Pfizer-BioNTech Covid-19 Vaccine 100% Effective in Study of 12- to 15-Year-Olds, Companies Say--2nd Update

By Jared S. Hopkins

The Covid-19 vaccine from Pfizer Inc. and BioNTech SE safely protects kids 12 years and older, the companies said, results likely to lead to inoculating children before this summer.

The vaccine was 100% effective in protecting against symptomatic disease in a study of more than 2,200 children, the companies said Wednesday. Researchers also didn't find any safety concerns.

The findings, though expected, were much anticipated by parents, health authorities and school officials. They have been waiting for signs on when vaccines that adults have been getting could also be made available to children.

Like other authorized vaccines, the Pfizer-BioNTech shot hasn't yet been cleared for use in adolescents. Health experts say children will need to be vaccinated for a population to move past pandemic restrictions, like masking and physical distancing.

Given the Pfizer-BioNTech results, adolescents in the U.S., at least, could start getting vaccinated as early as May, which would mean many would have the protection in time for attending camps and engaging in other summer activities.

Pfizer said it would ask U.S. health regulators in the coming weeks to expand use of the shots to 12- to 15-year-olds.

The U.S. Food and Drug Administration could grant Pfizer and BioNTech the additional authorization two to four weeks after receiving the application, making it possible for vaccinations to begin in May, according to a person familiar with the matter.

Pfizer and BioNTech said they would seek clearance in other countries, too, but didn't give a timetable.

The vaccine was authorized for use in people 16 years and older in the U.S. in December, after a pivotal trial in 44,000 subjects.

Pfizer last week started testing the vaccine in children ages 6 months to 11 years.

"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Pfizer Chief Executive Albert Bourla.

Covid-19 vaccination efforts in the U.S. and overseas have focused on protecting older adults who are at higher risk of severe disease caused by the coronavirus.

Children are at lower risk of contracting the coronavirus than adults. When they are infected, they tend to experience milder symptoms. Some can get seriously ill, however, and some can also spread the virus.

Health authorities say it will be important to vaccinate children, not only to protect them from the virus but also to help reach the communitywide immunity needed to move past the pandemic.

Children make up about 13% of Covid-19 cases in the U.S., according to the American Academy of Pediatrics.

The Pfizer-BioNTech vaccine is given in two doses three weeks apart. It is among three Covid-19 shots authorized for use in the U.S., along with ones from Moderna Inc. and Johnson & Johnson.

The vaccines from Moderna and Johnson & Johnson are authorized in the U.S. for use in adults 18 years and older. Moderna also is testing its vaccine in 12- to 15-year-olds and said its trial is fully enrolled.

In the Pfizer-BioNTech study of younger adolescents, 1,131 of the subjects received the vaccine, while the rest got a placebo. The volunteers who got the vaccine received the same dose that older people get.

Researchers found the shot to be 100% effective after observing 18 cases of Covid-19 in children who had received a placebo, compared with no cases in the group that got vaccinated, Pfizer said. Researchers didn't see any severe cases, deaths or hospitalizations, the company also said.

Researchers also said an unspecified number of vaccinated children had more neutralizing antibodies a month after receiving their second dose than subjects 16 to 25 years of age had in the vaccine's pivotal trial.

Neutralizing antibodies prevent the virus from entering cells and replicating and play an important part of the immune system's defense against viruses.

Children in the study reported side effects like fatigue and headaches that were consistent with those reported by young adults in the vaccine's larger pivotal trial, Pfizer said.

To further study the safety of the vaccine, researchers plan to follow the child subjects for two years after their second dose, according to Pfizer.

Thomas M. Burton contributed to this article.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

(END) Dow Jones Newswires

March 31, 2021 16:55 ET (20:55 GMT)

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