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CDC advisers recommend Pfizer, Moderna Covid-19 vaccine for babies and toddlers

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If CDC director Rochelle Walensky follows up on her advisory committee’s recommendation as expected, children in this age group could receive vaccines as early as next week.

Independent advisors have recommended that children 6 months to 4 years of age receive three 3-microgram doses of Pfizer-BioNTech vaccine. The first two doses should be three weeks apart, followed by a third dose at least eight weeks later. For now, children with compromised 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 advisers also recommended that children 6 months to 5 years old receive two doses of Moderna’s 25 microgram vaccine four weeks apart. In addition, children with certain types of compromised immune systems can receive a third dose of Moderna’s vaccine at least one month after their second dose.

Both vaccines elicited an immune response similar to that seen in young adults given two full doses with no serious side effects. Moderna’s two-dose vaccine, which was studied during the height of the Omicron peak, appeared to reduce the number of Covid-19 cases by an average of 41.5 percent, which researchers say at the time was roughly equivalent to the effectiveness of the vaccine in adults. Data from Pfizer and BioNTech showed that the three-dose series had an efficacy of 80 percent, but due to the small number of Covid-19 cases in the data Pfizer presented, advisors cast some doubt on that figure.

The studies on both vaccines were not large enough to confirm whether the vaccines prevent hospitalization and death. But since both vaccines reduce hospitalizations and deaths for older children and adults, CDC representatives believed it was safe to assume they would.

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

Background: 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 outnumbered older children, even without comorbidities. Data presented by the CDC also showed that while about 71 percent of children under the age of 4 show signs of a previous Covid-19 infection, it does not appear that these previous infections provide adequate protection against future illness.

Less than a third of U.S. children ages 5-11 have been vaccinated to date. Poll conducted by the Kaiser Family Foundation showed that while 20 percent of parents would like to vaccinate their children under 5, about 40 percent of parents are reluctant to vaccinate their babies and toddlers at all.

Representatives from the CDC also noted that they believed Covid-19 vaccines for these age groups could be administered with other vaccines, potentially saving parents and children trips to their health care providers. “We have extensive experience with non-Covid-19 vaccines that has shown… side effect profiles are generally similar when vaccines are administered concomitantly as when they are administered alone,” said Sara Oliver, the Covid-19 leader. vaccines for the Advisory Committee on Vaccination Practices within the CDC. Given the limited data on co-administration of Covid-19 vaccines with others, she added that “providers can make administration decisions on a case-by-case basis.”

Also, advisors have considered whether it would be possible to mix vaccines in this age group. The CDC’s clinical considerations team decided it would issue guidelines to doctors saying mixing the two vaccines was acceptable, provided a child received a total of three doses. If a child receives two doses of the Moderna vaccine, they are considered up-to-date.

On Thursday, assistant HHS secretary for preparedness and response Dawn O’Connell said state and local healthcare providers have ordered about 2.5 million doses of the Pfizer-BioNTech vaccine for infants and toddlers and 1.3 million doses of Moderna — about half. and a quarter of the doses provided by the federal government, respectively. All 50 states have pre-ordered vaccines, including Florida as of Friday. Representatives from the CDC said they expect carrier orders to rise after seeing discussions around the recommendations today.

What’s next: Walensky is expected to approve the vaccines soon.

The agency’s vaccine advisers 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 may already be receiving the Pfizer-BioNTech mRNA vaccine.

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