions about Moderna’s applications, which would have seen Spikevax approved for all children six months to 11 years. Instead, Prasad approved the vaccine for children in that age range but only if they had at least one underlying condition that put them at risk of severe COVID-19 outcomes.
It is unclear if the FDA’s reviewers granted this indication in their initial approval or if they endorsed a label between Moderna’s proposal and what Prasad eventually settled on.
In justifying his decision for a narrower label, Prasad argued that Moderna “has never shown a reduction in severe COVID-19, hospitalization, ICU stays or death in a randomized study in children.” Additionally, rates of severe COVID-19 outcomes are “extremely low” among children, and that these have even fallen, he said.
Moderna has also not yet shown that COVID-19 immunization “reduces long covid or transmission in any setting at any age with high quality data,” nor did the company establish that vaccinated kids miss fewer days of school, according to Prasad.
“FDA has a statutory mandate to only approve products when we have substantial certainty benefits outweigh harms,” he wrote. “We do not have substantial certainty benefits outweigh risks of healthy children” in Moderna’s submission.
Since being appointed as CBER director in May, Prasad has made unilateral decisions on drug approvals, going against FDA reviewers, on two previous occasions. In May, he went against reviewer recommendations on Novavax’s Nuvaxovid and Moderna’s next-gen shot MNEXSPIKE—both for COVID-19—opting to grant them narrower labels than the sponsors had applied for. Instead of broad approvals, Prasad allowed their use only for seniors 65 and up and people 12 through 64 at high risk of severe disease outcomes.
Prasad has also previously locked horns with Nicole Verdun, formerly the top regulator of cell and gene therapies at CBER. According to reporting from STAT News last month, Verdun had scheduled an advisory committee meeting to discuss Capricor Therapeutics’ cell therapy deramiocel, which the biotech was proposing to treat cardiomyopathy in Duchenne muscular dystrophy. Prasad unilaterally canceled the meeting.
Verdun was ultimately pushed out of FDA last month. Deramiocel was rejected last week on grounds of insufficient evidence to support its efficacy.
