 MERIAL, FMD vaccine production at Pirbright
26th September 2007
Following two separate investigations into the recent outbreak of foot and
mouth disease (FMD) in the UK by the British regulatory authorities, the
conclusion was reached that there had been no breach of biosecurity by MERIAL.
We welcome these reports and look forward to implementing the recommendations
they made that related to our company, and to the resumption of full production
at our Pirbright centre.
INTRODUCTION
In this memo, we describe the key role that MERIAL’s vaccines, produced
at Pirbright, play in the control and eradication of FMD throughout the world,
and in doing so, supporting the farming community. At Pirbright we also produce
vaccines for Bluetongue Virus (BTV), a recently emerging disease in several
countries in Europe.
By way of background, MERIAL is a world-leading, innovation-driven
animal health company, providing a comprehensive range of products to enhance
the health, well-being and performance of a wide range of animals. We are
a key player in world-wide biosecurity, the world leader in FMD vaccine production
and have recently introduced the first safe and effective vaccines against
BTV for affected countries in Europe. Our Pirbright facility produces vaccines
against both diseases.
FMD
As you know, FMD is a highly contagious viral disease of cloven-hoofed animals
(cattle, sheep, goats, camelids, swine, and some wildlife) which spreads
rapidly and can seriously impair livestock productivity. It may result in
severe trade and economic losses in affected countries.
Management of the disease is strictly regulated and most countries go to
significant length to eradicate the disease, or avoid (re-)introduction,
to retain their FMD-free status at all costs. International trade and large
scale livestock movements create a special risk to the spread of FMD. The
threat of a new outbreak is ever present as recent epidemics in formerly
disease-free countries, including Taiwan, Japan, South Korea etc., demonstrate.
Most of the developed world is free from FMD; the brunt of the disease burden
is borne by small scale and subsistence farmers of the developing world for
whom FMD signifies loss of productivity, food scarcity and even poverty.
In many countries today, vaccination is recognized as an essential, highly
efficacious and cost-beneficial component of FMD prevention and control.
Provided vaccines are sufficiently potent and fairly close in their protein
make-up to the wild type strains causing the outbreaks, they are very effective.
Where disease occurrence is widespread, vaccination is less disruptive and
costly than dealing with outbreaks by bio-security measures only, as they
often imply widespread culling which is less and less acceptable to the general
public.
For over 50 years, MERIAL and its predecessors have partnered with Veterinary
Authorities throughout the world in their fight against FMD. As a result,
MERIAL has gained significant expertise in FMD and can offer today a range
of more than 30 FMD vaccine strains and a variety of formulations. The MERIAL
FMD vaccine portfolio is broad and conceived as a versatile and adaptable
FMD vaccine tool-kit, unlike any other offered in the world.
MERIAL
MERIAL supplies vaccines to more than 50 countries around the world and
is responsible for one in five of all FMD vaccinations. These vaccines are
produced in two high security bio-containment production facilities of which
our Pirbright plant is one. The other is in Brazil.
While disease-free countries deploy considerable measures to control possible
outbreaks and eliminate the virus by culling infected herds and controlling
animal movements, in the event that the disease may spread, emergency vaccination
may be practised as an adjunct to the control and eradication measures. Emergency
vaccination relies on rapid availability of highly potent, antigenically
appropriate, safe vaccines, capable of inducing early protection with a single
dose and dramatically reducing virus replication in vaccinated livestock
when exposed to infection.
MERIAL has established antigen banks for most FMD-free countries around
the world and is capable of supplying emergency vaccines at short notice
to 20 countries and international organisations. The concentrated antigens
are stored in liquid nitrogen where they are very safe and stable. Upon request
by the subscriber, concentrated FMD antigen reserves are rapidly transformed
into vaccines before being delivered to the outbreak areas. It was from the
UK strategic reserve that MERIAL formulated within two days 300,000 doses
of FMD vaccines to be kept on stand-by in case the outbreak escalated and
the relevant authorities decided to vaccinate. In another example, MERIAL
previously delivered 5.66 million doses of FMD vaccines to the Turkish government
within ten working days of their request to activate their antigen bank.
MERIAL facilities at Pirbright represent a unique resource as one of the
very few centres to have maintained the expertise and the biosafety level
laboratory facilities required to produce FMD vaccines. It is located on
premises shared by the internationally recognised FMD reference laboratory,
the Institute of Animal Health, with whom we cooperate at a research level
and which is situated close to London’s international airports to facilitate
rapid despatch of vaccines around the world.
MERIAL has been producing FMD vaccines at the Pirbright site for 15 years
and employ approximately 80 people there, mostly from the local area, in
vaccine production.
BTV
As outlined above, the latest animal disease to appear in Europe is BTV.
Pirbright is not only a centre for FMD vaccine manufacture for MERIAL, it
also our main site for Bluetongue Virus vaccines. As you will know, bluetongue
has now reached the UK, having infected cattle and sheep in several countries
on the continent and there is much veterinary and farming concern here.
We have developed a range of inactivated BTV vaccines as part of the comprehensive
European control strategy which seeks to mitigate the impact of several BTV
viruses introduced in Europe between 2000 and 2007. We recently invested £10m
in the state-of-the art bio-secure facilities at Pirbright to produce these
vaccines. Merial has been developing a vaccine against BTV8, the strain that
has been found in the U.K, for the past six months. If full vaccine production
can be restored at Pirbright during October, we would expect to be able to
provide BTV8 vaccine by early summer 2008.
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