Younger children may soon be eligible to receive an Omicron-target booster shot later this year, following U.S. Food and Drug Administration (FDA) applications from Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA).
Pfizer, and its vaccine partner BioNTech (NASDAQ: BNTX), have asked the FDA this week to expand its emergency use authorization (EUA) for the companies' new bivalent COVID booster shots to include children ages 5- to 11-years-old. Similarly, Moderna has requested the FDA to authorize its booster for adolescents ages 12 to 17 and for children ages 6 to 11.
Like the updated booster shots that became available for adolescents and adults earlier in September, these vaccines target both the original SARS-CoV-2 virus as well as the Omicron BA.4 and BA.5 subvarinats that are now the dominant viral strains globally.
Pfizer's bivalent vaccine is currently authorized for Americans aged at least 12 years, while Moderna's is authorized for adults aged 18 years and older. Those seeking to receive the bivalent booster must first receive a primary vaccine series from either Pfizer, Moderna, Johnson & Johnson (NYSE: JNJ) or Novavax (NASDAQ: NVAX).
"The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant," said CDC Director Dr. Rochelle Walensky in a statement following the recommendation of the bivalent vaccines for older age groups. "They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants."
Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) said in its Fall Vaccination Operational Planning Guide that it expects to issue a recommendation on these bivalent vaccine boosters for children by early to mid-October.
In-line with previous guidance for older age groups, the CDC will recommend that the bivalent vaccine will be the only booster offered if authorized by the FDA, meaning providers will no longer provide a third dose of the original vaccine formulas as a booster shot.
According to the CDC, 4.4 million Americans have received an updated booster dose since they were authorized in early September.