Experimental COVID-19 Vaccine Being Tested on Babies
Story Highlights
- An eight-month-old baby is the youngest person in the world to have been fully vaccinated with two doses of Pfizer’s experimental COVID-19 vaccine.
- The Centers for Disease Control and Prevention had previously granted Emergency Use Authorization (EUA) of the experimental COVID vaccines for use in adults and has recently expanded its authorization to include adolescents over 12 years old, but no data are available pertaining to the vaccine’s use in babies and small children.
- Two “camps” have emerged: Parents who believe vaccination is safe, effective and the only way forward out of the pandemic and parents who are concerned about short- and long-term consequences of the experimental vaccinations and do not want their children used as “guinea pigs.”
An eight-month-old baby is the youngest person in the world to be given two doses of Pfizer/BioNTech’s experimental vaccine against COVID-19.1 Little Vincenzo “Enzo” Mincolla,” of Baldwinsville in upstate New York, was injected with his first dose at just seven months of age and got his second dose last week on May 12, 2021. Baby Enzo’s parents are both doctors and expressed “no qualms about getting their baby vaccinated,” stating that, “We are helping science and evidence-based medicine.”2
Little Enzo is one of six infants included in Pfizer’s phase 1 clinical trial at the Upstate Medical University in Syracuse, NY, along with another 10 babies and young children being vaccinated and evaluated at three other research facilities across the U.S. The babies in the study were given two three-microgram doses of the vaccine, with a three-week interval between doses, equating to one-tenth of the dose adopted for older children and adults. No immediate short term adverse reactions have been reported for any of the babies vaccinated so far, which has led to some concern among the researchers.
Researchers Concerned Dose Given to Infants May Be Too Low
Noting that the dosage might be too low for the age group,3 Joseph Domachowske, MD a pediatric infectious disease specialist at Upstate Medical University and chief investigator of the study, said that Pfizer has temporarily halted the study in order to evaluate the antibody response. If the babies do not develop antibodies to COVID-19, or the antibody response is lower than the targeted efficacy, Pfizer may recruit an additional 16 babies and treat them with a higher dose, which is projected to be 10 micrograms.4
Parents Split on Enrolling Children in Experimental Studies
Parents of other children participating in COVID-19 vaccine trials tend to agree with Enzo’s parents about the advantages of vaccination. Zinaida Good, PhD, a Stanford researcher whose young children are taking part in the vaccine trial at Stanford, said, ““I enrolled my kids, not because I want them to be part of a crazy experiment, but for them to have the best chance to stay healthy.”5
Other parents worry more about the potential side effects—both acute and long-term—of an experimental vaccine that has not been studied in larger, long term clinical trials and a more substantial history of safety. One parent, who wanted to remain anonymous because she was concerned that she would be judged harshly for her decision, said, “I think for my children, until we see a little bit more research and it’s proven that it’s something that is necessary, I think I’m going to wait.”
Krystal Shepard, another parent who agrees with that sentiment, said she does not want her kids being used “as guinea pigs.” She is quoted as saying, “What’s going to happen 10 to 15 years from now? I don’t want to find out with my kids…I’m not opposed to other people feeling that they want this for their family and for themselves. I think this is the right for every person to choose for themselves what they want to put in their body.”6
No Safety Data in Children Under 12 Years of Age
The U.S. Centers for Disease Control and Prevention (CDC) had previously approved the experimental biologic under emergency use authorization for use in adults and has recently updated its recommendations to include adolescents over age 12.7 Addressing the Senate Committee on Health, Education, Labor and Pensions, David Kessler, MD, chief COVID-19 scientific officer for the current administration, projected that safety and efficacy data on the vaccines might be available on children under age 12 by late fall of 2021. Responding to that prediction, Anthony Fauci, MD indicated that, “steps to vaccinate younger children will probably occur in stages, progressing younger and younger, as study evidence accumulates.”8
Noting that he believes the COVID-19 vaccines have so far been shown to be safe and effective, pediatric infectious disease specialist James Campbell, who serves on the American Academy of Pediatrics’ (AAP’s) Infectious Disease Committee, nevertheless acknowledges that, “Before COVID-19 vaccines become available for younger children, clinical trials need to be completed. This is to ensure they are safe and effective for these age groups. Children are not little adults; we can’t just assume a vaccine will have the same effect on a child as it does for someone older.”9
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