US FDA might approve Pfizer COVID-19 vaccine for teens 'within days': Fauci

White House chief medical advisor Dr Anthony Fauci, on May 5, said that the Food and Drug Administration (FDA) is likely to authorize the emergency use of Pfizer’s COVID vaccine in adolescents “within several days”. Late April, the regulatory body approved vaccines for all ages—16 years and above, taking the country a step closer to achieving herd immunity. Now, speaking to NBC network, the top infectious disease expert expressed his belief that it would not take “longer than several days” to get the FDA go-ahead.   

Based on trials

On April 9, Drugmaker Pfizer Inc. and its German partner BioNTech SE asked US FDA to grant emergency approval to their COVID-19 vaccine to include its use in adolescents ages 12 to 15. In a statement, Pfizer said that the request was based on data collected from the pivotal Phase 3 trial of the vaccine on teens belonging to 12-15 years age group, with or without prior evidence of SARS-CoV-2 infection. The company claimed that their vaccine demonstrated 100 per cent efficacy and robust antibody response in the subjects.

Advisers to the Centers for Disease Control and Prevention are scheduled to meet May 12 to review the use of Pfizer’s shot in adolescents, a CDC spokeswoman confirmed to Bloomberg News in an email. The CDC reviews the vaccine following the FDA approval. In the aftermath, Pfizer has shown intention to submit approval request for its vaccine for two more age groups: 2-5 years and 5-11 years after completing safety trials in September.

Earlier in November, Fauci gad stated that Pfizer's vaccine has “an extraordinarily high degree of efficacy". Developed with the German partner BioNTech SE, Pfizer’s COVID-19 vaccine was declared effective against SARS-CoV-2 by the independent Data Monitoring Committee (DMC) in an analysis conducted on November 8, 2020. US’ top infectious diseases expert, Dr Anthony Fauci, meanwhile, said at a presser that the first doses of a safe and effective vaccine will be available for high-risk Americans in late December. As of now, more than  248 million vaccine jabs have been administered across the 50 states of the US. 

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