New Delhi: In a major milestone, the US Food and Drug Administration (FDA) has approved the emergency use authorisation of a COVID-19 vaccine developed by Pfizer and BioNTech, reported Reuters on Saturday. The development comes a day after a panel of outside advisers to the US FDA endorsed emergency use approval of the vaccine for mass vaccinations of Americans. In a 17-4 vote with one abstention, the vaccine advisory group, which comprises independent scientific experts, infectious disease doctors, and statisticians concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and older.Post this, the US FDA had signaled imminent closure, saying it will “rapidly work toward finalisation and issuance of an emergency use authorisation”.
“Following positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation. The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the FDA had issued a statement on Friday.