The Centers for Disease Control and Prevention on Saturday recommended a COVID vaccine for children under 6 months old, who were among the last Americans to qualify for the shots. Parents should start vaccinating young children from Tuesday itself.
Federal regulators have now authorized the Moderna vaccine for children 6 months to 5 years of age and the Pfizer-BioNTech vaccine for children 6 months to 4 years of age. (Pfizer-BioEntech’s vaccine is available for children 5 years of age and older through November.)
CDC Director Dr. Rochelle P. Valensky said in a statement that all children 6 months of age and older, including those already infected with the coronavirus, should receive the COVID vaccine.
“Together, led by science, we’ve taken one more important stepaheadIn our country’s fight against Covid-19,” she said. “We know that millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can.”
Following Friday and Saturday’s meetings, the agency’s scientific advisers strongly supported vaccines, particularly regarding the efficacy of the Pfizer-BioNTech vaccine, despite reservations about a lack of data.
The CDC panel heard evidence supporting the vaccine’s effectiveness in the youngest children, but repeatedly pressed Pfizer on its estimates and noted that three doses of that vaccine would be needed, compared to two doses of Moderna Vaccine. .
Both vaccines are safe, and both produced similar antibody levels to those seen in young adults. But CDC advisors ran into difficulty recommending two different vaccines for the same population.
“The implementation of these two rollouts is going to be incredibly challenging,” said Caitlin Jetelina, public health expert and author of the widely read newspaper “Your Local Epidemiologist.”
“There’s going to be a lot of active communication about the difference between the two and the implications of taking one over the other,” she said.
In its clinical trials, Moderna found that two shots of its vaccine, each with a quarter of an adult dose, produced antibody levels that were lower than those seen in young adults.
The company estimated the vaccine’s efficacy against symptomatic infections at about 51 percent in children 6 to 24 months of age and 37 percent in children 2 to 5 years of age.
Side effects were minor, although one in five children experienced a fever. Efficacy against serious illness and death is thought to be high, similar to the effects seen in adults.
Based on those data, the FDA authorized two shots of Moderna Vaccine, spaced four weeks apart.
The Pfizer-BioNtech vaccine also produced a strong immune response, but only after three doses, company officials told Scientific Advisors on Friday.
Two doses of the vaccine were insufficient, he said – justifying the FDA’s decision in February to delay authorizing the vaccine until regulators had data about three doses. Some consultants said that two doses may not be enough because the company gave children just one-tenth of the adult dose in each shot.
Scientists at Pfizer claimed on Friday that the vaccine’s overall effectiveness in children under the age of 5 is 80 percent. But that count was based on just three children in the vaccine group and seven who received a placebo, which makes it an unreliable metric, CDC advisers noted.
“We should just assume that we don’t have efficacy data,” Dr. Sarah Long, an infectious disease specialist at Drexel University College of Medicine. But Dr. Long said she was “quite comfortable” with other data supporting the vaccine’s potency.
Three doses of the Pfizer vaccine produced antibody levels similar to those seen in young adults, suggesting it is likely to be just as effective.
“The Pfizer is a three-dose series, but as a three-dose series, it is quite effective,” Dr. William Towner, who led vaccine trials for both Moderna and Pfizer at Kaiser Permanente in Southern California.
Dr Towner said no vaccine would be better than none. He predicted that some parents may opt for Moderna because bringing kids to the pediatrician for two shots is easier than arranging for them to get three.
The Pfizer vaccine was authorized in November for children 5 to 11, but less than 30 percent of those in that age group have received two shots. In surveys conducted by the CDC, nearly half of parents said in February they would vaccinate their children, but as of May only a third of parents said they intended to do so.
Advisors debate whether vaccination increases protection against serious disease in children who have already been infected. Little information is available about children 5 to 11 years of age, because of the poor intake of vaccines in that age group.
But in adults, infection with the older Omicron variant by itself is not enough to protect against the newer versions.
Vaccinations will still be needed to protect children from future types, the experts concluded. “That combined protection is really the safest and most effective,” said Dr. Sarah Oliver, a CDC scientist who led the discussion on Saturday.
Dr. Towner said that parents of the youngest children may be more inclined to choose the COVID vaccine if it can be offered along with other routine vaccinations.
“That’s an area a lot of people aren’t sure about right now,” he said. “I hope to be given some guidance around this.”