Antioch, CA

What Protections Are Provided For Children When New Medications Come on the Market?

Natalie Frank, Ph.D.

The recent wrongly administered vaccines to children raises the question of what protections are provided for children when new medicines become available and what you can do to keep your child safe whenever they are prescribed medication.

Concern over protecting children from medical mistakes when new vaccines or medications become available was raised after the wrong dose was of COVID-19 vaccine was given to 14 children at the Sutter Health clinic in Antioch, California last weekend. While initially they weren’t releasing information about whether the children were given too little or too much, it was later confirmed by parents who were called by clinic personnel that the children were given 20 micrograms of the vaccine instead of 10 micrograms. Adults and adolescents receive 30 micrograms so instead of one third the dose, the 14 children were given two-thirds the dose, or double the recommended amount.

This incident followed the realization that over 100 children ages 5-11 had been incorrectly administered a COVID-19 vaccine dose intended for those over the age of 11 at a Virginia pharmacy between November 3rd and November 4th. On Tuesday, a pharmacy in Virginia was taken out of both state and federal COVID-19 vaccination programs after it mistakenly gave the COVID-19 vaccine formulated for individuals 12 years and older to 25 children ages 5 to 11 years old.

Experts Say The Wrong Dosage Shouldn’t Harm These Children

Experts, including those at CDC, say that parents shouldn’t panic over children receiving the wrong dose. According to the CDC,t the symptoms of receiving an incorrect vaccine dosage are predominantly just slightly more intense than what most people already experience. They still contend, “Vaccinating children will help protect them from getting COVID-19 and therefore reducing their risk of severe disease, hospitalizations, or developing long-term COVID-19 complications. Getting your children vaccinated can help protect them against COVID-19, as well as reduce disruptions to in-person learning and activities by helping curb community transmission.”

According to Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston said receiving the wrong dose isn’t likely to hurt younger children. He said he is not extremely concerned about harm resulting from the mistaken doses.

“There have been clinical trials that have looked at different doses in children and the current lower dose of the Pfizer vaccine, the 10-microgram dose rather than the usual 30 [microgram dose], in children ages 5 to 12, is really based on the clinical trials that showed that that lower dose is better tolerated and equally immunogenic," said Barouch. "So it is strongly recommended that children do get the appropriate dose. If they do get a higher dose, then it's possible they will have more reactive reaction symptoms. I wouldn't be extremely concerned because it actually has been studied in trials and it really was just the balance of evidence that made the company choose lower dose."

A Result of Mistaking Dosages, Not a Problem With the Vaccine

According to a Centers for Disease Control and Prevention (CDC) statement approval of the vaccine for children ages 5-11 occurred after researchers conducted clinical trials with about 3,000 children. The Food and Drug Administration (FDA) determined that the Pfizer-BioNTech COVID-19 Vaccine met the required safety and efficacy specifications to allow the vaccine to be given to children under the age of 12.

The approved dosage for this age group is one-third the dose given to adults and adolescents. The adverse effects that some of the children displayed were due to being given the wrong dose, and not because the vaccine is not safe for young children.

Watch the coverage of this developing situation below.

How Clinical Trials and Drug Approval for Children Work

As families waited for the COVID-19 vaccine to become available for children under the age of 12, many had difficulty understanding what was holding up the process. Approving the use of new drugs with children is something that researchers must take great care with.

Something parents are often not aware of is that the majority of drugs used to treat children were never tested and approved to be administered to this age group. Prior to the Food and Drug Administration initiating a pediatric program, only about 20 percent of drugs that were approved by the FDA were approved for use in children. Physicians have routinely prescribed drugs to children "off label." This means that the medication hasn’t been approved for use in children based on controlled clinical studies that demonstrated the safety and efficacy of the drug in question.

Prescribing in children is often based on a reliance on outcomes from adult clinical trials. Yet children are not little adults and have their own make up based on developmental stage. The was diseases and medications affect their bodies is extremely different from how adults are affected. They metabolize some medications differently than adults do, leading to there being to high or too low a concentration for effective treatment, along with adverse reactions including toxicity.

Yet children are rarely included in clinical trials testing new medications including vaccines. The main reason for this is linked to the process of clinical testing and ability of a child to consent to participate.

Prior to including a person in a research study, informed consent must be obtained. Children, especially young children, often don’t understand enough about the study to give informed consent. In the past, this alone was enough to decide not to include young children in clinical trials. More recently the scientific community has moved to using the child’s assent instead of informed consent as permission to enroll them in the investigation.

Yet even with this compromise, there are other issues that prevent children from being included in clinical trials. This is because of the traditional testing process that is divided into four phases.

Phase I trials test the safety and efficacy of a new medication for the first time and to determine what dose is safe and effective by increasing the dose amount which is given to a small number of subjects at a time. This phase also tests for toxicity and side effects and is therefore discouraged in children because of the unknown effects of the new drug. Phase I trials are more acceptable in children with severe or life-threatening conditions when no proven treatment exists or when standard therapies have proven ineffective.

Phase II trials, examine the safety and efficacy of the intervention and may sometimes include children but it is still rare.

Usually, with drug trials, it isn’t until phase III that children are allowed to be included. Phase III studies provide information about the investigational medication through extensive testing of the safety, efficacy, and proper dosing in a much larger group of patients. In phases II and III a placebo is given to one group of subjects. Control groups and placebos are utilized when there are no established therapies to compare to new drug to.

Although the intent of deferral the inclusion of children into clinical trials is to protect them from unnecessary harm, it also means that access to potentially useful medication is delayed. Phase III trials (randomized controlled trials) compare the investigational intervention with standard therapy, another effective therapy or placebo to estimate unbiased treatment effects.

Phase IV involves post-marketing trials of the investigative drug which very rarely include children. However, the Food and Drug Administration (FDA) Pediatric Research Equity Act (PREA) now can require pediatric trials of marketed medications including vaccines.

Protections Needed for Children When New Medications Are Made Available

When new medications, including vaccines, become available for use in children, special care must be taken. When new drugs come on the market, and have been tested in children, they have undergone the same rigorous investigation that medications developed for adults do.

When they haven’t been tested in children, as most still aren’t despite the push that drug investigations with youth become more common, it is up to all of us to do what we can to protect our children. Healthcare providers must know everything there is to know about the drug, and really consider how it might affect a particular pediatric patient in terms of what they know about the child. Only when they are certain there is every indication that the medicine will help the child without terrible side effects should they consider prescribing off label.

Caregivers need to ask questions about everything a provider is prescribing for their child, especially whether or not the drug was tested on and approved for children who are similar in age, illness and characteristics of their own child. If it is being prescribed off label, it’s important to know how often this occurs, how often it occurs with children similar to their child, and what the doctor knows about the safety, efficacy and side effects in children similar to their child.

When mistakes, such as the recent ones with the COVID-19 vaccine, are made, caregivers should double check that their child is being given the proper medication, at the proper dosage with the proper formulation they should be receiving and ask the provider to double check to make sure that is the case. A good provider will not get upset at the request to tell you how they know it’s the right drug that is supposed to be administered to your child and to check and make certain that’s the case.

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