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As students head back to school following the holiday break, the U.S. Food and Drug Administration (FDA) has approved the Pfizer booster vaccine for children aged 12 to 15 years, enhancing their defense against COVID-19. The FDA has also reduced the interval for receiving the booster shot from six months to five months after the second dose. Additionally, booster shots have been authorized for specific immunocompromised children aged 5 to 11.
This decision comes at a critical time, with the Omicron variant causing a rise in cases in various regions. “Throughout the pandemic, the FDA has had to swiftly adapt to the evolving virus using the best available science to prioritize public health,” stated Dr. Janet Woodcock, Acting FDA Commissioner. “With the current Omicron wave, it’s essential to continue implementing effective preventive measures, including vaccinations and boosters, while also adhering to safety protocols like mask-wearing and social distancing.”
In granting approval for the booster for teens, the FDA examined real-world data from Israel, which included safety information from over 6,300 adolescents in the 12 to 15 age range who received a booster at least five months after their initial vaccination series. The review indicated no significant safety concerns, including no new cases of myocarditis or pericarditis reported in this group. Furthermore, data from over 4.1 million individuals aged 16 and older in Israel who received a booster dose showed no alarming safety issues.
While boosters for those aged 16 and older are already available, the FDA has yet to authorize them for the general 5 to 11-year-old population. However, immunocompromised children in this age group are now eligible for an additional primary dose to ensure they receive adequate protection from the virus.
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