Ochsner Health is enrolling Louisiana children ages 12 to 17 in a U.S. trial of the Pfizer coronavirus vaccine, as drug makers nearing regulatory authorizations for adult use of their vaccines begin the process of testing them in children.
Currently, the first two vaccines expected to receive authorization by U.S. regulators, from Pfizer and Moderna, could get the go-ahead this month. But the authorization is only set to make the drug available for use in people over 18.
In order to receive authorization for use in kids — a critical step in achieving herd immunity across the population — both Moderna and Pfizer are now seeking younger trial participants. Ochsner plans to enroll 100 children for the Pfizer trials in Louisiana, serving as one of 24 sites across the U.S. that in total will aim to enroll 2,600 patients.
The Moderna vaccine trial plans to enroll 3,000 children, though it hasn't announced when it might begin the enrollment or the proposed sites.
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Dr. William Lennarz, Ochsner’s pediatric systems chair and a lead doctor on the study, said Friday that while few children have developed severe symptoms from the coronavirus, they can spread the disease to family and friends who are older and more susceptible to the disease. That's why their vaccination is critical to eventually ending the pandemic.
“Children themselves are at very low risk, however everyone they come in contact with is certainly susceptible to getting the infection from children just the way they are from adults,” Lennarz said.
The children who enroll in the Pfizer trial at Ochsner's Jefferson Highway campus will get two doses of the vaccine three weeks apart. Ochsner began enrolling participants in mid-November and has already identified enough patients in the 16-17 year old group.
Parental consent is required for participants in the study, which is set to run for two years. But if all goes as planned, there should be enough data to show safety and efficacy in children over 12 by June 2021, according to Dr. John Schieffelin, a pediatric infectious disease expert at Tulane University who is not involved in the study.
About 12% of coronavirus cases are identified in children, according to the American Academy of Pediatrics. Though symptoms are usually mild, at least 138 have died.
Children will be a necessary population to vaccinate in order to reach herd immunity, the point at which the virus can no longer easily circulate in the community. Scientists estimate about 60% of a community will need protection in order to stop the virus from spreading, and some adults and children may not be able to be vaccinated due to other health conditions — or may refuse to be vaccinated.
In Louisiana, children make up almost a quarter of the state's 4.6 million people.
“Children, especially teenagers, are at a high risk of having asymptomatic infection, so in the long term to get control of this virus we absolutely need to vaccinate children,” said Schieffelin.
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The vaccine trial at Ochsner is for Pfizer's mRNA vaccine, which does not contain a weakened or dead version of the virus like many other vaccines.
Instead, the mRNA contains a code that instructs the body to make a spike protein exactly like the one the real coronavirus uses to enter cells. When the body recognizes the harmless spike protein, it starts making antibodies against it. When the real coronavirus enters the body, the body's immune system has already learned how to fight it.
Pfizer has said its data indicates that the vaccine is 95% effective in adults, with no serious side effects. In adolescents, Schieffelin doesn’t expect any big surprises.
“There’s no reason to think that children in this age group they're testing are going to react any differently than young adults in their 20s and even 30s,” he said.
Still, that may change once the trials are extended to younger children, he added.
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Children under five have immune systems that are still developing. Due to the sheer amount of exposure to new viruses and the number of recommended vaccines they receive, they tend to have a “cranked-up immune system,” said Lennarz.
Some have theorized that’s why children don’t seem to get very sick from COVID-19 — and that when they do, the immune system can go into overdrive and trigger a severe reaction known as multisystem inflammatory syndrome in children, or MIS-C.
The vaccine likely won’t be tested in younger children until next year, when there is more data in older children. In elderly adults, it appears to be both effective and safe.
But the trial, like any other study, is not without some risk. Children may have different side effects than adults. They could also experience side effects to a greater degree.
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“This virus has humbled all of us many, many times and proved us wrong many times,” said Schieffelin. “That’s why we need to do testing.”
Those interested in signing up for the trial can email COVIDVaccine@ochsner.org for more information.
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