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Pfizer Asks FDA to Authorize Its Covid-19 Vaccine for Young Children - WSJ

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Pfizer Inc. and partner BioNTech SE asked U.S. health regulators to authorize use of their Covid-19 vaccine in children under 5 years, the last age group without access to the shots.

The application, which the companies said they began submitting to the Food and Drug Administration on Tuesday, could lead to the shots becoming available in March for children ages 6 months to under 5 years.

Some parents have been looking forward to vaccinating their children, who have been hospitalized in larger numbers as the Omicron variant has swept the U.S. The companies' application asks the FDA to clear the two-dose regimen even though it produced disappointing results in some children during testing.

In children ages 2 to under 5 years, the inoculations weren't found to provide the kind of immune response researchers say is needed to protect against symptomatic Covid-19. The reasons for those findings are unclear.

The children might eventually need to get a booster to be fully protected, just like adolescents and adults. That testing is continuing, and Pfizer expects results during the first half of this year.

The companies said they intend for children to receive three doses. They said they planned to submit additional data seeking to add a third dose given at least eight weeks after the second.

"Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants," said Pfizer Chief Executive Albert Bourla.

The FDA encouraged Pfizer to file the application for the first two shots now so that young children would be eligible for a booster should it prove to work safely during testing and gain clearance, according to a person familiar with the matter.

No serious safety concerns were observed during testing, according to the companies.

Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia who sits on the FDA's vaccine advisory board, said it would be straightforward to authorize a third dose, if testing shows it produces a strong immune response, but it would be challenging to decide how to handle the authorization if that doesn't happen.

"We're kind of building the plane while it's in the air. This is unprecedented. This isn't the way it normally works. The FDA doesn't normally request that a company submit data," he said. The vaccine advisory board is scheduled to review the matter on Feb. 15.

Pfizer and the government have said the U.S. should have enough supplies for the younger children, who could get vaccinated at doctor's offices, schools and other vaccination sites.

If the FDA authorizes the shots, young children would initially get two doses three weeks apart, just like adolescents and adults. But the children would get a lower dose of 3 micrograms, one-tenth of what people 12 years and older receive.

Health authorities and vaccine experts have pushed for vaccinating young children to protect them against Covid-19 and to help boost the safety of older adults including parents, grandparents and teachers who are at higher risk of severe disease.

Children tend to experience milder symptoms if they develop a case, but some can become seriously ill and some can spread the virus.

The more transmissible Omicron variant has driven more infections among children. More than 3.5 million cases were reported in January among children, according to the American Academy of Pediatrics.

Hospitalizations associated with Covid-19 have tended to be higher among the 4-and-younger group than older children and adolescents, who are allowed to be vaccinated.

In the week ending Jan. 22, the hospitalization rate for children up to 4 years was 7.1 per 100,000 people, according to CDC data, compared with a rate of 2.2 hospitalizations per 100,000 people for those aged 5 to 17.

People 65 years and older continue to be at the highest risk of hospitalization, at a rate of 39.4 per 100,000 people.

Clinical trials evaluating whether Covid-19 shots from Pfizer-BioNTech and Moderna Inc. have been taking longer than expected due to the challenges of testing in young children. The FDA also asked the companies to enroll more children than originally planned to properly evaluate the shots' safety.

Biden administration officials have been asked frequently at press briefings about the FDA's timing for authorizing shots for younger children.

"It will come," President Biden said at a January press conference. "I'm not a scientist; I can't tell you when."

The Pfizer-BioNTech Covid-19 vaccine, the first to be cleared in the U.S., is fully approved for people 16 years and older and authorized for use in children 5 to 15 years.

The drugmakers have been testing the shot in the youngest age group. In December, researchers saw in children ages 6 months to 2 years the type of desired immune response found to protect against severe disease in studies of adolescents and young adults. But scientists didn't see that kind of response in study subjects between 2 and 5 years old, the companies said, and Pfizer hasn't said why. A company spokeswoman didn't respond to requests for comment Tuesday.

The findings in the subjects ages 2 to under 5 might be because children have less mature antibody responses than adults, so they could simply need an extra dose, said Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.

He said many vaccinations for young children, such as the shots for pneumonia, tetanus and polio, involve more than two doses to generate the needed immune response. Yet Dr. Bar-Zeev said it was surprising that the Pfizer-BioNTech shot generated the desired immune response in younger children but not older ones.

Omicron was probably a factor, according to the person familiar with the application. Research so far indicates that adults need to get a booster to receive strong protection against Omicron.