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
Is it possible to get an A for a 5-paragraph essay assignment in 1 hour? We can safely say yes, a student can get an A+ mark if he turns to EduJungles


staycation

The ultimate guide to planning a long family staycation in Canada

To guarantee that everyone has an amazing time, careful planning is necessary when organizing a lengthy staycation. Here’s the ultimate guide to planning your family staycation in Canada. Canada, with its vast landscapes, diverse cities, and rich cultural heritage, offers endless possibilities for a memorable family staycation. Whether you’re exploring the stunning natural beauty of

Meal kits

Cost vs. Convenience: Analyzing meal kits and traditional cooking

In this modern world and modern times, convenience often takes priority over cost, especially when it comes to food. Meal kits and traditional cooking represent two different approaches to home dining, and each of them has advantages and disadvantages. Analyzing these methods through the lens of cost and convenience provides insight into why individuals might

Condo renovations

Condo renovations Dos and Don’ts: Expert Tips for a Successful Project

Embarking on a condo renovations journey can be both exhilarating and daunting. Imagine transforming your living space into a stylish haven that reflects your personality and meets your needs. While exciting, the process can be full of challenges and unforeseen hiccups. That’s why we’ve gathered some condo renovation dos and don’ts from the experts to

Terrific Hair

Terrific Hair Means Tamanu – Earth to Body

Curly, straight, thick, thin, kinky or silky, tamanu loves and makes terrific Hair.  And scalps. Nutritionally dense yet gentle, tamanu is an effective and versatile nut oil. It stimulates, helps promote growth. prevents hair loss, reduces scalp itch and irritations and adds a natural sheen! Make tamanu a part of your hair and scalp care

Understanding the 4 legal process after a DUI Crash

A single mistake can have serious consequences, especially when driving under the influence. The aftermath of a DUI crash extends beyond physical harm and property damage. It involves a complex legal process that may feel overwhelming. As a responsible citizen, it’s vital to grasp the legal system and your rights in such situations. This blog

personal injury lawyer

Pedestrian accident: How a personal injury lawyer can help you

Accidents involving pedestrians can be life-altering. You could be walking down the street or crossing a street. A vehicle’s sudden impact can change everything right away. If you’ve found yourself in such a situation, you might be wondering how to move forward. This is where a personal injury lawyer steps in, offering crucial help and

Mtltimes Subscription

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