A COVID-19 vaccine for kids ages 5-11 could be available as early as next month

A COVID-19 vaccine could be available for kids ages 5-11 as soon as next month, news that will likely bring relief to many parents whose youngsters are now packed into classrooms while the highly contagious delta variant of the coronavirus remains largely uncontained in the U.S.

Pfizer and BioNTech asked the FDA last week to approve their COVID vaccine for use in kids in that age range, making them the first COVID vaccine manufacturers to do so.

“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,” Pfizer said in a Tweet late last week.

In response, the FDA scheduled a tentative meeting of an advisory committee meeting for Oct. 26 in which regulators could approve the request by Pfizer and BioNTech.

“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population,” Acting FDA Commissioner Janet Woodcock said in a statement.

If the FDA approves the request, it will likely be kicked up to the CDC, whose recommendations are usually the federal government’s last word on vaccine policy. If the CDC also gives the request the green light, the Pfizer-BioNTech vaccine could begin being administered to children ages 5-11 next month.

Based on the companies’ previous research, the vaccine is expected to be administered in two shots 21 days apart. The dosage will also be lower — about 1/3 of the adult dosage — since children naturally show a stronger immune response to vaccines compared to adults.

The companies conducted trials using this method on 2,268 children between ages 5 and 11 earlier this year. Data from the trials showed that the vaccine “was safe, well tolerated, and showed robust neutralizing antibody responses,” the companies said in a statement.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” Dr. Ugur Sahin, the CEO of BioNTech, said in the statement. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”

Pfizer and BioNTech have been the first to reach each milestone in the race to get the country vaccinated. The FDA approved the group’s vaccine for use as a booster shot last month. The FDA is set to consider approval of the Moderna and Johnson & Johnson vaccines for booster use later this week.

Moderna is currently in the middle of its clinical trials for children ages 5-11. In July, the company expanded the size of its trials to include roughly 12,000 children under 12 amid worries that shots may trigger rare heart side effects in kids. The company expects to submit data for the 5-11 age group to the FDA later this year.

Johnson & Johnson has not yet begun testing its vaccine for use in kids between 5 and 11.   

Children rarely become severely ill from COVID, but the delta variant — thought to be twice as contagious as previous strains — has led to increased infections in kids. The American Academy of Pediatrics reports that more than 6 million children have contracted the disease since the onset of the pandemic, with more than 750,000 new child cases coming between September and October of this year.

The overall infection rate in the U.S. is declining, sparking hope that the surge caused by the delta variant is waning. But public health experts worry that colder weather could result in increased transmission.

At a Wednesday media briefing, Dr. Frank Bell of Pediatric Infectious Disease at Swedish Medical Center said he wants to remind parents that while it’s exciting to have kids back in school, it’s important to remember to do everything possible to keep them safe in the classroom. 

“COVID is not taking a holiday ... we need to take every measure we can to try and protect our kids, and it’s clear that the most important aspect of that is to vaccinate kids,” said Bell. He also said that parents who have questions or concerns should speak to their pediatricians. “We’re here to support you as parents and guardians.”