Bavarian Nordic’s vaccine, Jynneos, has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to increase vaccine supply for monkeypox.
The regulatory indicated the healthcare providers to use the vaccine as intradermal injection for people aged 18 years and above, who are at elevated risk for monkeypox infection.
Made using a live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), Jynneos is a suspension for subcutaneous injection.
It is said to be the only vaccine approved by FDA for the prevention of monkeypox virus.
The FDA noted that the new authorisation is said to increase the availability of vaccine doses by five-fold.
The latest EUA also enables the administration of Jynneos vaccine as a subcutaneous injection in people aged below 18 years, who are at high risk of monkeypox infection.
FDA Commissioner Robert Califf said: “In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand.
“The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals.
“By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.”
In 2019, Jynneos was approved for smallpox and monkeypox disease prevention in individuals aged 18 years and above who are high-risk of the disease.
Last month, the US Biomedical Advanced Research and Development Authority (BARDA) placed an order for additional 2.5 million doses of liquid frozen Jynneos vaccines.