The results of the clinical trial conducted by Pfizer-BioNTech COVID-19 on its vaccine showed 100 percent efficacy and that it is well-tolerated in younger individuals aged 12 to 15 years old, the two companies announced. A similar report is shown on WCVB Channel 5 Boston's YouTube video below.
According to a CNN report, Pfizer and BioNTech are planning to submit the data to the US Food and Drug Administration (FDA) as soon as possible to seek expanded emergency use authorization of the two-dosed jab.
Pfizer reported that during a Phase 3 trial of more than 2,200 volunteers aged 12 to 15 in the United States, the vaccine prompted strong antibody reactions one month following the second dose, surpassing the ones demonstrated in people whose ages range from 16 to 25 years in earlier trials. To date, the vaccine is authorized in the country for emergency use in people aged 16 years and above.
COVID-19 Vaccine Side Effects
Study authors found around 18 COVID-19 cases among the 1,129 participants who received a placebo. Meanwhile, they did not find any case of occurrence of the virus in 1,131 volunteers who were given the Pfizer-BioNTech COVID-19 vaccine. This data has yet to undergo a peer review.
The companies also said the side effects observed in young teens were similar to those observed in 16- to 25-year-olds.
The usual side effects include pain in the area of injection, fever, and fatigue. Participants will be observed for safety and protection for two years from their second dose.
The given comparisons to the older population are essential as study investigators are building off of the knowledge they got in trials for adults.
Researchers can identify the number of antibodies that are said to be a correlate of the protection observed in adult individuals and then search for that levels of antibodies in participants to determine if the vaccine indeed, provides protection.
This is the reason COVID-19 vaccine trials in children as well as in adolescents have, in general, necessitated lesser volunteers compared to the adults in trials.
Expansion of Authorization of the Vaccine to Younger Populations
According to Albert Bourla, Pfizer CEO, They're sharing the same urgency to expand the authorization of their COVID-19 vaccine to use in younger people and are encouraged by the clinical trial data involving adolescents who are aged between 12 and 15 years old.
Pfizer also said that the safety demonstrated in the adolescent trial they conducted helped them make the decision to start testing its vaccine in younger children.
A separate Phase 1, 2, and 3 study of the Pfizer-BioNTech COVID-19 vaccine in children aged six months to 11 years old launch a week ago, when the first children aged five to 11 years got an injection.
The companies said they are planning to start dosing two to five-year-olds in the coming week and are working their way down to participants aged six months to two years old.
In connection to this, Pfizer also said it is aiming to register more than 4,600 children in the trial and is expecting results by the end of this year.
Moderna, in the Same Path
The news report also specified that Moderna is also testing its COVID-19 vaccine in adolescents and children in two clinical trials of children whose ages range from 12 to 17 years and those aged six months to 11 years old.
Experts are expecting COVID-19 vaccines will not be available for kids 11 years and younger in time for the upcoming school year.
The National Institute of Allergy and Infectious Disease Dr. Anthony Fauci has said those younger children may have to wait until the first quarter of next year.
RELATED ARTICLE : Pfizer-BioNTech Launch Trials to Test COVID-19 Vaccine on Kids as Young as Six Months
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