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Duke researchers helped pave the way for FDA panel to greenlight Covid-19 vaccine for young kids

Vax Snax.jpg
Jessica Loeper
/
New Hanover County
Image taken at a June New Hanover County 'Vax and Snax' Event. Kids 12 and up can currently receive the vaccine; those 5 to 11 could receive the Pfizer Covid-19 vaccine in November.

After receiving the green light from an advisory panel, the FDA is expected to issue an emergency authorization of the Pfizer Covid-19 vaccine for children ages 5 to 11. One set of trials leading up to that approval was held at Duke University.

The trials started in March of this year, with about 4,500 kids participating, spanning ages 6-months to 11 years old. The trials used a 2 to 1 ratio of those receiving the vaccine versus a placebo. The study used several cohorts of different age groups. For now, only the five to eleven cohort is moving forward, based on a 90% efficacy rate — studies for younger kids are ongoing.

The study was led by Dr. Emmanuel 'Chip' Walter, chief medical officer of the Duke Human Vaccine Institute and a professor of pediatrics at Duke University School of Medicine.

He said getting children vaccinated is key to achieving overall herd immunity -- a rate that he said should be around 80 to 85%.

“But I think if you look at the population as a whole and consider that children account for roughly 20 to 20-some percent of the population, getting as many children vaccinated as possible will lead to overall population protection,” said Dr. Walter.

Walter said Pfizer will offer two vaccine doses, each dose will be a third of the adult version, given three weeks apart.

He said that the Pfizer vaccine's safety record in children is comparable to those in adults — and that he's "absolutely confident" that this is the right time to dispense the vaccine for this age group.

As for vaccine-hesitant parents, Walter said that with the onset of the summer Delta variant wave, children accounted for about 25% of positive cases — and that they can get seriously ill from the virus and there have, unfortunately, been children who have died from the virus.

Walter also addressed concerns that the FDA will likely issue an 'emergency authorization' of the vaccine as opposed to full approval; he said the standards for the trials leading up to either move are the same.

“There’s no difference in the safety standards. I think the only thing that would potentially be different in this case, because we’re in a pandemic situation here where we’re still experiencing the Delta wave, though it’s coming down … you really have a public health emergency so there is a need to get the data more quickly. So I think what you see here is the enrollments are more rapid, getting the data assembled is more rapid, getting the data reviewed is more rapid, it’s done on an ongoing basis with the FDA. So yes, there’s a sense of rapidity, but it is meeting all the same safety standards," Walter said.

Walter also touched on concerns about myocarditis, particularly in teenage boys.

“The risk for developing myocarditis really seems to be greater after the second dose of vaccine; it’s more commonly seen in males, particularly young males within the ages of 16-30. The rate in that particular group is about 40 per million [from] second doses of vaccine received," Walter said, adding that cases of myocarditis were "generally fairly mild" and that there were no cases in the trials he oversaw.

Walter also noted that cases of myocarditis from Covid-19 were more severe than those from vaccines.

According to Walter, this vaccine is the best tool for parents in preventing their children from contracting Covid-19 and eliminating serious health complications: "Children can have this condition where they get inflammation in their multiple organs in their bodies or their heart, lungs, kidneys, their GI tract. It's called multisystem inflammatory syndrome in children (MIS-C). There are also long-term effects of Covid that aren't well-defined in this population."

For side effects from the vaccine, like adults, Walter said, children may experience a low-grade fever, achiness, and headaches as a result of vaccination but that those he evaluated in the clinical trial reported side effects that were mild and gone within a day or two.

As for when the masks can come off for kids, he said now isn’t the time, as children can spread the virus.

“One, we have to get a good level of coverage in this age group of children, so that has to occur, and the rate of Covid in the community has to fall to a certain level for us to feel comfortable about lifting mask mandates,” said Walter.

Some local pediatric offices have already started soliciting interest from families who want to be first in line to receive the vaccine. Walter said pediatric offices are children's "medical home" and it's likely that many of them will receive their vaccinations there.

North Carolina Governor Roy Cooper said on Tuesday that vaccines may be available for younger children as early as the end of next week. A release from Cooper's office noted, "[m]ore than 750 locations are preparing to provide vaccines to this age group, including doctors’ offices, pharmacies, local health departments, community vaccination events and family vaccination sites."

New Hanover County's Chief Communications Officer Jessica Loeper told WHQR on Wednesday, "Our Public Health Department is closely following this conversation and is awaiting approval and guidance from the CDC and the Advisory Committee on Immunization Practices (ACIP) and then the standing order from NC DHHS, in order to begin offering the COVID-19 vaccine to children 5-11 years old. Our healthcare partners, like [local] pediatrician offices, will be important in this effort to help administer the vaccine once that approval and guidance is received, and Public Health is poised to be a provider as well."