While some Americans celebrate lifted mask mandates and relaxed pandemic health protocols, many parents are concerned for their children too young to be vaccinated.

Getting vaccinated against COVID-19 protects against severe illness, hospitalization, and death. But while most Americans are eligible for the shots, children under 5 can't roll up their sleeves just yet. That's left many parents frustrated as they wonder how to protect their smallest kids, especially as pandemic safety protocols have eased, and mask mandates are being lifted across the country.

"My son is nearly 18 months. He's not able to get vaccinated yet, and he's not able to wear a mask," says Melissa Bykofsky, Editorial Director of Trends & Features at Parents. "I was really grateful that the mask mandate was in place for high-traffic areas, allowing me to feel like he had some protection as cases rise again. It's a bit unnerving that now I can't rely on any layers of protection for him." She's especially concerned about what subsequent variants will look like, as there's always the concern that the next COVID-19 surge will have worse health outcomes and we won't have any protections in place.

Kimberly Zapata, SEO Writer at Parents, shares these concerns. Her son, who is under 4 years old, is susceptible to illness and has a weakened immune system. "As a parent of a vulnerable child, I feel frustrated and forgotten about. Cases are rising. Vaccines are still unavailable, and yet restrictions are being lifted," she says. "Everyone tells me 'if you're vaccinated, your odds are...' but my youngest cannot be inoculated. He is also too young to have masks enforced at his school. (I send him in with one but his teacher cannot make him keep it on.)" Zapata takes measures to keep her family safe—like limiting interactions and wearing masks when appropriate—but it "feels like we are rolling the dice with his health," she says.

Adding to the anxiety for parents, several airlines have recently made face masks optional, including United, Delta, American, Southwest, JetBlue, and Alaska. Many Americans are grateful for these relaxed guidelines, but parents of younger kids who have yet to be vaccinated remain concerned for their child's health.

"Reluctantly, my husband and I planned our first vacation as a family of four to a kid-friendly resort for May," says Melissa Mills, Associate Editorial Director at Parents and mom of two boys, ages 3.5 and 11 months. "I've been stressed out about the COVID tests and whether or not my toddler would keep his mask on for the entire flight. Now I'm stressed thinking about a flight full of maskless passengers around my unvaccinated kids. We desperately need some time away and are excited to go, but I'm definitely nervous. We'll still wear our masks, keep our distance as much as we can, and I've stocked up on sanitizer, and at the end of the day I'm prioritizing my family's mental health and we're going on the trip. I'm just hoping other families will be doing the same regardless of the mandate."

As we're waiting for definitive answers on the COVID-19 vaccine for younger kids, parents likely have several questions: How much longer will we have to wait? Is the vaccine safe? How well do vaccines work for my child's age group, anyway? Here's what you need to know.

COVID-19 Vaccine Timeline for Kids Under 5

In March 2021, Pfizer announced that it would be conducting clinical trials of its vaccine on children aged 6 months through 4 years, giving families hope that a shot was in sight. But in December, the company said that 2- to 4-year-olds hadn't produced a sufficient immune response after receiving two doses of the vaccine (3 micrograms each). Those ages 6 months to 2 years had adequate immunity. Pfizer then began testing a third low-dose shot, given two months after the initial vaccines, to boost effectiveness.

In February 2022, it seemed like the Food and Drug Administration (FDA) might grant an emergency use authorization for the first two Pfizer doses, knowing the third dose would shore up protection. Some argued that this could have bolstered the immunity of 19 million young American children, who had seen rising hospitalization rates with the advent of new coronavirus variants. But Pfizer decided to postpone its application and wait for data on the three-dose series of the vaccine, due in April 2022.

In a company statement, Pfizer officials emphasized that three doses "may provide a higher level of protection in this age group. This is also supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for Omicron compared to the two-dose regimen." Parents might dislike the delay, but the company has chosen to take their time and make sure that the vaccine works well.

And what about Moderna? In March 2022, the biotechnology company released promising pediatric data from phase 2/3 of its KidCOVE study. In children ages 6 months to 6 years old, a two-dose 25 microgram primary series of Moderna's COVID-19 vaccine (mRNA-1273) showed a "robust neutralizing antibody response," according to a March 23 announcement by Moderna. Experts reported minimal side effects and no red flags, and the vaccine even had "statistically significant" protection against the Omicron strain.

As the next step, Moderna will request vaccine authorization from the FDA and other global regulators. If approved, Moderna's vaccine could be available to children ages 6 months to under 6 years of age in late spring or early summer, estimates Paul Burton, M.D., Ph.D., Moderna's Chief Medical Officer.

Why Can't Children Under 5 Get Vaccinated Yet?

Younger kids were initially excluded from clinical trials, which is nothing out of the ordinary. "When testing vaccines, we usually start with adults and work down to children to establish safety data," says pediatrician Christine Turley, M.D., vice chair of research at Atrium Health Levine Children's Hospital in Charlotte, North Carolina. Kids have different bodies than adults, after all, and experts need to know how their immune systems will react to a particular vaccine or dosage before moving forward with it.

Ethical issues also come into play here, because small children can't fully consent to being vaccinated, or anticipate the outcome. Thanks to their still-developing brains, they have a harder time understanding potential consequences. "We want to make sure there aren't hidden risks for children," Dr. Turley explains. "We're balancing the risks and benefits against what is ethically acceptable."

The good news is that the FDA compiled enough safety and efficacy data to allow vaccine candidates to progress to pediatric trials. Vaccine manufacturers "start by enrolling older children, then school-aged kids, then toddlers, then infants. That's because the risks for all of those children are different," says Dr. Turley. With each age group, researchers evaluate dosage, frequency, side effects, and more.

As of March 2022, the Pfizer vaccine has received an emergency use authorization for children age 5 and older; it also has full FDA approval for those aged 16 and older. Kids age 5 through 11 get two doses of 10 micrograms each, which is one-third of the dose for older adolescents and adults.

Father Putting Home Made Face Mask on Little Daughter
Credit: Getty Images

Are COVID-19 Vaccines Effective for Younger Kids?

Yes. But they still need some work.

As noted, Pfizer's two-dose vaccine didn't provide the desired immune response in children ages 2 to 4 years old. That doesn't mean it didn't produce any response. According to The New York Times, an anonymous source familiar with Pfizer's data said kids that age who were given two shots were infected at a rate 57 percent lower than kids in a placebo group. Vaccinated children 6 months to 2 years old were infected at a rate 50 percent lower. A third dose will presumably increase effectiveness.

There are challenges in fine-tuning a vaccine for kids. In March 2022, the New York State Department of Health and University of Albany released a non-peer-reviewed study that found the effectiveness of Pfizer's existing vaccine had dropped to 12 percent among kids ages 5 to 11. Experts suggested that the smaller dosage, so carefully chosen to avoid side effects, was not strong enough to adequately combat the Omicron variant then sweeping the country. It isn't easy making a vaccine safe and tough.

When it comes to the older COVID-19 variants it was developed for, Pfizer's vaccine has had better results. In clinical trials, it generated an immune response in kids ages 5 to 11 comparable to that of individuals aged 16 to 25. "In addition, the vaccine was found to be 90.7 percent effective in preventing COVID-19 in children 5 through 11," the FDA wrote as it issued its emergency use authorization. Hopefully a three-dose vaccine provides similar results for younger kids, and extends that protection even further.

The effectiveness of the Mondera vaccine for younger kids was also less than many parents hoped for. "Vaccine efficacy in children 6 months to 2 years was 43.7 percent and vaccine efficacy was 37.5 percent in the 2 to under 6 years age group," according to the March 2022 Moderna announcement. "The majority of cases were mild, and no severe COVID-19 disease was observed in either age group."

Although the effectiveness of the vaccines isn't ideal, many parents are still relived about the news, stating that some protection is better than none. "I will definitely have a sense of relief once the vaccine rolls out, even if it is not 100 percent effective," says Bykofsky, whose son is nearly 18 months old.

Will Young Kids Need a Booster Shot?

When a vaccine is approved for those under 5, will young kids need a booster shot? We simply don't know the answer to that yet. After the vaccines start rolling out, experts will study protection from each vaccine over time. If they notice waning immunity, like they did with adolescents and adults, they might recommend a booster shot down the line. Only time will tell what will happen.

That said, Dr. Burton, Moderna's Chief Medical Officer, predicts a booster will probably be recommended for younger kids in the future. "Up against Delta and the original virus, you do need some boosting, but you can probably extend that time period out. Up against Omicron, we really do need an Omicron-specific booster. We're working on that right now," he says.

Should My Children Get Vaccinated Against COVID-19?

Only you can make that decision, but the top health experts say yes. While most kids get mild cases of COVID-19, several have died from the disease, and others have suffered from a life-threatening complication called multisystem inflammatory syndrome in children. Kids can also transmit COVID-19 to high-risk family members, who might develop more severe symptoms. Widespread vaccination could help things go back to normal sooner, lessening the physical and mental stress of the pandemic.

Parents shouldn't fear FDA-approved vaccines, emphasizes Purvi Parikh, M.D., an allergist and immunologist with the Allergy & Asthma Network and co-investigator on several vaccine trials. Pediatric clinical trial researchers thoroughly examine all aspects of vaccines for kids, and they won't approve them until they're absolutely sure of their safety.

Pediatrician Mona Amin, D.O., the mom behind @pedsdoctalk on Instagram, says she's ready to support an emergency use authorization for a new vaccine. "You can't argue with science and data and I fully trust this process," she wrote in a recent newsletter. Her take: Vaccination doesn't mean everything will return to normal for kids under 5, but it can reduce risks and let families live more safely.

Many parents, like Heather Kilby, Content Manager of Audience Retention for Parents, are hopeful about the prospect of a vaccine for younger kids—as long as it's proven safe. Kilby tested positive for COVID when her son was an infant. "To have to mask-up around him was painful emotionally. I couldn't kiss him or be too close for too long. I was breastfeeding at the time, and it was very difficult not to worry, no matter how safe I was," she says. Thankfully, her son didn't get sick, but now that he's almost 18 months old and attending day care—interacting with other children and caretakers each day—her guard is up again. "I know that children getting sick in environments like that is inevitable, but it would give me peace of mind to be able to protect him that much more if given the option. I also need to be certain that this is 1000 percent safe for my baby. It really is a complex predicament for parents."