Pfizer is asking the FDA to extend emergency use of its COVID-19 vaccine to children ages 12-15
- Pfizer Inc has asked the FDA to extend emergency use of its COVID-19 vaccine to Americans 12-15 years old
- Recent clinical trial data found the vaccine was 100 percent safe and effective in younger teenagers
- If approved by the FDA, 12-15 year olds could be vaccinated before the start of the 2021 school year
- Pfizer and its partner BioNTech are also investigating how well their vaccine works in children aged six months to 11 years and expect approval in early 2022
Pfizer Inc has asked the U.S. Food and Drug Administration (FDA) to extend emergency use of its COVID-19 vaccine to Americans 12-15 years old.
When the vaccine was originally approved for use by the FDA in December 2020, it was only intended for people aged 16 and over.
Recently, data from Phase III clinical trials showed the vaccine was 100 percent safe and effective in younger teenagers.
If approved by the FDA, 12 to 15 year olds could be immunized against coronavirus before the start of the 2021 school year.
In a statement on Twitter, the New York-based drug maker said it plans to move similar decisions in other countries that use the vaccine.
Pfizer Inc has asked the FDA to extend emergency use of its COVID-19 vaccine to Americans 12-15 years old. Image: Caleb Chung receives first dose of Pfizer coronavirus vaccine or placebo as a study participant for children ages 12-15 in December 2020
Pfizer said 12-15 year olds could be vaccinated before the start of the 2021 school year if approved by the FDA
Approximately 2,200 teenagers in the United States were enrolled in the study, compared with 40,000 in the study aged 16 and over.
Half of the group received two doses of the vaccine three weeks apart and the other half received two placebo injections.
A total of 18 cases of COVID-19 were reported in the placebo group, while no cases were reported in the vaccine group.
In addition, side effects were similar to those seen in the larger study in 16-25 year olds, including injection site pain, fatigue, fever, and headache.
At the time, Albert Bourla, Pfizer CEO, said the hope was to vaccinate this age group before the start of the next school year.
The researchers plan to follow the participants for two years to gather information about long-term protection, impact, and safety.
Pfizer and its partner BioNTech are also investigating how well their vaccine works in children aged six months to 11 years and expect approval in early 2022 (file image)
It is unclear how long it will take the FDA to review the data, but the director of the Centers for Disease Control and Prevention, Rochelle Walensky, told ABC News on Wednesday that she expected the vaccine from Pfizer by mid May for 12 to 15 year olds.
It is unclear whether the FDA advisory panel needs to meet first to recommend the use of the vaccine in younger children, as it did in December 2020.
Pfizer and its German partner BioNTech are also investigating how well their vaccine works in children between six months and eleven years of age.
The first early-stage volunteers received their first injections in March, and the companies hope to expand eligibility to this age group by early 2022.
Although children are less likely to develop severe COVID-19 or develop complications, health experts say vaccinating children and adolescents is a critical step in the US towards achieving “herd immunity.”
According to Market Watch, Pfizer’s shares rose 1 percent in trading on Friday following the news.
Children are often the last group to be tested in clinical trials as they are not just small adults.
Their bodies and immune systems behave differently, which means they may have different treatment needs.
Additionally, depending on their height, weight, and age, children may need different doses or sizes of needles. Therefore, most children are not vaccinated until safety has been well documented in the adult population.
To date, 112 million Americans – 33.7 percent of the population – have received at least one dose, and 66.2 million – 19.9 percent – are fully immunized.
An average of three million people are vaccinated every day, and President Joe Biden has set a goal of 200 million vaccinations in his first 100 days in office.