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Will kids or pregnant women be able to get a COVID-19 vaccine?

Children and pregnant women need to be vaccinated against COVID-19 to eliminate spread of the virus but have been largely excluded from vaccine trials.
Katelyn Evans, 16, receives a COVID-19 vaccine during a trial at Cincinnati Children's Hospital Medical Center on Oct. 14.
Katelyn Evans, 16, receives a COVID-19 vaccine during a trial at Cincinnati Children's Hospital Medical Center on Oct. 14.Cincinnati Children's Hospital Medical Center
/ Source: TODAY

In early February, Johnson & Johnson submitted its COVID-19 vaccine for emergency use authorization. If approved, it would be the third vaccine, along with Moderna and Pfizer-BioNTech, in the fight against the coronavirus — and would hopefully help the country vaccinate a wider portion of the population.

Yet as these vaccines become more readily available, the research at this stage has largely left out two crucial groups that must be vaccinated to keep the coronavirus fully at bay: pregnant people and children.

Pfizer has included kids as young as 12 in its clinical trials and Moderna has recently started recruiting adolescents for a COVID-19 vaccine trial. As for the pregnant population, Pfizer stated the company would evaluate the vaccine in pregnant women in a study starting early this year. This is especially troubling as pregnant women seem more likely to get severely ill from COVID-19 than their non-pregnant counterparts.

"The sooner we can get a vaccine out to everybody, you can reduce transmission to everyone," Dr. Yvonne Maldonado, a professor of pediatric infectious disease at Stanford University and member of the American Academy of Pediatrics' Committee on Infectious Diseases, told TODAY last fall. "As long as there are people out there who can spread it, we're just not going to get rid of this pandemic."

When will there be a COVID-19 vaccine for kids?

As of early January, Pfizer had enrolled nationwide 1000 kids between 12 and 15 and enrollment for 16-17 year olds will "continue as planned and we will share data in due course over the next few months," the company shared on their website.

In these trials, half of participants receive a placebo, and the other half receive the actual vaccine. The patients, doctors and nurses don't know who received which in what's called a double-blind study.

Dr. Robert Frenck, director of the Vaccine Research Center at trial site Cincinnati Children's said that researchers are looking for the same safety and immune response outcomes in kids as in adults. "If the immune response in kids is the same or better than in adults and if the vaccine is shown (to be) protective in adults, we will make the extrapolation that the vaccine should be protective in kids," he explained.

Frenck said in late October that he wasn't aware of Pfizer's plans to test the vaccine in kids younger than 12, and a Pfizer spokesperson did not share specifics about plans to expand pediatric trials at the time. But usually, the next groups to be included would be ages 11 to 5, then 5 to 2 and 2 to 6 months last, Dr. Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital in Columbus, Ohio, told TODAY.

"Even the vaccines that we developed for young babies, you always give it to adults first," he clarified.

It's unclear right now when the COVID-19 vaccine may be available to all kids, at least in part because there could be challenges to recruiting participants the longer trials go on, Ramilo said. It's also worth noting that that the distribution plan outlined by the Centers for Disease Control and Prevention doesn’t say when children would receive the vaccine, but it likely wouldn’t be until the later phases.

In late October, Frenck said there was a "good chance" that a vaccine would be available "at least for kids 12 years of age and above" by the start of the 2021 school year.

Maldonado added that she thinks "it could be feasible to think about a vaccine for kids in the fall of next year, but that's a really, pretty big guess. We don't know, but at least there's a possibility."

When will there be a COVID-19 vaccine that's safe for pregnant women?

According to the Centers for Disease Control and Prevention, people who are pregnant and part of a group recommended to receive a COVID-19 vaccine, such as health care personnel, may choose to be vaccinated. Though there is only limited data on the safety of COVID-19 vaccines given during pregnancy, pregnant people can discuss with their doctors if vaccination is right for them.

No safety concerns were demonstrated in rats that received Moderna COVID-19 vaccine before or during pregnancy; studies of the Pfizer-BioNTech vaccine are ongoing, the CDC reported. Both Moderna and Pfizer-BioNTech are monitoring people who became pregnant during clinical trials.

Pregnant people historically haven't been included in vaccine trials, said Dr. Stephanie Gaw, an obstetrician and assistant professor at University of California's San Francisco campus, who researches COVID-19 and pregnancy.

The flu shot in particular was never trialed in pregnant women but was determined to be safe after years of gathering data from women who got it without knowing they were pregnant or women who knew but got it anyway, Gaw said. This lack of systematic data gathering ultimately leads to delays in FDA approval for the pregnant population, she continued, adding that she has similar concerns about the drugs currently being trialed to treat COVID-19 (rather than prevent it).

"If they're not enrolled in a trial, then we can't do long-term follow-up because the biggest question about doing trials in pregnant women is what happens to the baby," she explained. "In a sense, not doing these trials on pregnant women, basically pregnant women are kind of always in this very uncontrolled trial, real life."

At the time TODAY spoke with Dr. Denise Jamieson, chair of the department of obstetrics and gynecology at Emory University School of Medicine in Atlanta and member of the American College of Obstetricians and Gynecologists' COVID-19 OB Expert Work Group, the COVID-19 vaccines had not yet been approved, but she stressed how important it was for them to be made available to the pregnant population.

"It'll be important that pregnant women are provided the opportunity, with careful counseling, to be vaccinated, even if there's not a lot of safety information," Jamieson said at the time.

How to talk to your doctor about the COVID-19 vaccine for your kids or if you're pregnant

As the widespread nature of COVID-19 vaccine trials suggest, it's crucial to have data to be able to make an informed decision about the safety of a given vaccine. If you're wondering whether it's worthwhile for you to give your children the vaccine, especially if they're high-risk, or to get it yourself if you're pregnant, then talk to your doctor.

You'll likely embark on the process of "shared decision-making," as Maldonado called it, where the family and provider decide together whether the possible risk of the vaccine, ideally determined with data in-hand, is worth it to protect against the disease.

"That could be something to be done early on, depending on the supply of the vaccine," she said.

For pregnancy, the conversation with your provider could be similar. As Jamieson explained it, "There are models whereby rather than just saying, 'We don't have any safety data, you can't get the vaccine because you're pregnant,' you counsel them."

"The way you counsel them is you say, 'Look, we don't have any information about this vaccine. This is what we know about the risks. This is what we know specifically about your risk.'" Jamieson added that your doctor should also clearly explain the unknowns and benefits and possibly discuss data from similar types of vaccines that have been used during pregnancy before. The CDC has also provided information for pregnant or breastfeeding people to review.

"Hopefully, we'll have more than one vaccine to choose from, and the messaging will evolve over time as more vaccines become available," she said. "I don't think the right answer is the simple answer, which is just to say, 'We don't have the safety data in pregnant women, and therefore, we will not offer you the vaccine.'"

This story was updated on Dec. 1 to include more information about vaccine distribution. This story was again updated on Feb. 5 to include information about ongoing clinical trials.