In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.
As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.
Uğur Şahin
BioNTech CEO Uğur Şahin told Endpoints News in an interview recently of the upcoming parallels between the flu and variant vaccines when it comes to FDA reviews:
We are generating a dataset to get a blueprint process approved — to ensure that if a new variant pops up that requires an adaptation of the vaccine because the original vaccine doesn’t work anymore, we can just come up with a variant vaccine, and not do a large clinical trial. That’s what we want to accomplish — like in the flu field, every time they need a new vaccine, there’s an alignment, this strain is not needed, and then you generate a vaccine with a limited amount of data and make this vaccine — that’s needed to prepare for the future.
That speed from development through the regulatory process may be key with Omicron, which has quickly spread to more than a dozen countries across the globe, although it’s unclear if this new variant will also increase the number of hospitalizations and deaths beyond the havoc wreaked by the Delta variant.
Scott Gottlieb
Former FDA commissioner and Pfizer board member Scott Gottlieb explained to CNBC this morning how the agency understands the general mRNA platforms now, the manufacturing sites have mostly been inspected, but what they’re looking for with a variant-focused vaccine is ‘immunogenicity data, maybe neutralization studies, the potential for this new vaccine to elicit antibodies that neutralize in vitro, in test tubes, this new variant … they won’t be looking for new outcomes studies.’
Jason Schwartz, associate professor at the Yale School of Public Health, explained to Endpoints how the second appendix in the FDA’s guidance on Covid-19 vaccine EUAs spells out the agency’s thinking.
‘There they state that clinical immunogenicity studies would be expected for a variant-targeted vaccine EUA,’ Schwartz said via email. ‘But conducted just in one age group and with a post-vaccination period — monitoring for safety — far shorter than the two months expected for the initial vaccines. So those could be relatively small trials — on the order of a few thousand subjects, if I had to guess — with a short duration prior to submission to FDA. Much much faster than the initial round of EUAs.’
The FDA did not respond to a request for comment. The agency has been in close communications with Pfizer-BioNTech, Moderna and J&J executives since the beginning of the pandemic and will likely outline what’s required for a new EUA submission even before announcing the details publicly.
Moderna CEO Stéphane Bancel also said on CNBC this morning that there should be more info on Omicron’s impact on vaccine efficacy in about two weeks.
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https://endpts.com/like-the-flu-vaccine-every-year-the-fda-could-move-quickly-on-a-variant-targeted-covid-vaccine
