US Authorizes Pfizer Covid-19 Vaccine for Children 5-11 Years

The US health regulator on Friday authorized Pfizer Inc and BioNTech SE’s coronavirus vaccine for children ages 5 to 11, making it the first COVID-19 vaccine for young children in the United States.

The decision is expected to make the vaccine available to 28 million American children, many of whom are back in school for in-person learning.

It comes after a Food and Drug Administration (FDA) advisory panel voted overwhelmingly to recommend authorization on Tuesday.

Only a few other countries, including China, Cuba, and the United Arab Emirates, have so far approved COVID-19 vaccines for children of this age group and younger.

The FDA authorized a 10-microgram dose of Pfizer’s vaccine for young children, less than the 30-microgram dose for the original vaccine for those 12 years and older.

Advisers to the FDA panel said a lower dose could help mitigate some of the rare side effects.

At the meeting, they paid close attention to the rate of heart inflammation, or myocarditis, which has been linked to the Pfizer / BioNTech and Moderna vaccines, especially in young men.

The regulator said Friday that the known and potential benefits of the Pfizer vaccine in people ages 5 to 11 outweigh the risks.

An advisory panel from the US Centers for Disease Control and Prevention (CDC) will meet next week to consider recommendations on how the vaccine should be used in that age group. The CDC director will have the last word.

Pfizer and BioNTech said their vaccine was 90.7% effective against coronavirus in a clinical trial in children ages 5 to 11.

The United States began vaccinating teens ages 12 to 17 with the vaccine in May. Vaccination coverage among children in that age group is lower than in older groups, according to the CDC.

Pfizer’s vaccine was the first to be licensed for emergency use in the United States in December of last year for people age 16 and older. It was licensed for the 12-15 age group in May and received full approval from the United States in August.

Pfizer shares were up 0.8%, while BioNTech was down 1.6% in recent trading.


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