This week the Food and Drug Administration authorized the Pfizer-BioNTech COVID-19 vaccine for kids age 12 and older. The vaccine had previously been authorized for use in people ages 16 and older. The Advisory Committee on Immunization Practices, of the Centers for Disease Control and Prevention, will meet Wednesday to update its recommendation for who should receive the Pfizer vaccine, NBC News reported. By the end of the week, kids may be able to receive vaccinations at their pediatrician's office, a clinic or possibly even in schools.
“I think this could be huge, it brings me joy, it brings me hope,” said Dr. Richard Besser, president of the Robert Wood Johnson Foundation, on TODAY. “Joy that there are now 17 million more people who have the opportunity to get vaccinated. Hope for so many kids who are in high school that this fall could feel like a normal high school year. And that’s incredible.”
What is the dosing of the Pfizer COVID-19 vaccine for kids?
The dosing is the same as what is given to adults: two doses, three weeks apart.
“That is the same for so many of the vaccines we use," explained Besser on TODAY. "For flu shots, it’s the same size dose for children in that age range. It’s very safe and expected that children in that age would have the same dose as an adult.”
Can schools or summer camps require the vaccine?
“For schools, it’s done at the state level, the CDC or advisory committee to the CDC could make a recommendation that these vaccines should be administered to all children for school," Besser said. "But it’s up to each state to decide to do that, it’s different for colleges … Summer camps have the right to require vaccines as well. I expect even if some states are requiring this, not all will.”
What is the latest on other COVID-19 vaccines for kids?
Trials of the other COVID-19 vaccines in kids are ongoing. In December, Moderna started its trial in kids between 12 and 17, and the company has since begun a study of the vaccine in children ages 6 months to 12 years old. Earlier this year, 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.
Johnson & Johnson has begun vaccinating adolescents and teens between 12 and 17 as part of ongoing clinical trials. The company also plans to test the vaccine in younger children, pregnant women and their infants, and then immunocompromised people.
When will all kids have access to a COVID-19 vaccine?
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.
Pfizer's vaccine was found to be safe and 100% effective in 12 to 15 year olds and was just approved by the FDA for that age group. The Pfizer shot is already being used in people 16 and up and the company has also launched a clinical trial in kids 6 months to 11 years. Data on how well the vaccine works in kids ages 5 to 11 could be available by the end of summer, CNBC reported.
Moderna has fully enrolled its clinical trial in ages 12-17, and recently launched a study in children ages 6 months to 12 years old. Moderna president Dr. Stephen Hoge told TODAY in mid-March that he expects to have data from the study in older kids "hopefully" by the summer.
But Hoge cautioned that the study in babies to preteens could take "the better part of this year" to complete because "you do need to be a little more cautious and progressive in working down dose levels in the (younger) kids to find the right dose." The study in younger kids is being done in two parts, he added. The first part is about "finding the right safe and effective dose" in this age group, and the second part will be testing it in a large number of kids, about 7,000, he said.
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.
Dr. Robert Frenck, who worked on the Pfizer trials at Cincinnati Children's Hospital, stressed and assured concerned parents that no corners are being cut on assessing safety.
Is the COVID-19 vaccine safe in kids?
The preliminary data in kids 12 to 15 that Pfizer released showed that the vaccine was safe and 100% effective in this age group. But the findings have not been peer-reviewed, and experts have said releasing the full data will be crucial to increase confidence in the safety of the shots for kids. Data on kids from Moderna and Johnson & Johnson has not been released yet.
Frenck said that based on his involvement in Pfizer’s pediatric clinical trials, “Anecdotally ... the adverse events have basically been the same in the kids as ... adults. 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.
Hoge also said that while Moderna's safety data in kids isn't available yet, researchers "haven’t seen anything concerning in our prior work that would suggest we can't use the vaccine in children."
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.
Now that the Pfizer vaccine has been authorized for kids over 12 years old, pediatricians could begin vaccinations as soon as the end of this week.
Hoge said that he thinks the Moderna vaccine could be available to adolescents between 12 and 17 "going into the school year."
For younger kids, Malley 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."
What does this mean for the fall 2021 school year?
More and more colleges and universities are stating that they will require students to be fully vaccinated by fall 2021.
As for younger kids, in March 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, though some states could make it a requirement.
"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," said Onyema Ogbuagu, a professor at Yale School of Medicine in New Haven, Connecticut, who led the university's Pfizer trials. "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."
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 May 11, 2021.