Ochsner joins Pfizer vaccine youth trial

Ochsner Health enrolled its first participants in the Pfizer COVID-19 vaccine trial for ages 5-11 Monday.
Dr. Julia Garcia-Diaz, the health system’s director of Clinical Infectious Diseases Research, said the first patient was enrolled at 8 a.m. Monday, and it was a positive experience.
“The child was excited to participate,” said Garcia-Diaz, who also is an infectious disease specialist.
Garcia-Diaz and Dr. William Lennarz, system chair of Pediatrics at Ochsner Health, met with reporters via Zoom Monday afternoon to discuss the newest trial the health system is participating in.
While Garcia-Diaz said adults in trials utilized a “placebo-controlled” study with a ratio of 1:1 in which half received the vaccine and half didn’t, she said in this study, 66% of children will get the vaccine.
“So your chances of getting the vaccine are certainly much greater,” she said.
Also, the dosage of the vaccine for children has been tweaked after detailed studies to determine the proper amount for an appropriate age group, Garcia-Diaz said. Lennarz said it’s a practice that could be used with other vaccines, too, to adapt them to children.
Six months after the injections, all participants will be notified whether they received the vaccine or not, and everyone in the study then can receive it.
“A total of 4,500 children are going to be enrolled, not just in the United States but also globally so that a number of countries abroad will be participating in this trial as well,” Garcia-Diaz said.
Ochsner in New Orleans is one of two locations in the state that is participating in the trials, and 70-75 children are expected to participate in the health system’s New Orleans trial.
“The goal with that is to have the equal number of subjects per site and be sort of able to have that diversity throughout all sites and all countries that are currently participating,” Garcia-Diaz said.
Those participating in the study will be monitored for about 18 months.
According to Pfizer’s website, it began a three-phase study on the vaccine with those ages 6 months to 11 years old in March.
In the future at Ochsner, the trials will expand to ages 2 to 5 and from 6 months to 23 months.
Those interested in partaking in this COVID-19 research should send correspondence to covidvaccine@ochsner.org.
The local vaccine trial expansion comes as efforts continue to reach herd immunity. Lennarz said children comprise about 1/3 of the population.
“You could even make an argument that they circulate more in the community, often more than adults, so it’s very important that children be part of the overall push to get herd immunity to kind of snuff this virus out by not making it possible to transmit to anybody susceptible,” he said.
While children are at much lower risk for a serious reaction to the virus, that’s not full-proof. Dr. Yvonne Maldonado, professor of pediatrics and epidemiology and population health at Stanford University School of Medicine, said in a press release from the school last month that a couple of hundred U.S. children have died as a result of the virus. She said the impacts long term are not known. She said youth can suffer from multisystem inflammatory syndrome weeks after catching the virus.
Much closer to home in Louisiana, Ochsner is seeing children with serious cases.
“Here at Ochsner Hospital for Children, we continue to this day to take care of children in the hospital who are amongst the rare subgroup that do get serious infection,” Lennarz said.
The virus is something Lennarz said parents should protect their children against like other infections they are inoculated for.
He noted the American Academy of Pediatrics and Ochsner Hospital for Children endorse it when it is approved for use by the U.S. Food and Drug Administration for each age group.