FDA gives the green light to Pfizer vaccine for children ages 5 to 11

Silver Springs, Maryland - The Food and Drug Administration on Friday approved the emergency use of Pfizer and BioNTech's Covid-19 vaccine for children ages five to 11.

Pfizer and BioNTech's Covid-19 vaccine had showed 90.7% efficacy against the coronavirus in a clinical trial of five to 11-year-olds.
Pfizer and BioNTech's Covid-19 vaccine had showed 90.7% efficacy against the coronavirus in a clinical trial of five to 11-year-olds.  © IMAGO / McPHOTO

The approval is one of the final steps needed to get around 28 million young children vaccinated against the coronavirus.

Now, the Centers for Disease Control and Prevention must sign off before vaccines can be distributed.

The CDC's Advisory Committee on Immunization Practices will meet next week to discuss clinical recommendations.

Early this week, FDA's Vaccines and Related Biological Products Advisory Committee recommended to the FDA that a lower dose of the Pfizer and BioNTech's Covid-19 vaccine should be administered for children ages five to 11.

The Advisory Committee unanimously voted for the decision with 17 supporting it and one person abstaining.

FDA said its latest decision was based on the "thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group."

Pfizer and BioNTech's Covid-19 vaccine had showed 90.7% efficacy against the coronavirus in a clinical trial of five to 11-year-olds. In the trial, three children who were vaccinated got Covid-19 compared to 16 children from the group that received a placebo. Twice as many children received the vaccine as the placebo.

No serious side effects recorded

The FDA approved the emergency use of Pfizer and BioNTech's Covid-19 vaccine for children ages five to 11.
The FDA approved the emergency use of Pfizer and BioNTech's Covid-19 vaccine for children ages five to 11.  © IMAGO / Xinhua

The vaccine's safety was studied in about 3,100 children age five through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.

"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against Covid-19 will bring us closer to returning to a sense of normalcy," said Acting FDA Commissioner Janet Woodcock.

"Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."

On Thursday, Pfizer had announced that it will provide the US government an additional 50 million pediatric doses of their Covid-19 vaccine. The company expect to deliver all these doses by April 30, 2022.

Cover photo: IMAGO / McPHOTO

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