FDA authorizes Pfizer's Covid vaccine for kids ages 5 to 11, shots could begin early next week with CDC clearance

Jamie Blank (L) holds Ari Blank's hands as Ari receives the Pfizer BioNTech Covid-19 vaccination from Jen Feinberg (R), at the Jewish Federation/JARC offices in Bloomfield Hills (Michigan) on May 13, 2021.
Before shots can be distributed, the Centers for Disease Control and Prevention have to sign off. The advisory committee will meet next week to discuss pediatric doses. They are expected to quickly clear them for distribution to the public immediately afterwards.

Friday's Food and Drug Administration approved the use of BioNTech and Pfizer's Covid-19 vaccines for children aged 5-11 years. This will allow the shots to be made available to an additional 28 million U.S. kids.

"As a mother, a doctor, and a parent, I know that parents and caregivers, school staff, as well as children, have been waiting for today’s authorization. In a statement, Dr. Janet Woodcock, acting FDA Commissioner, stated that vaccination of younger children against COVID-19 would help us return to normalcy.

FDA cleared the vaccine as expected after the agency's Vaccines and Related Biological Products Advisory Committee voted overwhelmingly Tuesday in favor of a lower dose of the Pfizer vaccine to be given to young children.

It claimed that its low-dose vaccine for children, which is one third of the dose given to adults is more effective than 90% in preventing asymptomatic infections. The shots are well tolerated by young children and produce side effects similar to those observed in people aged 16-25.

Many parents are eager to get their children vaccinated, with schools opening across the U.S.A and the delta coronavirus driving an increase in vaccine cases among children.

According to the American Academy of Pediatrics (AAP), nearly 6.3 million children had tested positive for Covid since the outbreak of the pandemic. However, experts believe that the actual number may be much higher. A CDC official informed the FDA committee Tuesday that Covid-19 was the eighth-leading cause of death for children aged 5-11 years.

The FDA reported Friday that 691 Covid-related deaths had been reported in the U.S. as of Oct. 17. 146 Covid-related deaths were reported in the 5- to 11-year-old age groups.

According to the Biden administration, it has already obtained enough vaccine doses to vacate all 28 million children aged 5 to 11, and is ready to start rolling out the first 15,000,000 shots within the week following approval.



FDA scientists acknowledged the risks of myocarditis or pericarditis, but stated that the benefits of shots, such as preventing serious disease and hospitalization, outweigh the risk.

Tuesday's FDA committee meeting members stated that vaccination of younger age groups would aid the United States in advancing to Covid's "endemic phase". This is where the virus is still present but at lower levels than now.

According to Dr. Fiona Havers, a CDC official, there have been over 2,000 school closures due to Covid since August. This has affected more than 1,000,000 children and 68,000 teachers.

Others on the committee noted that there are still unknowns such as the incidence of myocarditis among young children, but they still believed the benefits outweighed the risks.

One member questioned whether they should only recommend for children at high risk. Studies show that children who are otherwise healthy are less likely than adults to develop symptoms of the disease.

An analysis by the CDC found that children with underlying medical conditions like obesity, chronic lung disease, and neurological disorders are risk factors for serious disease. According to the agency, lung disease was the most common underlying medical condition, with asthma being the predominant cause.

This is still a developing story. Keep checking back for more updates.