A Food and Drug Administration advisory committee recommended a lower dose of Pfizer and BioNTech’s Covid-19 vaccine for children ages 5 to 11, as a critical step in protecting against the virus as the delta variant of the coronavirus spreads.
The committee recommended a two-dose regimen at one-third the dosage approved for adults.
The vote for the recommendation was 17 in favor and one abstention.
The FDA panel accepted Pfizer’s data demonstrating the vaccine is safe and 90.7% effective in preventing COVID-19 infections in this age group.
Soon, a Centers for Disease Control and Prevention(CDC) vaccine advisory group is expected to make its recommendation. If it issues approval, shots for young kids could begin immediately.
Some members of the committee said that vaccinating younger groups would help the United States move towards Covid’s “endemic” phase, where the virus is still circulating but at lower levels than it is now.
Others noted there are small risks, such as the rate of inflammation in the heart in young kids, but still indicated that the benefits of the shots, including preventing severe disease, hospitalization, and death, would generally outweigh the risk of the rare inflammatory heart conditions.
Dr. Mathew Oster, a CDC official, told the FDA’s vaccine committee that there have been 1,640 cases of myocarditis reported in people under 30 who received Pfizer’s or Moderna’s Covid vaccines Just 877 met the CDC’s case definition for myocarditis. He added the agency hasn’t seen increased rates of the condition among children ages 12 to 17.
The FDA modeled several scenarios to estimate the effect of vaccinating children. One showed that vaccinating 1 million kids ages 5 to 11 would prevent 58,000 infections, 241 hospitalizations, and one death.
In that 1 million children, there might be around 22 to 106 cases of myocarditis associated with the vaccine. Most would be expected to fully recover.
Many parents are anxiously awaiting the vaccine’s authorization with schools now open across the U.S. and the delta variant driving a surge in children’s cases.
Children, and especially younger children, are the last group to be vaccinated against COVID-19, following the elderly, adults, and adolescents.
As more people took the vaccine, rates of new infections have declined, along with hospitalizations and deaths from the disease.
But infections and diseases are climbing among the youngest children, emphasizing the need to vaccinate them quickly.
Children ages 5 to 11 account for roughly 9% of all reported Covid cases in the U.S., according to data presented to the committee by the FDA recently.
The number of new Covid cases in kids remains exceptionally high, with more than 1.1 million child cases added over the past six weeks, with approximately 8,300 children hospitalized to date, according to the CDC.
About one-third of these hospitalized children needed treatment in the ICU. The rate of hospitalization is three times higher among children of color than among white children.
Dr. James Hildreth, a committee member and president of Meharry Medical College in Nashville said,
he voted yes “because I want to make sure the children who need the vaccine — primarily the black and brown children in our country — get the vaccine.”
“We don’t want children to be dying from Covid, even if it is far fewer children than adults, and we don’t want them in the ICU,” member Dr. Amanda Cohn said before the vote.
COVID-19 vaccines are already authorized for children ages 12 and older, and the shots now have the support of a U.S. Food and Drug Administration (FDA) expert panel for younger children ages 5 to 11.