ACAM2000®, (Smallpox Vaccine (Vaccinia Virus, Live)) and TEMBEXA® (brincidofovir) Receive EUNDS Approvals by Health Canada
GAITHERSBURG, Md., December 13, 2023 – Emergent (NYSE: EBS) today announced that this month, both ACAM2000® (Smallpox Vaccine (Vaccinia Virus, Live)) and TEMBEXA® (brincidofovir) tablets and oral suspension, have each received Notices of Compliance from Health Canada for their Extraordinary Use New Drug Submissions (EUNDS). In Canada, ACAM2000® vaccine is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection, and TEMBEXA® is indicated for the treatment of human smallpox disease in adult and pediatric patients, including newborn infants.
Paul Williams, SVP and products business head at Emergent said, “We are pleased to receive Health Canada regulatory approvals for ACAM2000® vaccine and TEMBEXA® to address smallpox disease. It is a testament to the vital role medical countermeasures play to support public health preparedness efforts in the event of a biological or chemical emergency.”
Both products are critical components of Emergent’s smallpox franchise, and the EUNDS approvals mark a major milestone for the overall health and protection of Canadians in the immunization and treatment of smallpox.
About ACAM2000®, (Smallpox Vaccine (Vaccinia Virus, Live))
ACAM2000® vaccine is the primary smallpox vaccine designated for use in a bioterrorism emergency, with doses having been supplied to the U.S. Strategic National Stockpile. ACAM2000® vaccine is also licensed in Australia and Singapore and is currently stockpiled both in the U.S. and internationally.
Health Canada has authorized the sale of this Extraordinary Use New Drug for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection based on limited clinical testing in humans.
Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive the ACAM2000® vaccine. The risk for experiencing severe vaccination complications must be weighed against the risk for experiencing a potentially fatal smallpox infection.
The Product Monograph for ACAM2000® vaccine should be consulted for complete administration and safety information. The Product Monograph will be posted soon on Emergent’s website, or can also be found on the Health Canada website.
About TEMBEXA® (brincidofovir)
TEMBEXA is an oral antiviral indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for 2 doses. The TEMBEXA products are not indicated for the treatment of diseases other than human smallpox disease.
Health Canada has authorized the sale of this Extraordinary Use New Drug for adult and pediatric patients for treatment of smallpox disease based on limited clinical testing in humans.
The effectiveness of the TEMBEXA products for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA has a serious warning for increased risk for mortality when used for longer duration.
The Product Monograph for TEMBEXA should be consulted for complete administration and safety information. The Product Monograph will be posted soon on Emergent’s website, and the Product Information can be accessed on the Health Canada website.
About Smallpox
Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30 percent. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention, variola virus is ranked in the highest risk category for bioterrorism agents (Category A) due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, Twitter, and Instagram.
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