The complete results of the clinic trial for the US-based pharmaceutical giants Pfizer and BioNTech have been published in the New England Journal of Medicine on Thursday, 10 December, days after the US Food and Drug Administration (FDA) met to discuss its approval and called the COVID-19 vaccine safe to use and effective within ten days of administration, reported AFP.
In July, Pfizer and BioNTech began a medical trial with 44,000 people from US, Brazil and Argentina, giving half the vaccine and the other half, the placebo, reported AFP. The cases have seemingly tapered off within 10 days of the first dose for the former group, whilst the latter group experienced a steady increase in positive cases.
An editorial related to the scientific paper said: “The trial results are impressive enough to hold up in any conceivable analysis. This is a triumph,” reported AFP.
The Study Flagged Minor Issues
The scientific paper confirmed that a two-dose regimen of BNT162b2 was 95 percent effective in preventing COVID-19 infection, and said that the vaccine worked similarly across "age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions”, reported AFP.
The editorial that accompanied the study did flag certain "minor issues."
"The number of severe cases of COVID-19 (one in the vaccine group and nine in the placebo group) is too small to draw any conclusions about whether the rare cases that occur in vaccinated persons are actually more severe," it said.
Questions were raised about the safety issues of the vaccine when over million or billion people would administer the doses. The paper also stated that there is uncertainty whether more side effects will emerge with longer follow-up, how long the vaccine remains effective, whether it will limit transmission, and how it will work in children, pregnant women, and immunocompromised patients, reported AFP.
(With inputs from AFP)
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