The US Food and Drug Administration (FDA) has expanded the emergency use authorization or EUA of the Pfizer COVID-19 vaccine to include young individuals aged 12 to 15 years old.
A CNN report said that this is the first-ever COVID-19 vaccine in the United States authorized for administration in teenage people as well as in adolescents.
Previously, it had been authorized for 16-year-old individuals and older. Meanwhile, Johnson & Johnson and Moderna COVID-19 vaccines are authorized for administration in individuals ages 18 years old and above.
To back the extended use of the Pfizer vaccine, the FDA reviewed the data which the company submitted. Specifically, Pfizer said at the end of March, the clinical trial that engaged more than 2,200 12-to-15-year-old young individuals revealed its vaccine's efficacy is 100 percent, not to mention, "it is well tolerated."
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The FDA expanded the emergency use authorization or EUA of the Pfizer COVID-19 vaccine to include young individuals aged 12 to 15 years old.
Vaccination to Start After Recommendation From CDC
The independent Vaccines and Related Biological Products Advisory Committee of the FDA did not meet to vote on the recommendation to expand the EUA to the said group.
However, the Advisory Committee on Immunization Particles of the US Centers for Disease Control and Prevention is set to meet in the middle of this week to advise the agency if they would recommend using the vaccine among 12-to-15-year-olds.
According to Dr. Rochelle Walensky, CDC director, she will decide if the agency will recommend using the vaccine in this new group.
Vaccinations for this age group, this report specified, are not expected to start until after such a recommendation from the CDC.
In addition, the Biden administration has announced it is quickly mobilizing to prepare vaccinations for 12-to-15-year-olds through pediatricians, family doctors and the federal pharmacy program.
Expansion of EUA for Younger Groups
Expansion of authorization to people belonging to younger groups aged 12 to 15 years has opened COVID-19 vaccination to another five percent of the American population, almost 17 million more people. Expansion of authorization means 85 percent of the population in the US is qualified to get a COVID-19 vaccine.
Last week, Pfizer announced it is expecting to submit in September to EUA its COVID-19 vaccine for children ages two to 11 years old. The company's study on the vaccine's safety and efficacy in six-month to 11-year-old children is also ongoing.
The FDA set a meeting on June 10 of its Vaccines and Related Biological Products Advisory Committee to discuss the probable extension of EUA to children below 12 years old.
In a statement issued yesterday, the FDA said that during the meeting, the agency would give an update on the status of its approach to EUA for COVID-19 vaccines intended for administration in 12- to 17-year-olds.
BLA for COVID-19 Vaccine
The FDA statement also specified that the committee would discuss as well the data required to back an EUA, as well as a BLA or biologics application for COVID-19 vaccine designed for use in children whose age is below 12 years old.
To date, Johnson & Johnson COVID-19 vaccines for use in individuals who are 18 years old and above. According to the head of the FDA division in charge of vaccines, Dr. Peter Marks, they recognize that the next crucial step is to have vaccines available for use "throughout the pediatric population."
As with the initial authorizations for the COVID-19 vaccine, he added, they want to make sure that the public has a clear insight into their expectations for the information and data needed to back requests for EUA and BLAs for vaccines designed to prevent COVID-19 in this pediatric age group.
Related information about Pfizer COVID-19 vaccine for younger groups is shown on CNBC Television's YouTube video below:
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