Recently, many health-experts have debated on whether it took too long to test the COVID-19 vaccines on children. Some trials on the vaccines’ effect on children, haven’t been concluded yet.
A pediatrician at Duke University, Danny Benjamin, believes it took too long for COVID-19 vaccines to be tested in children. All clinical trials on children should have been completed by May 2021, he thinks, by which point some countries had already administered millions of doses to adults in their respective countries. The reality is, that in January 2023, some trials still haven’t concluded.
The shortage of pediatric data is not only limited to COVID-19. A lack of data is currently delaying pediatric labelling of drugs, and leaving physicians with little information about whether the drugs are effective or safe in children. This is despite an increase in the number of trials. An analysis of around 10,000+ prescriptions for children at Swedish hospitals in 2008 found that nearly half were off label, which means the medicines were not yet approved for pediatric usage by EMA (European Medicines Agency). The youngest children sampled were prescribed off label medicines at a higher rate than their older counterparts. “We don’t have a better alternative”, says Jenny Kindblom, a pediatric clinical pharmacologist at the University of Gothenburg, in Sweden.
On average, it takes at least seven years for adult approved drugs, to be authorized for use in children, says David Ziring, a pediatric gastroenterologist at Cedars-Sinai in Los Angeles, California. Without trials “we’re left using either drugs that are 30 to 40 years old and less effective or trying to use the most recently approved drugs and trying to justify to insurance companies that, despite its lack of an FDA label for pediatrics, we feel that it would be safe and effective”.
David Ziring has, for years, been advocating for drugs to be approved for pediatric use faster. “We’ve made very little progress” he says. “The community of pediatric sub-specialists that I belong to has become very frustrated”. For a long time, there was almost no incentive for pharmaceutical companies to pursue pediatric labelling with any urgency, he says. Pediatric trials are generally slower and more expensive than adult trials, as its harder to recruit participants, the ethical bar is higher, and there is less money to be made.
However, in 2002, the US Congress passed the Best Pharmaceuticals for Children Act, under which further marketing exclusivity is given as an incentive to firms that voluntarily conduct pediatric trials on drugs identified as a priority by the US Food and Drug Administration (FDA). Similarly, in 2007, the European Union brought in regulations in a bid to improve access to medicines for children, increase transparency around product information and boost the amount of pediatric research.
Although there are still few pediatric clinical trials, data suggests they are on the rise. A recent study in 2021 concluded that between 2008 and 2010, just over 7,000 pediatric trials were registered on the US clinical registry (clinicaltrials.gov). But between 2017 and 2019, this had increased to around 11,700. However, most of these were small-scale, single-site, and not funded by the US National Institute of Health or big pharmaceutical companies.
In conclusion, the lack of pediatric clinical data is a major problem in the medical field. It is crucial for children that we act now, and change the legislations affecting the problem.
- Source: Pediatric Drug Development: Key Considerations and Challenges: https://www.technologynetworks.com/drug-discovery/articles/pediatric-drug-development-key-considerations-and-challenges-353497
- Clinical trials in children: https://pubmed.ncbi.nlm.nih.gov/24325152/