Tuesday's recommendation by a key advisory committee of the Food and Drug Administration was to lower the doses of BioNTech and Pfizer's Covid-19 vaccines for children aged 5-11. This is a crucial step towards protecting some 28 million additional U.S. children against the virus spreading from the delta variant.
FDA will now consider the endorsement of the agency's Vaccines and Related Biological Products Advisory Committee. It could issue a final determination within days. It was almost unanimous, with 17 voting in favor and one abstention.
Although the agency may not always follow the recommendations of its independent committees, it does so often. A Centers for Disease Control and Prevention advisory group on vaccines will make its recommendation next week. Young children could start shots immediately if the advisory group issues its endorsement and Dr. Rochelle Walensky, CDC Director, signs off.
According to the Biden administration, the vaccines will be distributed as soon as they are approved by FDA and CDC. This is expected to happen in the early part of next month. According to the administration, enough vaccine has been purchased to inoculate all 28 millions children aged 5 to 11, and it will distribute it in smaller doses and with smaller needles so that it is easier for pharmacists and pediatricians to administer the vaccine to children.
Many parents are anxiously waiting for the approval of the vaccine. Schools across the U.S. have now opened and the delta variant is driving an increase in the number of cases.
According to data provided by FDA to the committee on Tuesday, approximately 9% of all reported Covid cases are in children aged 5-11 years old. According to the American Academy of Pediatrics, the number of Covid cases in children is still high. There have been more than 1.1million new cases of Covid in the last six weeks.
Despite the fact that children can still get the disease, advocates and parents argue against Covid vaccinations. Studies show that kids are less likely than adults to develop symptoms.
Tuesday's statement by some committee members suggested that vaccination of younger people would aid the United States in advancing to Covid's "endemic phase". This is where the virus is still present but at lower levels than now. Some others noted that there are still unknowns such as the rate of myocarditis among young children, but they still believed the vaccine's benefits outweighed any potential risks. One member questioned whether they should only recommend the shots for children at high risk.
Before the vote, Dr. Amanda Cohn stated that "we don't want children dying from Covid"
Dr. Peter Marks from the FDA, top vaccine regulator, requested that the committee keep the debate "civil" before the vote. He said there were strong feelings between the two sides.
Marks stated at the top that today's meeting was about the scientific data presented and not vaccine mandates which were left to FDA. "I ask that today's discussion be civilized and that we focus on the science surrounding these issues to ensure that we have a productive discussion."
Pfizer requested the FDA to approve its vaccine for children aged 5-11 on October 7. Pfizer published data showing that a dose of 10 micrograms, a third of what is used for adults and teens, was safe and generated a strong immune reaction in clinical trials with young children. The shots were easily tolerated, produced an immune response, and had side effects similar to those observed in a study of 16-25-year-olds.
Dr. Doran Fink is a deputy director in the FDA's vaccines division. She said Tuesday that a small army of FDA employees worked round the clock for the past month to ensure that the data they presented today on children was accurate.
FDA staff published a Friday analysis that found that a lower dose of Pfizer vaccine is safe and effective for young children. The FDA staff noted an increased risk of myocarditis or pericarditis, but stated that the vaccine's benefits, such as preventing death from severe illness, outweigh the risks.
As of Oct. 6, there were 1,640 cases reported of myocarditis among people aged under 30 who had received Moderna's Covid or Pfizer vaccines. Dr. Mathew Oster, a CDC official, informed the FDA's vaccine panel. Only 877 cases met the criteria for myocarditis as defined by the CDC. He said that the agency has not seen an increase in the incidence of myocarditis among children between 12 and 17.
This is still a developing story. Keep checking back for more updates.
