Now that the FDA has expanded its emergency use authorization for Pfizer’s COVID-19 vaccine, allowing it to be used for kids 12-15, the whole thing gets kicked over to the CDC’s advisory council on Wednesday.
The Advisory Council on Immunization Practices (ACIP) has scheduled an emergency meeting for Wednesday to talk about best practices, or “clinical considerations and implementation” for getting this vaccine to kids.
It’s likely those discussions will hit on several of the biggest questions right now:
1) How do we know this is safe for kids?
The FDA reviewed Pfizer’s data for an ongoing, randomized trial involving 2,260 kids age 12-15. About half got the vaccine, while half got a placebo. Most participants were able to be tracked for two months.
A week after getting the second dose, the placebo group had 16 cases of COVID. The vaccinated group had none. That’s a 100% effectiveness rate, which is even higher than the results we saw from similar studies in adults.
Side effects were minimal, too: pain at the injection site, cold and flu-like symptoms, lasting 1-3 days, and more frequently after the second dose than the first.
Based on this and the previous data from adult studies, the FDA says this meets “the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.”
Plus, we’ve been able to see these vaccines work for several months now in adults and kids 16 and over, says Dr. Liam Sullivan, an infectious disease doctor at Spectrum Health in West Michigan.
“I think they've proven their safety,” he said Tuesday. “They've proven their effectiveness. They were very efficacious in clinical trials. And in the real world, they're proving to be every bit as effective... So I think people can be confident that these vaccines are very safe.”
2) How soon can kids get this? And will we be able to get it from our pediatrician or family doctor?
That’s the hope. But it probably won’t happen overnight. You’re more likely to be able to get this at retail pharmacies first, because they’ve already got the logistics of storing and administering vaccinations figured out.
Still, everyone from the White House to private physicians wants this to be something kids, teens and their parents can get in their doctor’s office.
“A lot of infrastructure is being worked on for that, because we know that having the vaccine be available in one [centralized, mass distribution] place may be completely unrealistic for people, who cannot get around the city very well with impaired mobility, etc,” said Dr. Rosey Olivero, a Pediatric Infectious Disease Physician at Helen DeVos Children’s Hospital.
“Plus, a lot of people want to get their medical care at what we call their medical home, or the office that they usually go to seek medical care. So there is lots of work being done on that. I do not yet have a timeline on when that will be available at our pediatrician's offices… One of the biggest challenges with that: it's not just getting the vaccine there, it's the [ultra cold] storage of the vaccine and how the vaccine is drawn out of the vials that they've come in. So a lot of logistics around that. But the intent is to make it as widely accessible as possible to our pediatric and adult populations.”
3) How hesitant are parents about getting their kids vaccinated?
That’s a real issue. A recent study found that about 14% of dads and 25% of moms said they’re resistant to getting their kids vaccinated: especially parents of younger children.
Pediatricians have already been having conversations about this with the families they care for. And Dr. Olivero said the two big concerns they hear are that the vaccine could somehow alter your DNA (it can’t) or impact future fertility (also no).
“This is the most common hesitancy for our adolescent population, is the concerns about fertility,” Dr. Olivero says. “So COVID-19 itself, the viral infection, has not impacted fertility worldwide, nor have the mRNA vaccines. And really, that [myth] was a message that is completely unfounded and has not borne out to be true. So I just want to reassure our teenagers and our young adults of childbearing age: this really is not a concern. And I would certainly have my daughter vaccinated as soon as her age group gets approved.”
But because vaccine hesitancy itself isn’t new, doctors also know that you can’t just throw data at somebody and expect them to change their mind. Instead, the American Academy of Pediatrics is recommending doctors “avoid responding to concerns by telling parents everything they know about the topic,” because “[t]hat approach puts people on the defensive.
“Instead, motivational interviewing is an effective communication framework for conversations about COVID-19 vaccines. When parents are hesitant about the vaccine, Dr. Sean O’Leary [Vice Chair of the AAP’s Committee on Infectious Disease] said he listens to their concerns. Then, he asks, ‘Can I share with you what I found out about that?’ and succinctly explains what he knows to address their concern.”
4) Do kids really even need the vaccine, given that they can’t get that sick?
So yes, kids generally have a less serious reaction to COVID, and that’s good.
But they can, and do, get sick. Recently, the APP said, they make up as much as 22% of all new cases in the U.S. And here in Michigan, we had record numbers of children being hospitalized for COVID during the surge in April, including infants. Some even had to be put on ventilators. (Pfizer has said it plans to ask for an EUA for vaccinating kids 2-11 in September.)
Kids also face a risk from something called MIS-C, or Multisystem Inflammatory Syndrome in Children. There’s a lot we still don’t understand about this condition, but it seems to surface after a child appears to have recovered from COVID. It can include symptoms like “abdominal (gut) pain, vomiting, diarrhea, neck pain, rash, bloodshot eyes, or feeling extra tired.”
In Michigan, there’ve been 116 MIS-C cases confirmed and reported to the CDC. About 70% of those had to be admitted to the ICU. Fewer than 5 have died, though the state health department won’t say exactly how many.
5) Are we going to see this vaccine eventually be required by schools?
Possibly, but not right away. The vaccines can’t be mandated without first going through the full FDA approval process. Right now, they only have Emergency Use Authorization, but it’s expected that the pharmaceutical companies will eventually request full approval.
“Whether or not it should be mandated, I think is a completely different question,” Dr. Olivero said. “And I am not going to give a value judgment on that right now. But I would say that the use of the COVID-19 vaccines on a more mandatory basis for children, I think has a lot of potential upsides.”
Here’s why: kids are 25% of the U.S. population. And given that the coronavirus will likely be circulating for a while, the more kids who can transmit the virus to each other at school or activities, or give it to the adults in their lives, the longer COVID’s going to be around.
And the longer it’s around, the more time the virus has to evolve, and potentially develop novel variants like the ones we’re already seeing, some of which are more easily transmissible. Worst case scenario? A variant develops that doesn’t respond to the vaccine.
“So when we think about the vaccine and its role in preventing the virus from changing in a way that could be more dangerous to human health, really, we need to think about how we can slow the spread and the reproduction of that virus,” Olivero said.