After a detailed review, the FDA's scientists have decided to hold off on approving Moderna's vaccine for a booster jab, the latest bad news for the company's bottom line. Documents published Tuesday show that Moderna's two-dose vaccine course generates enough immunity from the virus and the delta variant that a third dose is "unnecessary".
The decision creates the possibility that the agency could approve Pfizer for a booster jab but not Moderna.
Well, it will be interesting if @US_FDA authorizes Pfizer but not Moderna booster. Pre-meeting document confirms Moderna vax is holding up well, but a lot of people are going to think it's unfair. And we're still waiting on J&J info... @matthewherper https://t.co/Yo7FyUYdTS— Liz Highleyman (@LizHIVHep) October 12, 2021
Modern submitted its data to the FDA's Vaccines and Related Biological Products Advisory Committee asking for approval of a booster jab for most adults. The biotech upstart, which rose to prominence thanks to its mRNA technology that undergirds the most popular COVID jabs, argued that immunity provided by its jabs wanes over time, with some studies showing immunity starts to wane at around the six month mark. Some studies have suggested that natural immunity is more effective than immunity from the jabs.
In the report, the FDA said "... data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States. There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions."
After detailing all the studies undertaken to try and assess the safety of the booster jab, namely whether it would increase the risk of dangerous heart inflammation in men, a rare side effect that has been documented in the mRNA jabs, the FDA said it believes a booster is safe.
"In adults 18 through 64 years of age, with the exception of axillary swelling or tenderness of the vaccination arm (indicating lymphadenopathy), solicited safety data do not show evidence of increased frequency or severity of local or systemic reactions after the booster dose..."
While the documents released by the FDA on Tuesday show that the agency is likely holding off on recommending a booster jab - for now, at least - the advisory committee will still meet to discuss the proposal on Thursday.
In September, the FDA granted emergency clearance for a third booster dose of the Pfizer-BioNTech two-shot vaccine for older people, as well as patients at particularly high risk, or who are at risk because of their job.
But the news isn't all bad for Moderna: Earlier this month, an EU drug regulator signed off on booster jabs of Moderna's vaccine, as well as Pfizer's two-dose shot, for vulnerable patients, although the EU based the decision on patients who have weakened immunity due to having had an organ transplant.
J&J also just asked the FDA for approval of a booster jab for adults 18 and older, and both Moderna and J&J insist that they've gathered enough data showing that a booster jab should be justified for the general population.
That would be the best outcome for them, at least.
Readers can find the briefing documents below: