Communication from the Ministry of Health No 420 / 2023 Coll.
Communication from the Ministry of Health on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2024
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29.12.2023
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420
COMMUNICATION
Ministry of Health
of 19 December 2023
on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2024
The Ministry of Health pursuant to § 80 (1) (e) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended, provides for the antigenic composition of vaccines for regular, special and exceptional vaccination for 2024 on the basis of recommendations from the National Immunisation Commission:
1. Antigenic composition of vaccines for periodic vaccination
(1a) combined diphtheria vaccine, coughs (acellular form), tetanus, polio-transmitted child (inactivated form), hepatitis B viral, Haemophilus influenzae type b disease (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
OR
1ab) Diphtheria, tetanus, cough (acellular component), hepatitis B (rDNA), polio (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
One dose (0,5 ml) contains:
Diphtheria toxoid1 not less than 20 IU
Tetanus toxoid1 not less than 40 IU
Antigena Bordetellae pertusis 1
Pertussis toxoid (PT) 20 micrograms
Haemagglutinium filamentosum (FHA) 20 micrograms
Pertactin (PRN) 3 micrograms
Fimbriae type 2 et 3 (FIM) 5 micrograms
Hepatitis B surface antigen 2,3 10 micrograms
Poliomyelitis virus (inactivated) 4
Type 1 (Mahoney) 40 D antigen units 5
Type 2 (MEF-1) 8 D units of antigen 5
Type 3 (Saukett) 32 D units antigen 5
Polysaccharides Haemophili influenzae type b
(Polyribosylribitol phosphate) 3 micrograms conjunctum cum protein meningococci type b2 50 micrograms
1 adsorbed on aluminium phosphate (0,17 mg Al3 +)
2 adsorbed on aluminium sulphate hydrated hydroxide (0,15 mg Al3 +)
3 produced by recombinant DNA technology in yeast cells Saccharomyces cerevisiae
4 reproduced on Vero cells
5 or equivalent antigen levels determined by an appropriate immunochemical method.
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 (Tdap)
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 (Tdap)
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 culture503
Parotitidis virus attenuatum1 (RIT 4385) min. 103,7 infectious dose for cell culture503
Rubeolae Attenuatum2 virus (Wistar RA 27 / 3) min. 103,0 infectious dose for cell culture503
1 propagated on chicken embryo cells
2 reproduced in human diploid cells (MRC-5)
3 50% infectious dose of tissue culture
OR
1ga) 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 Lynn ™ 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.
(1h) an anti-polio vaccine in inactivated form:
Each dose contains:
Inactivated type 1 (Mahoney) poliomyelitis virus.... 40 antigenic D units *
Inactivated type 2 virus (MEF-1)..... 8 antigenic D units *
Inactivated type 3 poliomyelitis virus (Saukett)..... 32 antigenic D units *
* or the amount of equivalent antigens determined using an appropriate immunochemical method.
1ch) pneumococcal infections vaccines used in the sequential schedule:
1cha) conjugated vaccine 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 2,2μ g
Streptococci pneumoniae polysaccharide serotype 19A1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 19F1 2,2 μg
Streptococci pneumoniae polysaccharide serotype 23F1 2,2 μg
1Conjugated with CRM197 carrier protein and adsorbed on aluminium phosphate (0,125 mg aluminium).
A
1chb) anti pneumococcal infections
25 micrograms of the following 23 pneumococcal polysaccharide serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F.
OR
1chc) conjugate vaccine against pneumococcal infections
One dose (0,5 ml) contains:
Polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 1 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 3 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 4 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 5 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 6A 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 6B 1,2 4,4 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 7F 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 8 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 9V 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 10A 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 11A 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 12F 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 14 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 15B 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 18C 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 19A 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 19F 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 22F 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 23F 1,2 2,2 μg
polysaccharide bacterium (pneumococca) Streptococcus pneumoniae serotype 33F 1,2 2,2 μg
1Conjugation with CRM197 carrier protein (approximately 51 μg per dose)
2Adsorbed on aluminium phosphate (0.125 mg aluminium per dose)
1i) diphtheria vaccine, coughs (acellular form), tetanus, polio communicable to children (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
1adsorbed on aluminium hydroxide, hydrated (Al (OH) 3) 0,3 milligrams Al3 + and aluminium phosphate (AlPO4) 0,2 milligrams Al3 +
2multiplied on VERO cells
OR
1ia) Diphtheria vaccine, coughs (acellular form), tetanus, polio (inactivated form):
One dose (0,5 ml) contains:
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Regulation Information
| Citation | Communication from the Ministry of Health No 420 / 2023 Coll., on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2024 |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.12.2023 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
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