The coronavirus vaccine by US-based Pfizer and BioNTech provides strong protection against COVID-19 within about 10 days of the first dose, according to a report published by the US Food and Drug Administration (FDA) on Tuesday, 8 December, reported The New York Times.
The document says the vaccine is safe and effective, and findings say it works well irrespective of the volunteer’s race, weight or age. The trial didn’t find adverse side effects, apart from some participants experiencing aches, fevers and minor side effects, reported The New York Times.
An independent committee advising the FDA will meet on Thursday to discuss the matter in advance of a vote to recommend the authorisation of the vaccine.
Last month, Pfizer and BioNTech announced a 95 percent efficacy rate after administering two doses, three weeks apart. However, analysis says protection kicks in earlier, reported AFP.
Efficacy of First Dose is 52% And Second Dose is 95%: Report
Data from 38,000 US trial participants suggests “a favourable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorisation),” the FDA document said, 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 taped off within 10 days of the first dose for the former group, whilst the latter group experienced a steady increase in positive cases.
The efficacy of the vaccine after the first dose is about 52 percent, according to Dr William C Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development. After the second dose, that rises to about 95 percent. “Two doses of vaccine provide maximum protection,” he said, reported The New York Times.
The FDA concluded that there were no “meaningful imbalances” in serious health complications between the two groups, the report added.
The FDA report highlighted that in order to confirm evidence, more research was needed.
Vaccine Side Effects Like COVID-19
Even after the authorisation of the vaccine, the trials will continue, and the companies have asked participants to stay in the trial for as long as possible so they could collect information to determine the effectiveness and safety of the vaccine, reported The New York Times.
On Monday, Kristen Choi, a psychiatric nurse and health services researcher at the University of California, Los Angeles published a first-hand account of her experience as a trial participant suggesting that her symptoms included chills, nausea, headache and fever. “Clinicians will need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could look a lot like COVID-19”, she said, the report added.
Britain became the first country to approve the vaccine last week.
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