Although, to date, most children and pregnant women have shown no special vulnerabilities to the SARS-CoV-2 virus, serious efforts should be made to “level the field” of knowledge about how COVID-19 progresses in these populations in case different treatments will be more effective for them than for others, drug development experts said this week.
During a May 6 webinar hosted by Certara, speakers from that company and from the Critical Path Institute noted that, because their symptoms are often mild, children may be contributing to the rapid spread of COVID-19 and could be a key factor in stemming the pandemic. Further, while data on pregnant women are limited regarding COVID-19, it is known that they can experience significant morbidity with some respiratory infections.
Currently, the totality of data that would support meaningful dosing guidance as well as long-term safety experience in COVID-19 cases is lacking, especially for special populations such as children and pregnant women, noted Jeff Barrett, PhD, senior advisor to the CEO at the Critical Path Institute.
“The happy news is that, after three decades of research, we have accumulated a lot of information about” the dynamics of drug treatments in pregnant and pediatric populations, Barrett said. This is “a step in the right direction…to leverage what we know and [focus on] what we don’t know [for COVID-19]. We shouldn’t be satisfied with any snapshot in time” in terms of current knowledge for these populations, he added.
“Our reaction to this pandemic would probably be quite different if children reacted similarly to older patients,” said Patrick Smith, PharmD, senior vice president of integrated drug development strategy for Certara. “While the [disease’s] overall rate and the rate of severe disease in children are quite low, that doesn’t mean it isn’t happening. There have been numerous fatalities in children,” especially in those with certain comorbid conditions, he noted.
Identifying safe and effective treatment options for children is an important goal, and getting there should involve testing novel dosing regimens of drugs that have been repurposed for adults, Smith said.
For COVID-19 and the next outbreaks, it is imperative that researchers build tools and processes to help tailor therapies for special populations, the experts advocated. They noted that electronic health records have the potential to generate meaningful real-world data in children and pregnant women by creating and connecting the relevant outcome data and decision support systems to become a part of the practice of medicine and not just a reference. Likewise, modeling and simulation approaches such as physiologically based pharmacokinetics can be used to simulate exposures and predict relevant doses in children and pregnant women, they indicated.
“We’d like to see an environment with a centralized repository of relevant data for pregnant women and children, an open environment for knowledge exchange amidst evolving situations, and an up-to-date, curated model platform that projects clinical outcomes based on best available knowledge and best practices,” Barrett said.
Author: Gary Cramer