The Canadian Ministry of Health wants to speed up the fight against the COVID-19 variants by making the licensing process easier for modified versions of vaccines.
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Certain mutations in the virus can reduce the effectiveness of vaccines designed to combat the classic strain of COVID-19.
For this reason, manufacturers are working to develop new versions of their vaccines.
The new guidelines, adopted jointly with four other countries, aim first to avoid duplication of work from one country to another by sharing relevant information and indicating the information that manufacturers will need to provide.
Going forward, “the manufacturer will have to provide evidence that the modified vaccine provokes an immune response in a sufficient number of people, but clinical studies will not be required, as this information does not improve the understanding of the safety, efficacy, or quality of the vaccine by the regulators,” The Canadian Department of Health reported on Thursday.
“In addition to the data on the immune response, the manufacturer will need to provide evidence of the safety and quality of the modified vaccine,” she added. Data from initial clinical trials and ongoing studies can also be used for real-world use by millions of people to inform regulatory bodies of decisions. ”
These new trends are shared by other members of the Access Consortium, namely the United Kingdom, Australia, Singapore and Switzerland. This alliance aims to exchange information between these countries to speed up the supply of pharmaceutical products, including vaccines.
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