FDA approves booster shot for 12- to 15- year-olds

The window for boosters to be administered has been narrowed from six months to five months.


On Monday, the Food and Drug Administration (FDA) approved the use of the Pfizer and BioNTech third dose for children 12 to 15 years old. The agency also approved the narrowing of the booster interval from six to five months. A third shot was approved for immunocompromised children aged 5 to 11 years. The approvals come as the U.S. battles a surge in COVID-19 cases at the hand of the Omicron variant. In the last week, the COVID-19 cases doubled to an average of 418,000 cases a day. The director of the FDA’s Centre for Biologics Evaluation and Research, Peter Marks stated, "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."


According to the Centre of Disease Control, two doses of the mRNA vaccine are 35% effective against Omicron while a booster provides 75% effectiveness. To ensure better protection against the variant the booster will be administered five months after vaccination, however Moderna’s booster interval remains unchanged and will be administered at six months. The FDA made their decision based on real-world evidence from Israel and safety data from more than 6,300 children aged 12 to 15 years who received the Pfizer-BioNTech booster dose at least 5 months after their second vaccination. United Kingdom and Israel are just some of the countries that have reduced the window for boosters to five months instead of six. The U.S. government has encouraged their vaccinated residents to get booster shots.