Pfizer seeks federal emergency approval to vaccinate babies, young children

MSN – San Francisco Chronicle

In a move many parents are certain to applaud, Pfizer on Tuesday asked federal regulators to allow emergency use of its vaccine to protect children ages 6 months through 4 years against COVID-19.

If the request is approved by the U.S. Food and Drug Administration, as expected, an estimated 350,000 Bay Area children would become eligible for vaccination. 

Pfizer and its vaccine partner BioNTech announced they have initiated their application to the FDA asking that the agency amend its emergency use authorization of their vaccine for older children to include dosage for babies and young children.

The FDA granted emergency use of the Pfizer vaccine for children 5 to 11 in the fall, and booster shots for that group in January.

The agency itself urged the companies to submit their new application, and the FDA’s vaccine advisory committee will discuss the issue at its virtual meeting on Feb. 15.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.

Although the companies’ application is for a two-dose vaccine, they plan to expand the request in the next few months to include a third dose to be given at least eight weeks after the second. Data related to the third dose is still being amassed for submission to FDA, Pfizer said.

“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 a statement from Albert Bourla, Pfizer’s chief executive.

The request comes as pediatric COVID cases have soared to more than 10.6 million across the country — 1.6 million in children under 4, the statement said.

One of them is the toddler child of Dr. Lekshmi Santhosh, a pulmonologist and medical director at UCSF’s post-COVID clinic for people experiencing long-term symptoms.

“As a doctor and as a parent of two young toddlers, this news is very welcome, and we will be ‘first in line’ to vaccinate” them, said Santhosh, whose family all became infected after one of her children got sick at preschool.

The family recovered. “But sadly, thousands of families have been horrifically impacted as we are still seeing record hospitalizations and deaths of children with this latest surge,” Santhosh said. “I urge parents of kids to trust the rigorous process and that once the vaccines are approved, to vaccinate your kids, as we will do.”

For many parents, being able to vaccinate their youngest children can’t come soon enough.

“I’m personally ecctatic that they’ll be eligible for vaccination,” said Kris Ongoco of San Francisco, who has two daughters, aged 4 and 17 months. “We didn’t feel as normal as everyone else. We couldn’t do as many things” — like traveling.

By the time Ongoco’s older daughter was 2, she had been around the world — to Vietnam, Japan and Italy. But her younger daughter has only made it to Los Angeles.

“On top of already just being a parent, you have that added (pandemic) anxiety,” Ongoco said.

Yet many parents are not ready to vaccinate their littlest ones against the coronavirus. Just 31% of 162 parents with children under age 5 surveyed by the Kaiser Family Foundation in January said they would get them vaccinated right away, according to the survey results released Tuesday. That’s up from 23% in September and 20% in July.

And while the number of “definites” is growing, the “definitely nots” is shrinking: 26% last month, compared with 35% in September — although 30% were against the vaccinated for their young children and babies in July.

Those in the middle, unsure one way or another, are also shrinking: from 40% in July to 29% in January. The rest said they would vaccinate their small children only if required.

The phone survey’s margin of error is fairly large, at plus or minus 10 percentage points.

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