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ICMRA: Continue COVID vaccine trials "as long as is feasible"

Posted 30 November 2020 | By Kari Oakes 

ICMRA: Continue COVID vaccine trials

An international coalition of regulators has issued a statement in support of continuing clinical trials for vaccines against COVID-19 “for as long as is feasible,” but ideally for at least one year after vaccination.
 
The International Council of Medicines Regulatory Authorities (ICMRA) issued the statement in part to address a thorny ethical dilemma to be faced by vaccine sponsors and healthcare professionals when a vaccine is authorized: Should trial participants be unblinded as to their allocation, and placebo recipients offered a vaccine?

Recognizing the importance of high-quality clinical data in regulatory and clinical decision-making about COVID-19 vaccines, the ICMRA statement notes that regulators are ready to make speedy decisions with the results that come before them for approval decisions. “These analyses will support clear, independent and transparent benefit-risk evaluations, leading to decisions on the approval of, or early access to, safe and effective vaccines against COVID-19,” said ICMRA.
 
Accordingly, ICMRA noted that continuing to gather clinical trial data over a longer period of time “will be of the utmost importance” in ongoing surveillance of vaccine safety and efficacy, including monitoring for severe disease, subgroup efficacy, whether enhanced disease is a risk for those who have received the vaccine, and the durability of vaccine efficacy.
 
Post-authorization followup should ideally be conducted for “at least one year or more” after the assigned doses are completed, according to ICMRA. “In making this recommendation, we recognize that the feasibility of maintaining the group assignment for at least one year will depend” on a variety of factors, said the coalition. These factors include participants’ risk for developing severe disease, how available vaccines are in a given region at a given time, disease prevalence, and “informed decisions made by clinical trial participants.”
 
ICMRA did not go into further detail about how trial participants’ decision-making might play into a decision to keep participants blinded and in their allocated study arm. Significant common good would likely come from an extended post-authorization surveillance period; however, conventional medical ethics principles would also give weight to factors such as beneficence and non-maleficence, as well as individual autonomy. These factors, for some, might tip the scales in favor of unblinding COVID-19 vaccine studies for some participants, in some situations.
 
This issue was also addressed in the US Food and Drug Administration’s (FDA’s) 22 October Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. FDA’s Philip Krause, deputy director of the Office of Vaccines Review and Research, noted that “there has not been any promise to the people in the trial that they will be eligible to receive a vaccine when it becomes available.”  RELATED: FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom, Regulatory Focus 23 October 2020)
 
From a practical point of view, many vaccine study participants will be far down the priority list when limited doses are first doled out, a point made at the VRBPAC meeting by University of Chicago Medical School Dean Archuna Chatterjee, MD, among others.
 
For its part, ICMRA is asking sponsors to develop strategies to maximize the opportunity to follow both the vaccinated and unvaccinated members of COVID-19 vaccine trials post-approval, in a fashion “that is based on planned analyses conducted while trials are still ongoing and after final analyses are completed.”
 
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