Pentaxim is a long-awaited vaccine to replace the outdated and very reactogenic DTP. In addition to the traditional three components (K - whooping cough, D - diphtheria, C - tetanus), the new vaccine contains protection against polio (inactivated vaccine) and Haemophilus influenzae infection. This is a very important drug in the vaccination calendar for children. Better tolerability (compared to DPT) is ensured by the acellular pertussis component. For a long time, the vaccine was only available commercially.
The well-known author of a blog about vaccination, Antonina Oblasova, some time ago visited the Russian one, where, as part of a collaboration with Sanofi, the vaccine, Pentaxim, is produced. Today we decided to share with you the blogger’s observations.
Vaccines are not a simple product. Their development and production require enormous costs. It's long and expensive. It’s even longer and more expensive to arrange delivery from abroad. One of the ways to increase the availability of a particular vaccine in a country is to localize production on its territory. And there may be several options. For example, a foreign manufacturing company creates its own plant in this country, or another option is that it is looking for a partner who will produce the vaccine under license and under its control. Modern operates as part of a collaboration with the international French pharmaceutical company Sanofi and produces the well-known vaccine - Pentaxim.
How it works
The plant is a whole complex consisting of several buildings.
At the same time, everything is arranged very conveniently: to move from one building to another, you don’t need to go outside - there is a connecting corridor running along all the buildings.
In the visualization above you can see all the buildings:
No. 1 - warehouse for raw materials and supplies; No. 2 - Administrative building, quality control laboratory;
No. 3 - Production of solid dosage forms; No. 4 - Production of vaccines and genetically engineered drugs; No. 5.
Reserve Corps. Antonina's tour began from building No. 2, where the entire floor is occupied by the quality control service. 120 people work here (which is almost half of all plant employees). The service consists of several laboratories:
- microbiological laboratory
(here everything that goes into production and everything that is released - the final product - is checked for sterility); - biochemical laboratory
(here the concentration of adjuvant and antigens in the vaccine is checked); - chemical analytical laboratory
(here tests are carried out to control the level of formaldehyde and 2-phenoxyethanol in vaccines).
The plant does not have its own vivarium (room for keeping laboratory animals). Therefore, such tests are carried out outsourced.
Composition of the Pentaxim vaccine
The pertussis component of the Pentaxim vaccine is acellular, which significantly reduces the likelihood of fever, swelling at the injection site, and deterioration in the child’s well-being.
The presence of inactivated polio in the composition makes it possible to replace vaccination with other drugs.
The component against hemophilus influenzae infection counteracts diseases such as otitis media, pneumonia, meningitis, septicemia
Pentaxim is an analogue of the domestic DTP vaccine, but the presence of five components allows you to reduce the number of injections, which means less discomfort experienced by the child and the number of complications.
How is Pentaxim created?
Let us remind you that Pentaxim is a 5-component vaccine (against diphtheria, tetanus, whooping cough, polio and invasive infection caused by Haemophilus influenzae type b )
. Therefore, to produce it, you actually need to produce five different vaccines and then combine them. This process is long and can take from 24 to 32 months. Each component is produced in stages:
Stage 1. Production of antigen (active substance of the vaccine). Stage 2. Purification of the antigen from what/in whom it was grown. Stage 3. Formation of the finished dosage form in large volume. Stage 4. The final filling into the container in which the vaccine will go on sale. Stage 5. Packing in cardboard.
All stages are closely related to each other, and there are also special rules. The first two stages must be carried out in one place. And only starting from the third, production can be transferred to the capacities of other factories. For example, the produced “concentrate” is sent to another plant for further finishing to the required concentration and bottling. Another option is to move the finished vaccine in large volumes to a subsidiary where only bottling and packaging will be carried out.
How is Pentaxim produced?
From the parent company of Sanofi in France, the liquid vaccine against diphtheria, whooping cough, tetanus and polio (Tetraxim) comes in large containers (the so-called “in bulk”) and is separately packaged in vials - lyophilisate (powder) of component No. 5 (for hemophilus influenzae infection).
What is happening at our Russian plant?
Here, the incoming vaccine is inspected, filled into individual syringes on a fully automated line, packaged into blisters and then into a cardboard box. It seems nothing complicated... However, it took 4 years to localize just this stage!
This may be news to some, but biopharma is a very regulated and complex area. It really takes years from the inception of an idea to its implementation, even if you just need to reproduce a ready-made technology at a new plant. For example, in order to launch equipment that has been delivered for several months, you need to first qualify it: prove and document that it works as it should. Not to mention training employees, describing departmental interaction processes, etc.
Let's return to the production of Pentaxim. The owner of the brand is Sanofi, which means that production at our Russian plant must comply with European standards. To ensure the quality of the products produced, all employees had to undergo training at the mother plant in France.
Directions for use and doses
Primary vaccination is carried out according to the Russian Federation preventive vaccination calendar at 3, 4.5 and 6 months, revaccination at 18 months. On the recommendation of a doctor, vaccination and booster immunization (re-vaccination) can be carried out according to an individual schedule. A single dose of the vaccine is 0.5 ml.
If the child is not currently scheduled to be vaccinated against hemophilus influenzae, it is possible to use only the vaccine in a syringe for the prevention of diphtheria and tetanus; whooping cough and poliomyelitis, without diluting it in a bottle with a lyophilisate containing 1 dose of Haemophilus influenzae B polysaccharide conjugated with tetanus toxoid.
Quality control
How does the quality control department work at ? The laboratories are equipped with a computer system to which all the equipment used to test products is connected. The results of all tests immediately go there and this “primary data” can no longer be deleted. If suddenly during the release control process it turns out that something is wrong with a batch of vaccine, it will be impossible to hide it. In addition, samples from each series are archived. They will be needed for investigation if the vaccine is suddenly suspected of causing harm. And they are stored for the entire shelf life of the vaccine!
Do I need to get the Pentaxim vaccine?
Vaccination is the only possible way to prevent a child from contracting diseases that cause serious complications. The immunobiological drug Pentaxim promotes the formation of reliable immunity against five serious diseases characteristic of childhood. It is a safe and effective vaccine that contains no toxic components and rarely causes adverse reactions.
If parents do not trust public clinics, they have the right to purchase the vaccine themselves and get vaccinated in a private clinic. Analogues of Pentaxim include DTP, Infanrix and Infanrix Hexa, Tetraxim. You should not completely refuse vaccination, because the risk of developing severe reactions to the drug is much lower than the risk of contracting dangerous diseases.
Quality Management System
It is difficult to deny that there is some mistrust of Russian production. We are already accustomed to the fact that many people cheat, passing off their work as high-quality. Unfortunately, this is everywhere and it has become the norm. Surprisingly, it turns out that this can be “cured.” To minimize the human factor (negligence, unprofessionalism, selfishness, accidents, etc.), the GMP (Good Manufacturing Practice) QUALITY MANAGEMENT SYSTEM is in place. This is modern protection that reduces risks to a minimum. It does not allow the manufacturer to deviate from protocols, hide information, or produce low-quality products.
GMP implies regular checks (audits), not only internal, but also external. And not only by “regulatory authorities” (Roszdravnadzor), but also by representatives from other pharmaceutical factories. Lists of these audits hang on the information stand at the plant. At the time of Antonina’s presence at the plant, the list consisted of 26 items over 2 years. If you count, this is more than once a month.
Roszdravnadzor, of course, checks on “its” points, but it does not know exactly how production should work. Any flaws can only be seen by people who themselves work every day on the same production lines, equipment, etc. Such additional mutual control, as objective as possible in biopharma, is a necessity, because the cost of errors is very high!
ASKO-MED-PLUS LLC expresses its sincere gratitude
to Antonina Oblasova for providing the materials.
Side effects
If the instructions are followed and administered correctly, the vaccine is well tolerated by the child's body, but in some cases the following side effects are possible:
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- fatigue, moodiness and drowsiness;
- headache;
- increase in body temperature to 38 degrees and above;
- digestive disorders (nausea, changes in appetite, diarrhea);
- deterioration of general health, sleep disturbances;
- pain, swelling, infiltration at the injection site;
- allergic reactions up to anaphylactic shock;
- muscle and joint pain, swelling;
- apnea.
Most often, side effects from the administration of Pentaxim are observed in premature infants or when the rules of administration are violated. Infiltration, a slight increase in temperature and moodiness in a child are considered normal - such symptoms, as a rule, go away on their own after a few days. To reduce the risk of developing unwanted reactions, the child must be shown to a doctor before vaccination.
When should the Pentaxim vaccine not be given?
- if the test results do not comply with the standards
- at elevated temperature in a child
- in case of intolerance to the components contained in the Pentaxim vaccine
- during exacerbation of chronic diseases
- in other cases mentioned by the pediatrician before vaccination
Additional Information
Is it possible to buy Petaxim from us or where to buy Petaxim in Moscow?
Family Medical does not sell the Petaxim vaccine, we vaccinate.
Where to get the Petaxim vaccination in Moscow?
You can get the Petaxim vaccination at the Family Medical Center, the Petaxim vaccine is available. Vaccination requires a mandatory examination before vaccination, the vaccination itself and observation after vaccination.
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PricesSpecialistsSign upContacts
| Name of service | |
| Reception | |
| Examination by a doctor before vaccination | 1600 |
| Examination by a doctor before tuberculin diagnostics | 800 |
| TUBERCULIN DIAGNOSIS | |
| Tuberculin (Mantoux test) | 1200 |
| Diaskintest (testing) | 2800 |
| PREVENTION OF HEPATITIS B | |
| Engerix B (for children) - vaccination against hepatitis B | 900 |
| Engerix B (for adults) - vaccination against hepatitis B | 1000 |
| Regevak B - vaccination against hepatitis B | 900 |
| Combiotech - vaccination against hepatitis B | 900 |
| PREVENTION OF WHOOPING COUGH, DIPTHERIA, TETANUS, POLIOMYELITIS | |
| Infanrix hexa - vaccination against polio, Hepatitis B, tetanus, whooping cough, diphtheria, Haemophilus influenzae infection | 4700 |
| Pentaxim - vaccination against polymyelitis, tetanus, whooping cough, diphtheria, hemophilus influenzae | 3000 |
| Tetraxim - vaccination against polio, tetanus, whooping cough, diphtheria | 3500 |
| Infanrix - vaccination against tetanus, whooping cough, diphtheria | 3000 |
| DTP - vaccination against tetanus, whooping cough, diphtheria | 700 |
| PREVENTION OF POLIOMYELITIS | |
| Poliorix - vaccination against polio | 1200 |
| Imovax polio - vaccination against polio | 1200 |
| BiVac - vaccination against polio | 600 |
| Polimilex - vaccination against polio | 2500 |
| PREVENTION OF DIPTHERIA, TETANUS | |
| ADS - vaccination against tetanus and diphtheria | 600 |
| ADS-M - vaccination against tetanus and diphtheria | 600 |
| PREVENTION OF MEASLES, RUBELLA AND MUMPS | |
| Priorix - vaccination against measles, rubella, mumps | 1200 |
| M-M-P II (MMR-II) - vaccination against measles, rubella, mumps | 2000 |
| ZhPKV - vaccination against measles, mumps | 800 |
| Rubella - vaccination against rubella | 600 |
| LCV - vaccination against measles | 550 |
| PREVENTION OF CHICKENPOX | |
| Varilrix - vaccination against chickenpox | 5000 |
| PREVENTION OF HEMOPHILUS INFECTION TYPE B | |
| Act-Hib - vaccination against Haemophilus influenzae type B | 1300 |
| Hiberix - vaccination against Haemophilus influenzae type B | 1200 |
| PREVENTION OF ROTAVIRUS INFECTION | |
| RotaTek - vaccination against rotavirus infection | 3900 |
| PREVENTION OF MENINGOCOCCAL INFECTION | |
| Meningo A+ C - vaccination against meningococcal infection | 2000 |
| Mencevax - vaccination against meningococcal infection | 2500 |
| Menactra - vaccination against meningococcal infection | 6000 |
| PREVENTION OF PNEUMOCOCCAL INFECTION | |
| Prevenar 13 - vaccination against pneumococcal infection | 3900 |
| Pneumo 23 - vaccination against pneumococcal infection | 4400 |
| Pneumovax 23 - vaccination against pneumococcal infection | 4400 |
| PREVENTION OF HUMAN PAPILLOMA VIRUS | |
| Gardasil - vaccination against human papillomavirus | 9500 |
| Cervarix - vaccination against human papillomavirus | 7500 |
| PREVENTION OF HEPATITIS A | |
| Avaxim 80 - vaccination against hepatitis A | 2000 |
| Avaxim 160 - vaccination against hepatitis A | 2500 |
| Havrix 720 - vaccination against hepatitis A | 2000 |
| Havrix 1440 - vaccination against hepatitis A | 2700 |
| PREVENTION OF HEPATITIS TICK-BORNE ENCEPHALITIS | |
| FSME (for children) - vaccination against tick-borne encephalitis | 1600 |
| FSME (for adults) - vaccination against tick-borne encephalitis | 2000 |
| Tick-E-Vac - vaccination against tick-borne encephalitis | 1000 |
| EnceVir - vaccination against tick-borne encephalitis | 1000 |
| FLU PREVENTION | |
| Vaxigrip - flu vaccination | 700 |
| Influvac - flu vaccination | 700 |
| Ultrix - flu vaccination | 700 |
| Ultrix quadri - flu vaccination | 1200 |
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