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29-06-2022 15:21 |
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EMA’s
human medicines committee (CHMP) has started a review of data to extend the
use of the smallpox vaccine Imvanex to include protecting people from
monkeypox disease. Imvanex is currently authorised in the EU for the prevention of smallpox in adults. It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara’, which is related to the smallpox virus. It is also considered a potential vaccine for monkeypox because of the similarity between the monkeypox virus and the smallpox virus. The
decision to start this review is based on results from laboratory studies
(non-clinical data) suggesting that the vaccine triggers the production of
antibodies that target the monkeypox virus and may help protect against the
disease. Supplies
of Imvanex are currently very limited in the EU. Imvanex is marketed as
Jynneos in the US where it is authorised for the prevention of both monkeypox
and smallpox. Advice on use of Jynneos Considering
the limited availability of Imvanex, EMA’s Emergency Task Force (ETF) has recommended that
Jynneos can be used to provide protection against monkeypox disease in the
EU. The task force has given this advice to support national authorities who
may decide, as a temporary measure, to import Jynneos from the US in view of
the rising rates of infection across the EU. The ETF
noted the US FDA’s conclusion that the efficacy of Jynneos in the prevention
of monkeypox disease can be inferred from the antibody responses against the
vaccinia virus in clinical studies. In
addition, studies in animals, including primates, showed that the vaccine
protected animals who were exposed to the monkeypox virus and boosted
pre-existing immunity induced by earlier generations of smallpox vaccines. The most
commonly reported side effects with Jynneos are pain, redness, swelling,
itching and hardening at the injection site, muscle pain, headache and
fatigue. Further information about the ETF’s advice is available here [LINK]. The ETF
has given its advice to address the outbreak of monkeypox in multiple EU
countries in the context of its public emergency preparedness activities
which include giving 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 infection with
smallpox and monkeypox. It contains a modified form of the vaccinia virus
called vaccinia Ankara, a virus that is closely related to the variola
(smallpox) virus and monkeypox virus but does not cause disease in humans and
cannot replicate (reproduce) in human cells. Because of the similarity
between the smallpox virus and the monkeypox virus, antibodies produced
against it are also expected to protect against monkeypox. When a person
is given the vaccine, the immune system recognises the virus in the vaccine
as ‘foreign’ and makes antibodies against it. When the person comes into
contact again with this or similar viruses, these antibodies together with
other components of the immune system will be able to kill the viruses and
help protect against disease. More about monkeypox Monkeypox
is a rare disease caused by infection with the monkeypox virus, which causes
symptoms similar to those of smallpox. Monkeypox begins with fever, headache,
muscle aches and exhaustion and can be fatal, even though it is typically
milder than smallpox. It is transmitted to people from various wild animals,
such as rodents and primates, but can also be transmitted between people
following close contact. Current outbreaks reported since May 2022 are the
first reported outside of Africa with no links to endemic areas. More
about the procedures The review
on the use of Imvanex against monkeypox was started on the basis of ETF’s
advice. EMA will now assess the available data while awaiting a formal
application to extend the use of Imvanex from the company that markets the
vaccine. This type
of review process is one of the ways authorities in the EU are working to
ensure that EU Member States have timely access to a vaccine against
monkeypox. The ETF
has given advice on the use of Jynneos during the review of Imvanex in the
context of EMA’s preparedness activities. The task force continues to monitor
the monkeypox outbreak in Europe and is in close contact with public bodies,
including the European Centre for Disease Prevention and Control (ECDC) and
the European Health Emergency preparedness and Response Authority (HERA), and
with developers to help make medicines available for preventing and treating
monkeypox. (AP) |
