Parents will have to wait for a coronavirus vaccine for their young children after Pfizer and BioNTech announced Friday that they are modifying their clinical trial to include a third shot at least two months after the initial two-dose regimen for children under age 5.
If three doses are successful at triggering a protective immune response, the companies expect to submit the data to regulators in the first half of next year.
“It is important to note that this adjustment is not anticipated to meaningfully change our expectations that we would file for emergency use authorization and conditional approvals in the second quarter of 2022,” said Kathrin Jansen, head of vaccine research and development for Pfizer in a call with investors.
Coronavirus vaccines have been authorized for everyone age 5 and older.
The companies have been testing two shots of a 3-microgram dose in children under 5, a small fraction of the adult dose. Because children’s immune systems are different from adults', smaller doses are expected to trigger equivalent immune protection. The trials were designed to test the safety and efficacy of the lower dose.
Many parents and pediatricians hoped that if the results had been positive, Pfizer would be in a position to file for regulatory authorization early next year.
Kawsar Talaat, one of the principal investigators of the Pfizer pediatric trial and a physician at Johns Hopkins Bloomberg School of Public Health, said that while the news may be disappointing, a third dose is expected to work well to provide protection, particularly against omicron.
“I think that a third dose will give a nice boost, and honestly, this is really exciting — as we know from the adult data, three doses is probably better for omicron. And I think it’ll be good to have similar data for children,” Talaat said.
The companies are also testing a third dose in 5- to 11-year-olds and a third low-dose shot for adolescents between 12 and 17.
The decision was informed by comparing the immune response in the youngest children to older teens and young adults, and by emerging data that three doses are most protective against variants such as omicron.
This is a developing story. It will be updated.
Coronavirus: What you need to know
The latest: The CDC has loosened many of its recommendations for battling the coronavirus, a strategic shift that puts more of the onus on individuals, rather than on schools, businesses and other institutions, to limit viral spread.
Variants: BA.5 is the most recent omicron subvariant, and it’s quickly become the dominant strain in the U.S. Here’s what to know about it, and why vaccines may only offer limited protection.
Vaccines: Vaccines: The Centers for Disease Control and Prevention recommends that everyone age 12 and older get an updated coronavirus booster shot designed to target both the original virus and the omicron variant circulating now. You’re eligible for the shot if it has been at least two months since your initial vaccine or your last booster. An initial vaccine series for children under 5, meanwhile, became available this summer. Here’s what to know about how vaccine efficacy could be affected by your prior infections and booster history.
Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.
For the latest news, sign up for our free newsletter.