Yale’s COVID- 19 vaccine trials to include babies
Moderna, Sanofi/ GSK studies will begin soon
NEW HAVEN — Clinical trials for COVID- 19 vaccines soon will be extending to infants and people with compromised immune systems, though the demand is high for people who want to enroll.
Dr. Onyema Ogbuagu, principal investigator for the Pfizer- BioNTech trials conducted at the Yale Center for Clinical Investigation, said a trial of that vaccine on children 6 months to 11 years old is in the first stage, in which researchers are determining the doses to use.
“They’re trying three different doses of the vaccine,” he said. “When they select the dose, will start to vaccinate 6 months to 11 years.” He said he thought subjects would be called the first week of May.
However, the chances of getting into the trial now are slim.
“We have a very long waiting list of parents and kids who are interested,” Ogbuagu said. “My initial target is at least to get 40 to 50 kids enrolled, but that’s a tentative target.”
The Pfizer vaccine is being given to millions of Americans age 16 and up, and the trial involving 12- to
15- year- olds, which Yale also participated in, has shown even better results, with 100 percent efficacy, according to Pfizer.
“I couldn’t even begin to imagine why it would be any different for younger kids,” Ogbuagu said.
He said the 12- 15 age group developed “higher levels of antibodies that even exceeded those of younger adults.”
Moderna
Yale also will begin a trial soon of the Moderna vaccine for ages 6 months to 12 years old.
“Yale has not been part of the Moderna trial to date,” Ogbuagu said. “The protocol is going through our Institutional Review Board. It’s really impending … which means anytime.”
He said the interest in the Moderna trial “far, far, far, by orders of magnitude, will exceed available spots for enrollment.” As a result of the pause in administering the Johnson & Johnson vaccine to investigate blood clots in a small number of patients, Ogbuagu said, “I think there’s going to be renewed interest for the Pfizer and Moderna. … I think there’s really going to be a rush.”
Pfizer and Moderna are messenger RNA vaccines, which use a bit of genetic code of the coronavirus’ spike protein to stimulate antibody production. Johnson & Johnson and AstraZeneca- Oxford vaccines use “adenoviral vectors,” made with a different virus that enters cells and produces the coronavirus’ spike protein.
Previously, this type of vaccine has been used only for Ebola, Ogbuagu said. AstraZeneca has not received emergency use authorization from the Food and Drug Administration. Ogbuagu said while “we have options in the U. S.” and can be cautious about using Johnson & Johnson, “I don’t think we should ban the vaccine outright.”
In the case of the blood clots, “the majority of them are in women and the vast majority are under 50,” he said, leading to the possibility that female hormones play a role. Therefore, it may be possible to continue using the vaccine in men and postmenopausal women, he said, but even that may not be necessary. “We have options in the U. S.,” he said.
Yale recently enrolled in the Sanofi/ GSK trial. “It’s a dosing study as well but this is for adults 18 and over,” Ogbuagu said. “We’re hoping by the first week of May — on or around — we’ll have data to then be used in a Phase 3 trial.”
He said Sanofi had conducted a trial with low doses of its vaccine, 1.3 and 2.6 micrograms, in people younger than 50, whose “response to the vaccine was poor. … Now in the redo, they’re starting with 5 micrograms” and testing 10 and 15 mcg as well.
He has been enrolling people with compromised immune systems, such as those with cancer or organ transplants “who can have some diminished response. … They produce lower [ numbers of] antibodies.” Ogbuagu believes they will respond to the higher dose.
Sanofi’s vaccine, as well as one by Novavax, which has shown success in clinical trials, is a recombinant protein vaccine, like flu vaccines, which use a lab- generated protein similar to one in the virus that cannot cause the disease. But it also contains molecules called adjuvants that boost the immune system.
Referring to Novavax, Ogbuagu said, “I actually was going to do that study, but when they started having manufacturing issues I lost faith in them,” but since it has proven effectiveness, “I’m not exactly sure why it’s not being utilized,” he said.