The European Union’s drug regulator has approved a strategy for countries to increase their monkeypox vaccine supply by five times by injecting a smaller dose, following similar advice that the U.S. Food and Drug Administration gave earlier this month.
The European Medicines Agency‘s Emergency Task Force advised that authorities can administer Bavarian Nordic’s Imvanex vaccine, a smallpox vaccine approved for use against monkeypox, using one-fifth of the current dose into the top layer of the skin instead of a full dose into the fat underneath the skin.
HHS APPROVES STRETCHING MONKEYPOX VACCINES THROUGH FIFTH DOSES AS OUTBREAK GROWS
“Given the currently limited supply of the vaccine, this means that more people can be vaccinated,” the agency said in a statement.
The regulatory agency said authorities could use the dose-sparing strategy as a “temporary measure” to protect populations vulnerable to the monkeypox outbreak. The vaccine has previously been authorized for subcutaneous injection or injection into deeper tissue.
A study of 500 adults showed that the smaller dose produced similar levels of antibodies to the subcutaneous injection, the agency cited.
The agency cautioned that there was a higher risk of localized reactions, such as redness or discoloration, when injecting the vaccine just under the skin.
The advice allows all 27 EU member states and Iceland, Liechtenstein, and Norway to stretch their supplies.
HHS Secretary Xavier Becerra previously said that the dose-sparing strategy would increase the availability of vaccines in the U.S. while maintaining “high standards for safety, effectiveness, and manufacturing quality.”
The recommendation comes as the Danish manufacturer supplying the vaccines warns that it may not be able to keep up with demand at its current facility in Denmark.
“Demand keeps rising and it’s no longer certain that we can continue to meet the demand we’re facing even with the upgrade of our existing manufacturing site in Denmark,” Rolf Sass Sorensen, a vice president for Bavarian Nordic, told Bloomberg.
The company said it is exploring expanding its manufacturing capabilities globally.
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Director-General of the World Health Organization Tedros Adhanom Ghebreyesus said last month that the monkeypox outbreak constituted a public health emergency of international concern. Over 40,000 cases have been identified globally as of Friday, according to the CDC.
