FDA Grants Emergency Use Authorization to Pfizer-BioNTech Renewed Booster Injection for Children 5 to 11 Years of Age. Previously, it had been approved for individuals 12 years of age and older. The agency approved Moderna’s bivalent booster for children ages 6 to 17. It has previously been licensed for use by persons 18 and older.
“As children have returned to school in person and people are resuming pre-pandemic behaviors and activities, the risk of exposure to the virus that causes covid-19 may increase,” Peter Marks, the FDA’s top vaccine official, said in a statement. “Vaccination remains the most effective measure to prevent severe consequences of covid-19, including hospitalization and death.”
Whether parents will get their kids vaccinated with the reconstituted booster is far from clear. Since the FDA launched the booster for the elderly population in late August, its uptake has been disappointingly slow. One-third of adults say they eventually plan to get these vaccines, according to the Kaiser Family Foundation poll.
The Biden administration has been urging adults to get modified boosters amid concerns that cooler weather will bring a surge in new Covid-19 cases as people move indoors and the spread of respiratory infections.
The reconstituted boosters are bivalent – they include components of the original strain of the virus and the omicron sub-variants BA.4 and BA.5, which make up about 80% of the circulating virus, According to the CDC. As the coronavirus continues to mutate, the updated version is designed to better protect against covid-19. Health authorities say boosters are needed to restore protection that has weakened since previous vaccinations, and that the new variants are more transmissible and able to evade immune defenses.
The updated booster can be administered at least two months after the initial two-dose series or the previous booster.
Vaccination of children and adolescents with the initial two-shot series has lagged. According to an analysis of CDC data by the American Academy of Pediatrics, only 31 percent of children ages 5 to 11 received two vaccines, and 58 percent of children ages 12 to 17 completed the series.
Authorization of the bivalent booster for children under 5 will take several months, FDA officials said.
The federal government purchased more than 170 million doses of bivalent covid-19 vaccine boosters for distribution as part of a campaign planned in the fall and early winter to strengthen protection against circulating strains.