If federal authorities allow their use in the coming weeks, the White House expects vaccinations of young children to begin in earnest as early as June 21, according to White House COVID-19 response coordinator Ashish Jha.
If and when the vaccinations are approved, Jha told reporters, the US government has enough COVID-19 vaccines from Pfizer and Moderna to start the program for young children.
He stated that the federal government would provide 10 million vaccines to state and local governments to begin mass immunization of children under the age of five.
Pfizer and BioNTech filed an application with the U.S. Food and Drug Administration on Wednesday to seek approval for their COVID-19 vaccine for young children.
According to preliminary data, Pfizer's pediatric COVID-19 vaccine has an efficacy of 80.3 percent and passes "all immunobridging criteria required for Emergency Use Authorization," the company stated Monday. The findings are based on clinical trials in which children aged six months to five years received three doses of the company's vaccine.
No COVID-19 shot is yet licensed for children in that age group in most parts of the world. It remains uncertain how many parents would get their little ones vaccinated as demand has been low in kids aged 5 to 11.
Moderna released trial findings in March indicating that a two-dose formulation of its vaccine was safe and had a similar immunological response in young children as in adults.
The FDA's independent advisers will meet on June 14-15 to consider the two applications, with the FDA expected to make a decision soon after, according to Jha.
If the FDA approves the vaccines, the Centers for Disease Control and Prevention must make a recommendation, and he said the agency would establish dates for its advisory committee meetings "very, very soon."
Many doctors' clinics may be closed on June 20 for the Juneteenth holiday, but if the vaccines are authorized by the FDA and CDC, vaccinations of small children could begin as early as June 21.
"Our expectation is that within weeks every parent who wants their child to get vaccinated will be able to get an appointment," he said. "We're going to ship doses out as fast as possible."
Pfizer's pediatric dose is one-tenth the size of its adult dose. Pfizer initially tested a two-dose regimen, but inconsistent results spurred the company to test a three-dose program.
The third dose was "well-tolerated among 1,678 children under 5 years of age with a safety profile similar to placebo," according to Pfizer's announcement.
