Health Canada working to fast-track vaccines for variant strains of COVID-19
While the number of new COVID-19 cases has been trending down for much of this week, health officials are concerned about variant strains of the virus, that present a risk of a third wave of the virus.
In order to prevent this, Health Canada is working to fast-track the modification of vaccines to treat the variant strains of the virus.
A new guidance by the Access Consortium--a coalition of regulatory authorities from Canada, the U.K., Australia, Singapore, and Switzerland--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.
Under this guidance, authorized COVID-19 vaccines that are modified in response to new variants would still need to be reviewed and authorized.
Additionally, 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.
However, clinical studies would not be needed, as they do not add to the regulatory understanding of a vaccine’s safety, efficacy, or quality.
Further, in addition to the data related to the immune response, vaccine manufacturers 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.
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