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CDC approves Pfizer Covid booster for children ages 5-11

The Centers for Disease Control and Prevention on Thursday approved booster shots of the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11.

Final approval, from CDC Director Rochelle Walensky, came within hours after the agency’s advisory committee on immunization practices voted 11 to 1, with one abstention, in favor of giving boosters to children 5 to 11 years of age at least five months after their second dose.

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“Today I endorsed the ACIP vote to expand eligibility for booster doses of the Covid-19 vaccine,” Walensky said in a statement. “Children 5 to 11 years old should receive a booster dose at least 5 months after their primary series.”

Walensky’s approval comes as Covid-19 cases rise again in the United States, fueled by the omicron subvariant, BA.2, and an offshoot of that strain, called BA.2.12.1.

Vaccination rates for children ages 5 to 11 in the United States “lag behind other age groups, making them vulnerable to serious illness,” Walenksy said. Less than 30% of the 28 million children in this age group have received two doses of a Covid-19 vaccine, CDC data shows.

While children are generally less likely than adults to get seriously ill from Covid, some do: More than 15,000 children aged 5 to 11 have been hospitalized and at least 189 of them have died, according to CDC data.

The panel met two days after the Food and Drug Administration cleared booster shots for this age group.

Clinical trial data presented by Pfizer representatives at Thursday’s meeting showed that a booster dose of 10 micrograms for children aged 5 to 11 – a third of the dose given to people aged 12 and over – increased levels of antibodies against the omicron variant and the original strain of the coronavirus, which has long been out of circulation.

The omicron variant tore through the pediatric population last winter, even among the vaccinated. In February, researchers from the New York State Department of Health reported that two doses of the Pfizer vaccine offered little protection against infection for children ages 5 to 11 during the omicron wave, although the CDC has found that it still protects against serious illnesses.

A recent CDC report found that about 75% of children 11 and under showed signs of infection in February, compared to 44% in December.

The high infection rate in children led some committee members to question whether two doses of vaccine plus one infection obviated the need for a booster shot at that time.

“Couldn’t it be that their initial exposure and two doses gave them this total immunity that we envision?” said committee member Dr. Helen Keipp Talbot, a professor of medicine at Vanderbilt University and the only “no” vote.

Dr. Sara Oliver, head of outbreak intelligence for the CDC, presented data at Thursday’s meeting that showed that during the winter omicron surge, unvaccinated children in this age group were twice as likely to be hospitalized as those who received the two-dose series. .

“As a mother and an infectious disease specialist and a member of ACIP, if my children were still in this age range, I would give them this reminder,” said committee member Dr. Camille Kotton, disease clinician infections at Massachusetts General Hospital. In Boston.

Committee member Dr. Matthew Daley, principal investigator at Kaiser Permanente Colorado, argued that the third dose should be considered part of a three-dose primary series and not a booster dose.

Indeed, he said, many vaccines given in early childhood against other viruses, such as hepatitis B and rotavirus, typically require multiple doses.

The decision to make boosters available to 5-11 year olds comes as Covid vaccinations have slowed, particularly among children.

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While vaccinated children should be allowed an extra dose, public health officials should exert greater pressure for unvaccinated children to receive their first two shots, said Dr Sybil Cineas, a member of the committee and associate program director for the Brown Combined Internal Medicine- Pediatrics Residency Program.

“As a primary care provider, it’s hard for me to have a discussion about these kinds of issues when only 28% have their primary series,” Cineas said.

Only children under the age of 5 remain ineligible for Covid vaccines, a sore point for many parents and doctors across the country keen to get their youngest vaccinated.

Committee member Dr. James Loehr, a family physician from Ithaca, New York, used the meeting to urge regulators to expedite the review of the Covid vaccine for these children.

Dr. Doran Fink, deputy director of the FDA’s vaccines division, told the committee that regulators were working quickly to review the data.

Fink said Moderna’s vaccine application to the FDA for children ages 6 months to 5 years was completed “just recently” and the agency is working to get the application to its advisory committee as “quickly.” as possible”. A final decision on this vaccine is expected in June.

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