Microgen: First Manufacturer of Rubella Vaccine in Russia · 2012. 10. 19. · and CRS prevention...
Transcript of Microgen: First Manufacturer of Rubella Vaccine in Russia · 2012. 10. 19. · and CRS prevention...
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Microgen: First Manufacturer of Rubella Vaccine in Russia
Progress toward Rubella Elimination and CRS prevention in Europe
8-10 February, 2012 Rome
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1991, Eliminating measles and rubella and preventing congenital rubella infection:
WHO European Region strategic plan for 2005-2010
1998, Health for All in the Twenty First Century:
WHO global health policy 2007, Prophylactic vaccination: Russian state healthcare programme
for 2007-2011
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State Report 2012, the State Sanitary Epidemiological Surveillance Service of the Russian Federation
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Microgen’s geography
Moscow (2) Perm (Biomed) Nizhniy Novgorod (ImBio) Tomsk (Virion) Yekaterinburg
Irkutsk
Stavropol (Allergen) Ufa (Immunopreparat) Makhachkala
Omsk
Tumen
Khabarovsk Belorechensk
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More than 300 medicines
Vaccines
71,1%
Bacteriophage
s 2,5%
Others 1,9%
Serums 1,8%
Probiotics
2,9%
Blood products
8,8%
Patented
medicines
11,0%
Microgen Scientific Industrial Company
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Measles vaccine
live, dried, strain Leningrad-16
Mumps vaccine
live, dried, strain Leningrad-3
Mumps-measles vaccine
live, dried, strains Len-3, Len-16
Rubella vaccine
live, dried, strain RA 27/3
Erythrostim (EPO):
500 IU, 2000 IU, 3000 IU,
4000 IU
Moscow Plant for Bacterial Preparations
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Pic.1. Undamaged neurons in peritraumatic zone Pic.2.Glio-mesodermal scar in thalamus
Preclinical animal studies demonstrated
safety of the vaccine
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Rubella virus strain RA 27/3, complete genome
• LOCUS JF727653 9762 bp RNA linear VRL 30-JUN-2011
• DEFINITION Rubella virus strain RA 27/3, complete genome.
• ACCESSION JF727653 / JF727654
• VERSION JF727653.2 GI:338858018 / JF727654.2 GI:338858020
• SOURCE Rubella virus
• ORGANISM Rubella virus Viruses; ssRNA positive-strand viruses, no DNA stage; Togaviridae;
Rubivirus.
• REFERENCE 1, 2, 3 (bases 1 to 9762)
• AUTHORS Sidorenko,E.S., Suhanova,L.L., Atrasheuskaya,A.V. and Ignatyev,G.M.
• TITLE Genetic stability and homogeneity of RA 27/3 live attenuated rubella vaccine strain
throughout the manufacturing process
• JOURNAL 1 Unpublished; 2 Submitted (24-MAR-2011) ; 3 Submitted (30-JUN-2011) Microgen, Federal
State Scientific-Industrial Company for Immunobiological Medicines of the Ministry of Health and Social
Development of the Russian Federation, 15, 1-st Dubrovskaya Str., Moscow 115088, Russia
• COMMENT On Jun 30, 2011 this sequence version replaced gi:335347244/ 335347247
/note="master seed; propagated in MRC-5 cell line genotype: 1a”
/note="vaccine final product; propagated in MRC-5 cell line genotype: 1a”
Ref.strain: Wistar RA 27/3 (GenBank acc. no. FJ211588)
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National Immunization Calendar of the Russian Federation
Age Infections
Newborns (0–12 hours after
birth)
Viral Hepatitis B (1st vaccination)
Newborns (3–7 days) Tuberculosis (vaccination)
1 month Viral Hepatitis B (2nd vaccination)
3 months Diptheria, Pertussis, Tetanus, Polio (1st vaccination)
4.5 months Diptheria, Pertussis, Tetanus, Polio (2nd vaccination)
6 months Diptheria, Pertussis, Tetanus, Polio (3rd vaccination)
Viral Hepatitis B (3rd vaccination)
12 months Measles, Rubella, Mumps (vaccination)
18 months Diptheria, Pertussis, Tetanus, Polio (1st revaccination)
20 months Polio (2nd revaccination
6 years Measles, Rubella, Mumps (revaccination)
7 years Diptheria, Tetanus (2nd revaccination)
Tuberculosis (1st revaccination)
13 years Rubella (vaccination for girls)
Viral Hepatitis B (vaccination)
14 years Diptheria, Tetanus (3rd revaccination)
Tuberculosis (2nd revaccination)
Adults Diptheria, Tetanus (revaccination every 10 years after the last
revaccination)
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Acknowledgments • Sidorenko E.S.
– Managing Director, Moscow Plant for Bacterial Preparations
• Sukhanova L.L.
– QA&QC Director, Moscow Plant for Bacterial Preparations
• Ignatyev G.M., Atrasheuskaya E.V.
– study of genetic stability and homogeneity of RA 27/3 live attenuated rubella vaccine strain throughout the manufacturing process
• Sharova O.K.
– pathohistological studies
• The teams of Moscow Plant for Bacterial Preparations and
• Microgen Central Office
– rubella vaccine development and organization of preclinical and clinical vaccine studies
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Thank you
for attention