European Union's drug watchdog European Medicines Agency (EMA), recommends approval of Imvanex against monkeypox disease. The agency's Committee for Medicinal Products for Human Use (CHMP) suggests the extended use of the smallpox vaccine by the Danish drugmaker Bavarian Nordic to include protecting adults from the once rare disease spreading across the globe.
The decision came after a study that showed a favorable result for the safety of using Imvanex against monkeypox. There are only mild to moderate side effects and they concluded that the benefits far outweigh the risks, Reuters reported.
Study Shows Positive Outcomes After Using Imvanex
EMA said in their press release that their human medicines committee CHMP based their recommendation on data from several studies that showed positive results of Imvanex protecting non-human primates against the monkeypox virus. More so, they have considered the vaccine's safety and effectiveness in preventing viral disease, which could be inferred from these studies.
The company will collect data from an observational study to confirm the effectiveness of the Imvanex vaccine against monkeypox, which is currently devastating many countries in Europe today.
CHMP said that the safety of Imvanex is favorable, with only mild to moderate side effects, concluding that the benefits of using the vaccine are greater than the risks.
But aside from the monkeypox virus, CHMP also authorizes Imvanex to be used to protect people against the disease caused by the vaccinia virus, which has symptoms similar to smallpox.
EMA will update the product information of Imvanex shortly with information useful for medical professionals and the public. They are also set to publish the results of their evaluation on their website. More information will soon be available about the vaccine's description, benefits, risks, and why EMA recommended its authorization to the European Union.
What to Know About Imvanex
According to EMA, Imvanex is a smallpox vaccine used in adults. It contains a live, weakened form of the vaccinia Ankara related to the smallpox virus, officially eradicated in 1980, with the last known case occurring in 1977.
The use of Imvanex is considered necessary against smallpox and now monkeypox in accordance with the official recommendations of health authorities. The vaccine is given by injection, preferably in the upper arm, in which each person will receive a 0.5 ml dose with a second vaccination after 28 days.
A booster dose was necessary in the past, for which they were given a single 0.5 ml dose. However, people with a weakened immune system should have two booster doses. Also, Imvanex can only be obtained when there is a prescription from a doctor.
Although side effects are mild to moderate, wherein 1 in 10 people may be affected, the common risks of taking Imvanex include headache, nausea, myalgia, tiredness, and injection site reactions characterized by pain, redness, swelling, harness, and itching.
Aside from the European Union, the US was the first to approve the use of the vaccine against the monkeypox virus sold as Jynneos in the country.
RELATED ARTICLE : US BARDA Orders 13 Million Freeze-Dried Smallpox Vaccines Capable of Providing Protection Against Monkeypox From Bavarian Nordic
Check out more news and information on Monkeypox in Science Times.
