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When will kids get the COVID-19 vaccine? What we know now

TODAY 17 hrs ago Maura Hohman

Every day, more people are receiving their COVID-19 vaccinations, with almost 77 million doses administered in the U.S., according to the Centers for Disease Control and Prevention. But one prominent group of Americans, children, still can't get the vaccine, though many experts agree they will need to in order for life to return to normal.

The initial clinical trials for COVID-19 vaccines didn't include kids, which is standard practice, especially for non-pediatric diseases. But in the fall, Pfizer launched its adolescent trial in kids as young as 12, and more pharmaceutical companies have followed suit. In December, Moderna started its trial in kids between 12 and 17, and earlier this month, AstraZeneca, whose COVID-19 vaccine is not currently authorized in the U.S., announced plans to test its vaccine in kids as young as 6 in three U.K. cities.

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Johnson & Johnson, which recently received emergency use authorization for its COVID-19 vaccine, said in its application that it plans to study its single-dose product in kids 12 to 17, followed by another study in newborns to teens under 18. It also plans to test the vaccine in pregnant women and their infants, and then immunocompromised people, but it's unclear when any of this research will begin.

The timeline for when kids of all ages will have access to the COVID-19 vaccines is still in flux and will depend on when the data from these trials is released. Here's what we know now about what the trials might reveal and what this means for school in the fall.

What is the status of COVID-19 vaccine trials in kids?

Pfizer fully enrolled its adolescent trial in kids 12 to 15 years old in late January, and data is expected as early as the spring, a spokesperson told NBC News. Depending on the results, trials in children younger than 12 could follow soon after. Dr. Robert Frenck, who worked on the Pfizer trials at Cincinnati Children's Hospital, told TODAY he "wouldn't be surprised" if results from the adolescent trial were available as soon as April.

Moderna announced on Thursday that it has fully enrolled its clinical trial in ages 12-17. The company previously said in December that its goal was to generate data from this study in the spring, and it hopes to have an extension to its existing EUA for kids 12 and up in the summer. Moderna also said Thursday it will start studies in kids from 11 to 6 months "in the near-term."

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Generally speaking, clinical trials in kids start with older age groups and progress downwards, with 5 to 2 year olds second to last, and 2 to 6 months last, Dr. Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital in Columbus, Ohio, previously told TODAY.

When looking at how trials in kids have progressed so far, Onyema Ogbuagu, a professor at Yale School of Medicine in New Haven, Connecticut, who led the university's Pfizer trials, said that it took about two to three months to have enough data on outcomes in older kids. Then, the FDA requires another two months of safety data after the second shot is administered. From there, the FDA will need at least another two to four weeks to review it before granting authorization.

Similarly, Frenck estimated that based on his experience with the Pfizer trial, the expedited process for other kids trials could generate data as soon as three to four months after full enrollment. He stressed and assured concerned parents that no corners are being cut on assessing safety.

Is the COVID-19 vaccine safe in kids?

Ultimately, only the data, which isn't available yet, can answer this question, but so far, signs are good for the Pfizer vaccine, Frenck said.

"Anecdotally, my experience, is that ... the adverse events have basically been the same in the kids as ... adults," he explained. "I don't have all the data from all the (trial) sites to be able to flat out say, but I have not seen that the kids are getting any different of a safety response."

Based on research in adults, the CDC has said that COVID-19 vaccines are safe and effective. The most common side effects in adults include pain and swelling near the injection site, and fever, chills, tiredness and headache throughout the rest of the body.

The ongoing and future studies in children are primarily looking at two things, safety and tolerability, and immune response, noted Dr. Rick Malley, an infectious disease pediatrician at Boston Children's Hospital.

"Immune response tells you that you're not seeing something that is unexpected ... that they're actually responding the same way (as) adults," he said. This data is also not available yet.

When will most kids be vaccinated against COVID-19?

Again, this will depend on when the data from clinical trials becomes available, as well as other factors relating to vaccine distribution. Malley and Frenck both think it's likely that vaccines will be available to older children, 12 and up, first.

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Frenck's "best guess," he said, is that this age group may be able to get vaccinated as soon as August and younger children in December 2021 to January 2022.

Malley provided a more conservative estimate. "I could envision, certainly for teenagers, so high school, middle school ... end of this year," he said. For younger kids, he suspected most vaccinations would occur in 2022. "We'll have to see how quickly these studies get done for younger children," he added.

"I think we do need to be careful because ... if we say fall, then (parents) start thinking, 'Well, I can vaccinate my kids before they go back to school,' and I don't know that that's going to be the case," Malley stressed.

Frenck estimated that the once vaccines become available to adolescents, it could take another several months for most kids to be vaccinated because, again, it will depend on the data from the younger trials. "Things may go quicker," he added. "COVID has kind of rewritten the books for doing clinical trials."

Another factor to consider in this timeline is how quickly more high-risk groups will be vaccinated, Ogbuagu explained. CDC data shows that most kids are less likely to get severely ill from COVID-19, but they can get sick and spread the virus.

"I can't imagine a scenario where kids would be the priority group for anyone," he said. "Even if the vaccine were available, I don't think you can just switch from the elderly that you haven't completed and people with underlying (conditions) to then vaccinate kids."

He added that even if the data from the Pfizer adolescent trials leads to an EUA as early as June, "the question is would the country be ready to ... offer it to kids? I don't know. ... There's just so many unknowns to make an exact prediction."

What does this mean for the fall 2021 school year?

This month, the CDC released a roadmap for opening schools during the epidemic, stressing the need for masking, hand hygiene and social distancing, and monitoring levels of spread in the community. It did not state that children and school staff need to be vaccinated to return.

"The data suggests that where public health measures are instituted and adhered to in school settings, that even in areas where there's high community transmission, the schools haven't contributed much to that problem," Ogbuagu said. "So it almost seems like vaccination will be a plus, but it's not indispensable with regards to schools reopening safely."

Frenck added that he sees teachers being vaccinated as a "good justification for sending kids back to school. ... It's unusual that kids are acquiring the infection in the school setting."

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But Malley cautioned that the COVID-19 variants spreading across the U.S. could change things.

"If ... schools become a greater center for spread from children to each other and children to adults, the urgency to try to prevent that, either through more distancing measures ... or, of course, vaccination becomes much more important."

This story was updated on March 1, 2021.

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