The European Public Assessment Report is summarized below (EPAR). Its goal is to clarify how the Committee for Medicinal Products for Veterinary Use’s (CVMP) evaluation, which was based on the available documentation, produced the recommendations for the conditions of use.
This overview is not a substitute for speaking with your veterinarian directly. Contact your veterinarian if you require any additional information regarding the medical condition or care of your animal. Read the scientific discussion if you want more details about the foundation for the CVMP proposals (also part of the EPAR).
A vaccination called Nobivac L4 is offered as an injection-ready solution. There are four Leptospira bacterial strains that have been inactivated (killed) in it.
From the age of six weeks, dogs are vaccinated with Nobivac L4 to lower their chance of contracting certain Leptospira strain infections. Dogs with the leptospirosis disease have bleeding, hepatitis (liver infection), jaundice (yellowing of the skin and eyes), or nephritis (kidney infection). Urine or soil or water that has been tainted with urine is the main cause of infection. The vaccine also lessens the danger of transmission by preventing infected dogs from excreting (shedding) the virus into their urine.
Dogs receive the vaccine in two under-the-skin injections, spaced by four weeks. From six to nine weeks of age, the first injection can be administered, and the second four weeks later. It is advised that the first vaccination be given to pups at nine weeks of age when it is known that they have high levels of maternally derived antibodies (special types of proteins received from the mother in the milk that aid the body in fighting infection). To keep the vaccine’s effects going, just one “booster” injection needs to be administered each year.
A vaccination is Nobivac L4. The immune system, the body’s natural defenses, is “taught” by vaccines how to fight a disease. When dogs receive Nobivac L4, their immune systems identify the microorganisms in the vaccination as “foreign” and develop defenses against them. In the future, the animals’ immune systems will be able to react more swiftly if they are exposed to the bacterium. This will assist in warding off the illness.
In order to prove the vaccine’s safety and efficacy, the manufacturer has submitted data from both laboratory and field experiments, including information on how long it took the dogs to become fully protected and the potential duration of protection.
According to the studies, the vaccine lessens the risk of contracting Leptospira and urinating with the germs. Additionally, they demonstrated that giving the vaccination to pregnant women is safe.
Following immunization, some puppies may have a small and transient increase in body temperature (1C), as well as decreased activity or appetite. Within two weeks of immunization, a tiny, transient swelling at the injection site may arise; this swelling will either go away or shrink in size. There may occasionally be a transient, acute (short-term), hypersensitive reaction.
The Committee for Medicinal Products for Veterinary Use (CVMP) came to the conclusion that Nobivac L4’s advantages outweigh its disadvantages and suggested that a marketing authorization be granted. The scientific discussion module of this EPAR contains information on the benefit/risk balance.
On July 16, 2012, the European Commission issued Nobivac L4 a marketing authorization that is good throughout the entire European Union. The label or exterior box of this product should have information on its prescription status.
L2 or L4 should I give my dog?
Dogs that stay within their immediate vicinity should already be protected enough with L2, whereas those who go to Europe and some parts of the UK will be better protected with L4. The strange issue is that you have to completely restart your vaccination course in order to switch between the two vaccines.
My dog needs the lepto 4 vaccine, right?
Leptospirosis (Lepto) is a disease that can affect both humans and animals and is brought on by the Leptospira bacteria. In fact, it is currently the zoonotic illness that affects humans the most frequently worldwide.
Wildlife such as rats, raccoons, opossums, skunks, squirrels, and deer can carry leptospirosis, which can be found in lakes, streams, puddles, or soil in your garden where they may urinate. But this does not imply that the only dogs who can be exposed are those who lick up puddles or swim in lakes! Any dog that frequently goes outside could be infected with this illness.
Leptospirosis vaccination for dogs is currently not necessary, although it is strongly advised for any dog that frequently ventures outside, even merely to use the restroom in the backyard. Although it may initially appear that small breed dogs and dogs living in cities are at a lower risk, these animals are really the ones who are diagnosed with leptospirosis the most frequently in veterinary hospitals! It’s crucial to realize that even if your dog has had the necessary vaccinations, there is no 100% assurance that they will not acquire leptospirosis.
Only a few of the several variants of the Leptospira bacteria that cause leptospirosis are now protected by the vaccine. The danger of your dog contracting leptospirosis does, however, decrease with vaccination.
The symptoms of this condition in animals can be challenging to spot and may look similar to those of other illnesses. In some cases, dogs may even show no symptoms. Some of the clinical symptoms that have been observed in dogs are listed below. These consist of:
- Fever
- Vomiting
- Continent pain
- Diarrhea
- refusal of food
- extreme lassitude and sadness
- Stiffness
- significant muscular ache
- being unable to have pups
The vaccine doesn’t really work all that well
In fact, according to the American Veterinary Medical Association (AVMA), 30% of dogs don’t respond to the vaccine at all.
Dr. Richard Goldstein, director of the Animal Medical Center, said that the vaccination “appears to work but, confesses this is based on data provided by the business that provides the vaccine.” He also asserts that the vaccination offers protection for a whole year, yet this assertion is based once more on drug industry statistics.
The vaccine can actually cause lepto
Numerous incidents of dogs having lepto after receiving the vaccine have been reported to us. Additionally, in the Canine Health Concern vaccine survey, 100% of the dogs who developed leptospirosis did so shortly after receiving the disease-prevention vaccine.
The vaccine only protects against a few serovars
For lepto, there are roughly 300 distinct serovars. And just four of them—Leptospira canicola, Grippotyphosa, Icterohaemorrhagiae, and Pomona bacterin—are protected against by the vaccination.
Oh, and those lentivirus-positive canines in Los Angeles County? The leptovirus vaccine does not protect against Automnalis, the most prevalent serovar detected in those dogs.
The vaccine isn’t very safe!
The lepto vaccination, according to the majority of veterinary specialists, is the one most likely to result in serious side effects. Events that the European Medicines Agency had already recorded, like unexpected death and autoimmune illness. Leptospirosis vaccines, according to the WSAVA, “may be connected with adverse reactions and are “related with as many adverse reactions as occur for any other optional vaccine on the market,” the organization even asserts.
However, MSD argues that their vaccination is safe, saying:
“We acknowledge that vaccinations occasionally have a negative impact on a dog’s health. Our pharmacovigilance monitoring does show that unfavorable responses, like brief malaise, lumps at the injection site, or even anaphylaxis, can happen infrequently. The hazards of the animal not receiving a vaccination and being exposed to disease must be evaluated against these uncommon consequences.
If that’s the case, shouldn’t someone start providing evidence of the risks associated with refusing vaccinations?
According to Chris Bradley, a veterinary advisor for MSD:
“The occasional instance that may have a connection to (L4) immunizations does exist, but because the incidence is so low, it is not thought to be important. We have very few records of other reactions and no instances of canine anaphylactic shock from our vaccine in our pharmacovigilance database.
But hold on, shouldn’t we be aware of the precise number of dogs who are injured by the lepto vaccine so that we may determine the appropriate amount of risk for our own pets?
In the UK, pet owners are learning that the risk is quite high. But if you want to know precisely how many dogs in the US have been damaged by the vaccine, you’ll never know.
What distinguishes the L2 and L4 dog vaccines?
The terms L2 and L4 describe how many different Leptospirosis strains are included in the immunization. We utilize L2 vaccines because, according to research, they are effective against the great majority of Leptospirosis cases identified in the UK.
L2 and L4 cannot coexist. Puppies who have received their initial L4 vaccination will thus need an extra L2 vaccination. If you are uncertain, please consult your veterinarian.
What negative consequences does the L4 vaccination have?
Following immunization, a moderate and temporary elevation in body temperature of 1 C has frequently been recorded in clinical investigations, with some pups exhibiting decreased activity and/or decreased hunger.
After L4, when may dogs go outside?
Your dog shouldn’t be taken for a stroll in public before receiving their first immunization. Puppies should still be introduced to novel sights, sounds, smells, and sensations, but only while carried and kept off the ground in public places. As long as you’ve never had a dog with an infectious condition, access to your own private garden is usually secure. It is safe for the puppy to meet healthy, fully vaccinated dogs if you have friends who own them.
Puppies won’t necessarily gain a lot of immunity after their first vaccine, thus the previous instructions should still be followed.
Your puppy will be protected against distemper, hepatitis, and parvovirus one week after receiving their second vaccination as long as they are at least 10 weeks old at that time. Your dog can now be taken for walks in public places and can typically enroll in puppy classes starting one week after their second immunization. They should stay away from leptospirosis-prone regions like livestock farms, stagnant water, and areas with rat infestations because they are not yet immune to the disease.
The second leptospirosis immunization, which needs to be administered four weeks following the first, will be your puppy’s third and last shot. You should continue to stay away from regions with a high leptospirosis risk after this injection since it takes three weeks for immunity to start developing after the second L4 vaccination.
What makes lepto 2 and lepto 4 different?
Typically, vaccinations can be administered starting at 6 weeks of age, 2 to 4 weeks apart, with the final dose starting at 16 weeks of age. To promote early socialization, several vaccines have been licensed so that the final dosage can be administered starting at 10 weeks of age. An illustration of a vaccination schedule for a puppy would be to provide the first shot at 8 weeks, followed by the second and final shots at 10 or 12 weeks.
So, if your puppy is 8 weeks old (the minimum recommended age for puppies to be removed from their siblings and mother), they may already have received their first immunization, and you may just need to take them for their second and final vaccinations.
Lepto 2 or lepto 4?
Whether to immunize dogs against leptospirosis with the Lepto 2 or Lepto 4 vaccination is a contentious topic with many opposing viewpoints. Both have pros and cons, just like everything else. Having this knowledge will enable you to decide what is best for your pet, regardless of what other people may think.
Lepto 2 protects dogs against the canicola and icterohaemorrhagiae serogroups of Leptospirosis, making it different from Lepto 1. Canicola, icterohaemorrhagiae, grippotyphosa, and australis are the four serogroups that Lepto 4 offers a more thorough defense against.
The two most prevalent serogroups in the UK are icterohaemorrhagiae and leptospirosis canicola. Leptospirosis grippotyphosa is uncommon in the United States but widespread in nations like France and Germany. Leptospirosis australis, a different form, has also been documented in the UK.
The quantity of adverse responses to these vaccines that have been documented is the second factor to think about. This is higher with the Lepto 4 vaccine because it causes a higher activation of the immune system to provide protection against a greater variety of pathogenic pathogens.
Less than 7 out of every 10,000 dogs who receive the Lepto 4 immunization experience an adverse response. In a similar vein, less than 2 out of every 10,000 dogs who receive the Lepto 2 vaccine experience a response. These can be modest, such a brief localized swelling at the injection site, or severe, like anaphylaxis.
When can I take my puppy out?
As soon as your dog is with you, you should take him outside. A puppy’s first 12 to 16 weeks of life are essential for ensuring appropriate socialization. Puppies learn throughout this time what is safe and hazardous, as well as what should be considered normal in adulthood. Your puppy’s exposure to many sounds, smells, people, and other animals will lay the groundwork for you to raise a confident, content dog.
The immunization regimen, however, is only completed at a minimum age of 10 weeks, as was previously discussed. One to three weeks following the final immunization, puppies only begin to show protection to the diseases covered by vaccination.
So, how can you safeguard your puppy while fostering a solid social foundation before they receive all of their vaccinations?
- Carry your puppy on walks or take them out in a cart. Never place an unvaccinated puppy on the ground in a public area, including parks or even the veterinary office;
- Let your puppy be carried and petted by as many people as you can;
- Bring them to a protected area (preferably inside) where they can be among fully vaccinated animals, such as a family member who has a cat or dog;
- Get your puppy acclimated to being manipulated at home. Always ensure that you associate having your mouth opened, your paws on them, cleaning their ears, and having their claws clipped with pleasurable experiences.
What will happen if I don’t vaccinate my puppy?
Herd immunity is a benefit of vaccinations in addition to providing individual immunity. This translates to a lesser probability of an unvaccinated animal coming into touch with these infectious agents due to the high number of canines that have received their vaccinations.
The situation would alter if everyone stopped immunizing their canines. Infectious hepatitis and distemper, which are currently uncommon in the UK, are expected to return to becoming prevalent. Leptospirosis and parvovirus are regrettably still highly prevalent in unvaccinated dogs in the UK. The chance of your puppy contracting these potentially fatal diseases is very great if they are not vaccinated.
As a result, immunizing your puppy will benefit both their personal health and the health and wellness of the entire canine population. Following the preceding recommendations will ensure that their social abilities are unaffected.
