Parents and pediatricians have been waiting for more than two years for a COVID-19 vaccine for kids under 5 but even as the Centers for Disease Control and Prevention is poised to authorize it later this week, public health experts warn that vaccinating the population won’t be as simple as sticking a few needles in arms.

On Wednesday, Food and Drug Administration vaccine advisers unanimously recommended that both Moderna and Pfizer’s COVID-19 vaccines for kids ages 5 and under receive emergency authorization. Pending CDC action, kids could begin rolling up their sleeves as early as next week.

While the federal government gave adults multiple opportunities to get their COVID-19 vaccines through pharmacies and on-site vaccination clinics at workplaces, it’ll be less convenient for the under-5 age group thanks to complications presented by federal law, vaccine hesitancy and the logistics surrounding dosages for the pediatric age group. 

“The likelihood of [kids under 5] encountering that vaccine opportunity is going to be smaller,” said Kaiser Family Foundation Senior Vice President and Director of Global Health and HIV Policy Jen Kates.

Federal law bars pharmacies from vaccinating kids under 3, so many are opting not to carry the vaccine, which has a unique dosage, for kids under 5. 

CVS will offer the vaccines for kids under 5 at their 1,100 Minute Clinics locations, not its nearly 10,000 pharmacies. This leaves the vaccinations largely to pediatricians, not all of whom plan to give out the vaccine. 

States and pediatric hospitals are working with the Biden administration to set up vaccine clinics for toddlers where clinicians can sign up kids in multiples of ten, the amount of doses size in a vaccine vial, in an attempt to reduce vaccine waste. But that sort of one-stop-shopping gives families less flexibility when it comes to scheduling a vaccine for their child, which some worry could lead to fewer shots in arms.

Approximately one-third of kids ages 5 through 11 were vaccinated at pharmacies, Kates said. But the CDC says in its COVID-19 vaccine guidance that pharmacies’ ability to vaccinate kids under 5 may be limited, regardless of their intent, because of a 2005 federal law on emergency preparedness. The Trump administration gave pharmacists the ability to vaccinate kids ages 3 to 18 years during the pandemic to free up pressure on physicians. But that still leaves those between six months old and 3 unable to go to a pharmacy to be vaccinated.

On top of all this, both the Pfizer and Moderna COVID-19 vaccines for toddlers come in a unique dosage compared to vaccines for older children and adults. Once a clinician opens a vial of vaccines, they must give out all ten doses within twelve hours or else the shots go bad — meaning they must line up enough kids to vaccinate each day. There are roughly 20 million kids under age 5 in the U.S., according to the CDC, and vaccine hesitancy is high in this age group. 

For some pharmacies, the logistics are just too much.

“There’s going to be a lot of referrals to the pediatrician for that service,” National Community Pharmacists Association Senior Director of Strategic Initiatives John Beckner said of vaccinations for kids under 5. He said most small community pharmacies are the main touchpoint of health care in rural communities. 

Because of the limitations on pharmacies, the Biden administration anticipates that pediatricians will do most of the vaccinating of toddlers in the United States. But some are concerned it will be difficult for pediatricians to shoulder the load.

“[Pediatricians] are understaffed, you know, they lost a lot of primary care, hospital systems, have lost a lot of staff and the same is true in outpatient settings. And so taking on sort of one more thing is really problematic right now,” said Sean O’Leary, a pediatrician at Children’s Hospital Colorado and a liaison to the CDC’s vaccine advisory committee.

The White House and the CDC both did not respond to requests for comment when asked what the administration is doing to incentivize pediatricians to participate in the vaccination effort.

The CDC has put the impetus on local public health departments to take the lead in vaccinating kids, and encouraged them to begin planning strategies for vaccination months ago. Children’s hospitals and health systems will play a big role in this vaccine rollout, and the administration asked states to ensure equity and prioritize kids at highest risk for COVID-19.

The agency has also encouraged clinicians in its Vaccines for Children program to enroll as COVID-19 vaccine providers. Currently, about two-thirds of Vaccines for Children Providers are enrolled as COVID-19 vaccine providers.

“We encourage every provider who can take this on to sign up,” a senior administration official told reporters Wednesday night.

A slow start

In anticipation of the coming Food and Drug Administration and CDC signoffs, last week the CDC made 5 million doses available to states for pre-ordering. 

But so far, jurisdictions have ordered just 58 percent of the Pfizer shots and 34 percent of the Moderna shots. Biden administration officials said that states are usually slow to order vaccines and urged reporters not to focus on the early numbers. But experience shows vaccine uptake for this age group could be slow going.

But even so, less than 1 in 5 parents of kids under 5 plan to vaccinate their child right away, according to May polling from the Kaiser Family Foundation. A larger portion of parents, roughly 40 percent, say they’ll wait and see how the vaccine is working for others. Another 40 percent don’t plan to get their child vaccinated.

Parents have been more reluctant to vaccinate their kids than get the shot themselves throughout the COVID-19 vaccination effort. Children are less likely to develop severe COVID-19, be sent to the hospital or die of the virus, compared to adults. And on top of that, parents and caregivers may need to take time off work to get their child vaccinated.

Even though vaccines for kids ages 5 to 11 have been available since November 2021, fewer than 30 percent of kids in that age group are fully vaccinated. Public health experts anticipate similar turnout among the younger age group, with an initial vaccine rush once the short is approved, followed by a plateau.

O’Leary said in many rural areas of the country, pediatricians themselves are reluctant to dole out the COVID-19 vaccine to children, despite the CDC and FDA recommendations. He emphasized the importance of families hearing about the vaccine from a trusted messenger, regardless of whether it’s a pediatrician.

The Biden administration’s vaccine outreach plan includes a public education campaign for families with help from organizations that often have contact with toddlers, such as Medicaid and Children’s Health Insurance Program (CHIP), community health centers, the Woman, Infants, and Children (WIC) program, the American Academy of Pediatrics and others. 

Surgeon General Vivek Murthy has repeatedly warned against misinformation in the pediatric COVID-19 vaccine rollout. As with previous vaccination efforts, anti-vaccine propaganda can run rampant. But when it comes to children, this sort of misinformation can lead to very low vaccine uptake.

“Please make sure the information you are relying on is coming from trusted sources like your doctor, your local children’s hospital, your department of health, medical associations,” Murthy said on Thursday.

Timing

The COVID-19 vaccine for kids under 5 could be available to the public as early as June 21, Ashish Jha, White House coronavirus response coordinator, told reporters. CDC vaccine advisers are scheduled to meet Friday and Saturday to discuss and vote on shots for those under 5.

Jha said it’ll take a few weeks for the vaccines to become broadly available, and the administration will initially make 10 million doses available to order initially. States can begin to place their vaccine orders on Friday, June 18. There are roughly 20 million kids under 5 in the United States who may be eligible for vaccination — the last group to access the live-saving shots.