Food and Drug Administration: Benefits of Pfizer Vaccine for Children Outweigh Risks

The US Food and Drug Administration announced that the Pfizer-Biontech coronavirus vaccine met its criteria for an immune response in children aged 5 to 11 years.

The federal administration confirmed a report Her, Friday, said the overall benefits of a vaccine for this age group outweighed its risks, including the rare, vaccine-related myocarditis.

This came on the same day that Pfizer published data showing that its vaccine recorded an effectiveness of 90.7 percent in preventing symptoms of Covid-19, during clinical trials conducted for children between 5 to 11 years.

The publication of the report also comes ahead of the upcoming meeting scheduled for Tuesday of the Advisory Committee of Vaccines Experts to advise the Food and Drug Administration.

In early October, US companies Pfizer and its German counterpart Biontech asked the US Food and Drug Administration (FDA) for a license to use the vaccine for children aged 5 to 11 years.

And if the Food and Drug Administration approves the emergency use of the vaccine for this age group, nearly 28 million American children will be eligible for vaccination in the first week of November, according to the newspaper.The New York Times“.

Although the risk of severe COVID-19 infection for children is much lower than for the elderly, the United States has recorded 542 coronavirus-related deaths for children under the age of 17, according to data from the Centers for Disease Control and Prevention.

In September, Pfizer-Biontech said their vaccine achieved strong immune responses in a study of nearly 2,270 children ages 5 to 11.

Each child received two doses separately for three weeks, and each dose contained one-third of the dose used for adolescents and adults.

The researchers estimated that the reduced-dose vaccine had an efficacy of more than 90 percent, based on 16 cases of COVID-19 among the youngsters who received the placebo, compared with three cases among the youngsters who received the vaccine.

No cases of severe symptoms were reported in any of the children, but those vaccinated had significantly milder symptoms than their non-vaccinated counterparts.

More than 25,000 pediatricians and primary health care providers have already signed off on the vaccine, while the Biden administration has bought enough children’s doses, which come in orange-lidded containers, to distinguish them from adult doses.

The Pfizer-Biontech vaccine was approved for emergency use in December last year for adults over 16, while in May it was granted the right to use it for adolescents 12 and older.

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