Syracuse, N.Y. – An 8-month-old baby boy from Baldwinsville is the youngest person in the world to receive two doses of the Pfizer Covid-19 vaccine.
Vincenzo “Enzo” Mincolla got his second dose Wednesday at Upstate Medical University where he is participating in a clinical trial.
Upstate is just one of four sites in the U.S. , the only places in the world, testing the Pfizer vaccine in children under age 5. So far the federal government has only approved the vaccine for children as young as 12.
Enzo is one of 16 infants at the four sites participating in Phase 1 of the trial that includes kids ages 6 months to 2 years old.
Enzo, who got his first shot three weeks ago when he was 7 months old, is the youngest, according to Dr. Joseph Domashowske, an Upstate pediatric infectious disease doctor and the trial’s principal investigator. There are five other babies participating in the Upstate trial.
Enzo’s parents, Mike and Marissa Mincolla, are doctors.
“We both feel it’s important to end this pandemic, and the quickest and safest way is to vaccinate our way out of it,” Mike Mincolla said
Mike Mincolla is a family medicine doctor at CNY Family Care in East Syracuse. Marissa Mincolla is a radiologist at Upstate.
They had no qualms about getting their baby vaccinated, Mike Mincolla said. After he got his shots, Enzo slept and ate well, was not irritable and did not experience any side effects.
Mincolla said he frequently encounters patients who are hesitant about getting vaccinated against Covid-19.
“I tell them, ‘I feel so comfortable with this vaccine I gave it to my 7-month-old child,’” he said. “It’s safe, effective and it works.”
Mincolla said his son’s participation in the trial is part of history. “We are helping science and evidence-based medicine,” he said.
The Mincollas also have a 4-year-old daughter they’ve enrolled to participate in Phase 2 of the Upstate trial.
Enzo and the other babies got two 3-microgram doses of the vaccine three weeks apart. That’s one-tenth of the amount of vaccine adults get.
Pfizer has temporarily halted the trial to determine if the infants are getting the correct dose, Domashowske said.
“The concern is the dose may be too low for that age group,” he said. That’s because all the babies tolerated the vaccine well without any side effects.
Blood tests are being done to determine if the vaccinated babies developed antibodies to fight Covid-19. If the blood tests show the infants developed low or no antibody levels, Pfizer may decide to test another 16 infants at a higher dose, such as 10 micrograms, he said.
Cases of Covid-19 tend to be milder in children. But some kids with Covid-19 develop Multisystem Inflammatory Syndrome in Children, or MIS-C. This is a serious condition that can cause severe inflammation of the heart, lungs, blood vessels, kidneys, digestive system, brain, skin or eyes. Upstate has cared for more than 100 kids with MIS-C since the pandemic began, Domashowske said.
“In general a child is much more likely to have a serious medical problem from the MIS-C than the infection itself,” he said.
The federal Centers for Disease Control and Prevention recently approved the use of the Pfizer vaccine in adolescents as young as 12.
An FDA review of Pfizer’s data confirmed the drugmaker’s clinical trial findings that the shots were safe and effective in adolescents and that the side effects were consistent with older age groups. The trial found 97.9% of adolescents produced enough antibodies in the month after their second dose.