Guidance for market authorization requirements for COVID-19 vaccines: Overview

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Organization: Health Canada

Published: 2020-12-08

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COVID-19 is the infectious disease caused by the most recently discovered coronavirus, SARS-CoV-2. This new virus and disease were unknown before the outbreak began in December 2019 and have since spread around the world.

COVID-19 has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory distress, kidney failure and death. Older people and those with underlying medical problems, such as high blood pressure, obesity, heart problems or diabetes, are more likely to develop serious illness.

The availability of safe, effective and high-quality vaccines will offer a potential means to reduce the spread and severity of disease and address its social and economic consequences.

About this guidance document

This document provides guidance to vaccine manufacturers seeking authorization for their vaccine that targets the SARS-CoV-2 virus. This guidance applies to applications under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 as per subsection 30.1(1) of the Food and Drugs Act. This should be read along with the guidance document concerning information and application requirements for drugs authorized under the IO.

Guidance includes information on developing the evidence and documentation needed to obtain an authorization for importing or selling a COVID-19 vaccine under the IO.

About the IO and market authorizations for a COVID-19 vaccine

Health Canada is committed to helping Canadians protect and improve their health by facilitating access to COVID-19 vaccines that are safe, effective and of high quality. The IO introduces new regulatory mechanisms to expedite the authorization of COVID-19 drugs, including vaccines, while protecting the health and safety of Canadians.

Vaccine manufacturers seeking to obtain market authorization through the IO should consult with us early on and throughout the development process. While the IO doesn't specify any timelines, we are committed to prioritizing the review of any application seeking authorization of a COVID-19 vaccine.

Health Canada will grant authorizations only if we determine that the benefits of the vaccine outweigh its potential risks. We will base our decision on the evidence provided on the vaccine's safety, quality and efficacy. Risk-benefit analysis weighs the uncertainties about a potential vaccine against the urgent public health need for a vaccine at the time of the decision.

The IO makes it possible for initial authorization, based on early data, while the manufacturer continues working on developing a vaccine. After receiving additional data and information on the drug's quality, safety and efficacy, we can move toward market authorization (under the Food and Drug Regulations).

The requirements described in this guidance are a minimum acceptable standard under the IO. Health Canada will consider alternate proposals for evidence standards and a rationale for using these standards. As we learn more about the virus and the effectiveness of new vaccines and treatments, we will adjust the evidence requirements as required.

As with all drugs, Health Canada will assess and monitor the safety and effectiveness of all vaccines authorized under the IO. We will impose terms and conditions when necessary and take immediate action, if required, to protect the health and safety of Canadians. This action may include suspending or cancelling authorizations or establishment licences.

Guidance for implementation

Industry sponsors have been seeking guidance from regulatory authorities on the requirements for developing a COVID-19 vaccine. Guidance has been discussed in pre-submission meetings with Health Canada and other regulators, and through publications following workshops under the International Coalition of Medicines Regulatory Authorities (ICMRA). Guidance documents have also been published by the US Food and Drug Administration (US FDA), World Health Organization (WHO) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

Health Canada's guidance is aligned with these international regulators.

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