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Monkeypox: EMA launches review of Imvanex

Monkeypox: EMA launches review of Imvanex

The EMA’s Human Medicine Committee (CHMP) has launched a review of data to extend the use of the smallpox vaccine Imvanex to include protection against humans from monkey pox.

Imvanex is currently authorized in the EU for the prevention of smallpox in adults. It contains a living modified form of the vaccinia virus called ‘vaccinia Ankara’, which is related to the smallpox virus. It is also considered a potential vaccine for monkey pox due to the similarity between the monkey pox virus and the pox virus.

The decision to start this review is based on results from laboratory studies (non-clinical data) which suggest that the vaccine triggers the production of antibodies which target the monkeypox virus and may help to protect against the disease.

Imvanex deliveries are currently very limited in the EU. Imvanex is marketed as Jynneos in the USA where it is authorized for the prevention of both monkey cups and smallpox.

The Emergency Task Force (ETF) advises on the import of US vaccines

Given the limited availability of Imvanex, the EMA’s Emergency Task Force (ETF) has recommended that Jynneos can be used to provide protection against monkey pox in the EU. The working group has provided this advice to support national authorities that may decide, as a temporary measure, to import Jynneos from the United States in view of the increasing rate of infection throughout the EU.

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The ETF noted the US Food and Drug Administration’s conclusion that the effect of Jynneos in the prevention of monkey pox can be deduced from the antibody responses to the vaccinia virus in clinical trials.

In addition, studies in animals, including primates, showed that the vaccine protected animals exposed to the smallpox virus and increased pre-existing immunity induced by previous generations of smallpox vaccines.

The most commonly reported side effects with Jynneos are pain, redness, swelling, itching and hardening at the injection site, muscle aches, headaches and fatigue. Further


PDF iconinformation on the ETF’s advice is available here

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The ETF has provided advice on dealing with the outbreak of monkey pox in several EU countries in the context of its public preparedness activities, which include providing advice to support regulatory activities and product-related assessments.

More about the vaccine

Jynneos / Imvanex is expected to prepare the body to defend itself against smallpox and monkeypox infection. It contains a modified form of the vaccinia virus called vaccinia Ankara, a virus that is closely related to the variola virus (smallpox), but which does not cause disease in humans and cannot replicate (reproduce) in human cells. Due to the similarity between the smallpox virus and the monkeypox virus, antibodies produced against it are also expected to protect against monkeypox.

When a person receives the vaccine, the immune system recognizes the virus in the vaccine as “foreign” and makes antibodies against it. When the person comes into contact with this or similar virus again, these antibodies together with other components of the immune system can kill the viruses and help protect against disease.

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More about monkey cups

Monkeypox is a rare disease caused by infection with the Monkeypox virus, which causes symptoms similar to smallpox. Monkeypox begins with fever, headache, muscle aches and fatigue and can be fatal, although it is usually milder than smallpox. It is transmitted to humans from various wild animals, such as rodents and primates, but can also be transmitted between humans after close contact. Current outbreaks reported since May 2022 are the first reported outside Africa without links to endemic sites.

More about the procedures

The review on the use of Imvanex against monkey pox was initiated on the basis of the ETF’s advice. The EMA will now assess the available data while awaiting a formal application to expand the use of Imvanex from the company marketing the vaccine.

This type of assessment process is one of the ways in which the EU authorities work to ensure that EU member states have timely access to a vaccine against monkey pox.

The ETF has provided advice on the use of Jynneos during the review of Imvanex in connection with the EMA’s emergency preparedness activities. The working group continues to monitor the smallpox outbreak in Europe and is in close contact with public bodies, including the European Center for Disease Prevention and Control (ECDC) and the European Health Emergency Preparedness and Response Authority (HERA), and with developers to help make medicines available to prevent and treat monkey pox.

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