The Food and Drug Administration on Tuesday authorized booster doses of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11, the first booster dose for the age group intended to revive waning immune protection.
The authorization comes as the US continues to see COVID-19 cases rise due to the extremely transmissible omicron coronavirus subvariants, specifically BA.2 and BA.2.12.1, which now account for an estimated 51 percent and 47.5 percent of all reported cases, respectively. Transmission levels are considered high in just over 50 percent of US counties, according to the latest data from the Centers for Disease Control and Prevention. The seven-day average of new daily cases is nearly 96,000, up 57 percent in the last two weeks, according to data tracking by The New York Times. Hospitalizations are around 22,000, up 26 percent. Daily deaths are averaging around 300.
But some experts highlight that data on the current omicron-subvariant wave is muted because testing sites have shuttered, and many people are relying on at-home testing results that are largely not reported. Peter Hotez, a vaccine expert at Baylor College of Medicine, tweeted over the weekend that the current wave could rival that of the original omicron wave in January. He strongly urged Americans to get vaccinated and boosted and to vaccinate their children.
Though numerous studies have noted that immune protection from vaccines and infections wanes over time—and is particularly weakened by omicron and its subvariants—booster doses can significantly strengthen protection, reducing the risk of infection and transmission while offering strong protection against severe outcomes.
Weak vaccination rates
Still, only about 30 percent of the US population is boosted. For children 5 to 11, the vaccination figures are particularly low. Though vaccines have been available for the age group since November, only about 29 percent of children 5 to 11 are fully vaccinated.
Public health experts, along with FDA officials, hope that more parents will vaccinate their children and will get booster doses when they’re available.
“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf said in a statement Tuesday. He continued:
The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.
In April, Pfizer announced trial data that found the booster dose produced a strong immune response in children and did not present any safety concerns. The FDA determined that the booster dose will help provide continued protection from COVID-19, outweighing any potential risks. The authorization allows for a booster at least five months after a child completes the primary two-dose series.
But before the boosters can go into little arms, the CDC needs to sign off on their use. The agency is convening its committee of independent expert advisers this Thursday and is expected to review and vote on the matter then. Outside experts expect that the committee will recommend the boosters and that CDC Director Rochelle Walensky will endorse the recommendation quickly.