The FDA granted full approval for the Moderna COVID-19 vaccine for patients 18 years and older on 1/31/2022. Moderna has given the vaccine the brand name Spikevax.
A CDC study of hospitalized adults, from August 2021 to December 2021, found the vaccine effectiveness to prevent COVID-19 hospitalizations was 82% in immunocompetent patients that received two doses of an mRNA vaccine and 97% with three doses. Vaccine effectiveness in immunocompromised patients was 69% with two doses and 97% with three doses.
A retrospective of the VAERS database by the CDC found the incidence of myocarditis with an mRNA vaccine to be the highest in young males (12 to 24 years) after their second dose.
In a 36-day, 721 patient, Phase II trial (NCT04762680), two doses of the Sanofi-GSK CPVOD-19 vaccine was well tolerated and elicited antibodies in in healthy volunteers and recovered COVID-19 patients.
Novavax submitted a request for an Emergency Use Authorization (EUA) for NVX-CoV2373, its COVID-19 vaccine candidate, for individuals 18 years of age and older. NVX-CoV2373 is a protein vaccine that delivers nanoparticles of the SARS-2 spike protein to elicit antibodies.
A meta-analysis (COMPILE study) of eight COVID-19 convalescent plasma studies enrolling 2,341 patients did not find any clinical improvement with convalescent plasma, but data did support use of real-time individual patient data pooling and meta-analysis during a pandemic. Using data from the COMPILE meta-analysis, researchers identified the characteristics of COVID-19 patients most likely to benefit from treatment with convalescent plasma. This data, called the treatment benefit index (TBI), was used to create a prediction tool, called the Convalescent Plasma Benefit Index Calculator. The TBI divides patients into three groups: substantial benefit from convalescent plasma, moderate benefit, and no expected benefit. The TBI was validated with four external data sets.
COVID-19 Antibodies and Antivirals
A Japanese in vitro study of the Omicron variant found it to be susceptible to the monoclonal antibodies tixagevimab and cilgavimab (AstraZeneca’s combination), sotrovimab (Vir), and the antivirals remdesivir, molnupiravir and nirmatrelvir plus ritonavir. Omicron was resistant to the monoclonal antibody combinations of casirivimab plus imdevimab (Regeneron) and bamlanivimab plus etesevimab (Lilly).
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