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Vaccine development in Russia:
current situation and prospects
Prof. I.V. Krasilnikov
Mass immunization allows to:
• decrease the child death rate;
• lengthen live expectancy;
• raise quality of life;
• decrease the risk of invalidization and loss of work capacity.
Cost-effectiveness of vaccication in thousand of rubls .
45
40
35
30
25
20
15
10
5
0
The economic loss
The cost of
The economic loss
The cost of
of 1 case of flu vaccination against
of 1 case of
vaccination against
flu for 1 person
Hepatitis B
Hepatitis B
Vision: a world in 2015 in which:
•
immunization is highly valued;
•
every child, adolescent and adult has equal access to immunization as
provided for in their national schedule;
•
more people are protected against more diseases;
•
immunization and related interventions are sustained in conditions of
diverse social values, changing demographics and economies, and evolving
diseases;
•
immunization is seen as crucial for the wider strengthening of health
systems and a major element of efforts to attain the Millennium
Development Goals;
•
vaccines are put to best use in improving health and security globally; and
•
solidarity among the global community guarantees equitable access for all
people to the vaccines they need.
Global Immunization Vision and Strategy (GIVS) for 2006-2015
(Adopted at the fifty-eighth World Health Assembly, 28.04.2005)
National immunization programmes
In developed countries
(the USA, Great Britain, Germany,
Australia etc.)
In the Russian Federation
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Measles
Mumps
Rubella
Poliomyelitis
Diphtheria
Tetanus
Pertussis
Hepatitis Р’
Influenza (since 2006)
Tuberculosis
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Measles
Mumps
Rubella
Poliomyelitis
Diphtheria
Tetanus
Pertussis
Hepatitis Р’
Influenza
Pneumococcal infection
Haemophilus influenzae type b
(Hib)
Vaccine production and R&D priorities for
Russian biopharmaceutical industry
• To develop and launch for public use:
a Hib Vaccine;
a Hepatitis C Vaccine;
an AIDS Vaccine;
a Human Papilloma Vaccine.
• To create new antigen delivery systems and vaccines in
different forms (nasal spray, emulsions and etc.).
• To develop new combined vaccines, gene engineering
vaccines and therapeutic vaccines.
WHO Global Pandemic Influenza Action Plan to Increase
Vaccine Supply (GAP)
Objective: To increase the supply of a pandemic vaccine and thereby reduce the
gap between the potential vaccine demand and supply anticipated during an
influenza pandemic (November 2006)
•
Increase in seasonal vaccine use
Increased use of seasonal influenza vaccine will reduce disease burden of
seasonal influenza infections, contribute towards the preparedness of countries
to respond to an eventual pandemic and motivate industry to develop greater
capacity for manufacturing vaccines.
•
Increase in vaccine production capacity
Short term: Produce enough vaccine to immunize two billion people; this vaccine
should be available on the market six months after transfer of the vaccine
prototype strain to industry.
Medium and long term: Produce enough vaccine to immunize the world's
population (6.7 billion)
•
Further research and development
The development of more effective influenza vaccines using new technologies.
WHO Global Pandemic Influenza Action Plan to
Increase Vaccine Supply (GAP)
The ideal product profile is a vaccine which:
is safe and highly protective, preferably in all target groups, including infants,
the elderly, pregnant women and immunosuppressed individuals;
is easily and inexpensively produced on a large scale;
is effective – preferably with a low dose of antigen;
is delivered, ideally, as a single dose,
is thermostable; and
offers protection for a minimum duration of one year, including protection
against antigenically drifted viruses.
Vaccine for Humans against the Avian Influenza Virus
H5N1 has been successfully developed in RF
Three pre-pandemic vaccine candidates based on the H5N1 avian
influenza virus strain NIBRG-14 (A/VietNam/1194/ 2004/A/PR8)
received from NIBSC and the H5N2 avian influenza virus strain
A/17/Duck/Potsdam/86/92 [Len17/H5] developed by the Russian
scientists were designed in the company production sites in Ufa and
Irkutsk. They are:
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Inactivated subunit adjuvanted with aluminum hydroxide
Inactivated split adjuvanted with aluminum hydroxide
Live attenuated influenza vaccine (LAIV) stabilized with M-2
Clinical studies of prepandemic vaccines
H5N1 inactivated prepandemic vaccines:
Clinical base: Research Institute of Influenza RAMS in St. Petersburg and
Mechnikov Research Institute of Vaccines and Sera in Moscow.
Dose, Volume, Route: 2 intramuscular doses of the vaccine with 15, 30 and 45
Ојg of HA in 0.5 ml, administrated 28 days apart.
The number of participants: about 600 healthy adults.
H5N2 LAIV candidate (6,9 and 7,5 lg EID50/0,5 ml):
Clinical base: Clinic # 163 of the Federal Medicobiological Agency of Russia
(Novosibirsk region) and Military Hospital # 1137 (Moscow region)
Dose, Volume Route: 2 intranasal doses sprayed 0,25 ml into each nasal track
(0,5 ml dose)
with a 10 and 21 day’s intervals.
The number of participants: 220 healthy adults.
Pre-clinical and clinical trials demonstrated safety, areactogenicity and high
immunogenicity of all pre-pandemic vaccine candidates. They have induced a
strong protection against the homologous vaccine strains and the other
heterologous H5N1 HPAIV strains including the Russian epidemic isolate
A/Chicken/Kurgan/Russia/2/2005 (H5N1).
OrniFluВ®, an inactivated subunit influenza vaccine, and
UltragrivakВ®, a live influenza vaccine, are licensed in the
Russian Federation.
Microgen State Scientific Industrial Company is ready to start
a large-scale production of avian influenza vaccines for
humans in the amount that will allow to provide the Russian
population with the vaccine in full.
Did I tell you there will be
no avian
influenza !
H1N1v influenza vaccines
Microgen has designed two pandemic vaccines,
an inactivated subunit and LAIV, against new H1N1v
influenza strain on the base of our previously
developed pre-pandemic avian flue vaccines.
The clinical evaluation of these candidate vaccines has
been started in September and mass production is
planned to be launched in November 2009.
DEVELOPMENT OF AN ACELLULAR PERTUSSIS
VACCINE
• An acellular pertussis vaccine developed in Microgen Scientific
Industrual Company is less likely to provoke adverse events
compared to a whole-cell pertussis vaccine because it contains
purified antigenic components of Bordetella pertussis. In terms
of immunogenicity it possesses the same capacity to confer
protection upon humans. The acellular vaccine demonstrated:
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a 3-fold decrease in acute toxicity LD50,
a 100-fold decrease in anaphylactogenicity,
a 120-fold decrease in pyrogenicity,
a 9-fold decrease in HSD50,
a 19-fold decrease in leucocytosis.
Pre-clinical evaluation of the vaccine candidate has proved its
safety, high histamine-sensitizing activity and protective
potency.
DEVELOPMENT OF A NEW CLASS OF VACCINES
THAT ACTIVATE INNATE IMMUNITY
•
A polybacterial vaccine Immunovac VP-4 composed of S.Aureus,
E.Coli, K.Pneumonia, P.Vulgaris antigen complexes has been created
in close collaboration with I. Mechnikov Research Institute for Vaccines
and Sera, RAMS.
•
The clinical studies of the vaccine have shown its high efficacy, safety,
good tolerability and prolonged and potent therapeutic and prophylactic
effect. High immunogenicity of the vaccine preparation can be
explained by the phenomenon of cross-immunity while safety is
obtained by the decrease of antigenic load. The polybacterial vaccine
exerts a positive effect on different diseases:
- bronchial asthma – 71%
- chronic bronchitis – 95%
- lung abscess – 75%
- herpes – 90%
DEVELOPMENT OF A NEW CLASS OF VACCINES
THAT ACTIVATE INNATE IMMUNITY
Immunoprophylactics with Immunovac VP-4 allows to indicate:
- 11 time relapse rate reduction in sickly and chronic children during 7
months,
- 3 time acute respiratory disease rate decrease in sickly and chronic
children during 12 months,
- 6 time allergy disease severity (in scores) decrease,
- 50% or more tumor size reduction in oncological processes.
DEVELOPMENT OF A RUBELLA VACCINE
In 2007-2008 cell culture-based rubella vaccine technology in MRC-5
(Stanley A. Plotkin) was developed. The production strains, the seed
strains and all the intermediate passages of rubella virus strains have
been obtained. The control tests to determine their biological sterility,
specific activity, physico-chemical properties and the absence of
mycoplasma have been performed. The vaccine candidate has
entered Phase I clinical trials.
The benefits:
- there is no analogues produced in Russia,
- simple and cost-efficient vaccine production technology in MRC-5
human diploid-cell culture allows rubella virus to be grown at high
concentrations,
- the series of the vaccine candidate for children are sorbitol based,
there is no nutrient medium added, which allows to decrease ballast
protein concentration.
Thank you for
attention
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