The Imvanex smallpox vaccine, produced by the Danish Bavarian Nordic Laboratory, is particularly indicated for vaccination against monkeypox. Manufacturer, composition, indications, side effects, number of doses… We take stock.
Imvanex is a smallpox vaccine produced by the Danish laboratory Bavarian Nordic. It has had European Marketing Authorization (AMM) since July 2013 and is available in France. Originally indicated for active immunization against smallpox in adults. On July 25, 2022, the European Commission approved the extension of the Imvanex vaccine in the vaccination strategy against monkeypox virus (Monkeypox). This vaccine is marketed in the United States under the name Jynneos and in Canada as Immune. What is his composition ? What are its directions ? What are the Side effects Imvanex vaccine? What is his price ?
Definition: what is the Imvanex vaccine?
The Imvanex vaccine (other name: MVA-BN) is a 3rd generation smallpox vaccine which has had European Marketing Authorization (MA) since July 2013. It is indicated for active immunization against smallpox in adults aged 18 years and over. It contains a live modified form of the vaccinia virus called “Vaccinia Ankara” related to the smallpox virus. It is marketed in Canada under the name by IMVAMUNE and in the United States as JYNNEOS. It has also been officially indicated in the vaccination against monkeypox since July 25, 2022.
Which laboratory produces the Imvanex vaccine?
The Imvanex vaccine is manufactured by the lBavarian Nordic Laboratory located in Denmark.
What is the composition of the Imvanex vaccine?
One dose (0.5 mL) contains:
- 1 antigen: live modified Ankara vaccinia virus produced on chicken embryo cells
- 3 excipients: Trometamol, sodium chloride, Water for injections
What are the indications for the Imvanex vaccine?
The Imvanex vaccine is originally indicated for active immunization against smallpox in adults. Since July 25, 2022, the European Commission has approved extension of the Imvanex vaccine against the spread of monkeypox virusas announced by the Danish laboratory Bavarian Nordic in a communicated. The monkeypox vaccination schedule includes 2 doses 28 days apart (or 1 single dose for people who have already been vaccinated against smallpox, and 3 doses for immunocompromised people).
How effective is the Imvanex vaccine against monkeypox?
According to’Pastor Institute, the smallpox vaccine (Imvanex) is said to be 85% effective against the monkeypox virus. Three clinical trials have also shown that the administration of a dose of Imvanex® in a person who had previously received a primary vaccination with another type of smallpox vaccine conferred a booster effect, even very far from this primary vaccination. “Vaccination does not confer immediate protection, also it is important to continue to avoid any risky contact with a person infected with the Monkeypox virus or suspected of being so” recalled the DGS in July 2022.
How is the Imvanex vaccine administered?
The vaccine should be injected subcutaneously, preferably in the upper arm (deltoid muscle).
Doses: what is the vaccine schedule for the Imvanex vaccine?
► Primary vaccination (persons not previously vaccinated against smallpox):
- A first dose of 0.5 mL should be administered on a given date.
- A second dose of 0.5 mL should be administered at least 28 days after the first dose.
► Reminder (persons already vaccinated against smallpox): There are insufficient data to determine the appropriate timing for booster doses. If a booster dose is deemed necessary, administer a single dose of 0.5 mL.
► Immunocompromised people (HIV, on immunosuppressive therapy) who have been vaccinated against smallpox should receive 2 booster doses.
What are the side effects of the Imvanex vaccine?
According to CPR vaccine Imvanexthem The most common adverse reactions observed in clinical trials were: reactions at the injection site and systemic reactions commonly observed after vaccination:
- headaches,
- myalgia,
- injection site pain,
- erythema at the injection site,
- swelling at the injection site,
- induration at the injection site,
- pruritus at the injection site,
- fatigue.
These reactions were mild to moderate in intensity and resolved without treatment within 7 days of vaccination. “To note that people with atopic dermatitis developed more local and systemic symptoms after vaccination” specifies theMedicines Agency in an information note published on May 26, 2022. In a non-placebo-controlled clinical trial that compared the safety of Imvanex in people with atopic dermatitis and in healthy subjects, the people with atopic dermatitis experienced erythema (61.2%) and swelling (52.2%)) at the injection site at a higher frequency than in healthy subjects (49.3% and 40.8%, respectively). 7% of people with atopic dermatitis experienced a flare-up or worsening of their condition.
What are the contraindications of the Imvanex vaccine?
According to CPR from Imvanex® vaccine authorized in Europeit is contraindicated in case of hypersensitivity to the active ingredient or to any of the excipients (Trometamol / Sodium chloride / Water for injections) or to residues present in trace amounts (chicken proteinbenzonase, gentamicin and ciprofloxacin). Finally, vaccination should be postponed in the event of severe acute febrile illness (high fever).
What is the price of the Imvanex vaccine?
Imvanex vaccine price information is not available.
Sources:
– Bavarian Nordic receives European approval for vaccine label extension to include Monkeypox, 25 July 2022, Bavarian Nordic press release
– Monkeypox, evolution of the course of action, DGS, July 8, 2022
— Smallpox Vaccine, Jun 2021, The Merck Manuals
– Imvanex 2019, European Medicines Agency
– Opinion on the revision of the smallpox plan, 21 December 2012, High Council for Public Health