Everything you Need to Know About the Pfizer COVID Vaccine for Children Aged 12-15

On Monday, May 10, the FDA issued Emergency Use Authorization for the Pfizer and BioNTech SE COVID-19 vaccine to be given children ages 12 to 15. That means a majority of children will be able to get vaccinated and protected from the virus. 

We talked with University of Rochester Medical Center infectious disease experts Mary Caserta, M.D., and Jennifer Nayak, M.D., as well as pediatrician Elizabeth Murray, D.O., about why the Covid pediatric vaccine is:

1. Effective, and

2. Thoroughly tested and safe for children.

Why is a pediatric vaccine necessary? I thought children don’t get seriously sick from the virus?

It’s true that kids usually get a milder form of the virus that adults, but they are still at risk for serious illness. A study conducted by JAMA found that more than 5,300 children were hospitalized from Covid between May and November 2020. In addition, asymptomatic children can transmit it to others. It’s important to get kids vaccinated to lower their risk and bring us closer to herd immunity and the pandemic’s end.

Are COVID pediatric vaccines effective?

All Covid vaccines available in the U.S. prevent serious illness.  And ongoing research suggests they also decrease adults’ risk of infection and reduce transmission to others.

Pfizer conducted comprehensive clinical trials of this vaccine for 12- to 15-year-olds and results show it was highly effective at preventing infection. These results have major implications for both preventing illness and the virus’ spread.

A total of 2,260 children were studied and 18 who received the placebo shot were diagnosed with Covid, while none who were vaccinated were infected.  And follow-up showed strong immunity a month after the second dose.  That’s good news.

How are Covid vaccines evaluated and tested?

University of Rochester Medical Center scientists have been heavily involved in vaccine trials, so we have a good sense of how these vaccines were developed and how safe they are. While it’s true that they were developed much more quickly than past vaccines, they were still subject to large trials and strict review by independent scientists.

The process moved quickly in part because groundwork had already been done on vaccines for other, similar coronaviruses, meaning parts of the process that could otherwise have taken years were already completed. In addition, trials were combined and manufacturing began before the trials were done. However, no steps were skipped and safety remained a top priority. More than 100,000 adult volunteers were injected with the vaccines to ensure they would not cause significant adverse effects.

Studies of the pediatric vaccine included more than 2,200 kids and results showed it was 100 percent effective in preventing illness.

Can these vaccines give you COVID?

Getting a coronavirus vaccine will not give you Covid. None of the vaccines currently being developed, tested and distributed in the U.S. use the live virus that causes COVID-19; they use other methods to stimulate our bodies to recognize and fight the virus. Learn about how COVID-19 vaccines work.

Are these vaccines safe?

Covid vaccines have been studied in tens of thousands of people. Side effects of the vaccine include:  arm pain, redness, or swelling at the injection site, and some people report symptoms similar to the flu, though most people endure the shot well. There is also a rare risk of anaphylaxis, a dangerous but treatable allergic reaction. 

Covid vaccines have been given to millions of adults, and its use has been closely monitored.  That is how health leaders identified rare side effects, such as blood clots in a small number of adults who received the Johnson & Johnson vaccine.

The Pfizer vaccine is the only one fully tested and approved for use in kids. During the pediatric vaccine trials, reported side effects were similar to those found in adults.

Are mRNA vaccines gene therapy?

The Pfizer and Moderna COVID vaccines are composed of short-lived messenger RNA, which is not the same thing as DNA. The RNA will not enter the nucleus of the cell (the command center of the cell and location of the DNA) and cannot change a cell’s genetic material in any way. Therefore, the vaccine is NOT gene therapy. Upon providing the “message” to make the protein that will protect from infection, the RNA contained in the vaccine is broken down by the body. 

Is vaccination necessary for teens? 

Vaccinating a majority of adults and children is the best way to stop the spread of the virus. To date, millions of kids been infected with Covid and while most experienced mild symptoms, more than 5,300 have been hospitalized with serious illness, including here in Rochester. A small number of kids developed a serious complication known as Multisystem Inflammatory Syndrome in Children (MIS-C) that can cause rapid onset of fever and symptoms such as headache, chills or muscle and joint pain, and even heart failure.  Understandably, preventing this dangerous Covid complication is a priority. 

Vaccines prevent infection and severe illness in adults and data supports its use in teenagers. It may also help to decrease the emergence of viral variants. 

Are variants spreading in kids, teens, and young adults? 

Children and many teens and young adults have not yet been vaccinated, and if not following precautions (masking and social distancing) are at risk of infections with Covid or a variant. And variants are circulating in our region and throughout the country. Vaccinating children and teens, who make up about 20 percent of the population, will reduce the overall infection rate with any form of the virus, and lead us toward herd immunity.  

How are these vaccines being tested in children?

Vaccine studies in kids are conducted with a focus on safety first.  Using lower doses of the currently approved adult vaccine, they evaluated its efficacy in children of varying ages.   

Following this initial evaluation, each vaccine is evaluated in a randomized (you can’t control what you get), blinded (neither participants nor scientists know what a person receives), placebo-controlled (the vaccine is compared to a placebo, typically a salt-water based substance) study to ensure safety and efficacy, with the goal of ensuring it is as effective as the adult vaccine.  Parental consent is required for any child to participate in vaccine studies.

Are people paid?

Being a part of important clinical research takes time and effort and participants are typically paid.  For vaccine studies, payments are between $10 and $100 per visit, depending on the length and complexity of the visit.  

What else can you do?

It is important to remember that other illnesses continue to circulate during this time. Therefore, it is essential to make sure that your child is up to date on all of their normal childhood immunizations!