Coronavirus Update: Pfizer/BioNTech Send In Data For Booster Approval
Plus A Shortage Of COVID-19 Treatment
Pfizer and BioNTech sent in Phase I data for a third dose of BNT162b2 to support future licensure, Gritstone bio will work with CEPI to develop its second-generation vaccine in South Africa and other areas, and Roche Genentech expects a shortage of the drug Actemra to last for several weeks amid a surge in cases.
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While some cancer centers report sufficient stocks of the drug, they have already been turning to potential alternatives due to supply issues that could last for weeks or months.
The FDA granted an expected, though long-awaited, approval to the COVID-19 vaccine. Also, Korean regulators have begun a review of Russian vaccine CoviVac, while Bavarian Nordic has initiated a Phase II study of its vaccine booster candidate and received a commitment for up to DKK 800m from the Danish government.
Updated EUA for mRNA COVID-19 vaccines left CDC room to define the type of conditions that meet the immunocompromised level described by the FDA. The recommendation for a third shot for immunocompromised patients was based on small studies using surrogates for vaccine efficacy, not hard clinical outcomes.