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Pfizer asks FDA to authorize third dose for children 5 to 11 years old

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Sandra Hughes, Dr. prepares for Elise Langevina (6), to receive the first dose of Pfizer BioNTech’s coronavirus vaccine COVID-19 in Storrs (Connecticut, U.S.A) on November 3, 2021.

Reuters| Reuters

PfizerOn Tuesday, the Food and Drug Administration was asked to approve a third dose for its Covid vaccine to children aged 5-11 years old.

Pfizer has released data from an earlier month small laboratory study that examined blood samples of 30 children in this age group. The results showed a 36-fold rise in antibodies against the Omicron variant, compared with two doses.

The booster shot has a 10microgram dose. This is the same dosage as the primary series. Pfizer said that the third shot showed no safety concern in the study.

Pfizer booster dosages were previously approved by the FDA for adolescents aged 12-15 years in January, when the omicron strain swept the country. In the case of the omicron variant, the protection provided by vaccines against infection has decreased over the years, especially because it is able to evade the antibodies which block the virus infecting human cells. The vaccines provide protection against serious illness.

However, it is not clear if the FDA’s advisory panel will meet to examine the data and make recommendations. Before authorizing the third shot for children aged 12-15 in January, and then for adults 50+ last month, FDA didn’t call any meetings with an outside panel.

Multiple members both of the FDA panel and the advisory committee at the Centers for Disease Control and Prevention include several individuals have criticized the agenciesYou are able to move forward repeatedly with enhanced booster eligibility, without consulting them.

This is important breaking news. Stay tuned for new updates.

CNBC Health & Science

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