Pfizer-BioNTech vaccine has favourable safety profile with no specific safety concerns identified: US FDA report

The US Food and Drugs Administration(FDA) today backed the Pfizer-BioNTech coronavirus vaccine in a document declaring that it has a "favourable safety profile", reports said.

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According to reports, the FDA found the Pfizer-BioNTech “met the prescribed success criteria” in a clinical analysis after releasing two separate studies.

Also Read: William Shakespeare from Warwickshire gets coronavirus jab in UK after Margaret Keenan

The US agency found the vaccine which needs two doses helped in “reduction in the risk of confirmed COVID-19 occurring at least seven days after Dose 2” including "reduction in the risk of confirmed severe COVID-19 anytime after dose 1."

The 53-page review report was presented today providing a detailed independent analysis of the vaccine.

The report said the vaccine has “favourable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].”

The FDA is set to meet on December 10 to decide on emergency approval with reports suggesting that it could be made available in the United States as early as this weekend. The United States is the worst-hit country with the virus with over 14 million infection cases and 283,7400 deaths.       

Last week Britain cleared the Pfizer-BioNTech vaccine for use across the country as British grandmother-of-four Margaret Keenan, 90, became the first person in the world to be administered the vaccine on Tuesday at a hospital in Coventry, central England.

Nurses cheered as Keenan received the guard of honour from clapping health officials as she received the coveted jab. "My advice to anyone offered the vaccine is to take it. If I can have it at 90 then you can have it too," she said, adding, "the best early birthday present".

Britain is the worst-hit country due to the virus with over 61,500 fatalities and 1.7 million cases.