Student View

STANDARDS

NGSS: Core Idea: ETS1.B, LS1.A

CCSS: Writing: 2

TEKS: 6.3A, 7.3A, 8.3A, B.3A

Testing Vaccines

Meet some of the young volunteers who took part in Covid-19 vaccination trials

CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER

JOINING TOGETHER: Abhinav, age 12, and his father, Sharat, both participated in the vaccine trial at Cincinnati Children’s Hospital.

AS YOU READ, THINK ABOUT how a new vaccine is created and tested.

The Covid-19 pandemic has affected the lives of nearly everyone in the world. But for 15-year-old Isabella Stiles, who lives in Bardstown, Kentucky, it hit particularly close to home. Her father, Matthew, is a doctor who practices family medicine. He was repeatedly exposed to the virus that causes Covid-19 while treating sick patients. Each time that happened, Isabella’s dad had to quarantine for two weeks, separated from his family to make sure he didn’t pass the virus on to them.

As of February 3, 2021, more than 26.5 million people in the U.S. had become infected with the virus that causes Covid-19 and more than 447,000 had died. When Isabella learned that teens and preteens could help test an experimental vaccine that might protect people from developing Covid-19, she considered joining the study. After much discussion, Isabella and her family decided that she could participate. “When this is all over, I can feel like I did something to help end the pandemic,” says Isabella.

The Covid-19 pandemic has affected nearly everyone in the world. But it hit especially close to home for 15-year-old Isabella Stiles. She lives in Bardstown, Kentucky. Her father, Matthew, is a doctor who practices family medicine. He was exposed to the virus that causes Covid-19 over and over, because he treated sick patients. Each time that happened, Isabella’s dad had to quarantine for two weeks. He stayed away from his family so he couldn’t pass the virus on to them.

By January 27, 2021, the virus that causes Covid-19 had infected more than 25.5 million people in the U.S. More than 425,000 had died. Isabella learned that teens and preteens could help test an experimental vaccine. It might protect people from developing Covid-19. Isabella considered joining the study. She and her family discussed the idea and decided that she could take part. “When this is all over, I can feel like I did something to help end the pandemic,” she says.

A NEW VACCINE

The vaccine Isabella would test is produced by the pharmaceutical companies Pfizer and BioNTech and relies on a new technology: messenger RNA, or mRNA (see How an mRNA Covid-19 Vaccine Works). Scientists have been studying mRNA technology for more than 30 years. When Covid-19 started to spread, companies realized that mRNA could be used to rapidly produce a vaccine against SARS-CoV-2, the virus that causes Covid-19.

To make sure a new treatment is safe and effective, companies carry out a series of clinical trials, or research studies that involve people. Each trial has three phases. Phase I tests the new treatment for safety on a small number of people. Phase II involves several hundred people and tests how well the vaccine works. Phase III, the final and largest phase, includes thousands of participants. The large sample size allows researchers to assess how effective a treatment is.

More than 44,000 adults participated in Phase III of Pfizer- BioNTech’s trial, which showed that the vaccine was 95 percent effective at preventing people from becoming ill with Covid-19. Once the new vaccine was deemed safe in adults, Pfizer-BioNTech expanded testing to more than 2,200 teens and preteens.

Isabella would test a vaccine made by the pharmaceutical companies Pfizer and BioNTech. It uses a new technology called messenger RNA, or mRNA (see How the New Covid-19 Vaccine Works). Scientists have been studying mRNA technology for more than 30 years. When Covid-19 started to spread, companies realized that mRNA could help. They could use it to quickly produce a vaccine against SARS-CoV-2, the virus that causes Covid-19.

Companies must make sure a new treatment is safe and effective. So they carry out a series of clinical trials. These research studies involve people. Each trial has three phases. Phase I tests the new treatment for safety on a small number of people. Phase II involves several hundred people. It tests how well the vaccine works. Phase III is the final and largest phase. It includes thousands of volunteers. With this large sample size, researchers can tell how effective a treatment is.

More than 44,000 adults joined Phase III of Pfizer-BioNTech’s trial. The results showed that the vaccine was extremely effective. It reduced people’s chances of getting Covid-19 by 95 percent. The new vaccine proved safe in adults. Next, Pfizer-BioNTech started testing teens and preteens.

EXPANDING THE STUDY

According to the American Academy of Pediatrics (AAP), in the U.S. alone, roughly 2.5 million kids under the age of 18 have tested positive for Covid-19. Most children don’t suffer as severely from the illness as many adults do. Oftentimes, kids don’t even experience symptoms. But the AAP says 1.3 percent of children suffering from Covid-19 have had serious complications from the disease, and about 0.01 percent have died. Young people can also transmit the virus to those who are more vulnerable, like parents, grandparents, and community members. That’s why pharmaceutical companies asked young people to volunteer for Covid-19 vaccine trials—because they may want to get vaccinated too.

Before any hospital could begin enrolling participants, though, its institutional review board had to determine whether the benefits of the study outweighed the risks. “If it’s not something we would give to our own children, we wouldn’t participate,” says Marty Osbourn, a nurse and research director at Kentucky Pediatric/Adult Research (KPAR) in Bardstown, which hosted the vaccine trial Isabella joined.

About 2.5 million kids under age 18 have tested positive for Covid-19 in the U.S., says the American Academy of Pediatrics (AAP). Many adults suffer serious symptoms from the illness, but most children don’t. Often, kids don’t even get symptoms. But the AAP says 1.3 percent of children with Covid-19 have had serious complications from the disease. About 0.01 percent of them have died. Young people can also spread the virus to those at greater risk. Parents, grandparents, and community members can get it from them. So kids will need to get vaccinated too. That’s why pharmaceutical companies asked young people to join Covid-19 vaccine trials.

But a hospital couldn’t just start signing up volunteers. First, its institutional review board had to consider the study. Would the benefits outweigh the risks? “If it’s not something we would give to our own children, we wouldn’t participate,” says Marty Osbourn. She’s a nurse and research director at Kentucky Pediatric/Adult Research (KPAR) in Bardstown. Isabella joined the vaccine trial there.

DOGUKAN KESKINKILIC/ANADOLU AGENCY VIA GETTY IMAGES

PUT TO THE TEST: A health-care worker holds a syringe containing a Covid- 19 vaccine created by the companies Pfizer and BioNTech.

In order to participate, Isabella and other kids, along with their guardians, had to sign informed consent forms to show they understood that trying any new medicine carries risks. These forms also detail how people can end their participation in a trial at any time for any reason. Isabella’s first visit to KPAR was about three hours long, and much of that time was devoted to making sure she fully understood how the trial would work.

Katelyn Evans, a 16-year-old from Green Township, Ohio, decided to join Pfizer-BioNTech’s trials at Cincinnati Children’s Hospital after intense discussion with her family. She was initially worried about experiencing some of the common side effects—like fever, headaches, and soreness at the injection site— associated with the vaccine. But she decided the long-term advantages outweighed the short-term inconvenience. “I think we should do whatever we can to help other people right now,” she says.

Trying any new medicine carries risks. To take part, Isabella and other kids had to sign informed consent forms. So did their guardians. This showed that they understood the risks. The forms also explained that people could leave a trial at any time for any reason. Isabella’s first visit to KPAR was about three hours long. Much of that time was spent making sure she fully understood how the trial would work.

Katelyn Evans is a 16-year-old from Green Township, Ohio. She discussed the matter intensely with her family. Then she decided to join Pfizer-BioNTech’s trials at Cincinnati Children’s Hospital. At first, she was worried about some of the vaccine’s common side effects. They include fever, headaches, and soreness at the injection site. But she thought about the long-term benefits. She decided they outweighed the short-term discomfort. “I think we should do whatever we can to help other people right now,” she says.

COURTESY OF STEPENOSKY FAMILY

TAKING THE SHOT: Kearston Stepenosky, a 16-year-old from Calabasas, California, receives her first dose of the vaccine or the placebo.

TESTING THE TREATMENT

Before the trial, Isabella learned that not all participants would get the new medication. Half would receive a placebo. But volunteers wouldn’t be told who got this inactive substance and who got the real vaccine. That’s because researchers didn’t want this information to influence how volunteers behaved. Comparing how many people in the two groups become sick with Covid-19 allows scientists to figure out how well the vaccine works.

Pfizer- BioNTech’s mRNA vaccine requires two doses. During Isabella’s first visit to KPAR, she got her first injection. Three weeks later, she returned for a second one. After both doses, she used an app to record possible side effects, like fever or chills. Pfizer- BioNTech will continue to monitor the health of all study participants for two years.

Not all volunteers would get the new vaccine. Isabella learned this before the trial. Half would receive a placebo. But volunteers wouldn’t know if they got this inactive substance or the real vaccine. That’s because researchers didn’t want this information to affect the volunteers’ behavior. Scientists compare how many people in the two groups become sick with Covid-19. That allows them to figure out how well the vaccine works.

Pfizer-BioNTech’s mRNA vaccine requires two doses. Isabella got her first shot during her first visit to KPAR. Three weeks later, she returned for a second one. After both doses, she watched for possible side effects, like fever or chills. She recorded them with an app. Pfizer-BioNTech will keep track of all study volunteers’ health for two years.

DAVE ZAJAC/RECORD-JOURNAL VIA AP IMAGES

SAFETY FIRST: As vaccines are distributed, the CDC recommends that people continue to wear masks and social distance to prevent transmission of Covid-19.

On December 11, 2020, the U.S. Food and Drug Administration (FDA) deemed the Pfizer-BioNTech vaccine safe and effective and authorized it for emergency use in people age 16 and older. The company will continue to gather more data for younger age groups. Other companies, like Moderna, have now opened up their trials to kids too. Both Pfizer-BioNTech and Moderna want to know if children’s immune systems respond differently to the vaccine than adults. Kids might need smaller doses of the medicine or multiple shots over a different period of time.

According to Pfizer-BioNTech and Moderna, their vaccines may be available to kids age 12 and older before the start of the 2021-2022 school year. The final decision to authorize the vaccine for anyone younger than 16 will fall to the FDA. Isabella, for one, is proud to have played a role in the development of a Covid-19 vaccine: “It was a really cool choice to be part of this,” she says.

On December 11, 2020, the U.S. Food and Drug Administration (FDA) decided that the Pfizer-BioNTech vaccine was safe and effective. It allowed the vaccine for emergency use in people age 16 and older. The researchers will continue to gather data for younger age groups. Other companies, like Moderna, have also opened their trials to kids. Do children’s immune systems respond differently to the vaccine than adults’? Both Pfizer-BioNTech and Moderna want to know. Kids might need smaller doses of the medicine. Or they might need multiple shots over a different period of time.

Pfizer-BioNTech and Moderna say their vaccines may soon be ready for kids age 12 and older. This could happen before the 2021-2022 school year starts. The FDA will make the final decision to allow the vaccine to be given to people younger than 16. Isabella is proud that she played a role in the development of a Covid-19 vaccine. “It was a really cool choice to be part of this,” she says. 

CONSTRUCTING EXPLANATIONS: Explain why pharmaceutical companies test their vaccines on people of all ages. Support your answer with evidence from the text.