FDA panel sets June 15 meeting on Pfizer, Moderna vaccines for infants and toddlers
Bridgette Melo (age 5) prepares to inoculate one of the two lower 10 ug doses Pfizer BioNtech COVID-19 vaccids.
Duke University | Duke University | via Reuters
On June 15, the Food and Drug Administration will hold a meeting of its expert committee to discuss new data. PfizerAnd ModernaCovid vaccines are available for toddlers and infants. This will allow for shots to be authorized early in the summer.
“We know parents are anxious for us to determine if these vaccines are safe & effective,” the FDA said in a post on Twitter on Monday. “We’re working fast to thoroughly review all of the data.
A committee made up of FDA independent experts will evaluate the effectiveness and safety data for the vaccines. The FDA should then recommend that the agency authorize these shots. Although the FDA does not have to accept the recommendation of this committee, it is often obliged.
After Pfizer, the FDA announced that June would be an FDA date. BioNTechAccording to preliminary results from clinical trials, their vaccine was effective for preventing the spread of illness caused by the omicron Covid variant in children six months through five years old.
Pfizer and FDA initially wanted to expedite authorization for the two first doses of winter omicron in February. Pfizer delayed its request to receive data on the third shot, as the effectiveness of the two first doses against omicron was only 30%-40%.
Moderna applied to the FDA for approval of its two dose vaccine for children younger than 6 years in April. Two-shot vaccination was effective in preventing infection by omicron from children as young as two years old. It had a 51% effectiveness rate for infants under two and a 37% success rate among toddlers aged 2-5. Moderna’s Chief Medical Officer Dr. Paul Burton believes that children with high antibody levels should be protected against severe illnesses.
Pfizer and Moderna applications will be reviewed by FDA within days. If the FDA feels the data supports such an order, both vaccines will receive approval at approximately the same moment.
Moderna offers a vaccine for toddlers and infants that consists only of two 25-microgram shots. Pfizer, on the other hand, uses three courses of 3-microgram shots. Each vaccine is administered in a smaller dose than that used for adults by the two companies.
The only age group that is currently not eligible to receive vaccination against Covid in the United States are children under 5. Since months, many parents and doctors have been asking the FDA for the approval of the vaccine. Omicron spread quickly through the community over winter and infected many children. According to the Centers for Disease Control and Prevention, 75% of all children aged 11 and below were infected by Covid at February’s end.
Although Covid in children is usually less severe than it is for adults, the CDC found that hospitalizations among kids younger than 5 years old were five times more during the omicron surge than they were during the delta surge. Experts in public health are concerned that children may develop multisystem inflammatory Syndrome (MIS-C) and long Covid, which can be caused by viral infections.
Covid infection rates are increasing in the U.S. due to the spread of transmissible micron subvariants. As of Friday, more than 105,000 Covid-related cases were reported in the U.S., a 16% rise over the previous week, according to CDC statistics. According to data, hospitalizations increased by 16% in the last week with an average of 3,300 Covid-infected patients per day.