The FDA is planning to review the submission on February 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, which the agency asked Pfizer to submit in light of the recent omicron surge,” said acting FDA Commissioner Janet Woodcock, MD, in a statement. “Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials.” The vaccine makers said their request comes in response to an urgent public health need in this population. Pediatric COVID-19 cases have surpassed 11 million children since the onset of the pandemic; and nearly two million of these cases have been added in the past two weeks. RELATED: Get Up-to-Date COVID-19 News in the Daily Coronavirus Alert The latest report from the American Academy of Pediatrics (AAP) shows that child COVID-19 cases are above 100,000 for the 25th week in a row. Since the first week of September, there have been almost 6.4 million additional child cases. For the week ending January 22, children under age 4 accounted for 3.2 percent of the total hospitalizations due to COVID-19, according to the Centers for Disease Control and Prevention (CDC). “As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” said Albert Bourla, chairman and chief executive officer of Pfizer. This application is for authorization of the first two 3-microgram doses of a planned three-dose series, and in the coming months, the companies expect to submit data on the third, which will be given at least eight weeks after completion of the second dose. For individuals 12 and older, the Pfizer shot is 30 microgram, and that drops to 10 micrograms for those between the ages of 5 and 11. The company underscores that multiple clinical trials and real-world studies have shown a favorable safety, tolerability, and efficacy profile for all age groups starting from 5 years old. “Ultimately, we believe that three doses of the vaccine will be needed for children six months through four years of age to achieve high levels of protection against current and potential future variants,” said Bourla. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.” The FDA authorized the Pfizer-BioNTech vaccine for use in children 5 through 11 years old in October 2021, and recently greenlighted the use of a single booster dose in individuals 12 through 15 years of age and older. Nationally, more than one-quarter (28.1 percent) of 5 to 11 year-olds had received at least one COVID-19 vaccine dose as of January 18, 2022, according to the Kaiser Family Foundation. KFF data suggest vaccinating a large portion of children may be a challenge as the rate of vaccination among 5- to 11-year-olds reached its peak before Thanksgiving and then dropped steeply. Ugur Sahin, MD, CEO and cofounder of BioNTech, however, stresses the vital protection offered by the vaccine. “If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection,” he said.
