Pfizer’s COVID-19 vaccine is recommended by FDA advisers for children under the age of 12.
As infections among children aged 5 to 11 remain high, a panel of experts from the US Food and Drug Administration suggested a lower dose of the Pfizer-BioNTech COVID-19 vaccine on Tuesday.
Members of the FDA’s Vaccine and Related Biological Products Advisory Committee concluded during the meeting that the advantages of avoiding COVID-19 infections in children outweighed the risks of adverse effects in children aged 5 to 11.
In a briefing document posted on the FDA website, the committee concluded, “The total analysis indicated that the numbers of clinically important COVID-19-related outcomes averted would clearly outweigh the numbers of vaccine-associated excess myocarditis cases.”
Myocarditis has been associated to the Pfizer-BioNTech and Moderna vaccines, both of which use mRNA technology, in young people, particularly young men. Myocarditis is an uncommon illness in which the heart muscle becomes inflamed.
The panel of experts recommended the vaccination injection for emergency use permission in children younger than 12 by a vote of 17 to 0 with one abstention. The FDA will now review the recommendation, and a final decision is expected within the next several days.
Although the committee’s recommendations are not legally binding, the FDA normally heeds its advice. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention will offer a recommendation if the FDA grants authorisation. The panel will meet on November 2nd.
The CDC will review the ACIP’s suggestion, which is non-binding as well. The CDC’s director, Dr. Rochelle Walensky, will next publish recommendations stating that health care institutions and experts may begin delivering COVID-19 vaccination doses to children aged 5 to 11.
The Biden administration has stated that it is prepared to provide the dosages as soon as the FDA and CDC give the shots emergency use authorisation. According to CNBC, the government claims it has enough vaccines to vaccinate 28 million children in that age bracket across the United States.
COVID-19 has been diagnosed in roughly 6.3 million children in the United States as of October 21. Over the last week, over 118,000 new cases were added to the total number of infections. According to the American Academy of Pediatrics, the numbers are still exceedingly high, albeit being lower than the record 252,000 child cases added the week of Sept. 2.