In response to the inclusion of smallpox vaccination in the global monkeypox public health strategy and the urgent need for smallpox vaccine safety surveillance, especially for newer vaccines, the GVDN convened the inaugural monkeypox/smallpox vaccine work group on 12 August. The work group, with representatives from 15 countries and attendees representing the U.S. Centers for Disease Control and Prevention (CDC), confirmed the need for rapid implementation of smallpox vaccine safety assessment as the number of monkeypox cases continues to rise globally and the number of individuals receiving smallpox vaccination increases.
There is an urgent need for the capacity to collect and assess vaccine safety data from hundreds of thousands to millions of smallpox vaccinations as they are deployed to identify possible rare and very rare vaccine-associated risks. However, few countries offering smallpox vaccination will vaccinate this many people.
Some possible risks have already been identified. For example, a risk of myocarditis and pericarditis has been associated with the older smallpox vaccines. However, for the newer smallpox vaccines, not enough have been administered to identify if they are associated with a risk of cardiac adverse events, or any other uncommon conditions.
The work group agreed that the GVDN vaccine safety surveillance protocols currently used by GVDN partner sites located around the globe to collect harmonised COVID-19 vaccine safety data can be amended to collect safety data on smallpox vaccines. The ability of the GVDN to collect and amalgamate harmonised global smallpox vaccine safety data from multiple sites with diverse populations will increase the ability to detect rare or very rare potential or actual vaccine-associated risks.
“The goal of the GVDN has always been to collect vaccine safety data to inform public health decision making,” said Co-Director Dr. Steve Black. “The use of smallpox vaccines provides another opportunity for us to meet that need.”
The agility of the GVDN to respond to the recent global increase of smallpox vaccination will demonstrate that established systems and processes can rapidly respond to vaccines safety concerns.