L4 interval

RE: L4 interval

Bob Russell — Mon, 23 Jul 2018 13:15:02 GMT

[quote user="janine redman"]

i Posted about an eight week old puppy who developed icterus , anuria and renal and hepatic failure 24hours after the first L4 vaccine combined with DHP. The puppy eventually died at a referral centre and has been logged as either an idiosyncratic vaccine reaction or Leptospirosis. has been logged .

[/quote]

Assuming there was no fault in manufacture then the puppy could not have 'caught' lepto from the vaccine. It is inactivated.

With an incubation period of 7-21 days it makes the vaccine an unlikely source (HSE state may be 2-30 days in man).

I suspect this is a sad coincidence. I try to avoid vaccination in newly arrived pets but do offer a free puppy/kitten check as early as possible. Give them a few days to settle.

Not that unusual for some sort of illness to show in that time. Some/many of these would have been blamed on the vaccine.

RE: L4 interval

janine redman — Fri, 20 Jul 2018 22:06:36 GMT

RE: L4 interval

Edward Jones — Fri, 20 Jul 2018 20:38:25 GMT

[quote user="Iain Richards"]But... off licence is not cascade[/quote]

Good point, thank you.

RE: L4 interval

Iain Richards — Thu, 19 Jul 2018 09:24:49 GMT

[quote user="Edward Jones"]Sure, but regulation 8 goes on to detail the exceptions, detailed in Schedule 4 and Schedule 6 - i.e. follow the cascade, observe statutory withdrawals, exceptions for small pets.[/quote]

But... off licence is not cascade, so using the L4 vaccinating at 27 or 29 days is off licence.....

Fairly certain some VDS cases have coughed up because a shister lawyer has trawled the SPC and found a "do not use" which is then very difficult to defend.

RE: L4 interval

Niall Taylor — Wed, 18 Jul 2018 20:58:29 GMT

[quote user="Bob Russell"]The Vet Times has gone to where the Vet Times always ends up - recycling![/quote]

Anon (2017) ‘VMD reassures vets following vaccine concerns’, Veterinary Times, vol. 47, no. 13, p. 6. (3 April). available at https://www.vettimes.co.uk/news/vmd-offers-reassurance-over-vaccine-concerns/ (accessed 13/3/18)

VMD reassures vets following vaccine concerns

THE VMD has moved to reassure vets following concerns raised in media reports of serious adverse events in dogs given the vaccine containing four strains of Leptospira bacteria.

A statement said: "The VMD is aware of media reports and concerns raised on social media following cases of serious adverse events in dogs given the vaccine containing four strains of Leptospira bacteria.

"The VMD receives adverse event reports from veterinary surgeons, animal owners and marketing authorisation holders.

"We would like to reassure vets - and through them, dog owners - we are constantly reviewing adverse event report data to ensure the benefits of each UK licensed veterinary medicine product outweighs the risk posed by their potential side effects.

There are a number of vaccines authorised in the UK containing either two (L2) or four (L4) strains of Leptospira.

"Based on the most recent periodic safety update report data received for each product, the incidence of adverse animal reactions for all L2 vaccine products combined is 0.015 per cent; for L4 vaccine products this figure is 0.069 per cent.

"In other words, the VMD has received fewer than two adverse reactions for L2, and fewer than seven for L4, for every 10,000 doses sold. "This includes every suspected adverse event reported - even cases that were considered unclassifiable or were later found to be unrelated to the vaccine.

"The overall incidence of suspected adverse reactions for both L2 and L4 vaccine products is, therefore, considered to be rare."

Robbins, H. (2017) 'Adverse events in dogs given Leptospira vaccine', (letter), Veterinary Record, vol 180, p. 257. http://veterinaryrecord.bmj.com/content/180/10/257.2

"The majority of reported signs are linked to allergic reactions, which are well recognised potential side-effects of any vaccine, and are presented on the product literature."

My (subjective) impression is that L4 is what we vets call "a wee bit more nippy" than L2 Claims of high levels of serious adverse events are agenda-driven anti vaccination propaganda.

Niall

RE: L4 interval

Edward Jones — Tue, 17 Jul 2018 17:08:04 GMT

[quote user="Iain Richards"]Regulation 8 of the VMR 2013 is "no administration unless in accordance with the marketing authorisation" ie the SPC. Contravention of Reg 8 is an offence. [/quote]

Sure, but regulation 8 goes on to detail the exceptions, detailed in Schedule 4 and Schedule 6 - i.e. follow the cascade, observe statutory withdrawals, exceptions for small pets.

RE: L4 interval

Richard Carter — Mon, 16 Jul 2018 19:10:34 GMT

[quote user="Elisabeth Knappett"] been informed by the manufacturers that we can't simply use Lepto 2 as the 2nd part of the vaccine as it is 'incompatible' [/quote] lazy answer, can't be bothered/ covering of the manufacturer ..se, forcing the clinical decision back on the vet???

Some science here - it may be the particles of the dead/inactivated lepto used for the L2 cover are now different in the L4 vacc - this may be responsible for a different immune response from different antigen sites so then would in effect not be 'boosting' the same antibody production on subsequent injections. If however the particle of dead lepto are much more coarse/ larger (which I suspect as not aware of the L4 being a product of genetic engineering) then there must be shared antigen in both vaccines, then of course they will boost the immune response over a slightly wider antigen range for the L2 serovars.

Interesting the data sheet on Virbac Canigen DHPPi in the 2018 NOAH still states to only mix with Canigen L2 or Canigen Rabies; the MSD Nobivac DHPPI (same vaccine, same factory, different label) can be mixed with all the lepto inactivated vaccines

The lepto in L2 (Virbac/MSD) range inactivated liquid suspension of L.interrogans Canicola strain Ca12-000; L.icterhaemorrhagiae strain 820K but the L4 L.interrogans same strain Canicola 12-000; L.icterhaemorrhagiae is Copenhageni strain Ic-02-001 so slightly different strains involved with second lepto.

Anyone know? Is this important enough of a difference to NOT cause immunity? Any studies on such compatibility trials done or is the 'safe' answer still as above - we don't know, we not putting our necks out to support our product..

RE: L4 interval

Iain Richards — Mon, 16 Jul 2018 18:04:30 GMT

Bob, Edward, I'd be delighted if there is no criminal act, but Regulation 8 of the VMR 2013 is "no administration unless in accordance with the marketing authorisation" ie the SPC. Contravention of Reg 8 is an offence.
It's hardly one to land one in clink, but it could lead to disciplinary or litigation. NSAIDs and caesars being a particular example

RE: L4 interval

Elisabeth Knappett — Mon, 16 Jul 2018 15:51:01 GMT

As a little aside - as a practice, we keep a small stock of Nobivac vaccines in for completion of vaccine courses where pups have started with their breeder (we use vanguard as our major brand). However, we have had several pups arrive having had Lepto 4 as their first vaccine and have been informed by the manufacturers that we can't simply use Lepto 2 as the 2nd part of the vaccine as it is 'incompatible' with Lepto 4. I understand that we wouldn't get coverage against the additional serovars, but am struggling to understand why we wouldn't get coverage on the 'usual' 2? Any suggestions?

RE: L4 interval

Bob Russell — Mon, 16 Jul 2018 14:24:46 GMT

The Vet Times has gone to where the Vet Times always ends up - recycling!

In the article it was stated that there is an increased level of reactions with L4 compared with L2.

My opinion is these are minor niggles, discomfort at injection (Nobivac), injection site lumps (Versican) and little of any of these (Eurican).

I am happy to follow an adapted version of WSAVA recommendations as they are logical and scientific. Data sheets are pretty much in line with these recommendations although perhaps less flexible due to the nature of the testing.

I can see little benefit in worrying about a few days here or there as I bet the immune system does not. Straying wildly outside the recommendations is not going to be sensible without the scientific back up to support it.

I don't panic about the VMD too much. My contact with them has been largely positive and they are able to use commonsense.

RE: L4 interval

Lucy Fleming — Mon, 16 Jul 2018 12:14:55 GMT

[quote user="Bob Russell"]Apparently there have been more reports of adverse reactions to L3 or L4 compared to the old L2.[/quote]

My understanding was that wasn't actually the case - despite the media hysteria, there had actually been fewer adverse reactions reported to L4 than L2 (over approximately the same time period). That was from a while ago, though, so things may have changed.

RE: L4 interval

Edward Jones — Mon, 16 Jul 2018 11:24:54 GMT

No criminality, but documented informed consent puts you in a much better position if there's any problem. Although are you really going to get a client to sign an off-licence consent because they've come for a second vacc at 26 days?! I might wish I had if the VMD come sniffing round.

RE: L4 interval

Bob Russell — Mon, 16 Jul 2018 09:41:09 GMT

There is no criminality in going off licence (except cascade).

Offering a variation on the data sheet recommendations is a clinical decision. I don't follow vaccine data sheets to the letter. I tend to use WSAVA and commonsense as justification where I differ from the data sheet.

Data sheets are not bibles. They tend to reflect the testing regimen chosen by the manufacturer rather than what works and what does not.

RE: L4 interval

Iain Richards — Sat, 14 Jul 2018 11:48:25 GMT

Thanks folks. More licensing idiocy, meaning an off-licence form may be needed for something other than what is written down. When, as a profession are we going to put enough pressure on VMD to change the VMR and stop the criminal aspect of off data??

RE: L4 interval

Bob Russell — Fri, 13 Jul 2018 15:58:38 GMT

Clearly it is fine to complain about better protection. Apparently there have been more reports of adverse reactions to L3 or L4 compared to the old L2.

Of course vets will tend to report reactions to newer pharmaceuticals than those that have been about for years.

More niggles with Versican and a few yelps with Nobivac. Nothing serious and nothing outside the data sheets.

We have a box of L2 in the fridge about to go out of date! Any takers? Bought for the vociferous clients but never used because they have the sense to listen! Thankfully only a box of 10.

RE: L4 interval

Robert FalconerTaylor — Fri, 13 Jul 2018 15:37:52 GMT

There's a piece in vet times today page 4 about client complaints of not being given diff. serovar options by vets at vaccination.

RE: L4 interval

emma o'connor — Fri, 13 Jul 2018 09:54:49 GMT

we rang MSD for advice on Nobivac L4, and they say 28 day interval but ok if done up to 2days earlier or 2 days later.

RE: L4 interval

Emily Rainbow — Thu, 12 Jul 2018 19:08:14 GMT

I spoke to Nobivac a few months ago and said 26-30 days.

RE: L4 interval

Andrea Tarr — Thu, 12 Jul 2018 16:50:59 GMT

It's 3 to 4 weeks for Versican Plus L4

The interval recommended in the SPCs seems to correspond to the interval used in the trials for marketing authorisation.

From the FAQ section of the WSAVA guidelines on vaccination (within 2 to 6 weeks):

Q When an animal first receives a vaccine that requires two doses to immunize (e.g. killed vaccines like Leptospira bacterins or feline leukaemia virus), and it does not return for the second dose within 6 weeks, is there any immunity?
A No. A single dose of a two-dose vaccine does not provide immunity. The first dose is for priming the immune system, the second for immunizing. If a second dose is not given within 6 weeks of the first, the regime should start again, making sure the two doses are given within 2–6 weeks. After those two doses, revaccination with a single dose can be done at yearly or greater intervals to boost the
response.

RE: L4 interval

Neil Wheadon — Thu, 12 Jul 2018 16:49:58 GMT

Nobivac can be 27days (from practice that asked) as long as 6 weeks (I'm not so sure on that one)

Versican 3-4 weeks

Neil

RE: L4 interval

Niall Taylor — Thu, 12 Jul 2018 16:12:26 GMT

I heard the reason for the precise interval is a tightening of licensing rules since L2 was produced and they can no longer be so vague as to say 2 to 4 weeks without doing seperate clinical trials to validate the whole period.

If you phone the drug company or speak to the rep they will usually say it's ok to go a day or two either way.

Niall