Health · June 23, 2022

FDA advisers vote to recommend Moderna Covid vaccine EUA for children ages 6 to 17

The effectiveness of Moderna’s vaccine ranged from about 77 percent for children ages 6 to 11 to 93 percent for 12 to 17 year olds. However, these studies were conducted when the delta variant/alpha strain was predominant, raising questions about how effective the two-dose primary series is against Omicron.

Committee members urged federal health officials to communicate the benefits of a possible third dose — which is not yet under consideration for these age groups in relation to Moderna’s shot — to protect recipients from the worst effects of Omicron and its subvariants.

The advisory committee on Wednesday will consider Moderna’s vaccine for children aged 6 months to 5 years, which would correspond to a dose of 25 micrograms, alongside Pfizer-BioNTech’s offer to vaccinate children under 5 years of age.

The FDA is not required to follow the recommendations of its advisory committees, but usually does. Should the FDA approve the injections this week, the Centers for Disease Control and Prevention’s independent advisory panel will likely consider approving their administration during Friday and Saturday sessions.

It’s unclear whether making Moderna’s vaccine available to teenagers and younger children will do much to change the course of vaccinating teenagers and children against Covid.

According to CDC data released on Dec.

When asked how the product could help improve vaccine uptake, Rituparna Das, vice president of clinical development at Moderna, said the company is reaching out to pediatricians and other vaccine administrators to answer questions.

“I think the goal would be for all of us together to increase vaccine uptake, but I can’t speculate on what the specific effect of the approval would be,” she said.

Recent surveys by the Kaiser Family Foundation suggest that about 20 percent of parents would like to vaccinate their children under the age of 5 as soon as they are allowed, while almost 40 percent plan to “wait and see” how the vaccine affects others Children and another 40 percent are reluctant to vaccinate at all.

No cases of myocarditis or pericarditis – inflammation of the heart muscle or the lining of the heart – were reported in Moderna’s pediatric studies. Both conditions are known risks of Covid-19 messenger RNA vaccines, particularly in men aged 12 to 39.

Data from international vaccine safety surveillance programs suggest that there is a higher rate of heart disease after vaccination with Moderna’s vaccines than with Pfizer-BioNTech. That information, along with the availability of the Pfizer vaccine for adolescents, convinced the FDA last fall not to proceed with an EUA for 12- to 17-year-olds, the agency said in the briefing document.

But analyzes of US data in active and passive surveillance systems conducted in April and May “support no difference in myocarditis/pericarditis risk for [Moderna] compared to [Pfizer-BioNTech] or suggest a small difference due to uncertainties,” the FDA said, later calling evidence of a risk difference between the two products “inconclusive.”

Committee members expressed ongoing concern about the side effect, but agreed with the FDA that a notable difference in risk between Moderna’s vaccine and Pfizer’s was unclear.