CDC Recommends Pfizer, Moderna Covid-19 Vaccine for Infants and Toddlers

Walensky supported the agency’s vaccine advisory committee’s unanimous recommendations for both vaccines earlier today.

“This infection is killing children and we have the ability to prevent it,” said Beth Bell, a professor at the University of Washington School of Public Health and a voting member of the committee.

With official approval from the CDC, children in this age group will be able to start receiving vaccines as early as next week.

Independent consultants recommended that children aged 6 months to 4 years receive three doses of the Pfizer-BioNTech 3 microgram vaccine. The first two doses should be administered three weeks apart, followed by a third dose at least eight weeks later. For the time being, children with weakened immune systems will not receive an additional dose, although the expert panel noted that this group may need an additional dose for optimal protection.

The consultants also recommended that children aged 6 months to 5 years receive two doses of Moderna 25 mcg vaccine four weeks apart. In addition, children with certain types of weakened immune systems may receive a third dose of Moderna vaccine at least one month after the second dose.

Both vaccines elicited an immune response comparable to that of young people who received two full doses without serious side effects. Moderna’s two-dose vaccine, which was being studied at the height of the Omicron surge, appeared to have reduced Covid-19 cases by an average of 41.5 percent, which the researchers noted was about on par with the efficacy of the adult vaccine at the time. Data from Pfizer and BioNTech showed that the three-dose series was 80 percent effective, but due to the small number of Covid-19 cases in Pfizer’s data, consultants questioned that figure.

Studies of both vaccines were not large enough to confirm whether the vaccines prevent hospitalization and death. But given that both of these vaccines reduce hospitalizations and deaths in older children and adults, CDC officials think it’s safe to assume they will.

Food and Drug Administration Both vaccines are approved for the youngest children on Friday after a meeting of its advisory committee, which also unanimously approved the vaccines.

Between March 2020 and mid-June 2022, there were approximately 2.5 million cases of Covid-19 in children aged 4 and under, and more than 200 deaths. During the Omicron wave, Covid-19-related hospitalizations among this age group exceeded older children, even without comorbidities. The data presented by the CDC also showed that while approximately 71 percent of children under the age of 4 have evidence of a previous Covid-19 infection, these previous infections do not appear to provide adequate protection against the disease in the future.

Less than a third of children aged 5-11 in the US have been vaccinated to date. Poll conducted Kaiser Family Foundation showed that while 20 percent of parents want to vaccinate their children before the age of 5, about 40 percent of parents do not want to vaccinate their babies and toddlers at all.

CDC officials also noted that they believe the Covid-19 vaccines for these age groups can be administered alongside other vaccines, potentially saving parents and children from traveling to their doctors. “We have a lot of experience with non-Covid-19 vaccines that have shown… side effect profiles are broadly similar when vaccines are given concomitantly and when given alone,” said Sarah Oliver, Covid-19 Vaccine Division Manager for working group of the CDC Immunization Practices Advisory Committee. However, given the limited data on co-administering Covid-19 vaccines with others, she added that “providers can make decisions about administering on a case-by-case basis.”

The consultants also considered the possibility of mixing vaccines in this age group. The CDC Clinical Research Group has decided that it will issue guidance to practitioners stating that mixing two vaccines is acceptable, provided that the child receives a total of three doses. If a child has received two doses of Moderna vaccine, they will be considered up-to-date.

On Thursday, HHS Assistant Secretary of State for Preparedness and Response Dawn O’Connell said state and local health care providers have ordered approximately 2.5 million doses of Pfizer-BioNTech infant and toddler vaccine and 1.3 million doses of Moderna vaccine – about half and a quarter of the dose provided by the federal government, respectively. All 50 states have pre-orders for vaccines, including Florida as of Friday. CDC representatives said they expect more orders from suppliers after seeing today’s discussions on the recommendations.

What’s next: The agency’s vaccine advisors will meet on June 23 to discuss Moderna’s vaccine for children ages 6 to 17, which has already been approved by the FDA. Children in this age group can already receive the Pfizer-BioNTech mRNA vaccine.