Communication from the Ministry of Health No 249 / 2018 Coll.
Communication from the Ministry of Health on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2019
Valid
249
COMMUNICATION
Ministry of Health
of 25 October 2018
on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2019
The Ministry of Health pursuant to Section 80 (1) (e) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related acts, as amended, provides for the antigenic composition of vaccines for regular, special and exceptional vaccination for 2019, on the basis of recommendations from the National Immunisation Commission:
1. Antigenic composition of vaccines for periodic vaccination
(1a) a combined diphtheria vaccine, an acellular cough, tetanus, polio (inactivated form), hepatitis B viral, Haemophilus influenzae type b (DTaPHibVHBIPV):
After reconstitution, 1 dose (0,5 ml) contains:
Diphtheria toxoid1 not less than 30 international units (IU)
Tetanus toxoid1 not less than 40 International Units (IU)
Bordetella pertussis antigens:
Pertussis toxoid (PT) 1 25 micrograms
Pertussis haemagglutinin Filamentosum (FHA) 1 25 micrograms
Pertactin (PRN) 1 8 micrograms
Hepatitis B (HBs) surface antigen 2,3 10 micrograms
Inactivated poliomyelitis virus (IPV)
type 1 (Mahoney strain) 4 40 D antigen units
Type 2 (MEF-1 strain) 4 8 D antigen units
type 3 (Saukett strain) 4 32 D antigen units
Haemophilus influenzae type b polysaccharide
(Polyribosylribitol phosphate) 10 micrograms
conj. cum atox. tetanus as carrier protein approximately 25 micrograms
1 adsorbed on aluminium hydroxide, hydrated (Al (OH) 3) 0,5 milligrams Al3 +
2 produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)
3 adsorbed on aluminium phosphate (AlPO4) 0,32 milligrams Al3 +
4 reproduced on VERO cells
OR
1aa) a combined diphtheria vaccine, an acellular cough, tetanus, polio (inactivated form), hepatitis B viral, Haemophilus influenzae type b (DTaPHibVHBIPV)
One dose of 1 (0,5 ml) contains:
Diphtheria toxoid not less than 20 international units (IU) 2
Tetanus toxoid not less than 40 International Units (IU) 2
Bordetella pertussis antigens
Pertussis toxoid 25 micrograms
Haemagglutinum filamentosum 25 micrograms
Poliomyelitidis virus (inactivated) 3
type 1 (Mahoney) 40 D units of antigen 4
Type 2 (MEF-1) 8 D units of antigen 4
Type 3 (Saukett) 32 D units antigen 4
Hepatitis B5 10 micrograms
Polyribosylribitol phosphate haemophili influenzae B 12 micrograms
(Polyribosylribitol phosphate)
conjugata cum tetanus toxoid 22-36 micrograms
1 adsorbed on aluminium hydroxide, hydrated (0,6 mg Al3 +)
2 as the lower confidence limit (p = 0,95)
3 reproduced on VERO cells
4 or equivalent antigen levels determined by an appropriate immunochemical method
5 produced by recombinant DNA technology in Hansenula polymorpha yeast cells
(1b) diphtheria, coughs (acellular form), tetanus (DTaP) vaccine:
Each dose (0,5 ml) contains the following active substances:
Diphtheria toxoid * ≥ 30 IU
Tetanus toxoid * ≥ 40 IU
Pertussis toxoid * (PT) 25 micrograms
Pertussis haemagglutinum filamentosum * (FHA) 25 micrograms
Pertactin * (69kD) 8 micrograms
* adsorbed on aluminium hydroxide total: 0,5 milligrams
OR
1ba) Diphtheria, tetanus and acellular cough vaccine with reduced antigens
One dose (0,5 ml) contains:
Diphtheria toxoid - Minimum 2 IU * (2 Lf)
Tetanus toxoid - Minimum 20 IU * (5 Lf)
Pertussis antigens
Pertussis toxoid - 2,5 micrograms
Haemagglutinum filentosum - 5 micrograms
Pertactin - 3 micrograms
Fimbriae, type 2 et 3 - 5 micrograms
Adsorbed on aluminium phosphate - 1,5 mg (0,33 mg aluminium)
* As the lower limit of the confidence interval (p = 0,95) of the activity measured according to the test described in the European Pharmacopoeia.
OR
1bb) Diphtheria, tetanus and cough (acellular component) vaccine with reduced antigens
One dose (0,5 ml) contains:
Diphtheria toxoid1 not less than 2 International Units (IU) (2,5 Lf)
Tetanus toxoid1 not less than 20 International Units (IU) (5 Lf)
Bordetellae pertussis antigen:
Pertussis toxoid1 8 micrograms
Pertussis haemagglutine filamentosum 1 8 micrograms
Pertussis membranae Extra protein 1 2.5 micrograms
1 adsorbed on aluminium hydroxide, hydrated (Al (OH) 3) 0,3 milligrams Al3 +
and aluminium phosphate (AlPO4) 0,2 milligrams Al3 +
1c) Haemophilus influenzae disease vaccine type b:
Each dose of lyophilised vaccine contains:
Hib purificatum (10 micrograms) cum Anatoxin tetanico (approximately 25 micrograms).
1d) tetanus vaccine:
Each dose contains:
Tetani toxoid - min. 40 international units
1e) hepatitis B viral vaccine in children's formula:
Each dose contains:
Hepatitis B - 10 micrograms
1f) an adult hepatitis B vaccine
Each dose contains:
Hepatitis B antigen - 20 micrograms
1g) measles, mumps and rubella vaccine:
Each dose contains:
Morbillorum virus attenuatum1 (Schwarz) min. 103,0 infectious dose for cell culture350
Parotitidis virus attenuatum1 (RIT 4385, derived from Jeryl Lynn strain) min. 103,7 infectious dose for cell culture350
Rubeolae attenuatum2 virus (Wistar RA 27 / 3) min. 103,0 infectious dose for cell culture350
1 propagated on chicken embryo cells
2 reproduced in human diploid cells (MRC-5)
3 50% infectious dose of tissue culture
OR
1h) measles, mumps and rubella vaccine
After reconstitution, one dose (0,5 ml) contains:
Virus morbillorum1 attenuated vivum (Enders' Edmonston strain) not less than 1x103 CCID50 *
Parotitidis1 virus attenuated (Jeryl LynnTM strain, level B) not less than 12,5x103 CCID50 *
Rubeolae2 virus attenuated (Wistar RA 27 / 3 strain) not less than 1x103 CCID50 *
* 50% cell culture infectious dose
1 produced on chicken embryo cells.
2 made on human diploid pulmonary WI-38 fibroblasts.
1ch) an anti-polio vaccine in inactivated form:
Each dose contains:
Inactivated type 1 virus (Mahoney)..... 40 antigenic D units *
Inactivated type 2 virus (MEF-1)..... 8 antigenic D units *
Inactivated type 3 virus (Saukett)... 32 antigenic D units *
* or the amount of equivalent antigens determined using an appropriate immunochemical method.
(i) a vaccine conjugated against pneumococcal infections:
Each dose contains:
Streptococci pneumoniae polysaccharide serotype 11 2,2 μg
Streptococci pneumoniae polysaccharide serotype 31 2,2 μg
Streptococci pneumoniae polysaccharide serotype 41 2,2 μg
Streptococci pneumoniae polysaccharide serotype 51 2,2 μg
Streptococci pneumoniae polysaccharide serotype 6A1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 6B1 4,4 μg
Streptococci pneumoniae polysaccharide serotype 7F1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 9V1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 141 2,2 μg
Streptococci pneumoniae polysaccharide serotype 18C1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 19A1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 19F1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 23F1 2,2 μg
1 Conjugated with CRM197 carrier protein and adsorbed on aluminium phosphate (0,125 mg aluminium).
1j) Diphtheria vaccine, coughs (acellular form), tetanus, polio (inactivated form):
One dose (0,5 ml) contains:
Diphtheria toxoid1 - not less than 2 International Units (IU) (2,5 Lf)
Tetanus toxoid1 - not less than 20 international units (IU) (5 Lf)
Bordetellae pertussis antigen:
Pertussis toxoid1 - 8 micrograms
Pertussis haemagglutinum filamentosum 1 - 8 micrograms
Pertactin1 2,5 micrograms
Inactivated poliomyelitis virus:
type 1 (Mahoney strain) 2 - 40 D antigen units
Type 2 (MEF-1 strain) 2 - 8 D antigen units
Type 3 (Saukett strain) 2 - 32 D antigen units
1 adsorbed on aluminium hydroxide, hydrated (Al (OH) 3) 0,3 milligrams Al3 + and aluminium phosphate (AlPO4) 0,2 milligrams Al3 +
2 reproduced on VERO cells
1k) tuberculosis (BCG vaccine)
1l) hepatitis B viral vaccine for persons included in the dialysis programme:
One dose (0,5 ml) of vaccine contains:
Hepatitis B1,2,3 - 20 micrograms
1 adjuvanted to AS04C containing: -3-O-deacyl-4 '-monophosphoryl lipid A (MPL) 2 50 micrograms
2 adsorbed on aluminium phosphate (total 0,5 milligrams Al3 +)
3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
2. Antigenic composition of vaccines for specific vaccination
2a) Hepatitis B viral vaccine in adult formula:
Each dose contains:
Hepatitis B antigen - 20 micrograms
(2b) rabies vaccine
2c) Viral hepatitis vaccine And in the adult formula:
Each dose contains:
Hepatitis A Inactivated Virus
2d) measles, mumps and rubella vaccine
Morbillorum virus attenuatum1 (Schwarz) min. 103,0 infectious dose for cell culture350
Parotitidis virus attenuatum1 (RIT 4385) min. 103,7 infectious dose for cell culture350
Rubeolae attenuatum2 virus (Wistar RA 27 / 3) min. 103,0 infectious dose for cell culture350
1 propagated on chicken embryo cells
2 reproduced in human diploid cells (MRC-5)
3 50% infectious dose of tissue cultures
OR
1h) measles, mumps and rubella vaccine
After reconstitution, one dose (0,5 ml) contains:
Virus morbillorum1 attenuated vivum (Enders' Edmonston strain) not less than 1x103 CCID50 *
Parotitidis1 virus attenuated (Jeryl LynnTM strain, level B) not less than 12,5x103 CCID50 *
Rubeolae2 virus attenuated (Wistar RA 27 / 3 strain) not less than 1x103 CCID50 *
* 50% cell culture infectious dose
1 produced on chicken embryo cells.
2 made on human diploid pulmonary WI-38 fibroblasts.
3. Antigenic composition of vaccines for emergency vaccination
3a) Viral hepatitis vaccine And in the adult formula:
Hepatitis A Inactivated Virus
3b. Viral hepatitis vaccine And in the formula for children:
Hepatitis A virus inactivated
Minister:
Mgr. et Mgr. Vojtěch, MHA, v. r.
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Regulation Information
| Citation | Communication from the Ministry of Health No. 249 / 2018 Coll., on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2019 |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.10.2018 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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