Pfizer Says 3 COVID-19 Shots Effective for Young Children, Will Push FDA to Authorize

A nurse prepares a Pfizer vaccine overseen by a doctor in Sydney, Australia, on Oct. 3, 2021. (Lisa Maree Williams/Getty Images)

Pfizer says that three shots of its mRNA COVID-19 vaccine offer protection for children aged 5 and younger, according to a May 23 announcement, as the pharmaceutical giant indicated that it would hand its data to federal health officials in its push to vaccinate small children.

Despite Pfizer’s proclamation, polls have suggested that parents of children aged 5 and younger are hesitant to give their children COVID-19 vaccines. In early May, a poll found that only 18 percent of such parents were eager to get their children vaccinated right away, while 38 percent said they were planning to wait—in spite of news reports claiming that some parents are anxiously waiting to vaccinate babies, toddlers, and preschoolers.

Numerous studies have shown, meanwhile, that young children have an exceptionally low chance of severe illness, hospitalization, and death from COVID-19, the illness caused by the CCP (Chinese Communist Party) virus. That’s in contrast to older and immunocompromised individuals, who have the highest chance of hospitalization or death, those studies have shown.

Pfizer, which saw its profit soar 61 percent in the first quarter of 2022, and partner BioNTech stated on May 23 that they evaluated 1,678 children under age 5 who had received a third shot at least two months after receiving a second dose of the vaccine, when Omicron was the main variant that was spreading across the world. The firms stated that their third shot was 80.3 percent effective in preventing illness.

The firms also said that three shots of a 3 microgram formulation of their vaccine generated a similar immune response in that age group to 16- to 25-year-olds who had received two doses of the 30 microgram formulation of the vaccine in an earlier clinical trial. Pfizer and BioNTech said their final efficacy data in the age group will be made public when it’s available.

“The study suggests that a low 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” BioNTech Chief Executive Ugur Sahin said in a statement.

Albert Bourla, the CEO of Pfizer, said the data was “encouraging” and confirmed his company will “soon” issue “submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”

In their news release, the companies said that most adverse side effects from the vaccine were mild or moderate in younger children.

The Pfizer shot is currently authorized for use in all Americans ages 5 and older: children aged 5 to 11 get two 10 microgram doses as their primary course, and individuals aged 12 and older receive two 30 microgram doses.

Reuters contributed to this report.