Yale doctor: 6-month-olds may get shots in early 2022

Yale trials of Pfizer COVID-19 vaccine expanded to ensure safety

NEW HAVEN — A final clinical trial for a Pfizer COVID-19 vaccine at Yale is recruiting children as young as 6 months old, Dr. Onyema Ogbuagu of the Yale Center for Clinical Investigation said.

Like the study for children ages 5 to 11, Yale is expanding its trial of children 6 months to less than 5 years old in order to rule out rare side effects, Ogbuagu said.

While the 5- to 11-yearolds should be eligible to get their shots by late October or early November, it may be early 2022 before a vaccine for those younger than 5 is approved, he said.

“It’s super exciting” to be testing the vaccine on the youngest patients, Ogbuagu said.

“The delta variant is stubborn. The cases in one week

peaked at 250,000” in the United States, he said, with 2,500 needing to be hospitalized.

“The delta variant almost abolished the mantra that kids are unscathed by COVID, so it’s important to have the vaccine to protect them,” he said.

“We completed 5 to 11,” and that data was submitted to the Food and Drug Administration, Ogbuagu said. “Initially we had targeted 2,200 (children) and then the FDA requested an expansion of the cohort to ensure safety.”

That increased the number to 4,500 children in the trial that has been completed, he said.

The same increase was requested for the youngest children, because “there were some very, very rare reports of myocarditis and pericarditis” in the 5-to-11 trial, Ogbuagu said.

“That’s why the doses were reduced,” but neither side effect has been found in Yale’s studies, he said. “We haven’t seen anything concerning,” he said.

“That 2,200 number is sufficient to allow us to test the immune responses to the vaccine,” Ogbuagu said.

Every study has shown the Pfizer-BioNTech vaccine to be highly effective and safe, he said.

In the 5- to 11-year-old trial, “the vaccines were safe in that group and the immune responses were similar to those age 16 to 25,” Ogbuagu said. They were given 10 micrograms of vaccine, one-third of the adult dose of 30 micrograms.

The latest trial is divided into two groups: 6 months to less than 2 years old and 2 to less than 5 years, he said.

“In both of those groups we’re testing one-tenth of the adult dose, so 3 instead of 30 [micrograms],” he said.

While people 65 and up are now receiving booster shots for both Pfizer and Moderna vaccines, the FDA has granted full approval for those ages 16 and older and has given emergency use authorization to those 12 to 15.

Moderna also is testing its mRNA vaccine on children 6 months old and up, but those trials are not as far advanced as Pfizer’s, Ogbuagu said.

Pfizer and Moderna are messenger RNA vaccines, which use a bit of genetic code of the coronavirus’ spike protein to stimulate antibody production.

Dr. Onyema Ogbuagu

Kristin Hynes / Yale New Haven Health Onyema Ogbuagu, and infectious diseases specialist for Yale New Haven Health and principal investigator at the Yale Center for Clinical Investigation for the Pfizer-BioNTech COVID-19 vaccine trial, receives his vaccination earlier this year from pharmacist Natasha Stroedecke.