The US Food and Drug Administration (FDA) authorized this Friday the emergency use of the Pfizer / BioNTech COVID-19 vaccine for children between 5 and 11 years old.
The FDA has released its decision three days after a scientific committee of that body recommended the use of the doses in minors in that population group. The agency indicated on its website that it based its authorization on the effectiveness of this vaccine, which is 90.7% to prevent COVID-19 among children of the aforementioned age group and also cited a study that indicates that “no serious side effects have been reported. “
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With a result of 17 votes in favor and one abstention, the committee had to vote on Tuesday “yes” or “no” to the question of whether the benefits of administering the two doses of the Pfizer / BioNTech vaccine outweigh the risks. in minors between 5 and 11 years old. The vote was preceded by a debate about the safety of vaccines in minors, since in some cases they have been related to a heart condition called myocarditis, which involves inflammation of the heart.
Expert Hong Yang, Risk-Benefit Assessment Advisor for the FDA Office of Biostatistics and Epidemiology, spoke of several possible scenarios regarding the evolution of the pandemic and in all of these cases she considered that the benefits of immunizing children outweigh ” clearly “the risks. Yang acknowledged that there is a theoretical risk of myocarditis, which is more present in those vaccinated, especially in young men, although for her it is possible that the benefits of immunization continue to be “strong”.
A pediatrician from the Centers for Disease Control and Prevention (CDC, in English), Matthew Oster, presented during the session on Tuesday the data of a study of children between 12 and 17 years old, and highlighted that they have not detected higher rates of myocarditis caused by vaccines in that group. In May, the US gave the green light to the Pfizer injection for teens 12 and older.
Oster explained that myocarditis can occur in minors with multisystem inflammatory syndrome caused by COVID-19. According to the CDC, although it is unknown what exactly causes this syndrome in which various parts of the body become inflamed, it is known that in many cases it occurs in children who had covid or who were close to a positive for the disease.
For its analysis, the CDC followed the cases of 5,000 children with that syndrome related to the covid and, according to Oster, the agency “has not yet seen any signal” that connects it to vaccines. Specifically, the CDC identified 24 volunteers who had been immunized before contracting the syndrome, of which 18 had been infected with covid. “We have not seen high rates of MIS-C (as that myocarditis is known) associated with vaccines in infants and older children,” Oster said.
