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, marking the beginning of the end of a catastrophic outbreak that has killed nearly 300,000 Americans in just 11 months this year. “I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19,” Denise Hinton, the agency’s chief scientist wrote in a letter to a Pfizer executive. Also Read - 17,072 More Health Workers Get Jabs on Day 2: Govt to Meet Pharma Majors Over Vaccine Drive Today
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. Also Read - No New UK Coronavirus Strain Reported in Past 24 Hours in India: Health Ministry
Post this, the US FDA had signaled imminent closure, saying it will “rapidly work toward finalisation and issuance of an emergency use authorisation”. “Following the 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. Also Read - Planning a Trip to Singapore During COVID-19? Now, PCR Test Mandatory on Arrival
Notably, Pfizer had made a strong pitch for its vaccine for “prevention of Covid-19 in individuals 16 years and older, with or without evidence of prior infection”. The pharmaceutical company said its overall vaccine efficacy of 95 per cent was observed in both younger and older adults as well as in diverse demographics.
Responding to multiple questions on efficacy in 16 and 17-year-olds, Pfizer suggested that efficacy in older populations could be extrapolated downwards into the pediatric population. William Gruber, Pfizer’s Senior Vice President of Vaccine Clinical research, listed fever, chills and pain at the injection site as the most commonly reported adverse effects after vaccination.
Meanwhile, the FDA vaccine panel, on December 17, will review a vaccine from Moderna and the National Institutes of Health, which has also shown over 90 per cent protection. Vaccines from Johnson & Johnson (single dose) and AstraZeneca/Oxford University are also in the pipeline. Multiple vaccines must succeed for countries to crush the virus.