International – ICMRA: Continue COVID vaccine trials « as long as is feasible »

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…