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The FDA has published a briefing document ahead of Friday’s advisory panel meeting showing that agency staff have found the promising, single-shot Johnson & Johnson COVID-19 vaccine safe and effective enough for Emergency Use Authorization (EUA). Read More
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will soon begin a phase 1 clinical trial of Moderna’s variant-specific COVID-19 vaccine candidate, mRNA-1273.351, which has been tailored to better protect against the virus’ South African mutation. Moderna will also conduct trials of its own. Read More
The World Health Organization (WHO) this week announced a vaccine injury compensation plan for the 92 low- and middle-income countries that are getting COVID-19 vaccines through its COVAX initiative. Read More
The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen. Read More
Pfizer has allegedly demanded that certain Latin American governments put up assets as collateral in order to secure supply deals of its COVID-19 vaccine, a nonprofit investigative news organization in the UK has claimed. Read More
Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Read More
COVID-19 vaccine makers appearing yesterday before a U.S. House subcommittee pledged to lawmakers they would meet — and in some cases accelerate — their vaccine supply commitments, as the federal government and states clamor for more doses one year into the pandemic. Read More