U.S. pharmaceutical company Pfizer and its German COVID-19 vaccine partner, BioNTech, announced Thursday recent trials show booster doses of its vaccine effectively protect healthy children ages 5 to 11 from the omicron variant of the coronavirus.
In a press release, the companies say their phase-three trials examined data from 140 children ages 5 through 11 who received a booster dose approximately 6 months after the initial two-dose Pfizer-BioNTech COVID-19 vaccine regimen.
The companies report, while all participants demonstrated significant increased protection, 30 of the trial participants showed omicron-neutralizing antibodies increased by 36 times compared to those who only received the original two-shot dosage.
The companies say more than 10,000 children under the age of 12 have participated in clinical trials investigating the Pfizer-BioNTech COVID-19 vaccine with no new safety concerns observed.
The studies have not been published or reviewed by independent scientists.
The companies plan to apply for U.S. Emergency Use Authorization of a booster dose in the 5-11 age group in coming days, with additional submissions to global regulatory agencies, including the European Medicines Agency, to follow.
Earlier this year, the U.S. Food & Drug Administration (FDA) authorized a third dose of the Pfizer-BioNTech vaccine for children ages 12 to 15 and those aged 5 through 11 years who are immunocompromised. The FDA has also approved a third booster of the vaccine for people 50 and older.
Some information for this report was provided by the Associated Press and Reuters.