An independent advisory panel of the U.S. Food and Drug Administration (FDA) has recommended the emergency use authorization (EUA) for Pfizer-BioNTech's COVID-19 vaccine to immunize children between the ages of 5 to 11, NPR reported. A trial conducted by Pfizer for this age group showed the vaccine to be safe and 90.7 percent effective against COVID-19.
According to the CDC, more than 1.9 million children in this age group have been reported to be infected with the disease that has resulted in 8,300 hospitalizations. Dr. Doran Fink, Clinical Deputy Director for vaccines at the FDA, said that the number accounted for nearly nine percent of all reported cases in the U.S. and currently, the case rate in this age group, is "near the highest" of any age group, NPR reported.
With 40 percent of children in this age group estimated to have been infected with the virus and already have some sort of immunity, the decision to vaccinate the children is partly to address the infections in children of color. Fiona Havens of the CDC presented some data at the FDA committee which showed that out of the 5,217 cases of the multisystem inflammatory syndrome (MIS-C) seen in unvaccinated children, who are infected with COVID-19, 60 percent were in children of color. Since August this year, COVID-19 outbreaks have resulted in the closure of 272 school districts, which also disproportionately affected children of color, she added.
NPR also reported that the number of participants in the Pfizer study was similar to the numbers enrolled by studies that were used to approve other childhood vaccines. The FDA was also open to receiving public comments on the matter and received some opposition citing that children do not get as sick as adults while also highlighting the side-effects of the vaccine.
Both Pfizer and Moderna vaccines have been reported to cause myocarditis - inflammation of the heart muscle, a rare, post-vaccination side effect. Myocarditis is a common occurrence after natural infection with other viruses as well, something that people recover fully from after the infection subsides. In the data submitted to the FDA, Pfizer said that it did not see any cases of myocarditis in children of this age group following vaccination, NPR reported. Serious adverse events reported following vaccination were less than two per 1000 with mild symptoms like pain at the injection area, fatigue, and headache being more common.
As per one of the models used by the FDA to weigh the risks and benefits of the Pfizer vaccine, immunizing one million children in this age group would prevent 58,000 COVID infections, 241 hospitalizations, and one death. The risks included myocarditis that could be seen in as many as 106 children, who would fully recover from it, NPR reported.
Captain Amanda Cohn, a medical officer with the CDC said that the U.S. has an incredible safety system in place to monitor and respond to myocarditis. Even though children were less likely to die from COVID-19 compared to adults, she did not want to see children in the ICU due to the infection. The benefits of the vaccine outweigh the risks, NPR reported.
Pfizer's vaccine for this age group contains one-third of the active ingredient that is present in the adult dose and also contains a substance that allows the vaccine to remain stable in a refrigerator for up to 10 weeks, unlike its previous iteration that needed freezing. Like adults, children in this age group will also need to take a second dose that can be scheduled at least 21 days after the first one.
The FDA is expected to follow the advice of the expert panel that voted in favor of granting EUA and will issue its decision in the next few days. A CDC panel will create guidelines on how the vaccine should be administered in this age group after its approval.