• 31 Aug 2024
• Admin
• News Article

Emergent Wins FDA Approval for Mpox Vaccine as Outbreak Rages On

Overview

Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
The FDA on Thursday expanded Emergent BioSolutions’ smallpox vaccine ACAM2000, allowing its use to prevent mpox infection in individuals deemed at high risk of the disease.

ACAM2000’s Mpox Approval

ACAM2000’s mpox approval follows the World Health Organization declaration earlier this month that the ongoing outbreak in the Democratic Republic of Congo—and in Africa more broadly—is a public health emergency of international concern.

Emergent Donation for Mpox

In response to the mpox emergency, Emergent last week announced it would donate 50,000 doses of ACAM2000 to the humanitarian relief organization Direct Relief, which will deliver the shots to “difficult-to-reach locations,” in partnership with local and regional health authorities.

About ACAM2000

• ACAM2000 is a live vaccinia virus vaccine that contains non-active components and cannot cause disease or be transmitted, according to its label. 
• It works by triggering a localized infection reaction at the site of the injection, in turn priming the body’s immune system to fight against active infections. 
• It also induces the production of neutralizing antibodies and B and T cells for long-term immune memory.

Vaccine Administration

• The vaccine is administered via a single-dose percutaneous shot using a bifurcated needle dipped into the vaccine solution before pricking the skin several times in the upper arm. 
• It carries a boxed warning for myocarditis, pericarditis, encephalitis, encephalomyelitis and other complications, which may lead to severe disability, permanent neurological damage or death.

FDA Approval

• ACAM2000 won its first FDA approval in 2007 for the prevention of smallpox in high-risk individuals. 
• Emergent filed a supplemental Biologics License Application in November 2023, supporting the vaccine’s mpox expansion using previously available human safety data, supported by findings from a well-controlled animal study.

Joining the Pharma Frontline

• With Thursday’s approval, Emergent joins Bavarian Nordic on the pharma industry’s frontline against the current mpox outbreak. 
• Last week, the Danish developer announced that it was ramping up the production of its vaccine Jynneos, which like ACAM2000 is also designed to elicit immune protection against mpox and smallpox.
• Total Jynneos doses
• Bavarian Nordic has so far received an order for 175,420 Jynneos doses from the European Commission’s Health Emergency Preparedness and Response Authority, as well as 440,000 more from an unnamed European country. 
• At its current capacity, the company can produce up to 2 million additional doses this year and 10 million more by the end of 2025.

According to the U.S. Centers for Disease Control and Prevention, Jynneos appears to be safer than Emergent’s ACAM2000, with the latter having “more side effects and contraindications” than Bavarian Nordic’s vaccine.