About IMVANEX®

IMVANEX is the first smallpox vaccine approved in all European Union countries for active immunization of the general adult population, including those with atopic dermatitis and weakened immune systems.

The approval is applicable to all E.U. member states and Iceland, Liechtenstein and Norway.

IMVANEX is an important component of any smallpox preparedness plan as traditional replicating vaccines are not sufficient to protect everyone or to have a successful pre-event vaccination program for first-line responders and military. It is approved for use in the adult population in general, but it is also appropriate for individuals not considered candidates for replicating vaccines (i.e., people with HIV and atopic dermatitis) and for pre-event vaccination of first-line responders (i.e., health care workers, military, police, etc.).

IMVANEX can be used for:
 
  Individuals previously not vaccinated against smallpox Individuals previously vaccinated against smallpox
General population
(including people with atopic dermatitis)
0.5 ml subcutaneous injections
+
0.5 ml subcutaneous injections no less than 28 days later
0.5 ml subcutaneous injections
Immunocompromised population
(including people with HIV)
0.5 ml subcutaneous injections
+
0.5 ml subcutaneous injections no less than 28 days later
 
IMVANEX, Summary of Product Characteristics, June 2014

IMVANEX is a non-replicating smallpox vaccine based on MVA-BN (a strain of the Modified Vaccinia Ankara virus). It is injected under the skin like other modern vaccines rather than pricked into the skin with a bifurcated needle as with traditional replicating vaccines. While the MVA-BN virus is highly attenuated and is thus incapable of replicating in the human body, it is capable of eliciting a potent immune response and does so without producing the replication dependent post-vaccination complications associated with traditional smallpox vaccines. Studies show the platform displays high immunogenicity and a favorable safety profile. The most common adverse reactions observed in clinical trials were mild to moderate and typical for vaccines, such as injection site reactions and common systemic reactions. They were resolved without intervention within days of the vaccination.

 

Very Common

(≥1/10)

headache, nausea, myalgia, injection site pain, injection site erythema, injection site induration, injection site swelling, injection site pruritus and fatigue.

Common

(≥1/100 TO <1/10)

appetite disorder, dizziness, pain in extremity, arthralgia, injection site discolouration, injection site nodule, injection site haematoma, injection site warmth, chills, underarm swelling, body temperature increased, troponin I increased and pyrexia.

Uncommon

(≥1/1,000 TO <1/100)

nasopharyngitis, influenza, upper respiratory tract infection, lymphadenopathy, sleep disorder, paresthesia, vertigo, pharyngolaryngeal pain, rhinitis, cough, diarrhea, vomiting, dry mouth, abdominal pain, rash/pruritus/dermatitis and related symptoms (both generalized and at the injection sites), back pain, neck pain, musculoskeletal stiffness, muscle spasms, flushing, axillary pain, chest pain, asthenia, malaise, hepatic enzymes increased and white blood cell count increased, white blood cell count and mean platelet volume decreased and contusion.

Rare

(≥1/10,000 TO <1/1,000)

sinusitis, conjunctivitis, peripheral sensory neuropathy, tachycardia, night sweats, angioedema, musculoskeletal pain, muscular weakness and oedema peripheral.

 

Because of the urgent need for a non-replicating smallpox vac­cine, many governments are already stockpiling IMVANEX. Bavarian Nordic is currently supplying 8 million doses of IMVANEX (known as IMVAMUNE® in the U.S.) in addition to the 20 million doses already delivered to the U.S. Strategic National Stockpile, as well as to nations in Europe and Asia.

Development

Development of IMVANEX (known as IMVAMUNE in the U.S.), began in 1999 with the goal of providing a licensed smallpox vaccine for the general population, which can be used to protect individuals with weakened immune systems (e.g., people diagnosed with HIV) or atopic dermatitis, military personnel, first responders and lab workers. Bavarian Nordic has worked in close partnership with the U.S. government – namely the Biomedical Advanced Research and Development Authority (BARDA) and National Institute of Allergy and Infectious Diseases (NIAID) – for over a decade on the development of the vaccine.

Efficacy

Seroconversion rates (SCR) - in previously vaccinia-naïve study populations (including individuals with atopic dermatitis and HIV)

photo: About IMVANEX

Who should be vaccinated?

IMVANEX® is for the protection of:

  • Military and first-line responders (health care workers, police, etc.); IMVANEX® is the only licensed vaccine that allows for pre-event vaccination based on an acceptable risk-benefit assessment
  • Individuals who are not considered candidates to receive replicating vaccines, including: immunocompromised (e.g., HIV) as well as individuals with atopic dermatitis and members of their households
  • The adult population in general

IMVANEX product site version 1. Last updated July 2014.