Alfie's petition, to suspend Lepto 4 and improve control/use

My Alfie passed away in March 2016. He declined rapidly after receiving the Versican Plus Lepto 4 vaccine, made by Zoetis. Alfie received Lepto 2 vaccines by two different manufacturers over 9 years without reaction.

I submitted a petition to the UK Parliamentary Petitions Committee in October 2016. After numerous emails and delayed responses, the Clerk to the House Of Commons (HOC) Petitions Committee rejected Alfie's petition because they felt Lepto is a trade mark rather than a disease - despite all the evidence provided to them.

I submitted Alfie's petition to the Parliament of the European Union (EU) in November 2016 asking for all the L4 vaccines to be suspended. The EU condensed the petition down to a single page (which pretty much destroyed it) and translated in to every language of the EU.

The EU Petitions Committee then deemed that the European Medicines Agency (EMA) are the body best suited to deal with the petition, rather than the Parliament dealing with it. So that petition was closed in 2017.

In May 2017, disheartened by the attitude of HOC and EU Petitions teams and whilst still grieving, I started a Change.org petition. The petition was translated in to French and German by friends, although it appears that there is less of a problem in those countries - possibly due to attitude and practices of vets in those countries.

The closed petition is at Change.org/Alfie's Petition

A Facebook group was created for dog owners to share their dog's experience of Versican Plus vaccines, although that has now been widened to include all Zoetis vaccines. I am aware that Zoetis staff view the group. The group is specifically to shares one's dog's experience and not a general vaccine discussion group.

The petition was also shared on Twitter to help raise awareness

By January 2018 Alfie's petition had received some 2500 signatures, at which point I closed the petition and submitted it to EMA and the UK's The Veterinary Medicines Directorate (VMD) on 28th January .

VMD protects animal health, public health and the environment. VMD is an executive agency, sponsored by the Department for Environment, Food & Rural Affairs (DEFRA)

On 28th February I received a joint response from EMA and VMD. The response is below

Since receiving the joint response from EMA and VMD, it's becoming clear that some UK vets are misleading customers by saying that the Adverse reaction to L4 (4 strain) vaccines is 1 in 10,000 vaccines sold when VMD states it is actually 7 in 10,000 vaccines sold. That might not sound like many dogs, but you have to consider that some vaccines are dropped, or go out of date so are not used, so the ratio of vaccines used to Adverse reactions is higher then recorded. The RSPCA estimated dog population figure of around 8,000,000, (8 Million), os if all 8,000,000 dogs did receive L4 then that's 5,000 (5 thousand) becoming ill, developing a life changing condition, or dying in the UK - every year.

VMD figures for Adverse reactions to L2 (2 strains) vaccines is less than 1 in 10,000 vaccines sold. So that's around 500 (5 hundred) Adverse reactions every year.

I know from personal experience and we are seeing on the Facebook groups that vets are dismissing any link between vaccination and any medical condition that presents after vaccination. VMD/EMA are aware of under reporting of Adverse reaction to vaccines. So it is important for dog owners to report to VMD where the vet has refused to acknowledge a genuine link between vaccination and new medical condition.

Lexie had her Versican Plus Lepto 4 injection at the same time as Alfie in 2016. Two years later and Lexie has still got a lump at the site of vaccine injection.

Continue down the page for Alfie's Lepto 4 story and the 2017/2018 petition

I don't really know what to do next

Alfie's experience of Versican Plus L4, made by Zoetis

Alfie was a beautiful tri coloured Cavalier King Charles Spaniel, born on 10th October 2006. Alfie had the Lepto 2 vaccine for 8 years from at least January 2007. In October 2012 he was found to have a Grade 2 (out of 5) heart murmur. By March 2013 at his yearly MOT and vaccination, Alfie was found to be Grade 3 murmur. Alf Alfie continued to be a Grade 3 when attending for his yearly MOT and vaccinations on Thursday 11th February 2016. I took both dogs in as usually, and was advised that they had a new lepto vaccine, which they were using due to an outbreak in Somerset. I was informed that this was Versican Plus Lepto 4, made by Zoetis. Because it wasn't the Nobivac L4 vaccine that I had heard so many bad stories about, I decided that both dogs could have the vaccine. Both dogs were OK in themselves for the rest of the day. The next morning I found that they both had lumps around the injection site, and I was unable to groom them for two days due to their being in pain when I touched the side. By Friday night I had noticed that Alfie's breathing had changed and became more laboured. Over the weekend I found that Alfie became less interested in going for a walk. On Wednesday I came home from work early and rushed up stairs, followed by Alfie. Alfie stopped at the top of the stairs and just sort of stood there confused. Clearly something wasn't right and as I walked towards him he collapsed. A quick check of his mouth showed blue tongue and gums. Rushed him to the vets and he is now a Grade 6 out of 6 - which means you can't actually hear the heart beat due to blood not pumping. An injection of Vetmedin helped him immediately, although he clearly wasn't right. Lexie by now was back to her normal self.

The weather got a bit colder, and restricted walks around the car park and literally just down the road weren't that pleasant for Alfie any more.

Four weeks after the first vaccination I took both dogs back for a check up and consider the second vaccination. I had by this point been assured by three partners of the veterinary practice that there was absolutely no way that the vaccine could have caused this degrading of the heart strings, and that it was just coincidence. By this point I had decided that as Alfie's life clearly wasn't anything like he was 4 weeks before,then I would allow him to have the second Lepto 4 vaccination injection. My thought was that he would either stay the same, or the second injection would make him worse. whilst Alfie was still a grade 6 out of 6, he was absolutely and totally clear of any fluid retention.

So on Thursday 10th March 2016, both dogs had their second Zoetis Versican Plus Lepto 4 vaccine. Again both dogs had lumps come up at the injection site, and I was unable to groom or touch their side for two days. Alfie had refused to go wee in the garden for years, so I was now just carrying him out to the grass by the road so that he could go toilet. As I put his coat on Sunday evening I had the stupid thought that he'd put weight on due to not walking. By Monday morning I'd realised that he was actually full of fluid. Back to the vets and at least one vet is now considering that the two vaccine injections might have caused this. Alfie is put on diuretics, and I am told to keep an eye on him and bring him back in a few days. On the Tuesday I ring the vets and express concern that he's still full of fluid and not improving. I am told to give the tablets time to work.

On Facebook we're hearing all sorts of horror stories, including of vets taking the vaccines straight out of the fridge and straight in to the dogs.

So I decided to do a Parliamentary petition for more research to be carried out on these vaccines - which turned out to be a waste of time.

Alfie's submitted petition

To the European Medicines Agency, the European Commission the European Parliament and UK Veterinary Medicines Directorate.

Currently in the UK we are seeing cases of vets remove the vaccine from the fridge and inject it into our animals before the vaccine has had time to reach room temperature, and more importantly injecting before discussing and reaching an agreed vaccine regime with the pet owner. Further, vets are vaccinating dogs over the age of 9, have a significant heart murmur, and various other existing health issues.

On the various Facebook canine vaccine groups we are seeing numerous adverse reactions and even death to our dogs following the dog receiving L4 and to a lesser extent L2 vaccines by a number of makes. We are frequently hearing of vets refusing to acknowledge any link between administered vaccine and a new medical condition that presents after vaccination. And we are hearing of UK vets having treated fatal cases of Lepto over the last 12 months, but no evidence of which strains of Lepto the dogs had and therefore no clinical need for L4.

Whilst HM Gov’s Veterinary Medicines Directorate records Adverse Event Reactions to Canine Lepto 4 vaccines as “Rare” at 7 in 10,000 injections, if 6 million dogs are vaccinated then at 7:10,000 – that is approximately 4,000 dogs having adverse reaction, life changing illnesses or death. We know that many vets are not reporting adverse reactions and we feel that these Adverse Reaction Events are unacceptable.

We are aware of dog owners in other Western European Countries whose dogs have also had AER or died following L4 vaccination.

Personally,

My Alfie had received Lepto 2 vaccines for 8 years without incident or reaction. In February 2016 my vet advised that they had the Versican Plus L4 vaccine by Zoetis, and unlike the Nobivac L4 vaccine, this vaccine is not shed by the dog.

As I had heard bad stories about the Nobivac/Canigen L4 vaccines, and this was a different brand then I decided to let my two dogs have it.

Alfie was a grade 3 of 5 heart murmur on the day of vaccination, and had been that grade for a couple of years prior to that.

I was unable to groom or touch either of my dogs for 2 days after they received the Versican Plus L4 vaccine. Alfie’s breathing had changed within 48 hours of being vaccinated, and he collapsed a week after vaccination. On the day of his collapse Alfie was classed as grade 5 of 5 murmur, which means that you can’t hear the heart beat for the blood swooshing

Three vets were adamant that it was not the vaccine. So at the 4 week point he had the second L4 vaccination. His chest was clear of fluid but a grade 5 of 5 heart murmur on the day of the second vaccination. Within 2 days his abdomen and chest filled with fluid. Three vets continued to deny any link to the L4 vaccine. Despite diuretics, Alfie drowned in his own fluids.

Autopsy by Pathologist at RVC claimed that as Alfie was a Cavalier King Charles spaniel then heart failure should be expected.

So, we the undersigned ask the European Medicines Agency (EMA), the European Commission, the European Parliament and UK Veterinary Medicines Directorate to;

1. To suspend authorisation of all Canine Lepto 4 vaccines from all manufacturers until such time as further research is done on the products. Specifically, to identify if the range of Adverse Event reactions is due to the additional Lepto strains or due to the liquid that the vaccines are suspended in, or both.

2. For the volume of all vaccines to be reduced to 0.5 ml.

Carrying half the excipients and therefore injecting only half the amount of excipient in to the dog, 0.5 ml vaccines have been available in America for a couple of years now.

3. For pharmaceutical companies to carry out laboratory trials to see just how long Duration Of Immunity lasts, compared to the current process of proving minimum immunity period.

4. For pharmaceuticals to give guidelines on what is a healthy animal, or what is not healthy enough to receive vaccines

5. For pharmaceuticals to give guidelines on what age dogs and cats should stop receiving vaccines.

6. For vets to acknowledge and proactively report to EMA illnesses/conditions that occur after vaccination. There is currently an attitude of instantly dismissing any link to the vaccine and blaming underlying issues but by administering the vaccine they have deemed the animal fit enough to receive it.

7. To encourage all European vets to follow the World Small Animal Veterinary Association 2015 guidelines on the Vaccination of Individual Dogs. E.g. Titre before vaccination, Lepto 2 if there is a high risk.

8. For vets to discuss openly and honestly the local disease issues with the animal owner and agree a course of action.

9. For vets to prove where they claim that the additional Lepto strains exist in their area.

10. To encourage vets to use L2 by default instead of the current trend of injecting L4 by default, which sometimes happens without client knowledge or agreement.

11. To encourage the use of Lepto vaccine only if there is a genuine high risk in the area, and for that vaccine to be L2 unless there is proven scientific evidence of other Lepto strains in the area.

12. To encourage vets and all places of vet education to adopt the attitude of “To titre test and only vaccinate core and non-core vaccines when necessary after the initial puppy/14 week injections”, compared to the current attitude of “Better to vaccinate every year with core and non-core to protect the dog”.

13. After initial puppy/14 week vaccinations, for all vets to discuss and offer titre testing for core vaccines before contemplating revaccinating with core vaccines.

14. For EMA to have figures of adverse reactions to each canine vaccine type readily available and displayed in reports and available on the EMA website.

15. For EMA to encourage all European vets to report to EMA of disease infected dogs, and in the case of Lepto, of which strains infected the dog, and when and where.

16. To encourage vets to show clients this data of infected dogs on EMA’s website when discussing vaccination regimes.

17. For dogs infected with Lepto, if the dog was vaccinated prior to infection then for EMA to encourage all European vets to report to EMA which strains the dog had been vaccinated with prior to it becoming infected with Lepto.

Mark Ellis

More details on the supporting website. Please visit www.Lepto.co.uk

Lepto 4 issues discussed on Social media - Facebook

There are two groups on Facebook dedicated to lepto 4, and a general vaccine conversation chat group on Facebook. You might need to check you message requests before being joined to the groups.

These two UK based groups are dedicated to the relevant pharmaceutical company, and are places to share your pets experience.

This UK based group is for general discussion on canine vaccines.

Dorsetdog also has a Twitter account