Wednesday’s meeting will see a Food and Drug Administration advisory panel weigh in on Covid vaccinations for children younger than 5.
The FDA must approve the endorsement of the committee before it can authorise shots from Moderna and Pfizer BioNTech for this age group. The only age group that is not eligible to be vaccinated in the United States is children under 5.
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Many parents with children under 5 have been waiting eagerly for the vaccines to become available. A Kaiser Family Foundation survey revealed that just 1 in 5 parents of children younger than 5 said they would get their child immunized “right away” once federal regulators approve it.
Although children are less likely to contract the disease than adults, it can still be fatal. Experts warn that infected children can transmit the virus to their family members.
“The earlier we get our children vaccinated, it will reduce the stress that families will feel after a long period of time,” Dr. Nusheen Amieenuddin, a pediatrician at Mayo Clinic Rochester, Minnesota, said.
According to Dr. Ashish Jha, White House Covid coordinator, vaccinations for young children could start as soon as next week.
After Wednesday’s meeting, the FDA is expected quickly to approve the shots. Friday and Saturday will see the Centers for Disease Control and Prevention’s advisory panel meet to discuss how vaccines should be administered to children below 5. If everything goes according to plan, Dr. Rochelle Walensky, Director of the CDC, will sign off on the authorization. Sometimes, this can happen within hours.
Pfizer has asked the FDA to approve a three-dose vaccine to protect children aged 6 months to four years. Moderna requests authorization to administer a two-dose vaccine to children 6 months to five years old.
FDA scientists published their own analysis over the weekend of both vaccines. Briefing documents posted online by FDA officials stated that both the Moderna and Pfizer shots appeared to be safe and effective for young children.
According to FDA briefing documents, early clinical trials showed that Pfizer’s three dose vaccine in 3 microgram doses was 80 percent effective in preventing symptomatic Covid.
Moderna’s two dose vaccine at 25 micrograms was found to be effective in preventing milder infections. FDA documents show that the FDA has conducted trials. However, the FDA has stated that the company is currently testing a booster dose.
This vaccine should protect children under five against the most severe effects of Covid. Ameenuddin stated that overall the safety profile of vaccines is “very encouraging”.
According to FDA documents, the vaccines were generally well tolerated. The most common side effects included pain at the injection site and irritability.
However, the agency stated that it does not have enough data to evaluate the risk of myocarditis, a rare condition characterized by inflammation of the heart, in the current age group.
Rare cases of myocarditis have been reported in teens, especially among young men and boys who received Moderna and Pfizer vaccines. The safety of heart inflammation was not a concern in the Moderna or Pfizer pediatric trials. Each trial tested the vaccines in just a few thousand children.
Former FDA vaccine chief Dr. Jesse Goodman, Georgetown University, stated on Monday that it was “reassuring” there were no myocarditis cases documented in clinical trials. However, he pointed out that such small trials wouldn’t have been expected to detect it.
According to a CDC report, 75% of children aged 11 and below had evidence of infection by February. This is up from 44% in December.
On Monday, Dr. Paul Offit, who is a member the FDA’s advisory board, stated that vaccinations for those who have had previous exposure to the virus have shown an advantage.
He also raised concerns about the effectiveness of the vaccines in children, noting that they were tested before the omicron-subvariants BA.4 or BA.5 began spreading rapidly in the U.S.
Anna Durbin, a Johns Hopkins University vaccine researcher, stated that although the vaccine data is encouraging, young children and other groups will need to be vaccinated using updated vaccines designed to target newer varieties.
The FDA’s advisory panel will meet on June 28 to discuss which strains should be included with Covid booster shots in the fall.
Moderna and Pfizer are working together to update shots that target the Omicron variant.
