The Food and Drug Administration (FDA) is expected to authorize the application of the COVID-19 vaccine from the pharmaceutical company Pfizer for young people between 12 and 15 years old next week, as indicated this Monday to
The Associated Press
news agency
sources familiar with the process.
The announcement will come a month after Pfizer found in clinical studies that its injection, which is already licensed for ages 16 and over, also provides protection to the youngest group.
A federal official consulted by the aforementioned outlet, who spoke on condition of anonymity, said that the FDA will expand its emergency use authorization for Pfizer's two-dose vaccine
early next week
.
Maybe even earlier.
High School Students Receive Coronavirus Vaccine Injection at East Hartford High School in Connecticut;
on April 26, 2021.AP
Another person with knowledge of the matter confirmed the schedule, adding that the FDA is likely to authorize the Pfizer vaccine for younger children this fall.
For the vaccine to be administered, however,
a federal committee will be required to approve its use in minors between 12 and 15 years of age after FDA action
.
Afterwards, the Centers for Disease Control and Prevention must adopt the recommendation of the independent expert panel.
Steps that could be completed in a matter of days.
The newspaper
The New York Times
first reported the FDA plans to expand its eligibility criteria.
Pfizer released preliminary results of a vaccine study in 2,260 volunteers ages 12-15 in the United States in late March, showing
no COVID-19 cases among fully vaccinated teens,
compared with 18. positive cases that occurred among those who received a placebo.
The children had side effects similar to those of young adults, the company reported.
The main side effects were pain, fever, chills, and fatigue
, especially after the second dose.
The study will continue to track participants for two years to learn more about long-term safety and security.
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Pfizer isn't the only company looking to lower the age limit for its vaccine
.
Results are also expected by the middle of this year from a study in the United States of Moderna's vaccine in 12 to 17-year-olds.
However, the FDA has already allowed the two companies to start their studies in children between the ages of 6 months and 11 years.
As of today, more than 131 million doses of Pfizer's vaccine have been administered in the United States, where the demand for vaccines among adults has dropped dramatically in recent weeks.
With information from The Associated Press
.