Pfizer and BioNTech has said their COVID-19 vaccine is safe, well-tolerated and produces a strong immune response in children 5 to 11, bringing hope to many parents that their children could soon be protected.
Officials for the vaccine makers said in a news release Monday that they would take the data to federal regulators soon, prompting estimates that younger kids could be vaccinated by the end of October.
The companies also said they will seek authorization for the vaccine’s use in children younger than 5 before the end of the year. The vaccine already is approved in adults and has emergency authorization for use in children as young as 12.
With pediatric COVID-19 cases on the rise in Maryland and across the country, Maryland Gov. Larry Hogan has pushed federal regulators at the U.S. Food and Drug Administration and Centers for Disease Control and Prevention to expedite their reviews. While awaiting federal guidance, state health authorities already are planning for pediatricians to provide the bulk of vaccinations.
Below is a condensed interview about the process and timeline with Dr. James Campbell, a pediatric infectious disease specialist in the University of Maryland School of Medicine who is the principal investigator of a similar trial in Baltimore of the Moderna vaccine in children.
What did Pfizer say about its vaccine for kids in the study?
Pfizer has been studying 5- to 11-year-olds, giving them a third of the adult vaccine dose, or 10 micrograms. They had over 2,000 kids in that study and two-thirds got the vaccine and one-third a placebo, 21 days apart.
They announced today [Sept. 20] that the safety profile looked as good or better than what they’d seen in young adults. And neutralizing antibodies are almost exactly the same a month after the second dose, when we have peak response in antibodies that can protect against COVID.
They need to meet a certain bar, that the vaccine results in young kids looks as good as results in young adults. They appear to have done that.
If the dose is lower, does that mean fewer bad reactions, such as rare cases of heart inflammation called myocarditis seen in adolescents? What are more likely side effects?
Pfizer didn’t report in their press release any cases of myocarditis, so I assume they didn’t see any. Even in adult studies, there weren’t a lot of cases in studies with 30,000 to 40,000 people. They had to wait until millions of people were vaccinated to relay that signal.
Side effects you’re more likely to see in 5- to 11-year-olds are the same list you see in older children and adults: fever, chills, fatigue and a sore arm. But it sounds like these may be even less likely in the younger kids. These are relatively minor problems.
If Pfizer requests emergency use authorization by the end of September, when might the FDA OK the vaccine’s use and how fast could doses be available?
The FDA already has a fair amount of knowledge about what’s happening in these trials but doesn’t have a complete submission from Pfizer at this point. The leadership at the FDA has said once data is made available they will review it quickly.
I’d anticipate that before the end of September to mid-October they’d have a meeting and the FDA and its advisory committee would be able to review data and decide to expand the authorization to younger kids. Then, it would be reviewed by the CDC and its Advisory Committee on Immunization Practices. That’s the advisory panel of experts that recommends who gets the vaccine, contraindications and a schedule.
Everyone’s current prediction is the end of October we’ll have the vaccine available. But we don’t have anything set in stone yet.
This will be two shots, three weeks apart, so how will that work with flu shots and even makeup routine childhood vaccinations?
The CDC will be part of this recommendation, but normally we recommend kids get vaccines on schedule, which means they can get more than one at the same time.
The reason we say this is when people try to space them out or not give them at the scheduled time, it leads to missed opportunities to get kids up to date. Life gets in the way, and people don’t come back for vaccines that you encouraged them not to get. It causes logistical problems because kids have to take off school again and parents have to take off work again.
It’s likely we’ll hear a recommendation from the CDC that it’s safe to get flu and COVID vaccines at the same time.
Children are now making up a larger share of COVID cases than at any time during the pandemic. In Maryland, kids age 9 and younger now make up 17.5% of new cases. How important is vaccinating them in ending the pandemic?
Maryland has a great history of very high vaccination rates and it’s not any different for COVID vaccinations. The state is in the top 10 for adults vaccinated. And that’s one reason I have kids in the hospitals with COVID but we are not overwhelmed with pediatric COVID cases. Vaccinated adults are protecting the kids.
But we do need the kids in the mix to end the pandemic.
We have done a study at Maryland looking at parents’ likelihood of vaccinating their children. There was no bigger predictor for parents wanting to vaccinate their kids than if they themselves were vaccinated or planning to be vaccinated. I have high hopes in Maryland since so many adults were ready and willing to vaccinate themselves that they will vaccinate their children.
We need everyone on board. I see lists of everyone admitted to the [University of Maryland Medical Center], adults and children, and almost all are unvaccinated. They go to a community hospital and get worse and worse and end up here in the hospital on ECMO, the machine that helps oxygenate their blood. It very sad and it’s very costly to treat someone with COVID. The vaccine is not that costly and prevents nearly all hospitalizations.
How might vaccination affect schools and their testing and other programs to keep kids safe?
Once students get vaccinated, it’s not likely to change what needs to be done in schools. Testing and mitigation efforts will continue. Not all kids will be vaccinated quickly and there will be a couple of cases even among kids who are vaccinated.
Hopefully, over the long run, things will change. Next year, when most children are vaccinated, it will allow us to change the way we do things.
For now, each school or district has made a decision on the best approach, and it’s all about risk mitigation. If you’re too restrictive, kids won’t be in school or out so frequently it’s worse than if you never started back. But if you’re not restrictive enough, kids continue to be at risk in school. There is a sweet spot most think they have figured out.
There has been value to having three vaccines available for adults because they increase supply and choices. Is that the same for kids?
Yes. The Moderna pediatric vaccine study we are a part of at Maryland is for children aged 6 to 11. For Pfizer, it’s 5 to 11. Our 6-to-11-year-olds are getting their second vaccination now and it’s half the adult dose. We don’t have data yet, but we will in upcoming months, and our hope and expectation is that it will mimic what we saw in Pfizer’s vaccine.
Hopefully, before this year is out, we will have two vaccines for all school-age kids. Then later this year or early next year, we’ll have a vaccine for preschoolers. Down the pike, we will have a Johnson & Johnson vaccine for kids.
And then there’s Novavax, which is studying its vaccine in adults and children. So, we could have a fourth vaccine for adults and children in the United States. I don’t encourage anyone to hold out for a certain vaccine, but Novavax is made in a more traditional way, and that may appeal to some people — so whatever we can do with a new vaccine or current vaccine to get people to take them.