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FDA approves Bavarian Nordic’s smallpox and monkeypox vaccine

First live non-replicating vaccine for both diseases


The US Food and Drug Administration (FDA) has approved Bavarian Nordic’s Jynneos for the prevention of smallpox and monkeypox. 

It becomes the first non-replicating smallpox vaccine to be approved by the FDA, and the only vaccine approved for the prevention of monkeypox. It is authorised for the prevention of the diseases in adults over the age of 18.

It will be available for people who are deemed to be at a high risk of contracting either infection, and will also become part of the Strategic National Stockpile in the US. This is the national supply of potentially life-saving medicines and medical supplies for use in the case of a public health emergency that causes supplies to be depleted.

The World Health Organization (WHO) certified that smallpox had been eradicated in 1980, with the routine vaccination of Americans halted in 1972. This means that the citizens in the US, like many countries, have no immunity to the disease.

“Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect. This approval reflects the US government’s commitment to preparedness through support for the development of safe and effective vaccines, therapeutics and other medical countermeasures,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Monkeypox is a rare disease which causes symptoms similar to smallpox, only not as extreme. It is contracted through contact with wild animals such as rodents and primates. Although the disease does not occur naturally in the US, there was an outbreak in 2003 which was the first time the disease was reported outside of Africa.

Bavarian Nordic’s vaccine is unique in that it does not physically contain the viruses which cause these diseases. It consists of a vaccinia virus, which is closely related to the viruses which cause smallpox and monkeypox but are not as harmful.

Following this approval, the Danish-headquartered biotech was granted a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure PRV programme. This voucher can be used to accelerate a review of a drug application but can also be sold on. The company has said that it intends to sell the voucher to a third party buyer.

A PRV is a coveted tool to have in the arsenal, but the prices of them have seen a decrease of late. Earlier this year, AstraZeneca picked up a PRV from Sobi for $95m. This is a far cry from the high point of prices paid for a PRV, with AbbVie paying $350m in 2015.

Article by
Lucy Parsons

25th September 2019

From: Regulatory



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