Social Distancing Measures Will Impede RSV Clinical Development

13 April 2020

GMP News

Emily Carter-Richardson, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on how introduction of social distancing measures could impact the development of respiratory syncytial virus (RSV) vaccines:

“The infection control measures of social distancing to prevent the spread of COVID-19 will also reduce the prevalence of seasonal RSV, since they exhibit similar modes of transmission. While the reduction in circulating viruses is positive for a population with an already stretched health system, lower overall prevalence could have a detrimental effect on candidate vaccines currently in development.

“GlaxoSmithKline, Johnson & Johnson and Pfizer all have large Phase II studies ongoing for their vaccine candidates. Vaccine clinical development is often troubled by failure to demonstrate protective efficacy, and this is particularly a problem for infectious diseases with low prevalence.

“Consequently, the only option a company may have is to extend trials, to include RSV seasons in 2021 or 2022 that hopefully will not be impacted by COVID-19–related infection control measures – if not, vaccine developers risk the possibility of missing the primary endpoints. This would result in delayed progression to Phase III studies and a push back for the timeline to approval.

“There remains enormous uncertainty surrounding estimates on how long the COVID-19 pandemic will last, which could be dependent on any successes in the development of therapies and vaccines for the disease. Data readouts from studies conducted over the 2019/2020 RSV season could begin to reveal the impact of social distancing on clinical development of RSV and other respiratory viruses.”

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