Pfizer requests authorization for booster dose in children aged 5 to 11 in the US

Pfizer and BioNTech said Tuesday that they have submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization of a booster dose of the Covid-19 vaccine for children aged five. to 11 years.

The companies said that a third dose of vaccine increased Omicron-fighting antibodies 36-fold in this age group.

In an analysis of 140 children with no evidence of previous Covid-19 infection, antibody levels against the original strain of the SARS-CoV-2 virus were six times higher one month after a booster dose than one month after the second dose. of the vaccine.

Studies by the New York State Department of Health and the US Centers for Disease Control and Prevention (CDC) found that the effectiveness of the Pfizer vaccine for children ages five to 12 dropped substantially during the Omicron outbreak, dropping from 68 % to about 12% against Covid-19 infection.

However, two doses continued to provide protection against more serious illness, resulting in urgent care or hospitalizations.

More than 10,000 children aged between six months and 12 years are enrolled in Pfizer Covid-19 vaccine trials at study sites around the world.

The companies expect to submit data from these tests focused on children under five in the coming months. This age group is the only one for which a Covid-19 vaccine has not been authorized in the US.

Pfizer and BioNTech said they plan to submit this data to the European Medicines Agency and other regulatory agencies for authorization in the coming weeks.

An initial two-dose series of the Pfizer Covid-19 vaccine was authorized in the US for children ages five to 11 in October.

Boosters are also available for children age 12 and older with certain types of immunocompromised conditions, as well as adults. Second boosters are authorized for anyone aged 50 and over.

*With input from Brenda Goodman and Amanda Sealy of CNN

Source: CNN Brasil

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