When Will Covid-19 Vaccines for Young Children Be Available in the U.S.?

Adults have had COVID-19 immunizations for almost a year, but around 18 million children under 5 years old are still waiting.

They may have to wait until the summer, despite some estimates that doses would be ready in early 2022.

While Moderna has released data on two doses of COVID-19 for younger children, Pfizer and BioNTech have not yet shared data on three doses for that age group.

Dr. Anthony Fauci, top medical advisor to President Biden and head of the National Institute of Allergy and Infectious Diseases, said the US Food and Drug Administration (FDA) is contemplating approving both the Pfizer/BioNTech and Moderna COVID-19 vaccines for young children at the same time.

The Pfizer vaccine's initial series of two 3-milligram doses tested in children under 5 didn't protect them from the more infectious Omicron form. It was geared toward the original coronavirus.

"It didn't meet the criteria for efficacy," Fauci said. While safety was never a concern, the test results meant Pfizer had to do more research with a third dosage as part of the primary regimen.

Pfizer CEO Albert Bourla said the goal is to have its Covid-19 vaccine available for kids 4 and younger by June. During the testing and approval process, he noted, the FDA has been exceptionally cooperative and flexible.

Pfizer's Third Dose Study

Pfizer and BioNTech were prompted by the FDA to file an emergency use authorization request for their vaccine for younger children with two doses. They continued to test a third dosage as the two-dose regimen progressed through the regulatory procedure.

The plan was modified again in February. A third vaccination shot in these younger children was required, according to Dr. Peter Marks, head of FDA's Center for Biologics Evaluation and Research.

Scientists working on clinical studies for young children can learn from older age groups. Following breakthrough infections in 2021, experts rapidly discovered that adults and adolescents need additional doses of Covid-19 vaccination.

Comparing not only against Delta, but also against Omicron, Bourla said they saw the same issue: Two dosages give minimal protection against Delta in adults, while the third dosage is powerful. So, they continued the studies on a third dosage for pediatrics also.

Safety Is Absolutely Critical

Moderna claimed their vaccination for young children was safe, while Bourla said the Pfizer vaccine's safety profile "looks very, very good." Neither company anticipates any safety issues going forward at all, especially given the small dosage amount for small children.

The primary questions with Pfizer vaccines are how protective they are and what is the best vaccination schedule and dosage. The trials should provide answers.

If the vaccine is approved, children may get it earlier than adults and adolescents. Contrary to other age groups, the youngest might have a third dose as soon as two months following the second.

Children are less likely than adults to be hospitalized or die from Covid-19, yet the disease has claimed at least 463 lives of kids under age 4 in the United States.

"We still vaccinate kids for polio, even though we haven't had it in over 50 years." Why? Because it still exists. This infection will continue to exist and cause harm," said said Dr. Paul Offit, the director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children's Hospital of Philadelphia, and a member of the FDA's Vaccines and Related Biological Products Advisory Committee.

"Every year, 3½ to 4 million children are born in this country who are unprotected. They are going to need to be protected for some time," he said. "And the sooner the better, the sooner you can do it safely."

Moderna continues with two doses

Moderna is also developing a vaccination for infants. The company's chief medical officer, Dr. Paul Burton, said a vaccination for this age range is a "big priority." It wants to apply to the FDA and other global agencies "as soon as possible." Moderna claims their Covid-19 vaccination works equally well in toddlers and adults.

“Two of its 25-microgram doses provided a similar immune response for children 6 months through 5 years as two 100-microgram doses for adults 18 to 25,” Moderna said. The two doses are given to children 28 days apart, and data shows that they are safe and produce strong, effective results.

Moderna said it was preparing to evaluate the potential of a booster shot for all children 6 months and older that would target the original strain of the virus as well as the Omicron variant.

Burton has said Moderna's vaccines for young kids will be available in a few months -- Not a few weeks."

What parents can do in the meantime

While parents wait for their children to be vaccinated, they can still protect them.

Experts advise all adults who interact with children to be vaccinated, and ideally boosted also. Adults should wear masks around unvaccinated children, despite numerous requirements being repealed.

Dr. Doran Fink, who leads the FDA's clinical and toxicological examination of experimental and US-licensed vaccinations, said he understood parents' worries on Wednesday. The FDA also vowed to "diligently" verify any data submitted.