Moderna COVID-19 Boosters Show Preclinical Efficacy Versus South African Variant
While preclinical data show boosters to MRNA-1273 can reduce the threat of viral variants, the biotech also told investors it sees no link between its vaccine and thrombotic episodes.
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J&J and Pfizer should benefit from India’s unusual move to grant accelerated approvals minus a prior local bridging study for COVID-19 vaccines granted emergency use authorizations by certain regulators or on the WHO’s emergency use list. But while this seems like a prelude to permitting private sales, where will the supplies come from?
CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.
The CDC and FDA recommended a pause on dosing of J&J's one-shot vaccine. Pfizer/BioNTech's vaccine showed signs of lower efficacy against the B.1.351 variant, but a prominent expert called the data "misleading." Gilead halted its Phase III study of Veklury in non-hospitalized, high-risk patients. And Rigel's Tavalisse may have a shot in the sickest COVID-19 patients despite the small size of a Phase II study.