The FDA said that conclusions could not be drawn from pre-publication drafts of two recent studies, because both studies were small and had imitations. The studies from researchers at Harvard and Columbia did not find an increase in antibodies with the new bivalent COVID-19 booster compared to the original vaccine.
Pfizer and BioNTech announced early interim data from a 900 patient, Phase II/III trial (NCT05472038), which demonstrated an increase in antibody titers, one-month after immunization with their bivalent booster vaccine, for the Omicron BA.4 and BA.5 subvariants by 13.2-fold in adults over 55 years and 9.5-fold in adults 18 to 55 years of age, compared to a 2.9-fold increase in adults over 55 who received the original booster vaccine
Novavax announced that in a 14-day, 2,090 patient, Phase III trial (NCT05372588), a bivalent booster targeting the BA.1 and BA.5 omicron strains did not elicit more antibodies than Novavax’s current vaccine or a monovalent vaccine aimed solely at BA.1.
The FDA approved an emergency use authorization (EUA) for anakinra (Kineret, Sobi) to reduce the risk of progressing to severe respiratory failure in hospitalized COVID-19 adult patients with pneumonia requiring supplemental oxygen who are at risk of and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).
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