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The Food and Drug Administration will soon decide on approving the Moderna and Pfizer vaccines for children as young as 5, after extensive tests from both vaccines returned strong immune responses in children ages 5-11 for Pfizer, and 6-11 year-olds for the Moderna shot.
Experts on a panel called the Vaccines and Related Biological Products Advisory Committee have been advising the FDA, and the panel, which is meeting Tuesday, is expected to review scientific data about the Pfizer vaccine’s safety and effectiveness in children. A vote to recommend whether the FDA should authorize its use is expected to follow soon after.
The Moderna vaccine returned a strong immune response against Covid-19 in the 6-11 age group that was generally safe, the company said Monday. Moderna said it would soon submit the results to health regulators in the U.S., Europe and elsewhere seeking authorization to broaden the vaccine's use to include the younger age group.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna Chief Executive Stéphane Bancel said.
Last week, the FDA said results from Pfizer's late-stage study met the criteria for immune responses in children between the ages of 5-11. The results also showed that the shot was safe and 90.7 percent effective at preventing symptomatic Covid-19 in the aforementioned age group.
The FDA must clear a vaccine before it can be used outside of testing. A greenlight from the FDA is followed by guidance from the Centers for Disease Control and Prevention to facilities such as pharmacies and vaccination sites as well as doctors. The CDC also sets policy for vaccine use.
If approved by the FDA, 28 million children in the U.S. and its territories would become eligible for the vaccine.
According to the Wall Street Journal, in a study of 2,268 children 5 to 11 years, the Pfizer vaccine was generally well-tolerated and generated levels of neutralizing antibodies comparable to those seen in subjects who were 16 to 25 years, according to the companies. Pfizer is also the furthest ahead in advancing shots for children.
While children are generally at low risk of severe Covid-19 disease or death, there was a marked increase in hospitalization among that age group as a result of the Delta variant. Additionally, physicians and doctors have said vaccination in children is important not only to protect the youngsters, but also those around them. The V.I. Dept. of Health said late Sept. that infections at daycare centers and school-age children represented a majority of the positive cases during that time period.
Covid-19 cases have been on the decline in the USVI, with active infections falling below 100 for first time since July, when the Delta variant took hold. Governor Albert Bryan has said he would move to loosen restrictions once cases drop below 100. Mr Bryan is expected to address the media during his weekly Covid-19 press briefing from Denver, Colorado today.
