Feature Article — COVID-19 Vaccines: Clinical Trials in Children
Published on in Parents PACK
Published on in Parents PACK
As schools prepare to reopen, parents and children alike are experiencing a range of emotions and concerns. On one hand, the need for in-person learning and socialization has become clear. On the other hand, the virus that causes COVID-19 continues to spread rapidly throughout many communities, and for most children, the best defense we have against this threat — the vaccine — is not yet an option. As a result, interest in the ongoing vaccine clinical trials in children has been high. With this in mind, we thought it was a good time to provide more information about the trials, the timeline and what it might mean for the upcoming school year.
Depending on the age of your children, you may be in a situation in which one or more of your children can get vaccinated and others cannot yet get vaccinated. Currently, those 12 years and older can get two doses of the Pfizer mRNA vaccine, separated by at least 21 days. Those 11 and younger remain ineligible.
Clinical trials tell us different things depending on how they are designed. As such, the way that one company designs their trial is likely to differ from that of another company. Understanding how the trials are designed is important for understanding the results. One current example of how these differences can affect the use of a vaccine is apparent in that the Pfizer vaccine can be used in those 12 years and older, but Moderna’s is currently only available for those 18 years and older. This does not tell us anything about how safe or effective the Moderna vaccine is in children; it is just this way based on the age groups each company chose to include in their original phase 3 clinical trials.
The clinical trials for children are important for determining three things:
Clinical trials are described on a website overseen by the U.S. National Institutes of Health and the National Library of Medicine, clinicaltrials.gov. Website visitors can search by a variety of factors, such as condition, recruitment status and location, to find out what clinical trials are available and how they are being conducted. A recent search for COVID-19 vaccine trials in children identified five trials recruiting participants and three active trials that are not currently recruiting participants. So, let’s take a closer look:
Of the five trials currently recruiting participants, three are studies of the Pfizer vaccine. One is a study of the Moderna vaccine, and one is a study that includes both vaccines. See below for more details about each.
Typically, “active, but not recruiting” status indicates that enough participants have been recruited for the study, but data are still being collected and evaluated. In the current review, one of these was a Pfizer vaccine trial looking at booster doses in those 16 years and older. One was a Moderna trial looking at vaccine safety and effectiveness in those 12 years of age to younger than 18 years of age, and a third trial was evaluating a vaccine that contains the spike protein with adjuvant in a lipid nanoparticle, sponsored by Novavax. This latter study included two phases. In the first phase they evaluated adults. Later, they extended the study to include those 12 years to younger than 18 years of age.
One final note about clinical trials if you are interested in participating or having your children participate. Unfortunately, the Federal Trade Commission (FTC) has identified scams related to fake clinical trials. The scammers are using the guise of COVID-19-related clinical trials to get people’s personal information and money. As such, before you decide to participate in any clinical trial, check the FTC’s tips for determining whether a clinical trial is real.
One of the questions we receive most commonly is when children younger than 12 years of age will be able to get COVID-19 vaccines, and the short answer is that we don’t know for sure. While the clinicaltrials.gov website includes dates, these are based on when all data and follow-up should be completed. These dates can change for reasons such as longer or shorter than anticipated recruiting timelines, unanticipated trial delays or temporary stops, or study sites not being recruited or approved in the expected time. However, it is also important to realize that companies can often submit data when they get to a certain point of follow-up post vaccination. For example, during the first approvals for adults, the companies were able to submit their data after they compiled eight weeks of follow-up data even though they were still following those vaccine recipients.
Currently, it is anticipated that the first data in children younger than 12 years of age may be submitted for review later this year; hopefully, sometime in the fall, but only time will tell.
Parents wondering what this means for their families, can take away three important considerations:
The best way through this pandemic is together. So even if your family is tired of the masks and limitations, try to remind them that we all need to work together in our homes, schools and communities to put this behind us!
Categories: Parents PACK August 2021, Feature Article
Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.
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