FDA Approves Pfizer's COVID-19 Vaccine for Younger Teens Ages 12-15; Pharma Claims It Is 100% Effective

The Food and Drug Administration (FDA) extended the emergency use authorization for Pfizer's COVID-19 vaccine for children ages 12-15, allowing millions of younger teens to receive the vaccine. Among other companies, only the Pfizer COVID-19 vaccine has been authorized for the use of 16-18-year-olds.

Younger teens could now receive Pfizer's COVID-19 vaccine

The vaccine was shown to be 100 percent effective in combating COVID-19 in a study involving 1,005 participants in this age group.

Per CBS News, acting FDA commissioner Janet Woodcock, MD, said, "The FDA's extension of Pfizer-BioNTech COVID-19 vaccine's emergency use authorization to cover teens aged 12 to 15 years is a significant development in the battle against the pandemic."

She continued by saying that today's intervention protects a younger generation from COVID-19, taking us closer to restoring normalcy and bringing the pandemic to an end. Parents and guardians should be assured that, as with all of their COVID-19 vaccine emergency use authorizations, the department conducted a comprehensive and detailed analysis of all available evidence.

When it comes to schools, the emergency use permit may be more beneficial to students and families, making it possible for students to return to normal education in person by the fall if they aren't already. According to Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, expanding the vaccine to this age bracket is a crucial move towards helping to reduce the massive public health burden created by the COVID-19 pandemic.

Pfizer has since requested full authorization of its COVID-19 vaccine from the FDA, indicating that it will no longer be sold under the emergency use approval. It would be critical to vaccinate children of all ages to return to normalcy.

The majority of COVID-19 vaccines for adults that are being rolled out worldwide have been approved. Pfizer's COVID-19 vaccine is now being used in several countries by teenagers as young as 16, with Canada being the first to extend its use to include those aged 12 and up.

Parents, school officials, and public health authorities across the country are eagerly anticipating the vaccine's availability to more children. Dr. Bill Gruber, a Pfizer senior vice president who is also a pediatrician, told The Associated Press, "This is a watershed moment in our ability to beat back the COVID-19 pandemic."

Pfizer's COVID-19 vaccine is 100% effective for teens

In the study, there were no cases of COVID-19 among fully vaccinated teenagers, but 18 among children received dummy shots. Researchers discovered that the children developed higher levels of virus-fighting antibodies than young adults in previous trials.

The younger teens received the same vaccine dose as adults. They experienced the same side effects, including sore arms, flu-like fever, chills, or aches, which indicate an overactive immune system, especially after the second dose. Pfizer's adolescent testing met the FDA's high expectations, said the FDA vaccine chief Dr. Peter Marks.

Pfizer-BioNTech recently applied for a similar approval in the European Union, with more countries expected to follow. The latest news is welcome for American families trying to figure out what activities are safe to continue because only the youngest family members have not been vaccinated.

In remarks at the White House last week, President Joe Biden said the administration was "ready to start quickly to make approximately 20,000 pharmacy sites across the country ready to immunize those teenagers as soon as the FDA grants its OK," as per TODAY.com. Vaccines may also be sent directly to pediatricians' offices, where parents may feel more at ease about their children's vaccinations.

Vaccinations will also be accessible at healthcare facilities and other locations. Pfizer announced in late March that results from a Phase 3 clinical trial found that its COVID-19 vaccine was 100 percent effective in preventing the infection in children aged 12 to 15.