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A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTech’s COVID-19 vaccine — and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public. Read More
Two doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Ad26.COV2.S) cut the risk of a COVID-related hospitalization by 85 percent, the company has reported — and the benefit may be coming from ramped-up T-cells rather than vaccine-induced antibodies. Read More
A federal court has ordered New Jersey-based Natural Solutions Foundation (NSF) to stop selling a “nano silver” solution marketed to prevent and treat coronavirus infections, and to recall and destroy all product distributed this year. Read More
People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South African data suggest. Read More
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Read More
Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year. Read More
Regeneron and AstraZeneca both say their therapeutic antibody cocktails remain active against Omicron, but questions remain in light of a Chinese study concluding that the variant escapes 85 percent of tested antibodies. Read More
AstraZeneca’s COVID-19 vaccine becomes completely ineffective against the Omicron variant by 15 weeks, according to real-world British data released yesterday. Read More
Sanofi and GlaxoSmithKline (GSK) said preliminary data from a phase 3 study showed that a booster dose of their experimental COVID-19 shot induces strong immunity but said they won’t release full trial results until early next year. Read More
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