Petition to Bring Pemgarda (Monoclonal Antibody) to Canada to Protect Immunocompromised People and Support Long COVID Clinical Trials

As COVID-19 continues to affect lives globally, many individuals—especially those who are immunocompromised—remain at significant risk. Despite limited treatments and preventative measures, vulnerable populations in Canada still face heightened danger due to a lack of access to effective protection.

One such option is Pemgarda, a monoclonal antibody therapy developed by Invivyd. It has shown strong potential to prevent COVID-19 in high-risk individuals and is currently available in the U.S. under Emergency Use Authorization (EUA). However, it remains unavailable in Canada—leaving immunocompromised Canadians without access to this critical treatment.

Why is this important?

• The COVID-19 pandemic is not over. Despite the scaling back of widespread testing, wastewater surveillance consistently shows elevated levels of SARS-CoV-2, providing clear evidence that the virus is still actively circulating in our communities—even as public messaging downplays the threat.

• The virus continues to mutate, and new variants pose serious threats—especially to those with weakened immune systems.

• Many immunocompromised individuals—including people with cancer, autoimmune diseases, organ transplants, and other forms of moderate to severe immunocompromise—may not develop adequate protection from vaccination alone.

• Each repeat COVID-19 infection increases your risk of developing Long COVID—even if earlier cases were mild. Long COVID itself can cause new or worsening immunocompromise.

• Pemgarda offers a vital layer of protection and hope for those whose immune systems cannot rely on vaccines alone.

In addition, we must support those already living with the long-term effects of COVID-19.

Long COVID affects hundreds of thousands of Canadians and can result in chronic illness, organ damage, and life-altering disability.

• Mounting scientific evidence suggests that viral persistence may be a key driver of Long COVID. This highlights the urgent need for research into combination treatments that include antiviral medications, monoclonal antibodies like Pemgarda, and interferons—to help eliminate persistent viral reservoirs and restore immune balance.

• Canada currently has no publicly funded clinical trials testing this approach.

In the U.S., Pemgarda was authorized using a regulatory mechanism called immune-bridging—a science-based pathway that compares immune response levels to a previously approved treatment rather than requiring a full-scale Phase 3 trial. This flexibility enables faster access in public health emergencies.

Unfortunately, Canada does not currently have an equivalent immune-bridging pathway. Health Canada typically requires more comprehensive data, including full Phase 3 trials, which are expensive and often impractical for smaller markets like Canada. As a result, Invivyd may choose not to pursue approval here.

To make matters worse, even Kavigale (Sipavibart)—a different monoclonal antibody that has already been approved by Health Canada—will not be made available at this time. AstraZeneca has publicly stated that because less than 5% of currently circulating variants are susceptible to Kavigale, they have decided not to launch it in Canada. While approval has been granted, the product will not reach patients unless the variant landscape changes significantly.

What needs to happen:

• Health Canada must adopt a more flexible and responsive regulatory pathway—similar to the U.S. FDA’s immune-bridging framework—to enable timely access to treatments like Pemgarda.

• Pemgarda should be made available immediately, not just for prevention, but as part of potential treatment research for Long COVID.

• Federal and provincial leadership must take responsibility for ensuring access, procurement, and transparency.

• AstraZeneca must release Kavigale (Sipavibart)—a Health Canada–approved monoclonal antibody that remains unavailable due to variant coverage decisions—so it can be included in potential treatment research for Long COVID.

• Public health decisions must reflect the reality of those living with immune compromise.

• Publicly funded clinical trials must be launched in Canada to study combination therapies involving monoclonal antibodies, antivirals, and interferons for those living with Long COVID.

• Compassionate or off-label access should be provided to promising therapies for patients with persistent symptoms.

• Long COVID patients must be involved in the design and implementation of clinical trials and health policy decisions.

What you can do:

• Sign and share this petition widely to show decision-makers that this issue matters.

• Write to your Member of Parliament (MP), your Premier, the Minister of Health, Health Canada, and the Public Health Agency of Canada (PHAC) to demand urgent access to monoclonal antibodies and regulatory flexibility for immunocompromised Canadians and clinical research for Long COVID.

• Contact Invivyd to show there is Canadian demand for Pemgarda.

Sign this petition to demand immediate access to Pemgarda and the launch of clinical trials exploring innovative treatments for Long COVID.

Let’s ensure no one is left behind—neither those who cannot prevent COVID-19, nor those still living with its aftermath.

#BringPemgardaToCanada

#ProtectImmunocompromised

#SupportLongCOVIDTrials

#COVID19IsNotOver

#MAbsForCanadaNOW