Pfizer’s COVID booster shot for younger teens wins FDA clearance

Harnoorvir Singh Jabbal, 11, gets the COVID-19 vaccine from nurse Chelsea Meyer at Arleta High School on Nov. 8 in the Arleta neighborhood of Los Angeles. Myung J. Chun/Los Angeles Times/TNS

Pfizer’s booster gets FDA clearance for ages 12-15

U.S. regulators cleared Pfizer Inc.’s COVID-19 booster shot for younger adolescents, widening access to additional doses as parents seek to protect their children from the omicron wave and school officials try to keep classrooms open.

The Food and Drug Administration said in a letter to Pfizer on Monday that it had granted an emergency-use authorization for people ages 12 to 15 to receive a third dose of the messenger RNA vaccine, which Pfizer developed with BioNTech SE. The agency also reduced the recommended interval between the second and third doses of the vaccine to five months.

Additionally, the FDA said that immune-compromised children ages 5 to 11 could receive a third primary-series shot at least 28 days following their initial two-dose immunization.

Next, a Centers for Disease Control and Prevention expert panel is expected to discuss the authorization and make further recommendations about how to dispense the shots. The group, the Advisory Committee on Immunization Practices, could meet as soon as this week.

Granting a broader group of teens access to boosters could help tamp down spread of the virus as government officials aim to keep schools open. New daily cases have surged past the peak levels seen in the U.S. a year ago and are expected to continue to climb at least until mid-January.

Many state and local leaders have expressed a desire to avoid moving to hybrid or remote schooling out of concern over other health and educational consequences. With children now returning to school after the holidays, districts are bracing for more students and teachers to contract the virus.

The risk of catching omicron is higher than with other variants, even for fully immunized schoolchildren and adolescents. Studies by the drugmakers and other researchers have found that breakthrough infections with omicron, which accounts for a majority of virus cases in the U.S., are more likely in people who haven’t yet been given a booster shot.

Pfizer said in December that in initial lab studies, company researchers observed a 25-fold reduction in neutralizing antibodies that fight the variant, compared with the original strain of the virus, in people who got two shots. A booster shot restored protection to previous levels.

Some researchers have questioned the need for boosters in younger people, as most adolescents who contract the virus don’t develop severe disease and omicron doesn’t appear to be as virulent as other strains. Additionally, a heart condition called myocarditis has been seen in some people, especially younger males, who have received messenger RNA shots.

Recently, the U.S. has seen an increase in hospitalized children with COVID-19, according to Rochelle Walensky, the director of the Centers for Disease Control and Prevention. Most of those children haven’t been vaccinated, she said. Children under 5 aren’t yet eligible to receive one of the three vaccines authorized in the U.S., and adoption of the shots among younger school-age children has lagged behind the pace of adult immunizations.

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