Communication from the Ministry of Health No. 375 / 2024 Coll.
Communication from the Ministry of Health on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2025
Valid
Communication
Text versions:
10.12.2024
Zobrazeno prvních 200 z celkem 300 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
375
COMMUNICATION
Ministry of Health
of 5 December 2024
on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2025
The Ministry of Health according 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 2025 based on 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) 2.4 (30 Lf)
Tetanus toxoid not less than 40 international units (IU) 3.4 (10 Lf)
Bordetella pertussis antigens
Pertussis toxoid 25 micrograms
Pertussis haemagglutinin Filamentosum 25 micrograms
Poliomyelitidis virus (inactivated) 5
type 1 (Mahoney) 29 D units antigen6
Type 2 (MEF-1) 7 D units of antigen
Type 3 (Saukett) 26 D units of antigen
Tegiminis hepatitis B antigen 7 10 micrograms
Haemophili influenzae type B polysaccharide (Polyribosylribitol phosphate) 12 micrograms
coniugatum cum tetani protein 22-36 micrograms
Adsorbed on aluminium hydroxide, hydrated (0,6 mg Al3 +)
2 As a lower confidence limit (p = 0.95) and not less than 30 IU as mean
3 As a lower confidence limit (p = 0,95)
4 or equivalent activity determined by immunogenicity assessment
5 Cultured on Vero cells
6 These amounts of antigen are exactly the same as those previously expressed as 40- 8- 32 D antigen units for virus types 1, 2 and 3, when measured by another appropriate immunochemical method.
7 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 IU6
Tetanus toxoid1 not less than 40 IU6
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.
6 or equivalent activity determined by immunogenicity evaluation
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
Pertactin 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:
After reconstitution, 1 dose (0,5 ml) contains:
Haemophilus influenzae type b polysaccharide 10 micrograms
conjugated with tetanus toxoid as a protein carrier of 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:
1 dose of reconstituted vaccine (0.5 ml) 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:
One dose (0,5 ml) contains:
Inactivated type 1 poliomyelitis virus (Mahoney)..... 29 antigenic D units * *
Inactivated type 2 virus (MEF-1)..... 7 antigenic D units * *
Virus poliomyelitis inactivated type 3 (Saukett)....... 26 antigenic D units * *
* Cultured on VERO cells
* * These amounts of antigen are exactly the same as those previously expressed as 40-8- 32 D antigen units for virus types 1, 2 and 3, when measured by another appropriate immunochemical method.
1ch) 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)
OR
1cha) Pneumococcal infections vaccines used in the sequential schedule:
1chaa) the conjugated vaccine contains:
Streptococci pneumoniae serotypi 11,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 31,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 41,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 51,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 6A1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 6B1,2 polysaccharide 4,0 micrograms
Streptococci pneumoniae serotypi 7F1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 9V1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 141,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 18C1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 19A1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotype 19F1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 22F1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 23F1,2 polysaccharide 2,0 micrograms
Streptococci pneumoniae serotypi 33F1,2 polysaccharide 2,0 micrograms
1Conjugated with protein carrier CRM197. CRM197 is a non-toxic mutation of diphtheric toxin (originating in Corynebacterium diphtheriae C7) recombinant expressed in Pseudomonas fluorescens.
2Adsorbed on aluminium phosphate adjuvant.
A
(b) the polysaccharide vaccine contains:
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
(1chb) pneumococcal infections vaccines used in the sequencing scheme:
1chba) the 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
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Communication from the Ministry of Health No. 375 / 2024 Coll., on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2025 |
|---|---|
| Regulation Type | Communication |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.12.2024 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
Public Contracts 5
dodávka očkovací látky IMOVAX POLIO proti dětské přenosné obrně v inaktivované formě
Zdravotní pojišťovna ministerstva vnitra České rep...
Avenier a.s.
16.12.2025
Notifications
Předmětem Dodatku je doplnění nového balení, resp. nového SÚKL kódu, dodávané očkovací látky IMOVAX...
VŠEOBECNÁ ZDRAVOTNÍ POJIŠŤOVNA ČESKÉ REPUBLIKY
Avenier a.s.
15.12.2025
Notifications
Dodatek č.1 ke smlouvě o zajištění komplexní dodávky a distribuce LP obsahujících očkovací látky pro...
Vojenská zdravotní pojišťovna České republiky
Avenier a.s.
13.12.2025
Notifications
Pravidelná očkování 2026 až 2029
Zdravotní pojišťovna ministerstva vnitra České rep...
Avenier a.s.
3 160 789 643 CZK
23.10.2025
Nové SÚKL kódy 0280502 u OL proti záškrtu, tetanu a dáv.kašli, 0259526 u OL proti dětské obrně, 026...
Česká průmyslová zdravotní pojišťovna
Avenier a.s.
27.02.2025
Notifications
Source:
Hlídač státu
(CC BY 3.0 CZ)
The regulation text is for informational purposes only.
Comments 0