After a detailed analysis, FDA scientists decided not to approve Moderna's vaccine for an eventualise, the latest bad news for the company's profits. Documents released Tuesday show that Moderna's two-dose vaccine course generates sufficient immunity from the virus and the delta variant that a third dose is "unnecessary."
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
Moderna submitted its data to the FDA's Advisory Committee on Vaccines and Related Biological Products asking for approval of a booster vaccine for most adults. The young biotech company, which has risen to prominence thanks to its mRNA technology used for one of the most popular Covid vaccines, has argued that the immunity provided by its shots wanes over time, with some studies showing that immunity begins to wane. around six months. After all, other studies state that natural immunity is even more effective, so you can't think of going on forever with bites.
In the report, the FDA said “… data indicates that COVID-19 vaccines currently licensed or licensed by the United States still offer protection against the serious COVID-19 disease and death in the United States. There are many potentially relevant studies, but the FDA has not independently reviewed or verified the underlying data or their conclusions. "
After detailed all the studies undertaken to try to evaluate the safety of the booster vaccine, namely whether it would increase the risk of dangerous heart inflammation in men, a rare side effect that has been documented in mRNA shots, the FDA said it feel that a booster is safe.
"In adults aged 18 to 64 years, with the exception of axillary swelling or tenderness of the vaccination arm (indicating lymphadenopathy), the required safety data show no evidence of an increased frequency or severity of local reactions or systemic after the booster dose … "
While documents released by the FDA on Tuesday show the agency is likely withholding a booster vaccine recommendation, at least for now, 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-dose vaccine for older people, as well as for patients particularly at risk, including work-related causes. Curiously, if the FDA has discarded the Modern option, on the contrary a European body has approved it, even if the EMA as a whole has not yet expressed itself. J&J has also just asked the FDA for approval of a booster vaccine for adults aged 18 and over, and both Moderna and J&J insist they have gathered enough data showing that a booster vaccine should be justified for the general public. general.
This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/fda-niente-booster-per-moderna/ on Wed, 13 Oct 2021 14:59:25 +0000.