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FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

18 June 2026 at 23:08

Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna's seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed.

In an all-day meeting, members of the FDA's advisory committeeβ€”known as VRBPAC for Vaccines and Related Biological Products Advisory Committeeβ€”pored over data and presentations on the vaccine, which is dubbed mRNA-1010 and branded as mFlusiva. The presentations included a review from FDA scientists, which was supportive of the vaccine.

Data from a Phase 3 trial including over 40,000 adults age 50 and older found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial, involving data from nearly 3,000 people age 65 years and older, showed the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for this age group. The safety profile of the vaccine was also generally good.

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Global Surveillance | Separating Fact from Fiction

3 September 2024 at 06:09
What are the facts on self-assembling electronic circuits or chips made with superconducting graphene nanotubes or graphene oxide that have been or will be injected into humans to connect them to the 'internet of things' for global surveillance?

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