Pharma To Date

On August 29, 2024, the U.S. Food and Drug Administration (FDA) granted expanded use approval for Emergent BioSolutions’ ACAM2000 smallpox vaccine to include individuals at high risk for mpox infection. This decision comes in response to the World Health Organization's (WHO) recent declaration of mpox as a global public health emergency due to a new, rapidly spreading variant, known as clade Ib.

Key Developments in Vaccine Approval

The expanded use approval follows Emergent’s application for Emergency Use Listing (EUL) with the WHO. In addition to this approval, Emergent BioSolutions has committed to donating 50,000 doses of the ACAM2000 vaccine to the Democratic Republic of the Congo and neighboring countries, including Burundi, Kenya, Rwanda, and Uganda. This donation aims to bolster efforts to control the ongoing mpox outbreak in these regions.

ACAM2000, a live, replicating virus vaccine, has been used primarily for smallpox. The FDA’s approval to include mpox reflects a growing recognition of the vaccine’s potential role in managing mpox outbreaks. However, it is important to note that ACAM2000 has been associated with higher risks, including myocarditis and pericarditis, occurring in approximately 1 in 175 vaccine recipients.

Implications and Importance

The expansion of ACAM2000's use is crucial at this juncture given the global health crisis posed by mpox. The rapid spread of the clade Ib variant has heightened the urgency for effective vaccines and treatments. The FDA’s move is expected to enhance the availability of protective measures against mpox, particularly in high-risk areas.

While the ACAM2000 vaccine presents a significant tool in the fight against mpox, it also underscores the ongoing need for careful management of vaccine side effects and monitoring of vaccine safety. The broader availability of vaccines like ACAM2000 and the recent WHO call for increased diagnostic testing are integral steps in mitigating the impact of this global health threat.

As the situation evolves, ongoing collaboration between health authorities and vaccine manufacturers will be critical in addressing the mpox outbreak and safeguarding public health.