EMA recommends approval of Imvanex vaccine for monkeypox – EURACTIV.com

Cases of monkeypox continue to grow, and the World Health Organization has decided whether to announce this outbreak as an “internationally concerned emergency,” but the European Medicines Agency (EMA) has another for the disease. We recommended the approval of the vaccine.

On Friday (July 22nd), the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indications for the A / S smallpox vaccine Imvanex in northern Bavarian to protect adults from monkeypox.

In early July, EMA’s Head of Vaccine Strategy, Marco Cavaleri, said, “Based on knowledge from animal studies and similarity to smallpox virus, it is considered an effective vaccine that is also relevant to monkeypox. I have. “

With a good drug safety profile and mild to moderate side effects, CHMP concluded that the benefits of the drug outweigh the risks.

This is possible because of the similarities between monkeypox virus and smallpox virus. “Smallpox vaccines can be used with a high level of efficacy in monkeypox,” said Sylvie Briand, director of WHO’s Global Infection Hazard Control Division.

This vaccine contains an attenuated vaccinia virus called “modified vaccinia virus ancara,” which is closely associated with smallpox and monkeypox viruses but does not cause human disease and cannot multiply in human cells. I have.

When a person is vaccinated, the immune system recognizes the virus in the vaccine as “foreign” and makes antibodies that are expected to protect against monkeypox, smallpox, and vaccinia. When a person later comes into contact with viruses, these antibodies, along with other components of the immune system, can help kill those viruses and protect them from disease.

The downside is that vaccine stockpiles are currently very limited within the block. To address this issue, the EMA’s Emergency Task Force (ETF) recommends the use of Jynneos, the US version of Imvanex, which is licensed to prevent both monkeypox and smallpox in the United States.

“As a temporary measure, we have made positive recommendations on the use of imported vaccines for emergency use, which will allow Member States to vaccinate groups that are already at risk.” Mr. Cavaleri emphasized.

Over 160,000 vaccines secured

The European Commission’s Health Measures and Response Agency (HERA) has so far Secured Bavarian Nordic 3rd Generation Vaccine Dose Over 160,000 These are distributed alongside Norway and Iceland based on the case rates observed in member countries.

Vaccine doses will be allocated according to the population of each country, as was done throughout the COVID-19 response.

The vaccine is not used for mass inoculation, but instead becomes available to certain risk groups.

Committee spokesperson explanation As the virus spreads through close skin-to-skin contact, “the contagiousness of the risk from the virus is not comparable to the risks we know in the context of COVID, for example.”

As of Monday (July 18th), six EU countries have been vaccinated and a total of about 25,000 have been distributed. Spain received 5,300, Germany received more than 5,000, Belgium received 3,400, Sweden received 2,700, Ireland received 1,400 and Italy received more than 1,000, a commission spokesman said the delivery of these vaccines He added that it is ongoing.

The spread continues

To address more than 14,000 non-monkeypox cases in 71 countries around the world by Thursday (July 21), the WHO Emergency Committee said that outbreaks now constitute a global health emergency. We met to decide if.

“We need your advice in assessing the immediate and medium-term impacts of this development on public health,” said WHO Executive Director Tedros Adhanom Gebreez in his opening remarks.

Cases have begun to decline in some countries of the world, but last week six more countries reported their first cases. The majority of cases continue to be reported among men who have sex with men.

WHO has not yet communicated its decision on whether monkeypox is an emergency of international concern.

As of Monday, there were 7,000 cases of monkeypox in the EU, “almost 50% more than a week ago,” said health commissioner Stella Kiriyakides.

[Edited by Zoran Radosavljevic]