Although fewer children are affected by COVID-19 compared to adults, children can get sick from the virus, and some develop severe illness. Hospitalization rates of children due to COVID-19 have increased since the beginning of school. As parents, we want to make the right decisions to safeguard our child’s health. But there is so much information out there, it is difficult to sort out who to listen to and what to believe. Here is some basic information to help you understand the concepts that you need to consider as you make important decisions that affect your child’s current and future health.
How Does the Drug Development Process Work?
Some people falsely think that one day a drug is in a test tube and a few days later, the drug is being tested on humans by researchers. Before a drug is available to be prescribed by your doctor or given as a vaccine, the drug is evaluated for efficacy and safety throughout multiple phases.
After a drug is identified during the research and discovery process, it is investigated in an artificial environment such as a test tube. Toxicology studies are conducted to see whether the drug is safe. For example, household bleach would kill the virus that causes COVID-19 if tested in the lab; however, bleach is toxic to humans if injected or ingested. If a drug has a therapeutic benefit and is safe, research continues onto Phase I clinical trials in humans.
Phase I. In Phase I trials, the drug is tested in a small number of healthy volunteers. Researchers look at side effects in a range of doses. They look at what the body does to the drug – how the drug is absorbed, distributed, metabolized and excreted. These parameters show how fast the drug starts working, how long it stays in the body and the pathway the body uses to eliminate the drug.
Phase II. Phase II trials are controlled trials conducted in a targeted patient population. A controlled trial means that one group of patients receives the study drug, and the other group gets an inactive substance (i.e., a placebo) or a different drug. The targeted patient population consists of patients who will benefit from the drug. For example, if the therapeutic benefit of the drug is to make it easier to breathe during an asthma attack, the drug is tested in patients who have asthma. Researchers evaluate safety and efficacy. Phase II trials can have up to 300 patients.
Phase III. Phase III trials involve a larger number of patients, from several hundred to several thousand. Researchers evaluate the drug’s benefit-to-risk ratio, testing the effectiveness of the drug at treating or preventing a disease versus the side effects. Researchers set up these trials to get the best possible data. Some patients are given an inactive substance and become the placebo control group. In randomized studies, patients are randomly assigned either the study drug or the placebo. Patient groups may be recruited in multiple geographic areas. If the outcome from Phase III trials is successful, then the drug is submitted to the Food and Drug Administration (FDA) for approval to bring the drug to market.
Phase IV. Phase IV trials are done after FDA approval. These trials build on the findings of the Phase III trials. They sometimes study use of the drug for a different target population, such as children, or they can expand a drug’s indications. A drug’s indication is what condition the drug is used to treat. For example, hydroxychloroquine is indicated as effective treatment for malaria and some autoimmune diseases. Recent studies were conducted by the World Health Organization to test the therapeutic effect of this drug as a treatment for COVID-19, but none was found.
Where Can I Get Factual Vaccine Information?
The currently available COVID-19 vaccines followed the required FDA drug development process. As with any newly approved (or authorized) drug, researchers continue to study and evaluate for safety and efficacy. Assessments are ongoing to see how the vaccine performs against changes in the virus (new variants), how long protection lasts and how well it protects against serious illness. Go to cdc.gov/vaccines/covid-19/effectiveness-research/protocols.html for the latest information in COVID-19 vaccine effectiveness research.
Bust Common Myths and Learn the Facts
Rumors and disinformation about vaccines are rampant. The CDC is a trusted resource that provides credible and updated information. Go to cdc.gov/coronavirus/2019-ncov/vaccines/facts.html to learn more.
Whose Advice Should I Trust About Vaccine Safety in Children?
When making decisions that will impact your child’s health both now and in the future, don’t hesitate to get expert advice. Talk to your child’s pediatrician. Pediatricians are trained to evaluate risks and benefits of therapies for pediatric patients. They can offer expert advice tailored to your child’s specific needs.
Brenda Schoolfield is a freelance medical writer based in Austin.