FDA Advisors Voted to Recommend EUNA Covid Vaccine for Children 6 to 17

The effectiveness of the Moderna vaccine ranged from 77% for children 6 to 11 years of age to 93% for children 12 to 17 years of age. But these studies were conducted when the Delta variant and the Alpha strain, respectively, were predominant, raising the question of how effective the two-dose primary series was against Omicron.

Committee members urged federal health officials to communicate the benefits of a possible third dose, which is not yet being considered for these age groups in regards to the Moderna shot, in protecting recipients from the worst effects of Omicron and its sub-options.

The Advisory Committee will review the Moderna vaccine for children aged 6 months to 5 years, which will be a 25 microgram dose, on Wednesday, along with Pfizer-BioNTech’s application to vaccinate children under 5 years of age.

The FDA is not required to follow the advice of its advisory committees, but usually does. If the FDA authorizes the vaccines this week, the Centers for Disease Control and Prevention’s independent advisory panel will likely consider their administration’s approval during meetings Friday and Saturday.

It is unclear whether Moderna can make the vaccine available to teens and young children to change the trajectory of vaccinating teens and children against Covid.

As of April 30, only 29 percent of U.S. children ages 5 to 11 are fully vaccinated against Covid, compared with nearly 56 percent of children aged 12 to 15 and 67 percent of children aged 16 and 17, according to CDC data as of April 30. .

Asked how this product could help improve vaccine adoption, Rituparna Das, Moderna’s vice president of clinical development, said the company is reaching out to pediatricians and other vaccine administrators to answer questions.

“I think the goal for all of us will be to increase the use of the vaccine, but I can’t speculate on what exactly the authorization will give,” she said.

A recent survey by the Kaiser Family Foundation suggests that about 20 percent of parents want to vaccinate their children under 5 as soon as they are allowed to, while nearly 40 percent plan to “wait and see” how the vaccine works for other children, and another 40 percent are more reluctant are vaccinated. generally.

No cases of myocarditis or pericarditis, inflammation of the heart muscle or mucosa, respectively, have been reported in Moderna’s pediatric studies. Both conditions are known risks of Covid-19 messenger RNA vaccines, especially among men aged 12 to 39 years.

Data from international vaccine safety surveillance programs show that more heart disease occurs after immunization with Moderna vaccines than with Pfizer-BioNTech vaccines. This information, along with the availability of a Pfizer vaccine for teens, convinced the Food and Drug Administration (FDA) last fall not to move ahead with EUA for children aged 12 to 17, the agency said in a white paper.

But an analysis of U.S. active and passive surveillance data in April and May “does not support a difference in risk of myocarditis/pericarditis for [Moderna] compared with [Pfizer-BioNTech] or suggest a small difference due to uncertainties,” the FDA said, later calling the evidence for a difference in risk between the two products “inconclusive.”

Committee members expressed continued concern about the side effect, but agreed with the FDA that the marked difference in risk between the Moderna vaccine and the Pfizer vaccine was unclear.