New York
USA's Food and Drug Administration (FDA) on Tuesday authorised Pfizer and its partner BioNTech SE's omicron single-dose booster shot for children under five years old. The kids who have previously been vaccinated with three doses of the original vaccine will be eligible to receive the booster, the agency informed.
FDA said the emergency use authorisation (EUA) was granted after receiving the clinical trial data of 60 children in the said group. The kids who had already been administered the three doses were given the new booster dose.
A month after receiving the injection, the immune system of children demonstrated effective protection against both the original Covid strain and omicron BA.5 and BA.5
“Today’s authorisation provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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Notably, Pfizer's primary series of Covid vaccines for children consists of three doses while rival pharma giant Moderna's primary series has only two doses.
According to government-released data, the uptake of the initial vaccine doses in children has been abysmally slow. Only 2.7 per cent of children under the age of two and five per cent of children aged two to four, eligible for the primary vaccination series, have completed the course.
Pfizer has been one of the biggest COVID-19 vaccine manufacturers in the world, ever since the world was hit by the pandemic. According to reports, its earnings stood at a record $100 billion last year, of which $57 billion was from the vaccine business and antiviral pill Paxlovid.
Pfizer's sale of COVID-19 vaccines and antiviral pills managed to generate more revenue in 2022 than it had in total sales in 2019.
(With inputs from agencies)
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