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The Food and Drug Administration pulled the emergency use authorizations for the original COVID vaccines produced by Moderna and Pfizer on Tuesday. Both vaccines were authorized for emergency use more than two years ago after they were developed under Operation Warp Speed during the Trump administration. In a news release, the FDA explained the older vaccines no longer offer full protection from new strains of the virus. The agency said it had amended the emergency use authorizations of the initial Moderna and Pfizer-BioNTech vaccines in order to “simplify the vaccination schedule for most individuals.” “This action includes authorizing the current...

Certain groups are now eligible for another dose of the bivalent COVID-19 vaccine, and the updated shots have now fully replaced the monovalent shots, the FDA announcedopens in a new tab or window on Tuesday. The agency scrapped the emergency use authorizations (EUAs) for the monovalent Moderna and Pfizer-BioNTech mRNA vaccines, and has authorized the bivalent boosters (original plus Omicron BA.4/BA.5 strains) for all doses starting at age 6 months. People age 65 and up can now get a second bivalent dose at least 4 months after their initial bivalent dose. FDA said the second dose is supported by data...

Merck said Monday it is seeking US Food and Drug Administration emergency use authorization for its experimental antiviral Covid-19 treatment, molnupiravir.If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight Covid-19. It comes in capsule form. Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe Covid-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly...

Novavax (NASDAQ:NVAX) published results of its U.S. phase 3 trials for its Covid-19 vaccine in mid-June, noting that the shot was over 90% effective overall and 100% effective against moderate and severe disease, roughly in line with Covid vaccine leaders such as Pfizer and Moderna. Although the shot is likely to hit the market only around Q4, almost ten months behind market leaders, considering that Emergency Use Authorizations are likely to be filed in the U.S., U.K., and Europe by the end of Q3, the emergence of concerning new coronavirus variants and a relatively slow pace of vaccination outside the...

CAMBRIDGE, Massachusetts: Moderna said it will apply for US and European emergency authorisation of its COVID-19 vaccine on Monday (Nov 30) based on full results from a late-stage study showing its vaccine was 94.1 per cent effective with no serious safety concerns. It also reported a 100 per cent success rate in preventing severe cases. The filing sets Moderna's product up to be the second vaccine likely to receive US emergency use authorisation this year. "We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna Chief Medical Officer Dr...