Microgen: First Manufacturer of Rubella Vaccine in Russia

Progress toward Rubella Elimination and CRS prevention in Europe

8-10 February, 2012 Rome

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

State Report 2012, the State Sanitary Epidemiological Surveillance Service of the Russian Federation

Microgen’s geography

Moscow (2) Perm (Biomed) Nizhniy Novgorod (ImBio) Tomsk (Virion) Yekaterinburg

Irkutsk

Stavropol (Allergen) Ufa (Immunopreparat) Makhachkala

Omsk

Tumen

Khabarovsk Belorechensk

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

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

Pic.1. Undamaged neurons in peritraumatic zone Pic.2.Glio-mesodermal scar in thalamus

Preclinical animal studies demonstrated

safety of the vaccine

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• JOURNAL 1 Unpublished; 2 Submitted (24-MAR-2011) ; 3 Submitted (30-JUN-2011) Microgen, Federal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)

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)

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

Thank you

for attention