It is almost as if we are living in two countries: one that cannot wait to get kids vaccinated against a virus that is filling intensive care units with new cases daily and another that can’t be bothered. For parents who are reading the stories about an increasing number of pediatric COVID-19 cases, the question is: What is holding up Food and Drug Administration approval of vaccines for kids?
Both Pfizer and Moderna are signing up children to take the shots in the drug trials but, as we certainly know by now, it takes several months of trials before the drug companies have enough data to show the FDA that the vaccines are safe and effective for that population. It appears that Pfizer will be ready first, if all goes well, with data likely available sometime in the fall, maybe September. That might put the decision in front of the FDA shortly after that.
Moderna will be a bit behind, probably. If all goes well, the vaccines might be delivered to children under age 12 before the end of the year.
But all of that is an estimate. And CNN quotes one expert who says even that timeline might be too optimistic:
“I can’t imagine that we’d be in a position to even consider how to use these vaccines until the very end of the calendar year of 2021, going into the first quarter of 2022,” said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University and one of the lead investigators for Moderna’s pediatric Covid-19 vaccine. “I love that we’re riding the success of how quickly we were able to get a vaccine for adults, but we’ve just got to be patient.”
Experts point out that while we await vaccines for children, the best thing we can do to protect kids from getting sick is for the teens and adults who can be safely vaccinated to do so right away.
As Dr. Creech puts so clearly, “children are not just little adults.” Their immune systems are still developing and drug companies are trying to find out whether the children need two doses, or one, or something else. And it may also be that toddlers need something different from preteens or teenagers.
Creech said finding the “Goldilocks dose” for young children takes time. Give too little and the child may not make enough of an immune response to the coronavirus. Then they’re getting a vaccine with the potential for side effects with little or no benefit.
Remember that COVID-19 deaths among children are rare. And even when children are infected, they tend to have much less severe symptoms than older people, which is why the testing and approval process began with the most vulnerable senior population first.
One other reason we need the FDA and drug companies not to rush into vaccinating young kids without enough data is to avoid something clinicians call “immune enhancement.” Immunologists have known about this danger for a long time — back to the 1960s — which, again, is why these drug trials have to move only at the pace of the data they produce.
A research paper in the National Academy of Sciences explains:
Some animals or people who received the vaccine and were later exposed to the virus developed more severe disease than those who had not been vaccinated. The vaccine-primed immune system, in certain cases, seemed to launch a shoddy response to the natural infection. “That is something we want to avoid,” says Kanta Subbarao, director of the World Health Organization Collaborating Centre for Reference and Research on Influenza in Melbourne, Australia.
The Philadelphia Zoo says it will vaccinate a number of “at-risk” zoo animals against COVID-19. The Philadelphia Inquirer reports:
The Philadelphia Zoo is gearing up to vaccinate its highest-risk animals with an experimental vaccine developed by Zoetis, a former subsidiary of Pfizer that develops drugs for animals. While animals are not a major concern for spreading the virus to humans, according to the Centers for Disease Control and Prevention, they may still get infected. Cases have been reported in some big cats and gorillas at zoos, household pets, and farmed minks, motivating zoos nationwide to help their animals build up immune defenses.
Last year it appeared that there might be a need to vaccinate cats and dogs after experts found that the virus can be transmitted from human to pet but not from pet to human, at least that we know of. Testing showed cats are more likely to get infected by sick humans than dogs.