Covid-19 vaccine makers Pfizer Inc. and BioNTech SE on Friday 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.
In a respite to a pandemic-hit world, the US drugmaker and its German partner had confirmed earlier this week that a final analysis of clinical trial data showed the shot was 95% effective at preventing the disease.
The filing with the Food and Drug Administration could permit the vaccine to be administered to high-risk populations in the US by the middle to 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 12-15 years of age. The company said 45 per cent of US trial participants are 56-85 years old.
Pfizer Chief Executive Officer Albert Bourla has said that this move by the drugmakers marks 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.
{{/usCountry}}““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.
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