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Pharmaceutical giant Pfizer has submitted a request to the Food and Drug Administration (FDA) to extend the use of its COVID-19 vaccine to children and adolescents aged 12 to 15. This request aims to amend the emergency use authorization that was originally granted for individuals aged 16 and older. The announcement comes amid rising COVID-19 cases among younger populations in various states, as reported by NBC News.
Recently, Pfizer revealed that clinical trials indicate its vaccine is both safe and 100% effective in preventing COVID-19 in the 12-15 age group (these findings are pending peer review). Side effects observed in this demographic were largely consistent with those experienced by adults, including sore arms, fatigue, and headaches. “We hope to initiate vaccinations for this age group before the upcoming school year,” stated Pfizer CEO Albert Bourla when discussing the trial results.
Additionally, Pfizer is conducting research on the vaccine’s effectiveness in even younger children, specifically those between 6 months and 11 years. The first doses for this trial were administered in March. “We understand the urgency to broaden the vaccine’s authorization for younger populations and are encouraged by the clinical trial outcomes for adolescents ages 12 to 15,” Bourla added.
Furthermore, participants in the trial showed levels of neutralizing antibodies comparable to those found in older adolescents and young adults who had received the vaccine. Pfizer’s Phase 3 trials in adults demonstrated approximately 95% efficacy in preventing symptomatic COVID-19, with the real-world efficacy slightly lower at around 90%, according to data from the Centers for Disease Control and Prevention.
Dr. Jamie Thompson, a pediatric infectious disease specialist at a prominent medical center in Nashville, emphasized, “Vaccinating teenagers is crucial for navigating our way through the pandemic.” She further noted that expanding the vaccine eligibility to younger age groups enhances protection for vulnerable populations, including older adults and those with pre-existing conditions.
As the U.S. continues its efforts to vaccinate adults swiftly, ensuring that children are also vaccinated is vital for achieving herd immunity, making any progress in this regard a significant victory.
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In summary, Pfizer is actively seeking FDA approval to extend its COVID-19 vaccine for use in adolescents aged 12-15, following promising trial results. This move is seen as a crucial step towards increasing vaccination rates among younger populations during the ongoing pandemic.