Pfizer seeks FDA clearance for COVID vaccine in children under 5

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Josh Wingrove and Riley Griffin/Bloomberg News (TNS)

Pfizer Inc. and its partner BioNTech SE said they had begun submitting data to U.S. regulators for licensing of their COVID-19 vaccine in young children, accelerating an effort to get more children vaccinated after the omicron wave caused pediatric infections to soar.

The companies said in a statement that they had launched a so-called continuing submission with the US Food and Drug Administration seeking emergency authorization for the vaccine in children aged 6 months to 4. year. A group of outside advisers is due to meet Feb. 15 to consider the request, according to a statement from the agency.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we are committed to reviewing the data in a timely manner,” Acting Commissioner Janet Woodcock said in the statement.

The authorization request arrived earlier than expected. Data released by the companies in December suggested that the ability of two doses to prevent infection was mixed and that more evidence would be needed before seeking authorization. The companies said at the time that they would study a third dose and, if successful, seek approval in the first half of 2022.

However, Pfizer and BioNTech have accelerated this timeline at the request of regulators. The FDA has asked drugmakers to submit data on two doses of the vaccine as part of a three-dose series, according to the statement. Data on a third dose given eight weeks after the second injection is expected in the coming months and will also be sent to regulators, the companies said.

Parents have been pushing the Biden administration and corporations to move faster to allow shootings for young children. With the rise in cases this winter, more children have been infected with the virus, complicating childcare and parents’ efforts to stay at work. At the same time, however, there are signs that families are more reluctant to get vaccinated for young children.

Although vaccines have been available for children aged 5 to 11 for several months, vaccination rates in this group remain lower than in older populations, even amid signs that the omicron strain is exposing children to a increased risk of disease. Cases of the virus in children have risen since omicron was first detected in the United States in December, with pediatric hospitalizations hitting a record high late last year.

In December, Pfizer vaccine manager Kathrin Jansen said that limiting the spread of the more infectious variant of omicron, which currently accounts for almost all cases of COVID-19, “can only be possible with three doses or more”.

Three injections are now recommended by the Centers for Disease Control and Prevention for everyone age 12 and older, and third injections are expected to soon be permitted for those ages 5 and older. While US regulators consider anyone who has received two doses of messenger RNA to be fully vaccinated, studies have shown that three doses are more effective in protecting against an omicron infection.

Anthony Fauci, President Joe Biden’s top adviser on the pandemic, said last week he believed the Pfizer vaccine for young children would be a three-shot regimen. Fauci told a press conference that the FDA is “very scrupulous” in reviewing vaccines, especially for children, and that if injections were to be allowed “we can be certain that they will be safe and that they will be effective”.

While faster clearance is likely to satisfy parents keen to get their children vaccinated, it could also exacerbate the unease of those who have been more uncertain about vaccines for children. Recent CDC studies have shown that the injections cause few side effects in the 5-11 age group and are extremely effective in keeping teens out of the hospital.

The vaccination effort in the United States has stabilized for all ages. Some 68% of people ages 5 and older are considered fully vaccinated, according to CDC data, while 42% of those who are eligible received a booster shot Monday.

The FDA is expected to convene a panel of expert advisers to review the evidence on the Pfizer vaccine for young children, likely later this month. The agency is not bound by the advice of the group but generally adheres to it. An expert panel that advises the CDC on vaccine policies is also expected to meet.

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