Pfizer Covid-19 vaccine safe, effective on adolescents in trial, companies say

Pfizer Inc and BioNTech said on Thursday their Covid-19 vaccine is around 91% effective at preventing the disease, citing updated trial data that included participants inoculated for up to six months.

"These data reinforce our view that we have some really potent vaccines", said Danny Altmann, a professor of immunology at Britain's Imperial College London, who was not involved in the Pfizer trial.

In a Phase 3 trial of 2,260 participants ages 12 to 15 in the U.S., the vaccine elicited strong antibody responses one month after the second dose - exceeding those demonstrated in people ages 16 to 25 in previous trials, Pfizer reported. "Those are the people who are most apt to spread".

"These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA", Albert Bourla, Pfizer's chairman and chief executive officer, said in a statement.

Pfizer's vaccine is already authorized for use in people starting at age 16.

Side effects generally mirrored those in adults, such as a sore arm, fatigue and headache.

"Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose".

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Since then, it has been used in millions of adults in more than 65 countries.

The data released Thursday says they had 800 volunteers in South Africa in the trial, and there were nine cases of COVID-19, all in the group that received the placebo. "These data also provide the first clinical results that a vaccine can effectively protect against now circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population".

"We all long for a normal life". "The initial results we have seen in the adolescent studies 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 the B.1.1.7 United Kingdom variant".

Earlier this week, Pfizer/BioNTech had hopeful results from a vaccine trial in children between 12 and 15 years old. Nevertheless, if the results hold strong, they could open the door to extending vaccination to this age group and younger.

The companies also studied a subset of teens to measure the level of virus-neutralizing antibodies generated a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults. The company aims to enroll 4,644 children in the trial and expects results by the end of 2021.

Whether COVID-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. 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 quarter of 2022, reported CNN.

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