Children aren’t just small adults – that’s why they need their own clinical trials

People travel again, dine at restaurants with friends, attend direct gatherings, and flock to cinema and major league baseball games.

However, for parents of children under the age of 12 who are not yet qualified COVID-19 vaccine, I haven’t sighed for relief yet. Many parents are concerned about the uncertainties surrounding the next school year and the Delta Variant.

Clinical studies of an mRNA-based vaccine in children under the age of 12 are underway, and approval of the vaccine for this younger age group is still at least a few months away. Children need these tests because they have important differences in physiology and response to vaccines from adults. Conducting a personalized survey of children under the age of 12 is an important step in ending the pandemic.

As a pediatric infectious disease expert, I have been researching vaccines associated with common pediatric infectious diseases for over 20 years. Here at the University of Pittsburgh, our Pittsburgh Vaccine Trial Unit has conducted both adult and pediatric clinical trials on vaccines to combat COVID-19.

Our facility is one of two COVID-19 vaccine clinical research trial sites in the Pittsburgh region, with 100 of the entire United States participating in this effort through the COVID-19 Prevention Network formed by the National Institutes of Health. It was one of the sites that surpassed. To fight the epidemic of the coronavirus. Our team is about to begin the next phase of the exam in the age group of 6-11 years, which depends on volunteer participants.

Test vaccines for safety and efficacy

Vaccines work by tricking the body’s immune system into making proteins called antibodies that fight the disease, but they don’t cause disease in humans.

Before the vaccine is approved for use by the general public, it usually goes through a clinical safety study that can take 2 to 15 years.

The US Government’s Operation Warp Speed ​​has accelerated this process in unprecedented ways. This was primarily due to a US $ 18 billion upfront investment to support lab space creation, infrastructure construction, research investments and vaccine pre-purchase. In December 2020, US healthcare professionals began receiving the first COVID-19 vaccine approved for adults.

Vaccine research begins with experiments in the laboratory. There, candidate vaccines will be developed and tested in animals. After pharmaceutical companies and government laboratories conduct initial trials of vaccine candidates, they rely on national and research groups around the world to carry out several stages of people’s clinical trials.

In Phase 1 trials, the main goal is to establish the safety of the vaccine in humans. During Phase 2, researchers will continue to assess the safety of the vaccine, but aim to determine the exact dose needed to achieve the immune response needed to provide protection.

As vaccine candidates enter Phase III trials, the main goal is to study how well people are protected from infections and illnesses, while continuing to assess safety and monitor potential side effects.

Even after clinical trials are complete, vaccines must undergo a rigorous evaluation process through the US Food and Drug Administration, the regulatory body that oversees the safety and efficacy of vaccines.

After tens of thousands of adults participated in a phase 3 clinical study of the COVID-19 vaccine over the months of 2020 and early 2021, the United States is now granted emergency use by the FDA for people over the age of 18. I have 3 vaccines and 1 vaccine. Vaccine, Pfizer, approved for use in children over 12 years old.

Difference between child’s body and adult’s body

Children are not just small adults. Their bodies differ from adult bodies in an important way.

Their brains are developing rapidly, and there are also important differences in the immune system, especially in infants and babies. During the first few months of life, the baby’s immune system still has antibodies received from the mother throughout the placenta during late pregnancy.

This changes the way newborns respond to pathogens and prevents them from starting an immune response to some vaccines. The infant’s body gradually strengthens its immune system as protection from the mother weakens.

As a result, vaccines often need to be specially tailored for young children. For example, pneumococcal vaccines that prevent infectious diseases such as pneumonia in adults are made from sugar molecules called polysaccharides that line the outside of pneumococcus. However, babies cannot initiate an effective immune response against these sugar molecules. As a result, researchers needed to develop a unique version of the vaccine for babies.

Even if adult vaccines prove safe for children, there can be important differences in how their bodies respond to them. For example, the most effective vaccine dose for adults can cause high fever in children. Therefore, one of the key goals of clinical trials of the COVID-19 vaccine in children is to determine the optimal dose for each age group.

Researchers should be aware of side effects that can only occur in adolescents and did not appear in adult vaccine tests. Safety is very important and each study is of a safety mechanism to ensure that researchers like us proceed carefully and evaluate all data and information at every step along the way. There are many layers.

For example, study participants keep a daily diary and report side effects and changes. Vaccine clinical trials include frequent safety checks by participants, and abnormal reactions are immediately reported to the sponsor so that problems can be identified immediately. Researchers also adhere to strict “suspension” rules in the event of serious safety concerns.

Clinical trials for children

After setting up a new clinical trial space and gathering all the staff and necessary equipment, the University of Pittsburgh trial unit is ready to host a Phase 3 clinical trial with volunteer participants.

Phase 3 adult clinical trials were conducted for both the Moderna and Johnson & Johnson vaccines from August to fall 2020. We recently focused on whether the vaccine can be safely used in these children and at what dosages it can be used in children Moderna 6-11 years and 6-24 months. You have enrolled in Phase 2 of the exam.

Our site is currently moving across the United States and Canada to Phase 3 of a pediatric trial scheduled to begin in mid-August for children ages 6-11. In this final stage of clinical trials, we will determine how well the vaccine actually works to prevent children from becoming infected with COVID-19. Early results from these studies are expected by this fall and will be reviewed by the FDA thereafter.

The FDA said on July 15 that emergency vaccine permits for children under the age of 12 are likely to come between early winter and midwinter.

The important role of volunteers in ending the pandemic

Volunteering for research is not for everyone. When a family volunteers to enroll in a vaccine study, our research team discusses the requirements and potential risks and benefits with them in detail.

We try to answer all their questions so that they can determine if the study is suitable for them. Ultimately, parents are trying to make the best decisions for their children.

Volunteers often want to help end a pandemic or feel that it is their personal responsibility to help others. Their willingness to participate is essential to finding a safe and effective vaccine that will help parents and children return to their pre-pandemic freedom of life by ending the pandemic.

Judy Martin, Professor of Pediatrics, University of Pittsburgh