By Jared S. Hopkins and Betsy McKay 

A federal advisory panel is scheduled to meet Wednesday to decide whether to recommend adolescents receive the Covid-19 vaccine from Pfizer Inc. and BioNTech SE.

U.S. regulators on Monday approved the two-dose shot for use in children as young as 12 years old, the first Covid-19 vaccine for children in the nation. Now the Advisory Committee on Immunization Practices, or ACIP, which advises the Centers for Disease Control and Prevention on vaccination policy, will review clinical trial data and other relevant information.

The 15-member panel consists of pediatricians, infectious-disease doctors and other medical experts. Its meeting is scheduled to start Wednesday morning. The panel is expected to vote on recommending the Pfizer-BioNTech Covid-19 vaccine for adolescents in the afternoon.

Many parents, school officials and health authorities are eager for children to receive vaccinations in time for summer camps and the start of the next school year. Health authorities expect children to be vaccinated at pharmacies, physician offices and existing mass-vaccination sites.

Some pediatricians and vaccine sites began administering shots Tuesday, but most are waiting for a formal recommendation from ACIP. The advisory committee will review data to determine whether the Pfizer-BioNTech vaccine can be recommended for the entire population of 12-to-15-year-olds or whether it should be restricted to certain subgroups. A committee recommendation becomes policy when the CDC's director, Dr. Rochelle Walensky, signs it.

State health departments, hospitals and other vaccination sites have said this week they were preparing to administer shots Thursday.

There are nearly 17 million children ages 12 to 15 in the U.S., according to the Kaiser Family Foundation, a health nonprofit.

Children are at lower risk of Covid-19 infection than adults, according to health experts, and when they are infected, they tend to experience milder symptoms. Yet some children can become seriously ill and some can spread the virus.

"We all want to get past this pandemic, and the more people who get vaccinated, the better," said Sean O'Leary, a professor of pediatrics at the University of Colorado School of Medicine and liaison to ACIP for the Pediatric Infectious Diseases Society. "If everyone in a family can get vaccinated, that makes a huge difference. This summer, families will be able to do a lot more things more comfortably than with the risk of getting Covid-19, since these vaccines are so effective."

At Wednesday's meeting, ACIP members are expected to discuss results of the Pfizer-BioNTech study of 2,260 adolescents that found the two-dose shot was 100% effective at protecting against symptomatic Covid-19 in 12- to 15-year-olds. Researchers found children who received the vaccine generated an immune response similarly strong as in adults. No serious safety concerns were found in that study, according to the companies.

So far, researchers haven't found evidence the vaccine poses any additional or different risks to children versus adults. The most common side effects of the vaccine are flulike symptoms such as fever, muscle aches and chills, according to the CDC.

The Pfizer-BioNTech shot has become the most widely used shot in the U.S. since regulators cleared it in December for use in people 16 years and older after a trial involving 44,000 subjects. More than 1 million Americans who are under age 18 have received the vaccine, according to the CDC.

The Pfizer-BioNTech vaccine is among three authorized for use in the U.S., along with shots from Moderna Inc. and Johnson & Johnson.

Covid-19 vaccines for children under 12 years may be available in the U.S. by the end of the year. Pfizer anticipates asking the Food and Drug Administration in September to authorize its vaccine's use in children 2 to 11 years old should ongoing studies prove positive. It plans to make a similar request for children 6 months to 2 years of age in the fourth quarter, Pfizer said.

Write to Jared S. Hopkins at jared.hopkins@wsj.com and Betsy McKay at betsy.mckay+1@wsj.com

 

(END) Dow Jones Newswires

May 12, 2021 07:14 ET (11:14 GMT)

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