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Everything we know about the timeline for COVID-19 vaccines for kids under 12

Update: Pfizer and BioNTech say their vaccine results in a strong immune response in kids ages 5 to 11. The companies will submit study data for FDA review by the end of the month.

If you've been holding your breath in anticipation of an updated timeline for COVID-19 vaccines for kids under age 12, you can let it out now: We've got news—and we'll keep updating this story as developments occur.

Updated September 20, 2021: Pfizer and BioNTech released a statement saying their vaccine elicits a strong immune response in kids ages 5 to 11.

Covid vaccine elicits a strong immune response in kids ages 5 to 11, say Pfizer and BioNTech

September 20: In an announcement, representatives from Pfizer and BioNTech state that their COVID-19 vaccine is safe and effective in kids ages 5 to 11. The companies plan to submit their clinical trial data to the FDA for regulatory review by the end of the month.

If all goes according to plan, that means millions of children could be vaccinated against the virus by Halloween, The New York Times reports.

Data for kids under age 5 is not expected until later this fall. However, at a time when 1 in 5 new cases affect children, the news of the vaccine's effectiveness is very promising—and likely comes as a great relief to many parents.

The Pfizer trial studied the immune response in 2,268 children ages 5 to 11, two-thirds of whom received two doses of the vaccine three weeks apart, and one-third of whom received a placebo saltwater injection. The vaccine was found to produce a comparable level of antibodies to those seen in the 16-to-25 age group; even though the dosage in the 5-to-11 group was only 10 micrograms—one-third the size of the 16-to-25 group's dose. At higher doses, researchers saw more side effects, such as fever and fatigue after receiving the shot. At the lower dose, these side effects were greatly diminished.

"You want to hit the sweet spot, where you're giving the lowest dose that might elicit reactions, but also high enough to get you a good, sustainable antibody response," said Dr. Yvonne Maldonado, chair of the American Academy of Pediatrics' infectious disease committee and who led the vaccine trial at Stanford University, to the Times.

In children under 5, one-tenth (3 micrograms) of the adult dose is being tested, with strong results so far, Dr. Maldonado says.

Pfizer and BioNTech plan to ask for vaccine approval for ages 5 to 11 in the coming weeks

September 10: The founders of German vaccine maker BioNTech, which developed an mRNA vaccine in partnership with Pfizer, announced today in German newspaper Der Spiegel that the company intends to ask regulators to approve the Pfizer-BioNTech vaccine for usage in kids ages 5 to 11 very soon.

"We will be presenting the results from our study on 5- to 11-year-olds to authorities around the world in the coming weeks," said Dr. Ozlem Tureci, chief medical officer and co-founder of BioNTech, The New York Times reports.

BioNTech is also preparing to make smaller doses of the vaccine for kids younger than age 5.

The co-founder and chief executive of BioNTech, Dr. Ugur Sahin, understands that time is of the essence when it comes to reducing the number of infections.

"There are still about 60 days left for us as a society to avoid a tough winter," he said, and urged anyone who is eligible to get their doses as soon as possible.

COVID-19 vaccines for kids under 12 may be available as soon as this fall

August 19: Pfizer expects to have enough data collected by the end of September to support an application for emergency use authorization for its vaccine in kids ages 5 to 11, according to NPR, but full authorization may not be granted until year-end.

For kids ages 12 to 15, shots became available in May 2021 after the vaccine-maker applied to the FDA for emergency use authorization in April. Given that timeline as a model, we can hopefully expect shots to be available for kids ages 5 to 11 sometime in October.

"We're hoping to have authorization—depending on both results and, of course, a few decisions—not too long after the school year starts," Dr. Phil Dormitzer, chief scientific officer for viral vaccines at Pfizer, told NPR.

Full FDA approval isn't expected until the end of the year

In a recent interview with NPR, Dr. Francis Collins, director of the National Institutes of Health (NIH), said that this September timeline is still accurate, but added, "I've got to be honest, I don't see the approval for kids—5 to 11—coming much before the end of 2021." Full FDA approval may empower more schools to require the COVID-19 vaccine for eligible students.

Vaccine safety data for kids under 5 is coming soon, too

Pfizer has also shared that the data for children between the ages of 2 and 5 should be available shortly after the data is collected for kids ages 5 to 11. They expect data on kids ages 6 months to 2 years to be available by year-end.

Moderna, the maker of another mRNA-based COVID-19 vaccine, is also collecting data on its use of the vaccine in children between the ages of 6 and 11. Currently, the Moderna vaccine is only available to people over the age of 18, but Moderna hopes to apply for emergency use authorization for ages 6 to 11 by year-end, as well.

Cases are increasing among children

With approximately 50 million children under 12 in the U.S., that's a significant portion of the population walking around unvaccinated. According to the American Academy of Pediatrics, children now make up 26% of COVID cases. And given the fact that the Delta variant now makes up 98.8% of COVID cases and is more than twice as contagious as previous strains, time is of the essence in getting shots in kids' arms.

Because so many children are ineligible for the vaccine, we're seeing pediatric cases—and hospitalizations—rising across the country. Currently, the best tool we have for fending off infections is to have as many adults and teens get vaccinated as soon as possible.

Hold on a little longer

With school already in session for thousands of kids across the country, the timing isn't great—but stay hopeful. It's also important to remember that both the Pfizer and Moderna vaccines require two shots spaced three or four weeks apart, and that immunity isn't fully built up until two weeks after the second shot. If shots become available for the 5 to 11 age group in October, that could mean many kids would have full immunity by Thanksgiving—something to be thankful for, indeed.

In the meantime, keeping up with kids' masking, hand-washing, social distancing and frequent testing can help curb the spread, plus encouraging vaccination for any and all teens and adults in your orbit.

This post was originally published on August 19, 2021. It has been updated.

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