Novavax, HHS Clarify on Post-approval Covid Study
Novavax and HHS are having to clarify that FDA is requesting a post-approval study and not a clinical trial that must be conducted prior to approval of the company’s Covid-19 vaccine, which is currently available under an emergency use authorization(EUA). The company’s pending BLA is seeking to convert the EUA to traditional approval for the upcoming vaccine booster season this fall.
The agency had initially set the BLA’s user fee-related review action target of 4/1, but that was deferred when principal deputy commissioner Sara Brenner asked for additional information. At the time, Brenner was serving as acting commissioner while Marty Makary’s nomination was under consideration. On 4/23,Novavax said its BLA was being held up while FDA seeks to conclude a post-marketing commitment from the company (see earlier story).
Confusion arose over the weekend when a Wall Street Journal article indicated that a new randomized clinical trial is being requested from the company, which was followed up by Makary’s 4/26 post on X: “To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies. Under this administration, we are prioritizing the Gold Standard of Science — not what saves pharma companies ‘tens of millions of dollars.’” Makary’s post suggests that booster vaccines may need different data packages than in the past.
The Journal article and Makary’s post disturbed investors into interpreting that Novavax’s vaccine might not be approved because the agency might be raising the bar on the vaccine’s regulatory hurdle, which also might foreshadow additional requirements on other vaccines. Requiring new clinical data prior to approval would normally have triggered an FDA complete response letter, which Novavax has not indicated it received.
On 4/28, Novavax reiterated its 4/23 disclosure: “Last week, Novavax responded to the formal communication received from the U.S. Food and Drug Administration (FDA) for our Biologics License Application (BLA) and our response addresses the request for a postmarketing commitment (PMC) for a clinical trial. PMCs by their nature are completed after BLA approval. PMCs are not unusual with many approved drugs and/or biologics having at least one PMC or requirement. We believe our application is approvable upon alignment on the details of the PMC. We look forward to continued engagement with the FDA.”
An HHS official 4/28 confirmed to FDA Webview that only a post-market clinical trial under a PMC is being requested from Novavax. Regarding other companies (Pfizer and Moderna) and their vaccines, the official said: “We will evaluate the data and make that determination with FDA’s review process as they submit their applications.” However, an earlier HHS statement provided to media outlets noted that “the urgency to rush approval of boosters without normal oversight no longer exists… A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years.”
FDA watchers have cautioned about changes to agency vaccine reviews and approvals under known vaccine skeptic and HHS secretary Robert F. Kennedy Jr. Novavax’s troubles in getting its BLA approved could be a harbinger of changes vaccine manufacturers may be facing in the future.