Pfizer says its vaccine is 100% effective in young people 1:02
Clinical trial results of the Pfizer / BioNTech covid-19 vaccine showed it to be 100% effective in adolescents ages 12 to 15, the companies reported Wednesday.
And in addition, this population tolerates the vaccine well, the companies added.
Pfizer / BioNTech plans to submit the data to the US Food and Drug Administration (FDA) as soon as possible.
Measure that seeks to expand the authorization of emergency use of the two-dose vaccine.
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During a phase 3 trial of 2,260 participants aged 12 to 15 years in the United States, the vaccine elicited strong antibody responses one month after the second dose, Pfizer said.
Which exceeded the responses demonstrated in 16 to 25-year-olds in previous trials, the company completed.
The vaccine is currently licensed for emergency use in the US for individuals 16 years of age and older.
Why is it important to vaccinate adolescents?
The researchers looked at 18 cases of Covid-19 among the 1,129 participants who received a placebo.
While there was no infection among the 1,131 volunteers who received the vaccine.
However, data has not yet been peer-reviewed.
Pfizer / BioNTech added that the side effects seen in teens were similar to those seen in 16-25 year olds.
The most common include injection site pain, fatigue, and fever.
Participants will be monitored for protection and safety for two years after their second dose.
Now, those comparisons with the slightly older population are important.
Precisely because the researchers are building on the knowledge they acquired during the trials with adults.
Researchers can define a series of antibodies that are a correlate of the protection seen in adults.
Then look for that level of antibodies in pediatric participants to find out that the vaccine provides protection.
That's why COVID-19 vaccine trials in children and adolescents have generally required fewer volunteers than trials in adults.
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"We share the urgency of expanding the authorization of our vaccine for use in younger populations and are encouraged by data from clinical trials in adolescents between the ages of 12 and 15 (years)," said Pfizer CEO Albert Bourla.
"We plan to send this data to the FDA in the coming weeks as a proposed amendment to our emergency use authorization and to other regulators around the world, hoping to begin vaccinating this population group before the start of the next school year." .
Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital, said Wednesday on CNN's "New Day" program that schools can open without vaccinating students.
However, he noted that vaccines will help.
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"I think there is probably a green light to move forward, to lower (the age) in terms of vaccinating adolescents from 12 to 15 years old," Hotez said.
Although, he also noted that the vaccine has yet to be evaluated for authorization in that age group.
“The bottom line is that by the fall I think there is a good chance that we will vaccinate adolescents, 12 years and older.
And for middle, middle, and high schools, it's very good news in America, for teachers and staff alike.
We will vaccinate teachers and staff, we will vaccinate students in those middle and high schools, "he completed.
Back to school is not the only factor on the table.
Health experts have emphasized the importance of protecting as many people as possible through vaccination.
Precisely, while more infectious variants of covid-19 continue to spread throughout the country.
We all long for a normal life.
This is especially true for our children, ”said BioNTech CEO Ugur Sahin.
'The initial results that we have seen in adolescent studies suggest that children are especially well protected by vaccination.
Which is very encouraging given the trends we've seen over the last few weeks in the spread of UK variant B.1.1.7. '
Pfizer recently told CNN that the safety this trial demonstrated in adolescents helped the company make the decision to begin testing its vaccine in younger children.
Pfizer advances in vaccine against covid-19 for children 0:48
A separate phase 1/2/3 study of the Pfizer / BioNTech vaccine in children ages 6 months to 11 years began last week, when the first children ages 5 to 11 received an injection.
The companies plan to begin dosing children ages 2 to 5 next week and reach participants ages 6 months to 2 years.
The goal is to enroll 4,644 children in the trial and expect results by the end of 2021.
Moderna is also testing its vaccine in adolescents and children, in two clinical trials of children aged 12 to 17 years and 6 months to 11 years.
Experts anticipate that covid-19 vaccines will not be available to children under the age of 11 before the next school year.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said those younger children may have to wait until the first trimester of 2022.
Dr. Buddy Creech, director of the Vaccine Research Program at Vanderbilt University and an investigator in Moderna's pediatric trials, estimates that a COVID-19 vaccine could be available to high-risk children 12 years of age and older in July or August.
However, it probably won't be available to kids under the age of 11 until November or December, at the earliest, he warned.
CNN's Naomi Thomas contributed to this report.
CNN's Naomi Thomas contributed to this report.