An unexpected delay in the FDA's authorization of COVID shots for children under age 5 could amplify parents' existing concerns about vaccinating their kids. Here's what we know about the situation.
Do children under five years old need COVID-19 vaccines? Answering that question should be a simple matter of comparing the risk of infection to the risks and benefits of vaccination in this age group. But nothing about this pandemic has been simple, and this issue is no exception. While we know quite a bit about how dangerous SARS-CoV-2 is to young children, we still don't know if it makes sense to vaccinate them, primarily because of the confusion emanating from Pfizer and the FDA regarding the efficacy of the shots.
While there's still a lot we don't know, one thing can be said with certainty: parents are already hesitant to vaccinate their children. The problem could get much worse if this situation isn't handled more delicately.
COVID poses low risk to children
First, the good news is that SARS-CoV-2 still seems to pose a relatively low risk to children. As of February 10, according to the American Academy of Pediatrics (AAP), “0.00%-0.01% of all child COVID-19 cases resulted in death.” Based on data from 24 states, the AAP also reported that “children ranged from 1.5%-4.6% of their total cumulated hospitalizations, and 0.1%-1.5% of all their child COVID-19 cases resulted in hospitalization.” The media has regularly reported post-omicron that pediatric hospitalizations have surged, but as our own Dr. Chuck Dinerstein noted on January 22,
they are released quickly, and their experience of COVID is more like the many seasonal respiratory diseases, asthma, croup, and bronchiolitis ...
Finally, data from 46 states show that pediatric cases represented 0.00%-0.23% of all COVID-19 deaths; the disease has killed fewer than 800 people below the age of 17, the CDC reported on February 9. The numbers look even better if we break them into subgroups:
Vaccines safe, effective in young children?
Here's where things get messy. Pfizer claims data from its ongoing clinical trial show that a two-dose series is highly effective against infection in children 6- to 24-months-old, though the same can't be said for children 2-5 years old. The company delayed its request for approval to the FDA for all children under five, reporting that it wants data on a third dose in this age range. The FDA announced its support for that decision on February 11:
Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
According to Dr. Robert Frenck, director of the Gamble Vaccine Research Center at Cincinnati Children's Hospital Medical Center, the FDA may not approve vaccination for children under five until May. This is all very confusing because The FDA originally asked Pfizer to submit the request for authorization of two doses on February 1. Pfizer CEO Albert Bourla told CNBC a week later that “I think that they will be pleased with the data and they will approve.” The CDC said the next day that there would be 10 million doses for children under five ready by February 21.
NBC's initial response to Pfizer's delayed EUA request was to call it "a setback for parents eager to vaccinate their young children.” Though as the parent of a young child, I have a more pressing question about another detail NBC included in the same story:
Two people familiar with the FDA’s plans said there had already been a lot of pushback on the agency from outside experts who had concerns that Pfizer’s data wasn’t sufficient. The experts felt, one of the people said, that their concerns were 'falling on deaf ears' within the agency.
It's even more important that we get an answer because the majority of parents are not enthusiastic about vaccinating their kids. Less than 30 percent of children ages 5-11 have been fully vaccinated so far. And a recent Kaiser Family Foundation poll showed that only 31 percent of parents are planning to vaccinate their younger children as soon as the FDA grants authorization.
A “setback” for vaccine-enthusiastic parents is the least of our problems from a public health perspective in light of this information. There are experts (which ones?) apparently expressing skepticism about Pfizer's data (which data?) just weeks after most parents signaled their disinterest in vaccinating their kids.
The problem isn't that the EUA was delayed. As vaccine expert Dr. Paul Offit told CNN this week, it would have been a mistake for the FDA to vote “no” on Pfizer's vaccine in February only to approve it a few months later. "That would have sent the message to the general public that something's wrong with this vaccine. And then [if] we come back a few months later and vote yes, people may still be suspicious or less likely to take the vaccine up," Offit noted.
What is concerning, however, is that the delay came at the last minute. At the beginning of February, the White House, CDC, FDA and Pfizer all seemed to be on the same page about the vaccine roll out. Then, less than two weeks later, reports of dissension in the ranks at the FDA hit the headlines. Something clearly changed suddenly. Is it too much to ask that regulators tells us what it was?
Public trust is paramount
None of this is intended to seed doubt about vaccinating kids against COVID-19. I hope the clinical trial data confirm the safety and efficacy of Pfizer's shot and parents and pediatricians can use it to make informed decisions. There's also no evidence that the company or the FDA have intentionally misled the public here. Dr. Dinerstein appropriately summed up the situation:
I think the Pfizer people (with a vested interest) and the administration (with a different vested interest) got out to far in front of their skis and that when scientists and outside experts looked at the data it was less than compelling.
For me the key here is to recognize the miscommunication because of vested interest vs. being intentionally misleading. Pfizer loved their data, the administration wants to project safety and strength and both view the data through those eyes - not ill intent, not financial gain. Outside views disagreed and out of an abundance of caution deferred until there was more data. The conspiracy takes hold in the 'flip-flop' not in the actual events.
But noble intentions don't blunt the damage done by miscommunication. The media, citing the AAP, recently reported that the “Covid-19 case load among children has been 'extremely high' during the Omicron surge,” despite AAP data showing that young kids face significantly reduced risk of severe disease. Combined with the mixed signals on vaccine authorization, we have another example of the confusing messaging that has crippled public trust in institutions like the FDA and CDC throughout the pandemic.
We know skepticism of the COVID shots is fueling efforts to rescind school mandates for other childhood vaccines. If we want to prevent these sorts of long-term consequences, regulators, drug companies and reporters need to assuage the concerns of wary parents. Right now, they're only making the situation worse.