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Youths ages 12 to 15 years old can now get a COVID-19 booster after the U.S. Food and Drug Administration amended its emergency-use authorization for the Pfizer-BioNTech COVID-19 vaccine.

The FDA announced the decision Monday, Jan. 3, along with two other changes regarding the Pfizer vaccine: reducing the time between the primary vaccination and a booster from six months to five months and allowing a third dose for certain immunocompromised children ages 5-11 years old.

A Pfizer booster was already approved for ages 16 and older.

The announcement wasn’t a surprise. Health officials had been expecting it since the week after Christmas as the Omicron variant of COVID-19 surged across the United States. The variant is a highly transmissible form of SARS-CoV-2, the coronavirus that causes COVID-19.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” stated acting FDA Commissioner Dr. Janet Woodcock in a media release. “With the current wave of the Omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing, and social distancing in order to effectively fight COVID-19.”

According to Texas Department of State Health Services data, Omicron became the prevalent variant in the state as of Dec. 18, when it accounted for almost 85 percent of reported cases. The Mayo Clinic reported that the average COVID-19 positive test rate is 21 percent as of Dec. 31. On Nov. 25, the rate was about 6 percent. The clinic determines the average positive test rate based on “the percentage of coronavirus tests that are positive for the virus in the past 14 days out of the total tests reported in that time period.”

In determining the amendment to its emergency-use authorization for the Pfizer booster, the FDA reviewed “real-world data” from Israel for more then 6,300 youths 12-15 years old. These individuals received the booster dose at least five months after their initial two-dose vaccination series.

According to the FDA, “the data shows there are no new safety concerns following the booster in this population.” 

The FDA also cut down the time between completion of the primary two-dose Pfizer vaccine and a booster to five months for ages 12 years and older. It had previously recommended waiting six months. Again, FDA officials reviewed data from Israel, where more than 4.1 million people 16 years and older received the booster a minimum of five months after the initial vaccination series.

The data showed no new safety concerns.

“Additionally, peer-reviewed data from multiple laboratories indicate that a booster dose of Pfizer-BioNTech COVID-19 vaccine greatly improves an individual’s antibody response to be able to counter the Omicron variant,” according to the FDA. 

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2 thoughts on “FDA approves booster for ages 12-15

  1. Please correct your headline: The booster was “authorized” (NOT “approved”), still under EUA (Emergency Use Authorization).

    Per the FDA website, NONE of the various vaccinations in use throughout the USA have been “approved” — they are ALL still only “authorized” under the EUAs and are ALL still in various phases of clinical trials, requiring “informed consent.”

    If prospective recipients consent to being part of the ongoing studies, they can then agree to receive any of the various injections.

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