Modified COVID-19 vaccines for variants to be fast-tracked

COVID-19 vaccines

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.  

Other articles from mtltimes.catotimes.caotttimes.ca

More vaccine arrival at Mirabel airport

How to register for COVID-19 vaccine shot -FREE parking downtown Montreal extended and restaurants may open

Facebook
Twitter
LinkedIn
Email
NFL

Revolutionizing sports with technology enhancing athletic performance

The integration of technology in sports is transforming the way athletes train and perform. From data analytics to virtual training environments, technological innovations are reshaping athletic performance. As these advancements continue to evolve, their impact on sports management and performance becomes increasingly significant. In today’s sports landscape, technology plays a pivotal role in enhancing both

flying private

Private Jet vs. First Class: Is flying private from Montreal worth it?

Flying private or choosing first class is a big decision. Both options offer comfort and luxury. But they differ in cost, convenience, and privacy. This article compares both choices for travellers leaving from Montreal. The goal is to help you decide which option suits your needs. Cost of Flying Private vs. First Class Private jets

safest cities

Why Montreal is one of the safest cities to visit in 2025

If you’re planning a trip to Canada, Montreal has been ranked the sixth safest cities to travel to in 2025, according to a recent report by insurance company Berkshire Hathaway. When you break it down, Montreal’s safety is a combination of aspects that makes this city a favourite destination among safety-conscious travelers. Here’s a look

dermal fillers

The ultimate guide to dermal fillers: Are they worth it?

For decades now, dermal fillers have remained the go-to treatment for fighting the signs of aging, such as lines, wrinkles, and sagging. Apart from these, they are also extensively used to elevate some facial features by adding contour and volume to areas like lips, cheeks, and chin. Although the average cost of a dermal filler

Winnipeg’s Bold Commerce announces new PayPal integrations

Winnipeg’s Bold Commerce announces new PayPal integrations

Bold Commerce has built on its existing long-standing relationship with financial services platform PayPal. The firm has announced that small and medium-sized enterprises (SMEs) in Canada currently using its OpenCart and Gravity Forms solutions will benefit from the integration of PayPal’s full payments suite. This includes digital wallets, Venmo, Fastlane, as well as its Buy

Mtltimes Subscription

The latest on what’s moving Montreal and the world – delivered straight to your inbox