FDA approves Pfizer's COVID vaccine in 5- to 11-year olds
Click to enlarge the image toggle caption JEFF KOWALSKY/AFP via Getty Images JEFF KOWALSKY/AFP via Getty Images
A Pfizer-BioNTech COVID-19 vaccine has been approved by the U.S Food and Drug Administration. It is recommended for children aged 5-11 years old. The lower dose formulation of the adult vaccine from Pfizer-BioNTech was approved by the U.S. Food and Drug Administration. It has been shown to be safe and effective at preventing COVID-19.
After Tuesday's strong support from an advisory panel of scientists, the FDA authorized Friday's action. According to the FDA, the EUA was based on a study that included approximately 4,700 children aged 5-11 years old.
"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. Janet Woodcock M.D., acting FDA commissioner, stated that vaccination of younger children against COVID-19 would help us return to normalcy. In a statement.
She continued to assure parents that their data had been rigorously reviewed by the agency and that "this vaccine meets all our high standards."
Next Tuesday will see the meeting of the advisory panel to the Centers for Disease Control and Prevention. This is the next step before the vaccine is released to pharmacies, pediatricians, and other distribution points.
Depending on the outcome, Dr. Rochelle Walensky, director of the CDC, would have final say about whether or not the vaccine is allowed to be used and under what conditions.
Children in this age group may be eligible to have their first shot as soon as Walensky has weighed in.
The dose of Pfizer vaccine for children under 12 years of age contains one-third of the active ingredient in the vaccine. After their first shot, children would be given a second dose 21 to 24 days later.
This vaccine is also different from the one that teenagers and adults are currently receiving. It can be kept in a refrigerator up to 10 weeks. This makes it easy for schools, private medical offices and other places to administer the vaccine.
Children aged 5-11 years have been responsible for approximately 9% of COVID-19-related cases in the U.S. and account for around 40% of all pediatric COVID-19 related cases, according Dr. Doran Fink. He is clinical deputy director for the FDA's division of vaccines. He says that the COVID-19 case rate among children aged 5-11 years old is "nearly the highest" among any age group.
Children who are not vaccinated against COVID-19 may develop a serious condition called multisystem inflammatory syndrome (MIS-C) if they get it.
Scientists and clinicians debated the potential side effects of the vaccine during Tuesday's advisory panel. Side effects of the vaccine, including myocarditis or pericarditis, that can result from viral infections such as COVID-19, have been considered rare, particularly among young men.
The FDA received the Pfizer-BioNTech report that showed no cases of myocarditis among the children vaccinated. The agency did not consider the possibility of these rare side effects in teen boys. Therefore, it weighed the benefits and risks of immunizing younger children.
Capt. Amanda Cohn, a doctor and medical officer at the CDC, and also a voting member on the FDA committee, stated that vaccinations of young children against COVID-19 could save lives and keep them out of the hospital.
She stated that "we have amazing safety systems in place for monitoring for the potential of myocarditis within this age group, and we can respond rapidly." The question seems pretty simple to me. Even if there are far fewer COVID-prone children than adults, we don't want their deaths. We also don't want them in ICU.
