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A highly anticipated meeting of the FDA’s COVID-19 vaccine advisory committee will take place Oct. 22 to discuss the emergency authorization and approval of vaccine candidates, including what is necessary for post-market studies. Read More
A group of Democrats led by Sen. Maggie Hassan (D-N.H.) have asked FDA Commissioner Stephen Hahn to detail what the agency is doing to ensure COVID-19 drugs and vaccines will be safe and effective in older patients. Read More
More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. Read More
The agency said that sensitivity below 80 percent will not be considered acceptable for authorization because the tests could produce too many false negative results. Read More
Pfizer said it will add participants as young as 12 to the global phase 3 trial of its COVID-19 vaccine candidate to glean more information on how the treatment affects different age groups. Read More
President Trump’s touting of Regeneron Pharmaceuticals’ COVID-19 antibody treatment as a cure for the disease that would imminently become available to all Americans for free has come under congressional scrutiny. Read More
Barely more than one in four air cargo companies that will be involved in distributing COVID-19 vaccines are well-prepared to do so, a new survey has found. Read More
Serious quality control violations discovered in the past year at Eli Lilly’s Branchburg, N.J., facility — a site that is preparing to manufacture the company’s COVID-19 antibody — are being “aggressively” addressed and will not impact product quality or safety, the drugmaker said Wednesday. Read More
HHS on Wednesday shot down a story claiming that department officials had asked the FDA to consider COVID-19 Emergency Use Authorizations (EUAs) as “pre-licensures” even as the FDA issued a statement detailing why pre-licensure approvals would not be appropriate for COVID-19 vaccines. Read More