Pfizer COVID-19 shot expanded to US children as young as 12

COVID-19 vaccines finally are headed for more kids as U.S. regulators on Monday expanded use of Pfizer’s shot to those as young as 12, sparking a race to protect middle and high school students before they head back to class in the fall.

Shots could begin as soon as a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds, expected Wednesday.

Vaccinating children of all ages will be critical to a return to normalcy. Most COVID-19 vaccines rolling out worldwide have been authorized for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up. Parents, school administrators and public health officials elsewhere are anxiously awaiting the shot to become available to more kids.

"This is a watershed moment in our ability to fight back the COVID-19 pandemic," Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press.

The Food and Drug Administration declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The study found no cases of COVID-19 among fully vaccinated adolescents compared to 18 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.

“I am thrilled,” said Patsy Stinchfield, a nurse practitioner at Children’s Minnesota. “We’re not surprised. We knew they had the data for quite some time now and were anticipating that this week so it’s very good news.”

Stinchfield told 5 EYEWITNESS NEWS they are ready to start vaccinating patients 12 through 15 years old this week.

“We have the vaccine in our clinics,” she said. “At Children’s Minnesota we are ready to start vaccinating our own patients Thursday, Friday and Saturday.

She added, "I have been impressed by the amount of chatter on social media of parents who are really looking forward to protecting their kids.”

The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.

Pfizer’s testing in adolescents "met our rigorous standards," said FDA vaccine chief Dr. Peter Marks. "Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic."

Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.

“There have been a lot of parents that have been waiting to vaccinate their young children. They may have a family where older children, young adults, the parents are vaccinated but not the middle scholars. So thinking about ‘What do we do with our summer vacation where some of us are vaccinated and the others are not?’” said Stinchfield. “I think this is a significant announcement,”

The CDC’s Advisory Committee on Immunization Practices (ACIP) will review the data on Wednesday. Stinchfield is liaison representative on the committee.

“What our job is to take it and think about it for the practical application,” she explained. “So what did the FDA approve? What’s written in the emergency use authorization? How will we apply this in a clinical setting? Are there other vaccines we have to think about?”

Stinchfield said it’s unknown how the COVID vaccine interacts with other vaccines.

“There’s a lot of vaccines in what we call that ’11-year-old platform’, young adolescents 11, 12, 13 and up, they are getting vaccines and especially this time of year,” she said. “We’ve been advising for several months now for individuals, clinics to get their patients caught up with their vaccines, especially those that got behind during the pandemic and stayed home, so hopefully now they’re all caught up and we’re ready to do this COVID vaccine.”

By Wednesday afternoon, the committee is expected to vote on recommendations for how to use the vaccine for the 12-15 year old age group. Stinchfield said liaison members will be able to ask questions.

“I’m interested in knowing if there were any unusual side effects in the 12 to 15. Anything that was unexpected,” she said. “I’ll be interested to know if they have anything new to say about the storage and handling […] if we get this into the regular refrigerators, freezers instead of that ultra-cold. That will be a game-changer for us to be able to bring it out to regular primary care clinics with ease.”

Stinchfield urges parents to talk to their children about the vaccine. And if they can’t agree on a path forward or have concerns, call Children’s Minnesota or another healthcare provider.

“Don’t get stuck,” she said. “I think sometimes people are like ‘I heard this on the internet, or I just don’t know about that.’ The worst place to be is to be stuck and have questions and fears and not know what to do with it, so we want to make sure we answer all of those questions and get those kids protected.”

Stinchfield said, “I think the thing that parents need to know about vaccinating children against COVID is that it is a very bad disease in children. We just this week have had teenagers in our intensive care unit – four of them – that after this vaccine recommendation would be eligible for prevention and so while it is rare for a child to be in the hospital, they can be extremely sick and so making sure that we prevent that from happening is really the best thing to do.”

The latest news is welcome for U.S. families struggling to decide what activities are safe to resume when only the youngest family members remain unvaccinated.

"I can’t feel totally comfortable because my boys aren’t vaccinated," said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated as are her husband and 17-year-old daughter.

The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son who would be unvaccinated. The family hasn’t yet resumed going to church, and summer vacation will be a road trip so they don’t have to get on a plane.

"We can’t really go back to normal because two-fifths of our family don’t have protection," Vittitoe said.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects. Another U.S. company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds as well.

Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun U.S. studies in children ages 6 months to 11 years. Those studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Gruber said Pfizer expects its first results sometime in the fall.

Outside of the U.S., AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.

Children are far less likely than adults to get seriously ill from COVID-19 yet they still have been hard-hit by the pandemic. They represent nearly 14% of the nation’s coronavirus cases. At least 296 have died from COVID-19 in the U.S. alone and more than 15,000 have been hospitalized, according to a tally by the American Academy of Pediatrics.

That’s not counting the toll of family members becoming ill or dying — or the disruption to school, sports and other activities so crucial to children’s overall well-being.

"Children right now are struggling," Gruber said. Plus, "we need as many people in the country who have the potential to transmit the virus to be protected."

Experts say children must get the shots if the country is to vaccinate the 70% to 85% of the population necessary to reach what’s called herd immunity.

In the meantime, the Centers for Disease Control and Prevention says unvaccinated people — including children — should continue taking precautions such as wearing masks indoors and keeping their distance from other unvaccinated people outside of their households.