With news that Moderna has submitted to the U.S. Food and Drug Administration a request for emergency use authorization for a vaccine for children ages 6 months to 6 years, the American Academy of Pediatrics (AAP) urges the final review process begin as soon as possible with the transparency and thoroughness that children and families deserve.
“For families with young children, the anxiety and frustration of the pandemic is ongoing, as they still lack the protection of a COVID-19 vaccine. We urge the FDA and CDC to move with all possible speed to review the data on the Moderna vaccine, and if it is safe and effective, to authorize it as soon as possible for this age group. Our youngest children deserve to have the same protection from a vaccine as every other group in our society,” said AAP President Moira Szilagyi, MD, PHD, FAAP.
COVID-19 vaccines have been available for 12- to 17-year-olds since May 2021 and for 5- to 11-year-olds since November 2021 and they have been shown to be safe and effective in these age groups.
“Pediatricians are eager to help families who are understandably anxious about making sure their youngest children are protected from COVID-19,” Dr. Szilagyi said. “They have waited a long time for the reassurance of a vaccine to protect their children and to minimize disruption from exposures and quarantines. Children are not immune from COVID, which can cause severe and long-term illness, hospitalizations and even death.”
Moderna initiated its request for authorization of a two-dose vaccine for children 6 months to under 2 years and 2 years to under 6 years of age. The company states it will finish the submission to the FDA next week.
The number of children infected with COVID has started to rise again after a brief decline following the omicron variant surge. As of April 21, more than 37,000 additional child COVID-19 cases were reported, an increase of about 43% from two weeks ago. This marks the second consecutive weekly increase in child cases.
AAP also urges parents of children already eligible for the COVID vaccine to make sure they are up to date on vaccinations. As of April 20, roughly 28% of U.S. children ages 5-11 years had received both doses of the vaccine, and 35% had received at least one dose. There are 18.6 million children ages 5-11 who have yet to receive their first COVID-19 vaccine dose, according to the CDC.
AAP is eager to see data on a COVID-19 vaccine for children under age 5, and recognizes the hardships placed on families whose youngest children remain without protection.
“AAP continues to urge that the process for authorizing a vaccine be transparent, data-driven and thorough to ensure the safety and efficacy of a vaccine for our little ones,” Dr. Szilagyi said. “Parents are encouraged to talk with their pediatrician if they have questions about the vaccine.”