Does the Novavax delay augur a COVID vaccine policy change?

A series of new revelations has come to light about the FDA's delay in granting full approval to Novavax's COVID-19 shot, thanks to recent reporting from the Wall Street Journal and STAT News.

On Friday - as WSJ reported, citing anonymous sources - the agency had asked Novavax to complete a fresh randomised control trial of the vaccine before it would grant the biologics license application (BLA) that was originally meant to be granted on 1st April. WSJ quoted experts, saying the trial could cost Novavax tens of millions of dollars.

Novavax, which is licensing the vaccine in partnership with Sanofi, originally received emergency use authorisation for the vaccine under pandemic rules, but was awaiting full approval.

For its part, Novavax issued two statements acknowledging that the FDA had requested additional data, but characterising it as postmarketing commitment to be completed after the BLA approval. A typical postmarket study would not be a full RCT.

"PMCs are not unusual, with many approved drugs and/or biologics having at least one PMC or requirement," the company wrote in a statement today. "We believe our application is approvable upon alignment on the details of the PMC. We look forward to continued engagement with the FDA."

On Monday, while investigating the WSJ story, STAT received messaging from HHS suggesting this could be the beginning of a broader policy change on COVID vaccines that could also impact Pfizer and Moderna. HHS Communications Director Andrew Nixon implied that HHS may not be treating COVID vaccines the same way as the flu shot when it comes to approving new formulations for seasonal strains.

"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,” he told STAT in an email.

This interpretation of events is further backed up by a post on X by FDA Commissioner Dr Martin Makary, who wrote, in a tweet quoting the WSJ story, "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." The Novavax vaccine is a new product only in the sense that it is a new formulation to address a seasonal strain.

In addition, HHS Secretary Robert F. Kennedy Jr addressed the delay in Novavax's approval in a CBS interview earlier this month, making it clear that it was a strategic decision based on the vaccine's mechanism of action, not an administrative delay.

Requiring COVID vaccines to seek new approval for seasonal formulations would seriously hinder COVID protections, because it would be difficult if not impossible to complete an approval process fast enough for the formulation to actually guard against the new strain - though, this could be mitigated if the trials are only required after the fact, as Novavax's statement indicates.