ProteqFlu

ProteqFlu is a vaccine for use in horses. It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively. ProteqFlu is available as a suspension for injection.

ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza and tetanus. The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection. Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.

The vaccine is given as an intramuscular injection (injection into a muscle). Horses should receive a primary vaccination, consisting of two injections at 5 - 6 months of age, given 4 - 6 weeks apart. This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations. In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).

ProteqFlu is a vaccine which was produced with the use of recombinant technology. This means that a gene from two different equine influenza strains (A/equi-2/Ohio/03 and A/equi- 2/Newmarket/2/93) was inserted in two live canary pox vector viruses respectively which were made capable to produce parts of these influenza strains (specific proteins).

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. When ProteqFlu is given to horses, the animals’ immune system recognises the specific proteins from the equine influenza strains as ‘foreign’ and makes antibodies against them. The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium. This will help to protect against equine influenza. The vaccine also contains an ‘adjuvant’ to stimulate a better response.

The safety of ProteqFlu was studied in several studies under laboratory and field conditions in a large number of horses, of all ages (from 1 month to 40 years) and physiological status (foals, non-pregnant and pregnant female adults and male adults). It was concluded that the product is safe at very high doses in the target species, also in pregnant mares, whatever the stage of pregnancy. It was also shown that, when used in the horse, the live viruses contained in the vaccine do not spread, nor disseminate, nor replicate on the place of inoculation and do not recombine with another virus. No environmental risk was identified through the use of this vaccine.

The effectiveness of ProteqFlu was studied in several studies under laboratory and field conditions. In studies under laboratory conditions, horses were challenged (infected) with equine influenza virus the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non vaccinated animals or vaccinated with a competitor product). The production of protective levels of antibodies against the two influenza vaccine strains was measured in all studies.

Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.

The studies showed that ProteqFlu is an effective vaccine in horses from 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, 14 days after primary vaccination. The duration of protection was 5 months after primary vaccination and one year after the third vaccination.

Swelling may occur, (max. diameter 5 cm) which decreases within 4 days. Pain and local hyperthermia (increase in body temperature) can occur in rare cases. A slight increase in temperature (max.1.5 °C) may occur for one day, exceptionally for two days.

In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. Also in exceptional circumstances, a hypersensitivity (allergic) reaction can occur, which may require appropriate symptomatic treatment.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The withdrawal period of the product is zero days.

Zero days.

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality. The Committee recommended that ProteqFlu be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te to Merial S.A.S. on 6 March 2003. Information on the prescription status of this product may be found on the label/outer package.