The FDA must issue its own decision on the matter, which is expected on November 1.
An advisory committee to the United States Food and Drug Administration (FDA) recommended on Tuesday the approval for emergency use of Pfizer’s covid-19 vaccine for children between the ages of 5 and 11.
After more than seven hours of meeting, the experts of this advisory body gave the green light to the recommendation, with 17 votes in favor and one abstention.
The committee had to vote yes or no on the question of whether the benefits of Pfizer’s vaccine outweigh the risks in children between the ages of 5 and 11.
Now, the FDA will have to issue its own decision on the matter, which is expected by November 1, and later the Centers for Disease Control and Prevention (CDC, in English) will have to scrutinize the immunization of this age group.
The CDC’s own advisory committee is scheduled to meet Nov. 2-3 to review Pfizer vaccine data for children ages 5 to 11, before that agency’s director, Rochelle Walenksy, have the last word on it.
During Tuesday’s session, expert Hong Yang, Risk-Benefit Assessment Advisor for the FDA Office of Biostatistics and Epidemiology, discussed several possible scenarios for the evolution of the pandemic.
In all cases, the benefits of immunizing children “clearly” outweigh the risks, Yang said, citing myocarditis, an inflammation of the heart, as one of the possible dangers.
On this issue, the expert indicated that, although there is a theoretical risk of myocarditis in boys and that it is more present in vaccinated people, especially in young men, the benefits of being immunized seem to remain “strong”.
A CDC pediatrician, Matthew Oster, who also spoke at the committee meeting, noted that they have not detected higher rates of myocarditis caused by vaccines among children 12 to 17 years old.
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 the covid or who were close to a positive for the disease.
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 signs” that connect 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. (I)
Paul is a talented author and journalist with a passion for entertainment and general news. He currently works as a writer at the 247 News Agency, where he has established herself as a respected voice in the industry.
