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Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference. Read More
Despite new study findings suggesting that the AstraZeneca (AZ)/University of Oxford COVID-19 vaccine provides only “minimal protection” against mild-to-moderate infection from the South African variant, Western governments still have faith in the vaccine as a valuable weapon against the pandemic. Read More
The FDA has revised its Emergency Use Authorization (EUA) for COVID-19 convalescent plasma, allowing only plasma with high antibody titers and only for hospitalized patients with early infections or patients with impaired immunity. Read More
Merck’s anti-parasitic drug Stromectol (ivermectin) is being studied in multiple clinical trials as a potential COVID-19 treatment, but — at least for now — the company is warning against its use. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s antibody cocktail as a potential treatment for COVID-19 patients who don’t require supplemental oxygen and are at high risk of progressing to severe disease. Read More
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Read More
The FDA intends to publish draft guidance in the next several weeks outlining the data it will require for modifying authorized vaccines to address new COVID-19 viral variants, according to FDA Acting Commissioner Janet Woodcock. Read More
The AstraZeneca (AZ)/Oxford University COVID-19 vaccine remains effective against the fast-spreading UK viral variant, Oxford researchers have shown in a late-stage trial. Read More