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FDA Authorizes Use of Pfizer COVID-19 Vaccine for Teens Age 12-15

drawing of girl who got her covid-19 vaccine

Verywell / Nez Riaz

The Food and Drug Administration (FDA) has approved the Pfizer-BioNtech COVID-19 vaccine for use in children aged 12-15 years of age. This announcement of Emergency Use Authorization (EUA) was made on the afternoon of Monday, May 10th, and signals a major step forward in the national effort to get every citizen inoculated.

In clinical trials of 2,260 12-15-year-olds, Pfizer reports that the vaccine was "well tolerated" by the recipients and 100% effective in preventing COVID-19 infection. There were no major side effects other than those already experienced by adults.

Official distribution details have yet to be disclosed, but CDC officials will meet on Wednesday to discuss plans for rollout. The goal is to get kids vaccinated before starting middle school in the fall.

Now that the vaccine is available, parents nationwide face the decision to vaccinate their teens. The decision is not always an easy one. Here, we aim to break down the facts to help you understand all you need to know. 

Is the Vaccine Safe?  

The short answer is yes. Children involved in the trial were kept under close medical monitoring for several days following their doses to ensure the safety of all participants. 

Emma Alda, co-founder of ModestFish, enrolled her 14-year-old daughter in the study after her other child was diagnosed with COVID-19. When speaking of the trial, Alda says, “As a parent, I feel that safety was their first and foremost priority, and it is clear that they are not in the business to cause harm.” 

Emma Alda, Mom of Vaccine Trial Participant

As a parent, I feel that safety was their first and foremost priority, and it is clear that they are not in the business to cause harm.

— Emma Alda, Mom of Vaccine Trial Participant

Alda reports that the children were monitored closely in the days surrounding their vaccinations in a combination of 24-hour inpatient facility care and outpatient appointments. “We have a 24/7 hotline that they did give us if anything does come up out of the ordinary and have been very helpful making her and us feel comfortable,” says Alda. 

Pfizer reports that they will continue to monitor participants for the next two years. Sharon Nachman MD, Director of Pediatric Infectious Diseases and Director of the Office of Clinical Trials at Stony Brook Children's Hospital, says that this is not something parents need to worry about in considering vaccination for their teens.

“In the vaccine world. We have typically seen pretty much all of the adverse events occur within the first month,” reports Nachman. “And if we're not seeing anything in the adults after a month, we're not going to see it in the kids either.”

She says that data from vaccinated adults indicates long-term risks of the vaccine are far lower than long-term risks of COVID-19 related illness. 

“When I talk about the theoretical ... risks of the vaccine long-term, versus the known and well ...documented risks of COVID disease short and long term, clearly I would rather not put emphasis on the theoretical risks of vaccine because I have the real risks of the disease,” says Nachman.

Is the Vaccine Effective?

Pfizer reports that the vaccine is 100% effective against COVID-19 one month after the second dose. Like adults, teens will be required to get two doses of the vaccine, approximately 21 days apart.

Of the trial participants, none of the vaccinated children contracted COIVD-19 but 18 cases of COVID-19 were observed in the placebo group. Researchers also found a stronger immune response in 12-15-year-olds versus the 16-25 year age group. 

Nachman explains that a more robust immune response is partly because kids’ immune systems are often in better working order than adults. “As you age you do a lot of injury to your body,” she says, “ ... we smoke, we drink, we don't sleep, we get stressed, we're obese, you name it. We're not seeing those underlying co-morbidities with children. And as a result, all of their parts of the immune system are actually smarter, better, faster.”

Pfizer has not yet released how long they expect immunity to last in teens, but Nachman suggests that the robust immune system of children will probably see their immunity last longer than in adults. 

Why Kids Need the COVID-19 Vaccine

If children are so low risk for getting severe COVID, and their immune systems are so robust, why should children be vaccinated? In short, the answer is to protect their loved ones who are vulnerable. 

Dr Sharon Nachman, MD

So if we do not vaccinate those 12 and up and do a better job with the young adults, we will effectively not be able to cut the spigot off for 41% of those infections causing death.

— Dr Sharon Nachman, MD

Nachman reports that data from the US has investigated COVID deaths and tracked cases back to find the original source of infection. 

“So, looking across the ages, 2.7% of infections that resulted in an adult who died, originated from kids 0-9. 7.1% originated from kids 10-19. 34% originated from kids 20 to 34,” reports Nachman. “So if we do not vaccinate those 12 and up and do a better job with the young adults, we will effectively not be able to cut the spigot off for 41% of those infections causing death.

“And that's why we're vaccinating,” continues Nachman, “ We're vaccinating them for them and vaccinating them for their families behind each kid. These 12-year-olds are not living by themselves. They're living with a family and that's the other piece of who we have to protect.”

What Can Teens Expect After Having the Vaccine?  

12-15-year-olds experienced similar side effects as those in the 16-25 year age group. 

Side effects from the vaccine can include: 

  • Pain at the injection site
  • Fatigue
  • Headache
  • Muscle pain
  • Chills
  • Joint pain
  • Fever
  • Injection site swelling
  • Injection site redness
  • Nausea
  • Malaise
  • Lymphadenopathy (Swollen Lymph Nodes)

Typically side effects should resolve within a few days and can be treated with rest. “I tell parents, anytime I'm giving a vaccine, you're going to feel yucky for the next few days,” says Nachman, “You'll have fever, you'll have this ache, that ache, a headache... I expect that. That's not unusual. It is not an allergic reaction. It's expected. Two days, no surprise.”

Alda says that her daughter experienced very mild side effects, “She thankfully suffered no serious side effects. Soreness in her muscles and tiredness being the only two that were recorded.”

Masking after vaccination is a hot debate topic in the medical world. Nachman recommends that parents and teens use common sense. For example, if you are in a crowded place with many people you don’t know, then masking is still recommended. However, if you are outdoors with lots of space, or indoors with a group of other vaccinated people, then it’s typically ok to leave the mask off. 

If you are worried about asymptomatically carrying the virus after vaccination, know that data is still being collated on how much virus vaccinated people carry on themselves if they are exposed to the virus. “Most of those studies are showing nicely that if you get the vaccine and you get exposed, you're unlikely to be infected. And if you are infected, you're unlikely to transmit,” says Nachman.

Which Teens Will Get the Vaccine First?

At this stage, it doesn’t appear that teens will be prioritized the way adults were. This had more to do with vaccine availability.

Now that vaccine production has increased, it’s likely that any teen should have access to vaccination. States will be allowed to prioritize vaccination of middle schoolers prior to the start of the 2021-2022 school year.

What about Younger Children? 

Pfizer is currently beginning trials in younger children. They say they will test 5-11 year-olds, then aged 2-5 years, then under twos. Once these trials are completed, vaccination will hopefully be available for younger kids around September 2021. 

What This Means For You

Pfizer's clinical trials included children both healthy kids and those with pre-existing illnesses such as asthma, diabetes, and other medical conditions.

Therefore, teens with pre-existing conditions should be able to receive the vaccine the same as their peers. But, you should always check with your doctor who can offer advice based on your child's individual circumstances.

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Article Sources
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  1. Pfizer. Pfizer-biontech announce positive topline results of pivotal covid-19 vaccine study in adolescents. March 31, 2021.

  2. Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents | pfpfizeruscom. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal