Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variants

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Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. As a result, manufacturers are adapting authorized COVID-19 vaccines to provide protection against infection and disease caused by virus variants.

We encourage sponsors to meet with us to discuss their development and regulatory filing plans for variant COVID-19 vaccines. This includes sponsors who are adapting authorized COVID-19 vaccines against variants as well as sponsors who are developing new vaccine platforms against variants.

The emergence of SARS-CoV-2 variants is an evolving field. We will update our guidance as we gain experience with variant COVID-19 vaccines.

Submission type

The submission type for a variant COVID-19 vaccine will depend on the specific vaccine, taking into account:

Vaccine manufacturers seeking to obtain market authorization for a variant COVID-19 vaccine should consult with us to discuss their regulatory filing plans.

Quality, non-clinical, clinical and post-market requirements

We are collaborating with other international regulatory authorities to align the requirements for evaluating, authorizing and post-market surveillance of variant COVID-19 vaccines as much as possible.

In the pandemic context where clinically proven vaccines are broadly available, large safety and efficacy studies, similar to those required for the initial approval of a COVID-19 vaccine, may not be feasible for a variant COVID-19 vaccine.

We have collaborated with the Access Consortium to develop a guidance document to support regulatory alignment on the minimal requirements for variant COVID-19 vaccine authorization. This guidance is for variant COIVD-19 vaccines that are made using the same process and by the same manufacturer as an authorized COVID-19 vaccine (the prototype vaccine).

Sponsors should refer to the Access Consortium points to consider for strain changes in authorized COVID-19 vaccines in an ongoing SARS-CoV-2 pandemic for specific guidance on the quality, non-clinical, clinical and post-market information required to support authorization of a variant COVID-19 vaccine. The Access Consortium guidance is closely aligned with international regulators, including guidance released by the European Medicines Agency (EMA) and US FDA.

An updated Risk Management Plan (RMP), including a Canadian-specific addendum, should be submitted to ensure that adverse events can be appropriately captured for both the variant and prototype vaccine versions. The safety specification, pharmacovigilance plan and risk minimization plan should be updated for both variant and prototype vaccine versions. Traceability of the brand and batch, and distinguishing suspected AEFIs with new and old formulations should be a key focus of the updated RMP.

Labelling requirements

Sponsors should follow guidance in the relevant sections of this document on labelling. They should also indicate how the variant vaccine will be clearly distinguishable from the previously authorized vaccine.

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