CDC advisers recommend Moderna vaccine for adolescents

By Bernard Turk On Jun 24, 2022

Parents are on the brink of having a second option to vaccinate older children after outside advisers to the Centers for Disease Control and Prevention on Thursday unanimously recommended the agency clear Moderna’s two-shot coronavirus vaccine for children 6 through 17 years old.

CDC Director Rochelle Walensky is expected to sign off shortly, which would allow the vaccine to become available by the end of the month.

The Pfizer-BioNTech vaccine is already on the market for children 5 through 17, with kids below the age of 12 eligible since November.

The CDC’s Advisory Committee on Immunization Practices voted 15-0 in favor of the Moderna regimen for children at its Thursday meeting. Concerns raised by committee members mostly related to language on the vaccine vials. They urged Moderna to simplify the wording to avoid confusing those administering the shots.

Experts do not expect the new Moderna option to drive up a low pediatric vaccination rate. Less than a third of children ages 6 to 11 received two Pfizer-BioNTech shots. Officials cited an April survey by the Kaiser Family Foundation showing about a third of parents of children over the age of 5 do not plan to vaccine them.

CDC officials presented data to the advisory panel showing more than 10 million children 5 through 17 years old have contracted coronavirus and more than 600 have died, while vaccinated children are less likely to develop severe illness.

Moderna told Food and Drug Administration advisers last week for every 1 million doses of vaccine distributed in the United States, 95 hospitalizations and 24 intensive care unit stays for children 6 through 11 years old would be avoided. The company estimated 200 hospitalizations and 52 ICU stays would be avoided for children 12 through 17.

Moderna held clinical trials for its adolescent vaccine before the omicron variant emerged. Experts raised concerns the data may not be as reliable given how omicron managed to evade other vaccines, but they expressed confidence Moderna’s shots would still prevent severe illness.

Regulators determined Moderna’s vaccine does not produce serious side effects.

Moderna’s request to approve its vaccine for adolescents last year was held up after concerns about the risk of rare cardiac side effects including myocarditis. There were no reported cases of myocarditis in the Moderna trials on adolescents, but experts said the trials were not large enough to rule it out as a potential side effect.

Nevertheless, CDC officials said the benefits outweigh risks. They said the risk of myocarditis could be further reduced by administering the second dose eight weeks after the first instead of the four to eight week interval recommended for most adults. Research from Canada showed that side effects are less likely when the shots are spaced further apart.

Moderna is also testing a booster for children ages 6 through 17 and plans to request authorization as early as July. Regulators have already approved a third shot of the Pfizer-BioNTech vaccine in that age group.

June has been a significant month for pediatric vaccine. Walensky endorsed Moderna and Pfizer-BioNTech vaccine for children under 5 on Saturday, allowing the youngest Americans to start getting shots this week.

Laurie McGinley contributed to this report.

Source