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Biologics License Application

COVID-19: Moderna Vaccine Gets Full Approval From FDA COVID-19: Moderna Vaccine Gets Full Approval From FDA
Covid-19: Moderna Vaccine Gets Full Approval From FDA Federal officials have granted full approval to Moderna’s COVID-19 vaccine following its authorization last year for emergency use. On Monday, Jan. 31, the Food and Drug Administration (FDA) announced that Moderna’s vaccine has been granted its full approval, joining the Pfizer shot which was authorized months ago. The move comes after tens of millions of doses of the Moderna vaccine have already been administered across the country. It also represents Moderna’s first FDA-approved product in the US. Officials said the FDA reviewed months of additional follow-up data submitted by Moderna to…
COVID-19: Pfizer Seeks Federal Approval To Market Vaccine Directly To Consumers COVID-19: Pfizer Seeks Federal Approval To Market Vaccine Directly To Consumers
Covid-19: Pfizer Seeks Federal Approval To Market Vaccine Directly To Consumers Pfizer and European partner company BioNTech are seeking full approval from the federal government to market their two-dose COVID-19 vaccine directly to people age 16 and over, as well as businesses and schools. The vaccine has been available in the United States since mid-December under an Emergency Use Authorization waiver by the Food and Drug Administration. Since then, the companies have delivered more than 170 million doses of the vaccine across the United States. “We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in col…