Pfizer-BioNTech 'full results' appear in New England Journal of Medicine

WION Web Team
New Delhi Published: Dec 10, 2020, 08:22 PM(IST)

Pfizer Inc's COVID-19 vaccine Photograph:( Reuters )

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The New England Journal said the Pfizer-BioNTech vaccine efficacy was "(generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index.

The New England Journal of Medicine of Medicine on Thursday published the full results of the Pfizer-BioNTech(BNT162b2) coronavirus vaccine trial declaring that it was "95 per cent effective in preventing COVID-19".

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The journal said the Pfizer-BioNTech vaccine efficacy was "(generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions."

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"The safety profile of the vaccine was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache," it said, adding,"the incidence of serious adverse events was low and was similar in the vaccine and placebo groups."

The medical journals said that vaccine ensured "protection" for persons 16 years of age or older.  "Safety over a median of 2 months was similar to that of other viral vaccines," it informed.

Pfizer-BioNTech had declared last month that its vaccine was 95 per cent effective against COVID-19 beginning 28 days after the first dose. It had evaluated 170 confirmed cases of COVID-19 while asserting that "safety data milestone" required by US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) was achieved as it was "well tolerated across all populations with over 43,000 participants enrolled."

The report comes as US FDA officials are set to begin the process of approval from today as the United States which is the worst-hit country grapples with the virus. The UK began administering doses on Tuesday across the country starting with the elderly population and health workers.

According to the company, during the trial, there were 42 per cent global participants and 30 per cent US participants with racially and ethnically diverse backgrounds, and 41 per cent global and 45 per cent US participants who were 56-85 years of age.

"These results met our prespecified success criteria, which were to establish a probability above 98.6 per cent of true vaccine efficacy," the New England Journal said, adding, "two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95 per cent effective against COVID-19."

The report comes as the virus continues to ravage people's lives and destroy economies worldwide recording over 65 million infected cases and more than 1.5 million fatalities.

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