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Pfizer / BioNTech plans to submit the data to the U.S. Food and Drug Administration as soon as possible for expanded authorization for emergency use of the two-dose vaccine.
In a phase 3 trial involving 2,260 participants aged 12 to 15 in the United States, the vaccine elicited strong antibody responses one month after the second dose – exceeding those shown in people aged 16 to 25 in previous trials, Pfizer reported. The vaccine is currently cleared in the United States for emergency use in people 16 years of age and older.
The researchers observed 18 cases of Covid-19 among the 1,129 participants who received a placebo, and none among the 1,131 volunteers who received the vaccine. The data has not yet been peer reviewed.
Pfizer / BioNTech added that the side effects seen in young adolescents were similar to those seen in 16 to 25 year olds. Common side effects include pain at the injection site, fatigue, and fever. Participants will be monitored for protection and safety for two years after their second dose.
These comparisons with the older population are important because the researchers rely on knowledge gained from trials on adults.
Researchers can define a number of antibodies that are a correlate of the protection seen in adults, and then look for that level of antibodies in pediatric participants to find out that the vaccine provides protection. This is why trials of the Covid-19 vaccine in children and adolescents have generally required fewer volunteers than trials in adults.
“We share the urgency to extend the authorization for use of our vaccine to younger populations and we are encouraged by the clinical trial data on adolescents aged 12 to 15 years,” said Albert Bourla, CEO of Pfizer. “We plan to submit this data to the FDA as a proposed amendment to our emergency use authorization in the coming weeks and to other regulators around the world, in the hope of starting to vaccinate this age group before the start of the next school year. ”
Dr William Gruber, senior vice president of clinical vaccine research and development at Pfizer, also noted last week that the vaccine could be ready for this age group by the next school year.
Getting back to school isn’t the only factor at play. Health experts have stressed the importance of protecting as many people as possible through vaccination, as more infectious variants of Covid-19 continue to spread throughout the world. all the countries.
“We all aspire to a normal life. This is especially true for our children, ”said BioNTech CEO Ugur Sahin. “The first results we have seen in studies on adolescents suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of variant B. 1.1.7 UK. “
Pfizer recently told CNN that the safety demonstrated in this trial in adolescents helped the company make the decision to begin testing its vaccine in young children.
A separate Phase 1/2/3 study of the Pfizer / BioNTech vaccine in children aged 6 months to 11 years was launched last week, when the first children aged 5 to 11 received an injection. Pfizer / BioNTech plans to start dosing children 2 to 5 years old next week and work their way through participants aged 6 months to 2 years. The company aims to enroll 4,644 children in the trial and expects results by the end of 2021.
Moderna is also testing its vaccine in adolescents and children, in two clinical trials in children aged 12 to 17 and 6 months to 11 years old.
Experts predict that Covid-19 vaccines will not be available for children 11 and under in time for the next school year. Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said these young children may have to wait until the first trimester of 2022.
Dr Buddy Creech, director of the Vanderbilt University Vaccine Research Program and Moderna Pediatric Trials Researcher, believes a Covid-19 vaccine may be available for high-risk children 12 years of age and older. ‘by July or August, but likely won’t be available for children 11 and under until November or December at the earliest.
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