Pfizer set to request emergency approval of COVID-19 vaccine for children younger than 5

U.S. regulators are planning to review and authorize Pfizer and BioNTech’s COVID-19 vaccine for children younger than 5 before data on a third — and potentially necessary — shot is available.

The decision is a bid to jump-start vaccination among the youngest Americans by the end of February as the country attempts to move on from the pandemic.

Pfizer said Tuesday it started to submit the data that would support emergency authorization of the first two doses of a planned three-dose primary vaccines series for children from 6 months to 4 years old.

The company said it began its submission, which should be completed within days, at the request of the Food and Drug Administration to get a head start on the rollout while it waits for additional data on a third dose, which is given eight weeks after the second shot. Collecting third-dose data could take months.

The vaccines being studied in young children use one-tenth of the dose in existing jabs and proved to be safe in trials.

The two-dose course seemed effective in children up to age 2 but not in children ages 2 to 5, so the companies are testing the third shot to see if it can combat the highly transmissible variants, akin to the boosters in adults.

“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,” Pfizer CEO Albert Bourla said. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”

The FDA said it will be important to protect children against the virus amid the ongoing omicron surge and they will consult with an outside advisory committee before authorizing the shots. The advisers will convene and discuss the vaccine for young children on Feb. 15.

“It’s going to take a few weeks for FDA to go over it very, very carefully and thoroughly,” Mark McClellan, a former Food and Drug Administration commissioner, said of Pfizer’s application Tuesday in a webinar hosted by Duke University. “I do expect FDA to keep looking at the data there. And just like we’ve seen in other age groups [regulators will] probably authorize a booster dose a couple of months after that second dose that would be considered right now.”

It’s unclear how eager parents will be to vaccinate the youngest children, an age group that accounts for around 0.1% of COVID-19 deaths. 

The Kaiser Family Foundation released polling Tuesday found only 3 in 10 parents of children younger than 5 said they would get their child vaccinated “right away” once able. A similar share said they want to “wait and see” how it works for other young children first and a quarter said they would “definitely not” opt for vaccination. Another 12% said they would vaccinate their young kids “only if required.”

Yet some parents say they’re eager to vaccinate the youngest children, who are the only Americans ineligible for the shots, heaping pressure on President Biden and his administration to start the rollout.

“It will come,” Mr. Biden said at a press conference marking his first year in office. “I can’t tell you when. But it is really very important that we get to that.”

The administration considers widespread vaccination as key to pushing the virus into the background and getting back to normal, yet there are nearly 20 million Americans who are younger than 5 and ineligible for shots right now.

Roughly 68% of eligible Americans aged 5 and older are fully vaccinated.

The American Academy of Pediatrics said pediatric cases of the virus surged during the omicron wave, including over 808,000 child cases in the week ending Thursday, or triple the peak level during the delta wave.

Children accounted for 1.6% to 4.4% of total hospitalizations, while 0.1% to 1.5% of all child COVID-19 cases resulted in hospitalization in the 24 states, plus New York City, that reported data to the academy.

The 0-to-4 age group accounts for 392 deaths, or 0.1% of COVID-19 deaths overall, according to Centers for Disease Control and Prevention data that is available for about 750,000 of the 886,000 U.S. deaths that have occurred.

Panagis Galiatsatos, assistant professor at Johns Hopkins School of Medicine in Baltimore, said infections and cancers typically afflict older adults more than children but that any pediatric death is cause for alarm, so society should push to prevent them if they can.

“The COVID vaccine is by far the right move, and a move made that is consistent with how we approach pediatric-related diseases,” the doctor said. “Do I see parents clamoring for it? Of course — those with kids under 5 live in a very different world than those with [vaccine-eligible] kids. So yes, I do seem them asking a lot.”

Dr. Scott Gottlieb, a former FDA commissioner who sits on Pfizer’s board, said Sunday said it is clear that vaccination will not protect people from any infection at all but said two doses might build up enough immunity to stave off severe disease in children in the near term.

For more information, visit The Washington Times COVID-19 resource page.