Canada Expands Smallpox Vaccine Indications

A Denmark-based vaccine producer announced that Health Canada has expanded the approval of the Company’s non-replicating smallpox vaccine, IMVAMUNE® to include indications for monkeypox and related orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure.

IMVAMUNE is currently approved in Canada under the Extraordinary Use New Drugs Pathway. 

Announced by Bavarian Nordic A/S on November 12, 2020, the extended approval was granted following an assessment of additional clinical and non-clinical data, generated since IMVAMUNE received approval as a smallpox vaccine by Health Canada in 2013.

Smallpox is a systemic viral disease caused by the variola virus, a species of the Orthopoxvirus.

Because the monkeypox virus is closely related to the virus that causes smallpox, the smallpox vaccine can also protect people from getting monkeypox. 

These data include among others a Phase 3 study which demonstrated that, in terms of efficacy, IMVAMUNE was non-inferior to replicating smallpox vaccines, while also confirming its favorable benefit/risk profile.

IMVAMUNE is a non-replicating vaccine that, unlike traditional vaccines, cannot spread in the vaccinated person. Therefore, none of the serious side effects normally associated with traditional vaccines have been seen with IMVAMUNE, says the company.

Paul Chaplin, CEO of Bavarian Nordic said in a press release, “While monkeypox is endemic to certain parts of Africa, orthopoxvirus infections may occur from animals to humans all over the world. Although cases are rare, no vaccine has previously been approved for these indications, and we are pleased to receive this extended approval of IMVAMUNE.”

Bavarian Nordic has collaborated with the Canadian authorities since 2008 on supplying IMVAMUNE, initially for the Canadian Department of National Defence. Subsequent to the initial Canadian approval in 2013, Bavarian Nordic has also collaborated with the Public Health Agency of Canada for stockpiling of the vaccine for the general population.

In 2003 and 2004, Bavarian Nordic received contracts from the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the clinical development of IMVAMUNE.  In 2007, BARDA awarded the company a procurement contract to supply 20 million doses of the vaccine.

The U.S. CDC’s website indicates JYNNEOS (also known as Imvamune or Imvanex), has been licensed in the United States to prevent monkeypox and smallpox.

Past data from Africa suggests that the smallpox vaccine is at least 85% effective in preventing monkeypox. The effectiveness of JYNNEOS against monkeypox was concluded from a clinical study on the immunogenicity of JYNNEOS and efficacy data from animal studies. Experts also believe that vaccination after a monkeypox exposure may help prevent the disease or make it less severe.

Smallpox vaccines licensed in the United States include ACAM2000, which contains a live vaccinia virus, and JYNNEOS, a live non-replicating vaccine.

Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture, and commercialization of life-saving vaccines.

PrecisionVaccinations publishes research-based vaccine news.