In the midst of back-to-school for millions of students, the U.S. Food and Drug Administration (FDA) on Monday authorized the third dose of the Pfizer-BioNTech COVID-19 vaccine for children 12 to 15 years of age. (FDA) on Monday authorized the third dose of the Pfizer-BioNTech COVID-19 vaccine for children 12 to 15 years of age, in the face of a growing number of cases nationwide, driven by the Omicron variant.
The agency also shortened the time between the second Pfizer dose and a booster dose to at least five months, which is expected to result in more and more people coming forward for vaccination.
In addition, and as a measure to mitigate the impacts being caused by the Omicron variant, the FDA authorized a third dose of the primary series for certain immunosuppressed children 5 to 11 years of age.
"Throughout the pandemic, as the virus that causes COVID-19 has continually evolved, the need for FDA to adapt quickly has meant using the best available science to make informed decisions with the health and safety of the American public in mind," said FDA Acting Commissioner Janet Woodcock.
"With the current wave of the Omicron variant, it is critical that we continue to take effective life-saving preventive measures such as primary vaccination and boosters, use of masks and social distancing to effectively combat COVID- 19," he added.
The agency has determined that the health protection benefits of a single booster dose of Pfizer Pharmaceuticals' COVID-19 vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur, including hospitalization and death, outweigh the potential risks in persons 12 to 15 years of age.
The decision was made after the FDA reviewed data from Israel, including safety data from more than 6,300 people aged 12 to 15 years who received a booster dose of the vaccine at least 5 months after completing the two-dose primary vaccination series.
These additional data allowed the FDA to reevaluate the benefits and risks of using a booster in the younger adolescent population in the context of the current increase in COVID-19 cases.
Thus, the data showed that there are no new safety concerns after a booster in this population. To date, no new cases of myocarditis or pericarditis have been reported.
In addition, peer-reviewed data from several laboratories indicate that a booster dose of Pfizer vaccine greatly enhances an individual's antibody response to counteract the omicron variant.
Therefore, allowing booster vaccination at five months instead of six months may provide better protection for people against the variant that is gaining more and more strength due to its high transmissibility.
"While today's action applies to the Pfizer-BioNTech COVID-19 vaccine, FDA continues to review data on all available vaccines and will provide additional updates as appropriate," the FDA said in a statement.
On the other hand, the agency pointed out that children aged 5 to 11 years who are fully vaccinated and not immunosuppressed do not need a third dose at this time.
However, he said he will continue to review the information and communicate with the public if data emerges that suggests booster doses are needed for this pediatric population.
"Based on FDA's evaluation of currently available data, a booster dose of currently licensed vaccines may help provide better protection against the delta and omicron variants. In particular, the omicron variant appears to be more resistant to the levels of antibodies produced in response to doses of the primary series of the current vaccines," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research.
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