What’s Holding Up COVID Vaccines for Kids Under 5?

As the United States eases pandemic restrictions some experts are advising 70% of AmericansThey don’t need to wear a mask. Many parents of young children want to know when a vaccine will be approved for kids below 5.

In the face of confusion and anxiety caused by the U.S. Food and Drug Administration and the drugmakers, as well as whiplash due to the changing timeline and unexpected delays that have occurred, there was no clear communication. Some parents are obsessively tracking every press release, investor report and social media announcement to glean information, and a few have even lied about their kids’ ages to get their children vaccinated. Many feel they are alone.

“I just feel like we are being left on Pandemic Island,” said Jen Wendeln, mother to a 3-year-old boy in Cincinnati. “They’ve sent rescue boats several times and then told us: ‘Never mind, none for your children. Don’t worry, we’ll come back, just keep waiting.’”

Parents have been told that vaccines for little ones are coming “soon” over and over. In September, Pfizer’s CEO Albert Bourla said that two-shot data for 2- to 4-year-olds would be available “before the end of the year,” with submission to the FDA soon after. It turned out that the data contained mixedNews, timelines, and timelines were pushed aside when Pfizer added a third shot. Parents felt hopeful when Dr. Anthony Fauci announced his new drug. suggestedAuthorization could occur sometime in February and momentum seemed to be building as the FDA scheduled a meeting of outside experts to review Pfizer’s data on Feb. 15 to consider authorizing two doses first while waiting for data on the third. However, the FDA decided to delay the meeting due to new information. waitMore information is available.

All this happened because the first omicron and then the delta variant sent increasing numbers of children to the hospital, filling up the pediatric wards. Hearing experts urge parents to get vaccinated immediately to prevent their children from contracting the highly infectious variant. Some parents were disappointed not to have that option. “I put my kids in car seats. I laid them on their back when they were babies so they wouldn’t suffocate,” said Dr. Amy Cho, an emergency room physician in Minnetonka, Minnesota. Knowing that vaccines are preventing deaths in kids over 5, it pains her that one isn’t available yet for her 3-year-old. “I couldn’t live with myself knowing I didn’t do everything I could to prevent that outcome,” she said.

Many parents have turned to Facebook groups for information and answers to their questions. Why the delay? When will the data become public? What is the story with the trials There are many conspiracy theories and rumors.

To clarify the conversation, I researched FDA policy and asked officials from Moderna, Pfizer, and FDA the most important questions that parents want answered. What I discovered dispels a common myth, provides context for the factors being considered and gives an update on the timing.

Why Should Parents Get Vaccines?

Children under 5 years old are less susceptible to the coronavirus than adults. However, they are still vulnerable to serious consequences. More than 460 children below 5 years old died in the United States from COVID-19. accordingAccording to the CDC. They’ve been hospitalizedAccording to the agency, and have died at an increased rate than children aged 5-11 years. “It’s very frustrating for us, writing off kids who have died — what’s the acceptable number of child deaths for people?” asked Dr. Scott Krugman, vice chair of pediatrics at the Herman & Walter Samuelson Children’s Hospital at Sinai. “If it’s preventable, it should be zero.”

A source of anxiety for many parents is that it’s hard to predict which kids may have bad outcomes. While children with asthma or other lung conditions are more likely to suffer from pneumonia if they are infected, researchers still don’t know what puts a child at higher risk of suffering from multisystem inflammatory syndrome, or MIS-C. This condition can lead to serious and even fatal complications. It involves inflammation of many organs, including the brain, heart, lungs, kidneys, and brain. Children with no preexisting conditions are often the ones who experience MIS-C, Krugman said: “They’re perfectly healthy 4- or 5 year-olds who randomly show up with cardiac enzymes through the roof and who need close monitoring and support.” Some other children also experience symptoms that last for months.

Experts advise parents to surround their children with people who have been vaccinated, boosted, and masked. This will ensure that their children are safe. Many parents are concerned that restrictions are being relaxed and that people are becoming more active means that there is an increase in the risk for their children. Some parents worry that their older children could spread the virus to their younger siblings if they don’t have the mask mandate.

“Things are getting less safe for those of us who cannot vaccinate our family members — knowing there are even fewer people wearing masks makes everything that much more dangerous for us,” said Chris Nammour, father of a 2-year-old in Puyallup, Washington. So far, he’s chosen not to send his daughter to day care. “Our world is very small.”

What is the FDA’s Priority Before Approving the Vaccine?

Many parents who want a vaccine say they don’t expect perfection: They don’t expect it to prevent infection, but want to lower the risk of the worst outcomes for their children, like hospitalizations or Long COVID. Emily Whittington is one such example. Her 4-year-old son, Jeremy Whittington, was born with a rare genetic mutation that causes brain malformations. He is at high risk of having a seizure if he becomes sick. Whittington is a rural West Virginia resident and stated that because of the low rate of vaccination in her area, she had to keep Jeremy from pre-K in order to avoid being exposed. “Can any of those doctors or advisory boards look me in the eye and say, ‘Your son is better off getting COVID without the vaccine than with some protection?’”

But the agency isn’t considering Whittington’s situation in isolation; it has a far more complicated calculus to make. “In addition to those people who are really excited about getting their kids vaccinated, there are also a lot of people out there that are like … I really want to know that, if the FDA tells me I’m going to have to give this to my kid or I should give this to my kid, I want to know that it really works,” an FDA official, who spoke on the condition of anonymity, told me. Only 1 in 4 childrenAges 5-11 were fully vaccinated by March 1st. polling has shown that about a third of parents want to “wait and see,” while another third do not plan to get their child the shot.

“The challenge we have is, if we take something forward where there’s tremendous controversy because the data are not really clear, there can be a lot of confusion in the public, and ultimately, it can be counterproductive for getting the population vaccinated,” the official said.The FDA also considers what’s going on in real time. The agency took action when cases of omicron grew and more children were being hospitalized. unprecedented moveIt stated that it would consider authorizing two shots for children under 5 of the Pfizer vaccine while waiting for more efficacy data for a third shot. This was to allow those children to get a head start on the vaccine series prior to the authorization of the third shot. The plan was also based on the assumption of the third dose working. What if Pfizer’s three doses still weren’t enough? Some experts feared it was a risky step for the agency.

“If it didn’t work out, the price they could pay could be a lack of confidence not just in the COVID-19 vaccinations but a spillover into other childhood vaccinations,” said Dr. Peter Hotez, a pediatrician and dean for the National School of Tropical Medicine at Baylor College of Medicine. What if a fourth or fifth dose was needed? Dr. C. Buddy Creech is a professor of pediatrics and director at Vanderbilt Vaccine Research Program. “Do side-effect profiles go up when we do that? Does it change over time if you keep hammering the immune system with the same antigen over and over again?”

Pfizer, which was collecting data in realtime, reportedly discovered that its shots were incorrect less effectiveThe omicron variant was not approved. The FDA took this information into consideration and decided to wait for data from all three shots before approving authorization. One factor in the FDA’s decision was that overall, the risk for children has decreased as omicron case numbers have fallen. “In the midst of a huge surge, the benefit/risk [calculation] could be different than when you’re now coming towards the tail of a surge,” the FDA official said. “It doesn’t change our essential considerations, which are that the vaccine has to show the safety that we need … but it is true that the efficacy that we would expect, that could be a little bit different depending on the amount of disease that was circulating at a given time, the amount of hospitalizations, etc.”

The agency has a challenging job of balancing the need for thoroughness with speed, said Dr. Paul Spearman, director of the division of infectious diseases at Cincinnati Children’s Hospital Medical Center. Children are not just little adults — their immune systems are different — so you can’t just scale down the existing vaccine proportionally and presume it’ll be both safe and effective. It’s not unusual for children’s vaccine trials to take longer than adults’ because of additional steps needed to find the correct dosage for different age groups, Spearman said. “There’s more care taken about safety and finding a precise dose, and more scrutiny, because it’s a vulnerable population.”

Ian Stone, parent of a 4-year-old in San Diego, said he’s willing to wait for a vaccine. “I want it to be safe. I want it to work. I don’t want it to be pushed forward because we have to have something,” he said. But Stone, who works in public relations, said he thinks the unexpected delay “may cause more harm than good. It’ll make people question and scrutinize it that much more. If it wasn’t ready, I wish they hadn’t gotten hopes up because you’ve drawn unwanted attention.”

Is “Age De-escalation” a Real FDA Vaccine Policy?

Parents have been misinformed, which has led to unfounded concerns about vaccine delays.

In December, Pfizer saidThe two shots were safe for all children under 5. However, children under 2 years old produced antibodies similar to those seen among 16- to 25 year-olds. The 2- to 4-year olds did not reach the same level of effectiveness. The drugmaker announced that it would begin testing a three shot regimen to see if it could increase the level protection.

Parents of children younger than 2 years old had a clear question: Why not authorize the shots for the babies first?

It was difficult to find a clear answer. The myth that the FDA had a policy that prevented it from authorizing vaccines for certain age groups was widely circulated on the internet. It was also printed in traditional media and repeated many times by doctors. It was referred to as an “age de-escalation policy.”

Age de-escalation is how certain clinical trials are conducted, including the COVID-19 vaccine trial trials. After the vaccines have been proven safe and effective, the trial is extended to younger age groups. This is important for a number of reasons including safety — adults and teens are better able to articulate side effects they may be experiencing, so if a side effect is identified as related to the vaccine, researchers can look out for that symptom in younger kids who may not be as articulate; a fussing baby, as every parent knows, can be difficult to interpret.

But when it comes to authorizing vaccines, that doesn’t apply. “There’s no such policy, and we would have been happy to skip an age group,” the FDA official told me.

I also asked Pfizer why, then, it hadn’t sought authorization for kids under 2 first. The oblique answer I got from a spokeswoman was: “We’re continuing to study a third dose in this population.” I asked for more information and was told, “If successful, we will pursue a three-dose series based on the ongoing late stage study.”

Pfizer is now pursuing a three dose series for all children under 5. But Pfizer is pursuing a three-dose series for all children under 5.

FDA is tightlylimitedBy regulation, trial data cannot be discussed publicly without approval. That has accounted for much of the agency’s reticence. The official could only tell me, enigmatically, that “eventually it will become clear that there was not a way to skip an age group here.” Perhaps something in Pfizer’s data in infants made the drugmaker or FDA determine it wasn’t sufficient for authorization, but until data becomes public, it is impossible to know.

Moderna’s vaccine has been delayed in the U.S. for 12-17-year-olds due to concerns that it could cause myocarditis (inflammation of the heart muscle). Moderna is currently testing a lower dose for adolescents and 6-to-11-year-olds. However, the company stated that it expects data from the March trial of children under 5 years old.

Parents were again confused by the age-de-escalation policy. They speculated that Moderna could never ask the FDA for authorization to allow vaccine access for the youngest children before the teens.

Not so, a Moderna spokesperson told me: “Once the data are available in this age group, Moderna will review the data and decide whether to file for Emergency Use Authorization independent of whether other EUA submissions currently under review have already been approved.”

What’s Next for Vaccines for Small Children?

Here’s the good news: Two companies could have data on vaccines in kids under 5 in a matter of weeks. Pfizer has said it’ll have data on three doses “in spring” and Moderna has said it’ll have data by the end of March. If the data looks good, there’s nothing to stop the FDA from authorizing a vaccine for kids of a certain age group, even if an older cohort misses the mark or hasn’t yet gotten the green light. Creech, who is also a principal investigator for Moderna’s pediatric vaccine trials, and Spearman both told me they expect authorization by April or, in a worst-case scenario, May.

The bad news is that communication is still struggling this far into the pandemic. This is despite a public distrusting federal health agencies and scientists.

It’s true that the FDA is legally limited in discussing data particulars and manufacturers are traditionally secretive about ongoing trials. But nobody has acknowledged that the legal and conventional restrictions mean that answers to basic questions like, “Why was this review delayed?” tend to result in impenetrable answers like, “We realize now in data that came in very rapidly because of the large number of cases of omicron that at this time it makes sense for us to wait until we have the data from the evaluation of a third dose.” None of this helps the public understand the scientific process.

What is apparent is that while many parents would like to see more data, what they want even more is to be reassured that their kids’ health is a priority.

“They’ve never spoken to parents of underage kids to say: ‘We’re sorry this is so hard. It grieves us too that it’s been so complicated,’” said Jennifer Martin, a parent of three in Seattle. “There’s a lack of urgency,” said Samirah Swaleh, parent to a 9-month-old boy in the Los Angeles area. “They just don’t seem to care about babies and toddlers?!” wrote Wendeln, the mother in Cincinnati. Cho, the emergency department physician, longs to see a clear timeline. “If you’re running a marathon and you know there’s an end, people can do amazing things. But it’s really, really hard when you don’t know if there’s an end in sight.”

These sentiments I conveyed to FDA officials I spoke with. The FDA official responded in many ways that the parents requested. I wish it could have come earlier, more often and been on the record, but I hope it provides some parents a bit of reassurance that they’ve been heard.

“We are going to work as expeditiously as possible,” the official said. “What does that mean? In general — though I can’t promise anything — you’ve seen that after an EUA [application] in this area, we generally are trying to take action in two to four weeks.”

The official emphasized: “We’re not going to be sitting on anything here.”

“I would want parents to know that we understand their concerns. We’re parents too,” the official added. “We are going to move as fast as we can once we have the data in our hands.”