On Saturday, the Centers for Disease Control and Prevention recommended the Covid vaccine for 6-month-old babies, 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 regulators have now approved the Moderna vaccine for children 6 months to 5 years old and the Pfizer-BioNTech vaccine for children 6 months to 4 years old. (The Pfizer-BioNTech vaccine is available for children 5 years of age or older from November.)
CDC Director Dr. Rochelle P. All children 6 months of age or older who have already been infected with the coronavirus should receive a covid vaccine, Walensky said in a statement.
“Together, we have taken the lead in science Another important stepForwardOur country’s fight against Kovid-19, “he said. “We know millions of parents and caregivers are interested in vaccinating their young children, and with today’s decision, they can.”
After Friday and Saturday’s meeting, the agency’s scientific advisers strongly supported the vaccines, despite concerns about the lack of information, especially about the effectiveness of the Pfizer-BioNTech vaccine.
The CDC panel heard evidence supporting the vaccine’s efficacy in young children, but repeatedly pressured Pfizer into its hypothesis, stating that the Moderna vaccine would require three doses more than two doses.
Both vaccines are safe, and both produce antibody levels that are seen in young people. But CDC advisers wrestled with the difficulty of recommending two different vaccines for the same population.
“The implementation of these two rollouts is going to be incredibly challenging,” said Caitlin Jatelina, a public health expert and author of the widely read newsletter “Your Local Epidemiologist”.
“There has to be a lot of active communication about the difference between the two and the effect of taking one over the other,” he said.
In her clinical trials, Modernna found that two shots of her vaccine, including one-fourth of the adult dose in each, produced antibody levels that were higher than those seen in young adults.
The agency estimates the vaccine’s effectiveness against significant infections in children aged 6 to 24 months is about 51 percent and in children aged 2 to 5 months is 37 percent.
The side effects were mild, although one in five children developed a fever. Effectiveness against serious illness and death is thought to be as high as the effects seen in adults.
Based on this information, the FDA approved two shots of the Moderna vaccine every four weeks.
The Pfizer-BioNTech vaccine has also developed 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 vaccine approval until regulators received information about the three doses. Two doses may not be enough because the company has given children only one-tenth of the adult dose in each shot, some advisers say.
Pfizer scientists claimed Friday that the vaccine has an overall effectiveness of 80 percent in children under 5 years of age. But that calculation was based on just three children in the vaccine group, and seven who received a placebo made it an unreliable metric, CDC advisers noted.
“We should just assume that we don’t have data on efficacy,” said Dr. Sarah Long, an infectious disease specialist at Drexel University College of Medicine. But Dr Long said he was “comfortable enough” with other information supporting the vaccine’s power.
Three doses of the Pfizer vaccine produce levels of antibodies seen in young adults, suggesting that it may be just as effective.
“Pfizer is a three-dose series, but as a three-dose series, it’s quite effective,” said Dr. William Touner, who led the vaccine trial for both Modern and Pfizer at Kaiser Permanent in Southern California.
Either vaccine will not be better than any, Dr. Touner added. He predicted that some parents would choose Moderna because bringing children to a pediatrician for two shots is easier than arranging three for them.
The Pfizer vaccine was approved for children ages 5 to 11 in November, but less than 30 percent of those ages received two shots. In a survey conducted by the CDC, about half of parents said in February that they would vaccinate their children, but by May, only one-third of parents said they would do so.
Counselors have debated whether vaccination enhances protection against serious illness in already infected children. Very little information is available from children between the ages of 5 and 11, due to poor use of the vaccine by that age.
But in adults, the transmission of the previous Omicron variant is not enough to protect against the new version.
Vaccines will still be needed to protect children from future variations, experts conclude. “That combined protection is truly the safest and most effective,” said Dr. Sarah Oliver, a CDC scientist who led the discussion on Saturday.
Parents of the youngest children may be more willing to choose the covid vaccine if it is given in addition to other regular vaccinations, Dr. Touner said.
“It’s an area that a lot of people aren’t sure about right now,” he said. “I hope there will be some guidance around this.”