FDA authorizes Pfizer booster dose for 12- to 17-year-olds

As schools across the country return to in-person learning after winter break amid soaring cases of COVID-19 caused by the Omicron (B.1.1.529) variant, the Food and Drug Administration (FDA) this morning authorized the use of a booster dose in children ages 12 to 17 if it has been at least 5 months since completing the primary vaccination series.

The regulatory agency also said children ages 5 to 11 who are immunocompromised can receive a third dose, as well. The booster period was also reduced from 6 months following the primary series to 5 months for adults.

The FDA said no new safety concerns have appeared since May, when the Pfizer/BioNTech vaccine was first approved for use in 12- to 17-year-olds. They also referenced Israeli data in their decision, which showed no new safety concerns in 4.1 million kids in this age-group who received a booster.

"Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research in a press release.

The Pfizer vaccine is the only vaccine approved for use in children in the United States.

The FDA's authorization must also be approved and signed off on by the Centers for Disease Control and Prevention, which will likely do so later this week.

The CDC COVID Data Tracker shows 62% of Americans are fully vaccinated against COVID-19, 73.3% have received at least one dose of vaccine, and 33.4% of fully vaccinated Americans have received a booster dose.

Some school districts move to virtual instruction

Because of significant case increases across the country, some school districts have moved to in-person learning for at least part of January. According to the Associated Press, Milwaukee Public Schools moved to virtual instruction this week, as did districts in Detroit, Newark, and Cleveland.

School officials say they are short staffed as teachers and employees call in sick and are unable to provide tests for staff.

A lack of at-home tests has promoted the FDA to authorize two more rapid tests for emergency use, one from Roche and the other from Siemens, using its new fast-track system.

In related news, the Department of Defense and the Department of Health and Human Services have awarded a $136.7 million contact to MilliporeSigma to establish US production of nitrocellulose membrane production, a key material used in COVID rapid tests.

Omicron infections continue to cause record high case counts across the country. Yesterday, the United States reported 254,091 new COVID-19 cases yesterday and 244 deaths, according to the Johns Hopkins COVID-19 tracker.

The 7-day average of new daily cases is 410,039, with 1,578 deaths and 99,763 hospitalizations, according to the Washington Post tracker. New daily cases rose 101% in the past week, deaths rose 37%, and hospitalizations rose 27%.

Other US developments

  • Coronavirus levels detected in sewage samples across the country are higher now than at any previous point in the pandemic, NBC News reports.

  • Texas Gov. Greg Abbott announced on Friday that the state had requested federal assistance to help with COVID-19 testing and treatment amid a surge in cases, according to The Hill.

  • Novavax has submitted its emergency use authorization application for its recombinant nanoparticle protein-based COVID vaccine to the FDA.

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