Benefits of Pfizer jab outweigh risks for children as young as five, says FDA

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Scientists at the US Food and Drug Administration (FDA) have said that the benefits of giving young children the Pfizer vaccine against the coronavirus outweigh the risks.

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A panel of outside experts is due to vote on Tuesday whether the FDA should authorize JAB, the first Covid-19 vaccine for this age group, for children aged five to 11.

Government scientists published the views after Pfizer announced new trial data that said its jab had 90.7 percent efficacy against the coronavirus among under-11s.

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Both Pfizer/BioNTech and Moderna Vaccines have been linked to rare cases of an inflammation of the heart called myocarditis, especially in young men.

However, the FDA believes that if the number of cases of myocarditis seen in the younger age group is higher than that seen in 12- to 15-year-olds, the number of Covid-19 related hospitalizations may be higher due to myocarditis. will exceed that number. .

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Pfizer suggests that myocarditis rates in younger children are likely to be lower than in 12 to 15-year-olds, because they will receive lower doses.

If the FDA approves the jab, it could be made available as early as next month. It is already in use for people 12 years of age and older.

In a recent trial by Pfizer, children ages five to 11 were given two shots of a 10 microgram dose, more than a third given for -12.

Sixteen children in the trial who had received a placebo got Covid-19 against three who were vaccinated. Because more than twice as many children in the 2,268-participant study were given the vaccine compared to a placebo, that equated to more than 90 percent efficacy.

Pfizer and BioNTech said last month that their Covid-19 vaccine induced a strong immune response in children, and FDA staff now say it meets the agency’s criteria for immune response.

Pfizer has now expanded its trial, and the drug firm said the adverse event profile in the larger cohort suggested no new safety concerns from the vaccine.

The second group of children has been observed for a shorter period of time. All of them had received their second dose, with more than 70 percent of them at least two weeks prior.

About 190 million people in the US have been fully vaccinated, with more than 11 million people between the ages of 12 and 17 receiving the Pfizer jab.

Additional reporting by Reuters

Credit: www.independent.co.uk / Pfizer

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