COVID-19 vaccine makers Pfizer Inc. and BioNTech SE on Friday (November 20) said they plan to file for an emergency use authorisation that could allow their COVID-19 vaccine to be used in the US next month. The US is the worst affected by the COVID-19 pandemic so far.
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Earlier this week, Pfizer Inc. and BioNTech SE had confirmed that its vaccine candidate is 95 per cent effective at preventing COVID.
The filing with the Food and Drug Administration could permit the vaccine to be administered to high-risk populations in the US either by the middle or the end of December, the companies said in a statement.
In their application, Pfizer Inc. and BioNTech SE have also included safety data on about 100 children between 12 and 15 years of age. The company said 45 per cent of US trial participants are 56-85 years old.
Pfizer Chief Executive Officer Albert Bourla described the drugmakers’ move as ‘a critical milestone’.
“Filing in the U.S. represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Bourla said in a statement.
So far, apart from the Pfizer Inc. and BioNTech SE vaccines, the Oxford vaccine, manufactured by AstraZeneca, Russia’s Sputnik V vaccine, and India’s indigenous vaccine, Covaxin, have all shown encouraging results. Dr Harsh Vardhan, Union Minister for Health, even said he is ‘confident’ that a vaccine will be out in the next two to three months.