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FDA approves Pfizer’s COVID-19 vaccine for children

October 29, 2021 – The FDA has approved Pfizer’s COVID-19 vaccine for children between the ages of 5 and 11, which means that vaccines may be available to school-going children from next week.

The move brings families with young children one step closer to resuming their normal activities, and it should further help the transfer of the coronavirus in the usa

States have already placed their orders for initial doses of the vaccines. Friday’s FDA authorization causes the shipment of millions of doses to pediatricians, GPs, children’s hospitals, community health centers and pharmacies.

A panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet on Tuesday to vote on recommendations for the use of the vaccine.

Once the CDC director signs these recommendations, children can get the shots, perhaps as early as next Wednesday.

Pfizer’s vaccine for children is 10 micrograms, or one third of the dose given to teens and adults. Children receive two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were injection site pain, fatigue and headache. These side effects were mild and quickly disappeared. No serious adverse events were detected in the studies, which included approximately 3,100 children. In one study, the vaccine was 90% effective in preventing COVID-19 infections with symptoms in younger children.

There are approximately 28 million children in the United States between the ages of 5 and 12.

“As a mother and a doctor, 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,” FDA Acting Commissioner Janet Woodcock, MD, said in an FDA news release.

“Our comprehensive and rigorous evaluation of the data regarding the vaccine’s safety and efficacy should help ensure parents and guardians that this vaccine meets our high standards,” she said.

Since the onset of the pandemic, there have been at least 1.9 million cases of COVID-19 in children aged 5 to 11. At least one-third of the children admitted to the hospital for the infection had no underlying medical conditions.

The FDA has also approved a manufacturing change to the vaccine, which does not affect the safety profile of the shots, says Peter Marks, MD, who heads the FDA’s Center for Biological Evaluation and Research.

The change makes the vaccine more stable at refrigerator temperatures for longer periods, Marks said.

“If I had a child in this age group, I would not hesitate for a second to give my child one of these vaccines,” Marks said.

Marks said the companies are still studying the use of the vaccines in even younger children and that COVID-19 vaccines are still a few months away for children under 5.

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