Health Canada announces new guidance issued today by the Access Consortium—a coalition of regulatory authorities from Canada, the U.K., Australia, Singapore and Switzerland. The guidance, developed by Health Canada in consultation with its Access partners, lays out what information regulators would need to approve any modifications to authorized COVID-19 vaccines, should virus mutations make them less effective at preventing COVID-19. With this guidance, authorized COVID-19 vaccines that are modified in response to new variants will need to be reviewed and authorized.
According to the guidance, vaccine manufacturers would need to provide evidence that the modified vaccine produces an immune response in a sufficient number of people, but clinical studies would not be needed since they do not add to the regulatory understanding of a vaccine’s safety, efficacy or quality.
This is because researchers are now better able to measure protection by looking at antibodies in the blood following vaccination, reducing the need to determine whether people in a trial develop the disease. This would reduce the length of time needed for a modified vaccine to be ready for use.
Along with data on the immune response, the vaccine manufacturer would also be expected to provide evidence of the modified vaccine’s safety and quality. Data from the original clinical trials and the ongoing studies on real-world use in millions of people can be used to support any decision by the regulators.
This approach is based on established regulatory processes used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating each year.
The Access Consortium began as the Heads of Agencies Consortium in 2007. Health Canada was a founding member of this group. The Consortium’s goal is to maximize international cooperation between partners in the Consortium, reduce duplication and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products, including vaccines, drugs and medical devices.
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