Paxton Bowers, 5, received a Covid shot at Texas Children’s Hospital in November. Credit… Meridith Kohut for The New York Times
The Centers for Disease Control and Prevention on Saturday recommended Covid vaccines for children as young as 6 months old, who were among the last Americans to qualify for the shots. Parents should be able to start vaccinating young children as early as Tuesday.
Federal authorities have now approved the Moderna vaccine for children ages 6 months to 5 years and the Pfizer-BioNTech vaccine for children ages 6 months to 4 years. (Pfizer-BioNTech’s vaccine has been available for children ages 5 and older since November.)
All children as young as 6 months, including those who have already been infected with the coronavirus, should receive a Covid vaccine, said Dr. Rochelle P. Walensky, the director of the CDC, in a statement.
“Together, and with science at the forefront, we have taken another important step forward in our nation’s fight against Covid-19,” she said. “We know millions of parents and carers are anxious to get their young children vaccinated and today’s decision allows them to do that.”
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dr Rochelle P. Walensky, director of the Centers for Disease Control and Prevention, endorsed the decision after a scientific panel supported the recordings despite reservations about a lack of data. CreditCredit … Centers for Disease Control and Prevention
After meetings on Friday and Saturday, the agency’s scientific advisors strongly supported the vaccines, despite reservations about the lack of data, particularly on the efficacy of Pfizer-BioNTech’s vaccine.
The CDC panel heard evidence of the vaccines’ effectiveness in the youngest children, but repeatedly pushed Pfizer back on its estimates, noting that three doses of this vaccine would be needed compared to two doses of the Moderna vaccine.
Both vaccines are safe and both produced levels of antibodies similar to those found in young adults. However, the CDC advisors struggled with the difficulty of recommending two very different vaccines for the same population.
“Executing these two rollouts will be incredibly challenging,” said Katelyn Jetelina, a public health expert and author of the widely read newsletter Your Local Epidemiologist.
“There’s going to have to be a lot of proactive communication about the difference between the two and the implications of emphasizing one over the other,” she said.
In its clinical trials, Moderna found that two injections of its vaccine, each at a quarter of the adult dose, produced antibody levels at least as high as those seen in young adults.
The company estimated the vaccine’s effectiveness against symptomatic infections at about 51 percent in children aged 6 to 24 months and 37 percent in children aged 2 to 5 years.
Side effects were few, although about one in five children had a fever. Its effectiveness against serious illness and death is believed to be higher, similar to adults.
Based on this data, the FDA approved two doses of the Moderna vaccine four weeks apart.
The Pfizer-BioNTech vaccine also generated a strong immune response, but only after three doses, company officials told scientific advisers on Friday.
Two doses of the vaccine were insufficient, they said, justifying the FDA’s decision in February to delay approval of the vaccine until regulators had data on three doses. Two doses may not have been enough, as the company only gave children a tenth of the adult dose with each injection, some advisers said.
The vaccine has an overall effectiveness of 80 percent in children under the age of 5, Pfizer scientists claimed on Friday. However, that calculation was based on only three children in the vaccination group and seven receiving a placebo, making it an unreliable metric, CDC consultants noted.
“We should just assume that we don’t have efficacy data,” said Dr. Sarah Long, an infectious disease expert at Drexel University College of Medicine. But dr Long said she was “comfortable enough” with other data showing the vaccine’s effectiveness.
Three doses of the Pfizer vaccine produced antibody levels comparable to those seen in young adults, suggesting it’s probably just as effective.
“The Pfizer is a three-dose series, but as a three-dose series it’s quite effective,” said Dr. William Towner, who led vaccine trials for Moderna and Pfizer at Kaiser Permanente in Southern California.
Any vaccine would be better than none, added Dr. Towner added. He predicted that some parents might choose Moderna because it’s easier to take kids to a pediatrician for two shots than making sure they get three.
The Pfizer vaccine was approved in November for children ages 5 to 11, but less than 30 percent in that age group have received two shots. In CDC polls in February, about half of parents said they would vaccinate their children, but in May only a third of parents said they intend to do so.
The consultants discussed whether vaccination increases protection against serious illnesses in children who are already infected. Little information is available for children aged 5 to 11 years due to the low uptake of vaccines in this age group.
But in adults, infection with the earlier Omicron variant alone has not been enough to protect against the newer versions.
Vaccinations are still needed to protect children from future variants, the experts concluded. “This combined protection is really the safest and most effective,” said Dr. Sara Oliver, a CDC scientist who led Saturday’s discussion.
Parents of the youngest children may be more willing to choose a Covid vaccine if it can be offered alongside other routine vaccinations, said Dr. towner
“That’s the area that a lot of people are unsure about right now,” he said. “I hope there will be a guide to that.”