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Public Citizen is urging the FDA to convene an expert panel to discuss rescinding approval for Gilead Sciences’ Veklury (remdesivir) as a COVID-19 treatment. Read More
FDA investigators observed multiple problems at Emergent BioSolutions’ beleaguered Bayview facility in an April 12 to April 20 inspection prompted by a manufacturing mix-up for Johnson & Johnson (J&J)’s and AstraZeneca (AZ)’s COVID-19 vaccines, making it unlikely that the plant will be authorized to produce J&J doses anytime soon. Read More
The U.S. will have 300 million or more surplus COVID-19 vaccine doses by the end of July, a stockpile that could and should be shared with countries in need to reduce uneven vaccine distribution, says former FDA Commissioner Mark McClellan and the co-authors of a new report. Read More
In a move that clears the way for EU member states to resume inoculations with the Johnson & Johnson (J&J) vaccine, the European Medicines Agency (EMA) concluded yesterday that the vaccine’s labeling should include a warning about the risk of blood clots and the company said vaccine deliveries in Europe will resume. Read More
The EU has exercised its option to purchase 100 million additional doses of Pfizer/BioNTech’s two-dose COVID-19 vaccine, putting the trade bloc in line to receive 600 million shots in total this year as it clamors for additional supplies to boost its vaccination efforts. Read More
Emergent BioSolutions has agreed to an FDA request to temporarily cease manufacturing at its Baltimore, Md.-based Bayview site, a pause that will last at least until the agency’s ongoing inspection concludes and remediation action is taken to clear the way for production of the Johnson & Johnson (J&J) vaccine. Read More
The SHYCOCAN, which Shreis said can be used alongside handwashing and sanitizing of personal protection equipment, has been granted CE mark certification as a Class I device. Read More
The Russian Direct Investment Fund (RDIF), which funded Sputnik V’s development, said the vaccine has now been authorized in more than 60 countries. Read More