CDC panel recommends Pfizer's COVID-19 vaccine for kids as young as 12

Adolescents ages 12 to 15 should get the Pfizer-BioNTech COVID-19 vaccine and they can get their other routine vaccinations along with it, a federal advisory committee said Wednesday.

The Centers for Disease Control and Prevention's panel met to discuss the safety, immune response and effectiveness of the vaccine in this age group, after the Food and Drug Administration signed off Monday on the shots.

The same Advisory Committee on Immunization Practices last December signed off on the Pfizer-BioNTech vaccine for adults and teens ages 16 to 17.  Fourteen members of the panel on Wednesday endorsed lowering the age limit to 12, with one member recusing herself.

CDC Director Rochelle Walensky officially signed off on the recommendation Wednesday evening. 

"This official CDC action opens vaccination to approximately 17 million adolescents in the United States and strengthens our nation’s efforts to protect even more people from the effects of COVID-19," she said in a statement.

Out of an abundance of caution, the original recommendation for COVID-19 vaccines had included a two-week window of separation between a COVID-19 vaccine and any other vaccine so the cause of any side effects would be clear and so that safety data could be collected.

The recommendation also was updated for all age groups by the committee on Wednesday, said CDC's Dr. Kate Woodworth.

In a statement, the American Academy of Pediatrics recommended COVID-19 vaccination for all children and adolescents, 12 years of age and older who do not have a medical reason not to.

The academy also supports children and adolescents getting the COVID-19 vaccine together with other vaccines “given the importance of routine vaccination and the need for rapid uptake of COVID-19 vaccines,” said Dr. Yvonne Maldonado, the academy’s representative on the advisory committee. She is a professor of pediatrics at Stanford University School of Medicine.

On Wednesday, the CDC expanded emergency-use authorization in kids ages 12 to 15.

So many children have fallen behind on their vaccinations during the pandemic that allowing them to get all the shots they need at once will be helpful, said L.J. Tan, chief strategy officer with the Immunization Action Coalition.

"This is necessary to ensure that we can continue to get back to pre-COVID-19 coverage levels for routine adolescent vaccines and also for the catch up vaccinations," he said. 

Pfizer-BioNTech tested the vaccine in more than 1,000 adolescents, giving an equal number a placebo. Among the 2,260 participants, only 16 developed COVID-19, all of whom received the placebo.

None of the adolescents suffered a severe reaction to the vaccine and the biggest side effect for adolescentsin COVID-19 vaccine trials was headache and arm pain. The advisory committee said it was fine for parents to give their children pain relievers after the shot, Woodworth said. 

COVID-19 is now one of the top 10 causes of death among adolescents ages 12 to 17, said Dr. Sara Oliver, co-lead for the ACIP COVID-19 Vaccines Work Group. The disease accounted for 1.3% of all deaths among adolescents between Jan. 1, 2020, and April 30, or 127 deaths overall.

“While this sounds low, it's worth noting that this would still be in the top 10 causes of deaths among children,” Oliver said.

Adolescents ages 12 to 17 years also are at risk of severe illness from COVID-19. There have been more than 1.5 million reported cases and more than 13,000 hospitalizations to date in that age group, Oliver said.

They’re also more likely to transmit COVID-19 to people in their households and communities than younger children, she added.

Other vaccine makers are also testing their shots in teenagers but have not yet completed their studies or requested authorization to deliver their shots to minors. 

Pfizer-BioNTech and the others are also testing their vaccines in three groups of younger children, stepping down in age: 5- to 11-year-olds, 2- to 4-year-olds and 6-month-olds to 2-year-olds.

The first of those studies in older children is expected to be completed in late summer or early fall, but vaccines are unlikely to be available to these age groups before the start of the school year.

It may take until the end of the calendar year or early next year before there is enough data on the youngest children, Pfizer-BioNTech has said, because they may require lower doses of the vaccine, which need to be tested.

Oliver noted surveys show that between 46% and 60% of parents plan on vaccinating their children against COVID-19.

When adolescents between 13 and 17 were asked if they wanted to be vaccinated, 51% said they definitely wanted to be and 20% were not sure, she said.

The ACIP work group anticipated a quick ramp-up to make the vaccine available to the younger adolescents. 

A back-to-school campaign would be launched from July through September. Getting vaccines to this age group would include working with federal health centers, pharmacies, public health, and adolescent provider networks to hold programs at schools, the committee said.

It's unclear whether school districts and summer programs will require adolescents to be vaccinated, now that shots are available to them. Many colleges have said they expect students to be vaccinated before arriving on campus in the fall. 

"This is a big step for our country. Vaccinating a younger population brings us closer to returning to a sense of normalcy and to ending the pandemic," acting FDA Commissioner Janet Woodcock said on Monday.

Multiple efforts are underway to make the vaccine more available, the Biden administration said Wednesday.

Together with states, CDC is working to enroll more pediatricians and family practitioners as COVID-19 vaccination providers and to make sure shots are available at pharmacies so teens can get them close to home.

Because 40% of the nation’s children are enrolled in Medicaid and the Children’s Health Insurance Program, the Centers for Medicare and Medicaid Services will work with state Medicaid programs, and plans to reach out to families and answer questions.

An ad campaign aimed at teens and their parents will launch in the coming weeks from the Department of Health and Human Services and partners. In August, “back to school” ads will encourage families to make vaccination part of annual physicals and sports physicals.

Contributing: Karen Weintraub, USA TODAY