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Regulatory Focus™ > News Articles > 2020 > 3 > ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies

ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies

Posted 24 March 2020 | By Michael Mezher 

ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies

Credit: NIAID-Rocky Mountain Laboratories

After meeting last week to discuss vaccine development for the coronavirus disease (COVID-19), the International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday released guidelines for the data required before proceeding to first-in-human (FIH) studies for candidates.
 
So far, two vaccine candidates developed by Moderna and CanSino Biologics have moved into Phase I clinical testing, while many other companies and researchers have said they are in preclinical development.
 
In a summary report from the meeting, ICMRA says that pre-clinical and preliminary data must be generated to support moving to Phase I studies and to address the potential risk that a candidate vaccine could make patients more susceptible to the virus.
 
Vaccine-induced disease enhancement has been documented for multiple types of viruses, including other coronaviruses such as the original SARS virus.
 
Preclinical Data
 
According to the meeting report, “the extent of preclinical data to support proceeding to FIH clinical trials depends on the vaccine construct, the supportive data available for the construct and data from closely related products.”
 
The report also advises developers to leverage knowledge from their experience with a vaccine platform and suggests that toxicology data and clinical data from other vaccines from the same platform could be used to support FIH clinical trials.
 
However, ICMRA says that vaccine developers should be able to “justify why preclinical studies such as toxicity studies would not need to be conducted prior to proceeding to FIH clinical trials.”
 
Other important preclinical data include adequate chemistry, manufacturing and controls (CMC) characterization and data from animal studies to characterize the immune response induced by the vaccine.
 
ICMRA also says that developers do not need to demonstrate vaccine efficacy in animal challenge models before proceeding to FIH clinical trials.
 
Vaccine-Induced Disease Enhancement
 
While the regulators at the meeting acknowledged the pressing need for a vaccine against COVID-19, they agreed that sponsors must mitigate the risk that a vaccine could cause vaccine-induced disease enhancement.
 
As such, ICMRA says that animal models should be used to evaluate the potential for disease enhancement, despite “limitations in the current knowledge and understanding of risk enhancement of disease and the value of these models in predicting the likelihood of occurrence in humans.”
 
While participants at the meeting were not unanimous on these points, they generally agreed that some vaccines may proceed to FIH clinical trials without conducting animal studies to assess the potential for disease enhancement “provided adequate risk mitigation strategies are put in place.”
 
They also generally agreed that some vaccines may require specific preclinical data to proceed, such as postvaccination challenge data or immunopathology studies in animal models.
 
However, in cases where FIH clinical trials are allowed to proceed without evaluating the potential for disease enhancement in animal models, ICMRA says that such studies “are expected to be conducted in parallel.”
 
ICMRA also says that enrolling healthy younger adult volunteers and “careful safety follow up and frequent monitoring” can mitigate some of the risks.
 
ICMRA

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