The Food and Drug Administration is planning to authorize Pfizer-Biotech’s COVID-19 vaccine in adolescents aged 12 to 15 later this week or early next week, according to The New York Times.
The Times cited unnamed federal officials who were not authorized to speak publicly on the FDA’s plans if the FDA allowed the vaccine to be used by teenagers this week, the Centers for Control and Prevention’s Vaccine Advisory Panel. The disease is likely to meet the next day to review clinical trial data and make recommendations for its use, the Times reported.
On March 31, Pfizer announced that the vaccine completely protected adolescents ages 12 to 15 from COVID-19 in a small, Phase 3 clinical trial.The vaccine was also well tolerated in the age group, causing it. Most standard side effects
In the trial, 2,260 people, 1,131 adolescents aged 12 to 15 were vaccinated, while 1,129 were given a placebo.There were 18 patients with COVID-19 in the trial, all of which were placebo-controlled. The vaccinated group appeared to produce higher levels of neutral antibodies than the group previously seen in people aged 16-25, Pfizer noted.
“We share the urgency to expand our vaccine authorization to the younger population and this is supported by clinical trial data from adolescents aged 12 to 15,” said Albert Bourla, Pfizer CEO. In a press release at the time. “We plan to send this information to the FDA as a proposed amendment to our emergency authorization in the coming weeks and hopefully other regulators around the world. That I will start vaccinating this age group before the next semester of the school year. “
Pfizer and Biotech are conducting clinical trials in children 6 months to 2 years, 2 to 5 years and 5 to 11 years old. Pfizer-BioNTech It is allowed to be used only by persons aged 16 and over
So far, more than 105 million adults in the United States, about 32 percent of the population, have been fully vaccinated against COVID-19, more than 147 million about 44 percent have had at least one dose.
But vaccination rates in the United States have been down since mid-April, down from an average of 2.6 million vaccinations a day to 2.3 million today. Permission to use the vaccine Pfizer-BioNTech In adolescents, the need for vaccines in the country can be re-energized before summer activities and the start of school in the fall.