Update: 118 Signatures & Growing

Thank you to everyone who has signed and shared this petition—we’re now at 118 signatures and counting. Your voices are being heard, and your support matters deeply.

Here’s the latest on two key monoclonal antibodies for COVID-19 prevention and treatment in Canada:

Pemgarda (Pemivibart)

Pemgarda was granted Emergency Use Authorization (EUA) in the U.S. based primarily on immune-bridging data, rather than a full Phase 3 clinical trial. Immune-bridging involves showing that the drug produces comparable immune responses—such as neutralizing antibody levels—to previously authorized products, rather than proving efficacy through large-scale randomized trials. This pathway provides critical flexibility during public health emergencies.

Unfortunately, Health Canada does not currently have an equivalent EUA mechanism. Regulatory approval for new biologics in Canada generally requires more extensive data, including full Phase 3 efficacy results. For Invivyd, the developer of Pemgarda, conducting a full-scale efficacy trial for the Canadian market would cost tens to hundreds of millions of dollars—an investment that may not be seen as worthwhile given Canada’s relatively small population.

Invivyd is now focusing on developing a next-generation monoclonal antibody, VYD2311, currently in Phase 1 trials in Australia. This product is intended to be effective against newer variants and may eventually be offered in more patient-friendly forms such as intramuscular (IM) or subcutaneous (SC) injections. However, Phase 3 trials and regulatory approval are likely still far off.

In the meantime, Canadian patients are being left behind.

Lives are on the line. We urgently need leadership, flexibility, and innovation from Health Canada.

We call on Health Canada to consider adopting a regulatory framework similar to the U.S. FDA’s immune-bridging approach to allow for emergency access to Pemgarda (Pemivibart) in Canada.

Kavigale (Sipavibart)
Approved in Canada — But Still Unavailable

In a major step forward, Health Canada has approved Kavigale (Sipavibart)—a long-acting monoclonal antibody designed to protect immunocompromised individuals from COVID-19. This is a significant milestone, especially for vulnerable populations including immunocompromised individuals and many people with Long COVID.

However, approval does not mean the drug is currently available.

Kavigale is still not being marketed or distributed in Canada, as AstraZeneca has not yet chosen to bring it to market. Canadians remain unable to access a treatment that Health Canada has already deemed safe and effective.

While some data suggests Kavigale may have reduced effectiveness against certain currently circulating variants, transparency and access remain essential. Variant evolution is unpredictable—and access to authorized monoclonal antibodies is vital for pandemic preparedness and patient protection.

This gap between approval and availability is unacceptable. Canadians deserve access to the same life-saving medications available elsewhere.

We urgently need:

• Public pressure on AstraZeneca Canada to make Kavigale available.

• Government action to support procurement and patient access.

• Clear timelines, transparent data on variant coverage, and open communication about patient pathways to access.

Please consider contacting AstraZeneca Canada to express the urgency of this need. Every voice matters.

Keep sharing this petition and encouraging others to take action. Approval is only the first step—access and transparency must follow.

Together, we can push for the care and protection that Canadians deserve.

Thank you for your support,
Rowan

Disclaimer: This update is for informational and advocacy purposes only and does not constitute medical or legal advice. For medical guidance, please consult a qualified healthcare provider. References to medications or regulatory processes do not imply endorsement or official affiliation with any companies or health agencies.