Pfizer Just Made Another Major Announcement About Its Vaccine
The vaccine manufacturer is taking a big step in helping to contain COVID.
While there are three COVID vaccines available for use in the U.S., it's clear that Pfizer's vaccine has experienced the most developments in the last year. In May, the U.S. Food and Drug Administration (FDA) voted to authorize Pfizer's vaccine for use in people ages 12 to 15, making it the only vaccine available for teens. Then in Aug. 2021, Pfizer became the first—and so far only—vaccine to gain full approval from the FDA, cementing its place in the medical community. Now, Pfizer's manufacturer has just announced the next step for its vaccine.
On Oct. 7, Pfizer tweeted out that it had "officially submitted" its request to the FDA for emergency-use authorization of its COVID vaccine for children ages 5 to 11. The FDA is scheduled to meet on Oct. 26 to discuss and consider Pfizer's vaccine for kids, and a ruling is expected sometime between Halloween and Thanksgiving, according to The New York Times.
"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19," the vaccine maker said in a follow-up tweet.
According to data from the American Academy of Pediatrics and the Children's Hospital Association, nearly 5.9 million children have tested positive for COVID since the pandemic started, but new cases among this age group have exploded alongside the rise of the Delta variant. More than 173,000 new child COVID cases were reported during the last week of September, and nearly 850,000 child cases occurred during the month of September, per the agency. Kids now represent more than 16 percent of all COVID cases.
"I think we have underestimated the impact on children," top White House COVID adviser Anthony Fauci, MD, said during a CNN interview on Oct. 4. "Look at the pediatric hospitals throughout the country … They're seeing a lot of children in the hospital with severe infection."
In terms of mortality, the CDC says around 645 children have died from COVID in the U.S., per CNN. "In this latest wave of COVID-19, particularly down south, there have been thousands of children hospitalized. And, frankly, it's an embarrassment in a developed country to have even 100 children, like we've had, die of infectious disease that's preventable," Peter Marks, MD, the director of the Center for Biologics Evaluation and Research (CBER) at the FDA, said during an Oct. 5 town hall.
Pfizer announced that a Phase 2/3 trial had found that its vaccine has a "safe" and "robust" response in children 5 to 11 years old on Sept. 20. The researchers analyzed 2,268 children who received two lower-dosed vaccine shots 21 days apart. People 12 years and older have been receiving 30 micrograms of Pfizer's vaccine, but the trial tested a dosage of 10 micrograms on children. Janet Woodcock, MD, the acting FDA commissioner, said that children might require "a different dosage or formulation from that used in an older pediatric population or adults," per the NYT.
"We're committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat," Pfizer tweeted on Oct. 7. The vaccine manufacturer has also already indicated that it is conducting trials for children aged 2 to 5, and 6 months to 2 years.