The coming COVID vaccine for children ages 5-11 is safe, effective and the best way for parents to protect their kids from the insidious disease, a Duke doctor who led a trial examining the vaccine’s effectiveness said Wednesday.
Dr. Emmanuel Walter Jr., a pediatrician and chief medical officer at the Duke Human Vaccine Institute, said government regulators’ expected approval of the Pfizer vaccine for use in young kids can be a true game-changer -- if enough parents choose it for their children.
“My advice to parents is this is the best way to protect your child from serious illness and potentially death from COVID, … get them vaccinated,” Walter said. “It’s the best tool we have. By all means I would recommend and suggest they get the vaccine.”
Walter led a trial at Duke examining the vaccine’s effects on youngsters, a study that evaluated several different doses. His study and others found the best results in that age group came from a 10-microgram dose, which is one-third of what adults receive. That is the dose the Food and Drug Administration is expected to soon approve for use in children 5-11.
In a virtual media briefing with reporters Wednesday, Walter discussed his study findings and the overall vaccine trial process, potential side effects, and the need for herd immunity in American communities.
Watch the briefing on YouTube.
Here are excerpts:
On concerns about vaccine approval process
“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.”
On potential vaccine side effects months or years from now
“I’d look first at the experience so far with this vaccine and the millions of doses that have been administered to older children and adults, and look at the safety track record there, which has actually been quite good. I don’t think we have any reason to believe the safety track record will be any different in children. People can be reassured that the safety of this vaccine in children will be really comparable to that which is seen in adults.”
Does the children’s vaccine differ from the first version already being administered?
“The vaccine is pretty much all the same vaccine. It will be a reduced dose. It’s a third of the dose.”
“When it is packaged it will look different; … the current vaccine has a purple cap ln the vial. This one will have an orange cap on the vial. It will be labeled that it will be just for children. So the adult dose should not be used for children.”
On differences in children from 5 to 11
“I think what we can say is that probably for the most part … in terms of immune response, children between the ages of 5 to 11 should respond … with a good, robust immune response to the vaccine at that one dose, even with a big variation in size. You might have some small 5-year-olds and some rather large 12-year-olds. But the immune response will be adequate for those kids. In terms of safety, we did study a range of kids within that age group … and the safety really didn’t appear to be different across the age group.”
On concerns over the myocarditis side effect
“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 second doses of vaccine received.”
“I think it’s really important to recognize that not all myocarditis is the same. You can develop myocarditis after developing COVID as a complication and that myocarditis from COVID is usually quite severe and makes people quite ill and causes a prolonged hospitalization.”
“The myocarditis that we’ve been seeing after vaccine is generally fairly mild. It does often lead to hospitalizations but it is usually easily treated once it’s recognized.”
“So I think you have to weigh that risk of developing COVID – depending on the prevalence of COVID in your community – versus the risk of myocarditis from vaccine, which is exceedingly rare.”
On whether children will need two shots
“It will be very, very similar to the adult dosing schedule. It’ll be two shots of a lower dose … administered three weeks apart.”
On how many young kids need to be vaccinated to reach community protection
“Without achieving a certain level of protection in the community, you may not get the full benefit of the vaccine to achieve what we call herd protection or community protection. In fact, vaccination rates with these particular vaccines, with this virus, probably has to be on the level of 80, 85 percent to really achieve that herd or community protection from infection.”
“If you look at the population as a whole and consider that children are roughly about 20 percent of the population, getting as many vaccinated as possible will lead to overall population vaccination.”
On vaccinating kids to protect others
“We have to be able to afford children the same protection from COVID through vaccination that we afford to adults. That is the right thing to do. We do need to realize that with this current delta surge, children now account for about 25 percent of reported cases of COVID. That’s really been a little bit different with Delta than it was earlier in the pandemic. Part of that may be related to the fact that we have a larger portion of the adult population vaccinated right now.”
“We’ve been kind of lulled by this thought that yes the pandemic is worse … for older adults and adults with co-morbidities. But children aren’t totally spared from COVID. When I last looked the other day there had been 750 deaths from COVID in children under age 18, 160 deaths in this age group for which we’re now considering approval or authorization of the vaccine, between the ages of 5 and 11. And that’s way more deaths than occur due to influenza in a typical year. So if you kind of put it in that perspective in terms of health, we really do need to get children vaccinated.”
“It’s really to allow kids the freedom to be kids and do all the things comfortably that kids do. Go to school, do sports activities, other after-school activities and recreational activities and do the normal things kids want to do.”
On if new vaccines should prompt removal of mask mandates
“I think right now it’s premature to do that. We have to get a good level of coverage for vaccination in this age group of children … and the rate of COVID in the community has to fall to a certain level I think for us to feel comfortable about really lifting the mask mandate. I think it’s a little premature, we’re not there yet. Maybe we can have those discussions in a few months.”
On whether kids will need booster shots
“It depends on where we head with the pandemic. What we do know in adults is the level of the antibody over time, over the period of six to seven months or so, declines. So your level of protection from vaccination decreases over time. So I think a few things that would have to happen: We’d have to study boosters in children and do that first.”
“I think you would have to have a compelling need. There would still have to be COVID in the community in order to do that. So a few questions have to be answered before we decide on boosting.”
On why many young kids will get the vaccine in a doctor’s office
“Children generally get vaccinated in a physician’s office, whether it be a pediatrician or a family practitioner’s office, for most of their routine shots. That’s kind of their medical home, that’s where they feel comfortable and that’s truthfully where the vaccinators feel comfortable having those discussions with families about vaccination and administering vaccine.”
On whether parents of 11-year-olds should wait for full dose once a child turns 12
“I would not wait. At age 11, children will develop as good an antibody response or protection, protected level of neutralizing antibodies in the blood, from 10 micrograms of vaccine as they do from 30 micrograms. I’m confident they’ll have the same protection. I would not wait.”
Faculty Participant
Emmanuel Walter Jr., M.D.
Dr. Emmanuel "Chip" Walter Jr. is chief medical officer of the Duke Human Vaccine Institute, where he directs the Duke Vaccine and Trials Unit. Walter is also a professor of pediatrics at Duke University School of Medicine.