US vaccine advisory panel has approved mass use of the Pfizer-BioNTech Covid-19 vaccine. Vaccine shots could come within days wherein the US Food and Drug Administration is expected to follow the panel's recommendation on preparing a stage for the largest vaccination drive in America's history.
In a 17-4 vote, the usually obscure Vaccines and Related Biological Products Advisory Committee (VRBPAC), decided that Pfizer's shot is safe in people aged 16 and older while 3-panel members said they would prefer the vaccine only for people older than 18.
"The question is whether you know enough" to get the country to a safer place, said panel member Dr Paul Offit of the Children's Hospital of Philadelphia. Offit voted to greenlight the vaccine.
Thursday's decision marks the beginning of a giant U-turn in the pandemic's winter surge as death and daily cases are increasing with more than 3,100 succumbing to the virus on Wednesday alone.
Pfizer by the end of December had announced to provide the US with 25 million doses of the two-shot vaccine, prioritizing health care workers and nursing home residents to receive the shot first.
The Pfizer - BioNTech vaccine is yet to be tested among pregnant women and the immunocompromised. Although Pfizer has made the strong tone of it being safe for “individuals 16 years and older, with or without evidence of prior infection", there's not enough data on children under 16, although trials are on among children as young as 12.
Pfizer said its overall vaccine efficacy of 95 per cent was seen in both younger and older adults as well as in diverse demographics and demonstrated a favourable safety and tolerability profile in more than 40,000 individuals," Kathrin Jansen, Head of Vaccine research at Pfizer, told US regulators Thursday.
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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.
The US is the worst-hit nation with coronavirus, killing more than 292,000 people and affecting more than 15 million by far.