Vaccines in short supply: will foreign drugs return to the Russian market?

Vaccine shortage

In January 2016, major foreign vaccine manufacturers Sanofi and GlaxoSmithKline (GSK) announced that they could not supply their drugs to the Russian market with their certification. Difficulties with paperwork for foreign pharmaceutical companies arose due to the fact that in November 2015 federal Service for accreditation (Rosakkreditatsiya) after an unscheduled inspection suspended the accreditation of FBGU " Science Center examination of funds medical use”(NTsESMP), subordinated to the Ministry of Health. It was in this body that all Sanofi and GSK vaccines underwent mandatory certification. December 7 NCESMP returned accreditation, but vaccines in short supply have not yet returned to the market.

Due to problems with certification, the children's vaccines against whooping cough, diphtheria and tetanus Pentaxim (Sanofi) and Infanrix Hexa (GSK), as well as the vaccine against infections caused by Haemophilus influenzae, have disappeared from the market. Act Hib» (Sanofi and GSK).

Representatives of GSK, Sanofi and Pfizer (produces the Prevenar-13 vaccine) told RBC that they are not yet aware of the government's plans to cancel the certification of vaccines in Russia.

new standard

The planned refusal of certification is not directly related to the shortage that has arisen on the market, says RBC's source in the Ministry of Health. The fact is that from January 1, 2016, foreign pharmaceutical companies are already required to register new drugs in accordance with Russian requirements. According to the already adopted amendments to the law “On the Circulation of Medicines”, from 2016, all foreign pharmaceutical companies that are going to introduce new drugs to the Russian market must register them according to the Good Manufacturing Practice for Medicinal Products (GMP) standard. From 2017, this requirement will generally apply to all medicines sold in Russia. Many enterprises of large Western manufacturers (including those that supply foreign vaccines that have disappeared from sale) already comply with the GMP standard, so additional certification of their products in Russia will not be required, a source in the Ministry of Health explains.

What is GMP standard

Standards for the safe production of drugs began to be developed in the United States in the 1960s, the status international standards GMP received in 1968. GMP rules include a list of requirements that manufacturers of medicines and other pharmaceutical products must comply with. In world practice, GMP certification of production is carried out by state inspections or authorized private companies, says Nikolai Bespalov, Development Director at RNC Pharma.

In Russia, responsible for checking supplier enterprises for compliance GMP rules appointed by the Ministry of Industry and Trade. Since January, the ministry has been given the authority to inspect drug factories directly abroad (but until 2017, such an inspection is mandatory only for suppliers of those drugs that were not previously supplied to Russia). However, this rule still does not work, Kommersant wrote: there is no legal basis for the work of the Russian inspectorate abroad.

The return of vaccines

Western vaccines that are missing in Russia may appear on sale even before the government approves the refusal of certification. At a meeting on February 20, the Ministry of Health and NTsESMP was instructed to ensure the renewal of certification of immunobiological preparations located at customs and in the warehouses of manufacturers from March 5, follows from the protocol. According to the director of the Association of International Pharmaceutical Manufacturers Vladimir Shipkov, we are talking about 1.5 million packages of drugs.

Certification of the Pentaxim drug will take place no earlier than March 15, 2016, a representative of the NCESMP commented to RBC on the execution of the order. “The duration of the validation process for this vaccine is due to the complex biological analysis, the reagents for which the vaccine manufacturer submitted to the certification body on February 29,” he explained. The issuance of a certificate for Infanrix Hexa due to the duration of animal testing is planned for the first half of April 2016.

Certification is a useful tool that allows you to monitor the quality of products, says David Melik-Guseinov, director of the State Budgetary Institution Research Institute of Health Organization and Medical Management of the Moscow City Health Department. “But if this tool shows failures, as was the case with vaccines, then it is better to either adjust it or cancel it altogether,” he said. Now the public procurement system for vaccines is going through Nacimbio, it is possible that this organization will also be transferred to the functions of quality control of vaccines, he admits. The press service of Nacimbio (a subsidiary of Microgen, is the only supplier of vaccines for vaccinations that are included in the NCIE for 2015-2017) did not provide a comment.

The idea to abandon certification is sound, but it is necessary to debug the inspection of foreign manufacturers by the Ministry of Industry and Trade, says RNC Pharma Development Director Nikolai Bespalov. “If certification is canceled, and the GMP inspector does not have time to check the sites, Russia may again face the risk of drug shortages,” he warns.

But there are also experts who consider the idea of ​​abolishing certification dangerous. “There can be no simplified mechanisms for immunobiological drugs,” says the CEO of the analytical company DSM Group Sergey Shulyak. “Each time, the property of an immunobiological molecule must be proven anew.” “The control that is carried out during certification is necessary,” the head of the private company"Format of Quality" (also involved in the certification of medical products) Mikhail Yaroshenko. - Immunobiological preparations are a special category, they need to be checked very carefully. We cannot know for sure that they are bringing us from abroad!” Shipkov believes that periodic inspections by state bodies of immunobiological preparations in circulation will be enough.

Declarations instead of certificates

The certification procedure can be replaced by declaration, this option was discussed at a meeting in the government on February 20, says Viktor Dmitriev, general director of the Association of Russian Pharmaceutical Manufacturers, who took part in the meeting.

When certifying the quality medicines is confirmed by an independent certifying body on the basis of tests, when declaring - by the applicant himself, Yaroshenko explains the difference. In the first case, both the manufacturer and the certifying body are responsible for product quality, in the second case, only the manufacturer. But even in this case, Roszdravnadzor may reserve the opportunity to periodically conduct drug quality checks, Dmitriev notes.

Even now, the quality of some medicines is confirmed with the help of declarations. But there is not a single immunobiological preparation in the corresponding list of products.

Supplies of the Infanrix vaccine, which children are vaccinated against whooping cough, diphtheria and tetanus, will definitely not be available in Khabarovsk until 2017.

This was announced in the city center for vaccination. The last batch of the drug arrived at the regional center back in December, and even then quite a small amount. Only a limited number of applicants managed to vaccinate.

"Infanrix" then did not even reach the private clinics of the city, although they were waiting for it there. As Anna Stepanets, a pediatrician at a commercial medical institution, explained, there was a so-called waiting list since spring, the parents booked the vaccine, but to no avail. The vaccine never arrived.

Now in parental circles there is a little panic about what to do. For many, it's time for another injection. But experts say that the panic is out of nowhere. According to leading specialist Anna Stepanets, there is no cause for concern.

although the imported vaccine is better than the domestic DPT (no vaccination side effects children tolerate the drug without problems), there are no irreplaceable medicines today, so it is necessary to vaccinate children with what they have. Because not vaccinating at all is not an option, the doctor comments on the situation.

But parents do not agree with this and do not want to vaccinate their children with the domestic vaccine, and are looking for the remnants of the drug in other cities. Olga Rodionova, having called all the clinics of neighboring Birobidzhan and Komsomolsk-on-Amur, found the remnants of the Infanrix in the city of Yunosti. However, this trip did not come cheap.

It took us about five thousand rubles for round-trip gasoline, food and the vaccine itself (for comparison, Infanrix cost a little more than 800 rubles at the Khabarovsk vaccination center), but the health of the child is more important. The first injection was given - Russian DTP, four-month-old Margarita had a fever and a rash appeared, so this time we decided not to risk it, but there is still a third vaccination, and what to do while my husband and I don’t know, Khabarovsk parents shared their fears.

As explained on hotline network of city pharmacies, Infanrix the Belgian vaccine, but it has not been re-registered in Russia and it is possible that in 2017 it will not be imported to Russia.

Now the French Pentaxim vaccine will be supplied to the regions, but it will be bottled and packaged in Russia in St. Petersburg, in a branch of the French plant, and now the certification process is underway. As soon as it is over, the vaccine will go to the cities of our country, they said in one of the Khabarovsk pharmacies.

Pediatrician Natalya Petrova expresses doubts about the use of a foreign vaccine.

We were expecting Pentaxim in mid-April in Khabarovsk, but there is no information yet on when it will arrive in the region. By the way, this vaccine is not suitable for all children, the drug is a five-component one, and those who have already been vaccinated against polio, then Pentaxim will not work, said Natalia Petrova.

Meanwhile, from municipal children's clinics, where the vaccination plan is not being fulfilled, doctors call parents and tell their passions.

Sofya Moskvina, mother of a one-year-old daughter, shared her feelings about the use of the new vaccine.

A nurse from the district polyclinic called, urged me to come to DPT, when she heard a refusal, she began to say that an epidemic of all these diseases was just around the corner, because parents massively refuse to be vaccinated with a domestic vaccine and miss all the vaccination dates. And "Infanrix" in general, as the nurse said, she read in medical journal, dangerous and harmful, and this has already been proven.

Pediatrician Natalya Petrova, however, assured the Khabarovsk parents that it is still necessary to be vaccinated, but with what vaccine and when is the decision of the parents.

I would not draw any loud conclusions, the main thing is that parents should remember that it is necessary to be vaccinated, but it is up to them to decide which vaccine and when.

By the way, they have no right to refuse admission to a kindergarten or school to "unvaccinated" children, which parents sometimes fear. If such cases arise, then it is necessary to contact the Khabarovsk Health Department or the Education Department.

Anna Demina, Khabarovsk news on DVhab.ru

Source - News of Khabarovsk on DVhab.ru

Infanrix Hexa (Infanrix Hexa)- imported analogue domestic vaccination against diphtheria, whooping cough and tetanus. The uniqueness of this vaccine lies in the fact that, in addition to these three diseases, it also protects against polio, hemophilic infection and hepatitis B. This is the most multicomponent vaccine of all DTP analogues (which also include Infanrix, Infanrix IPV and Pentaxim), the owner of a peculiar " record" in 6 diseases to which it forms immunity. Moreover, each of these diseases is included in the National Immunization Calendar for 2018.

How does the National Immunization Schedule work?

If you support the idea of ​​immunity through vaccination in principle, your child will have to be vaccinated quite often in the first year after birth. The National Immunization Schedule provides the following vaccination schedule for children in their first year of life:

Thus, following the schedule, up to a year the child must be vaccinated against the following eight diseases: tuberculosis, hepatitis B, diphtheria, whooping cough, tetanus, hemophilic infection, poliomyelitis and pneumococcal infection. Six of the eight required vaccinations are contained in the Infanrix Hexa vaccine.

Infanrix Hexa: the pros

The main advantage of this vaccine is obvious: fewer injections - less stress that the child experiences. The advantage for parents is also the fact that the risk of forgetting about some of the vaccinations is reduced to zero. It is important that all components are made and combined into a vaccine by one reliable manufacturer (GlaxoSmithKline) - potentially such a vaccine is less reactogenic than a “cocktail” of different vaccines against different manufacturers and often a single multicomponent vaccine is also cheaper.

Contrary to popular belief, in frequency and appearance adverse reactions Infanrix Hexa is practically no different from a simple three-component Infanrix (pertussis-diphtheria-tetanus). In addition, vaccine components “missing” according to the schedule will still be compensated by other, separate vaccines - for example, a child will receive a three-component pertussis-diphtheria-tetanus vaccine plus a separate hepatitis B vaccine plus a polio vaccine.

Infanrix Hexa: cons

The main disadvantage of Infanrix Hexa is that due to problems with certification, it is not always freely available in Russian clinics, and when it appears, it ends rather quickly due to its popularity and good reputation.

There is another point: upon careful study of the calendar, it is easy to see that the hepatitis B vaccination schedule does not quite coincide with the vaccination schedules for the other five infections. If the child was vaccinated exactly in accordance with the National Calendar, by the time of the first Infanrix Hexa vaccination against hepatitis B, he is already fully vaccinated, which means that the need for the sixth component is no longer necessary.

(According to the schedule, it would be more logical if the sixth component was not a vaccine against hepatitis B, but a vaccine against pneumococcal infection, but for a number of medical reasons it is sold as a separate vaccine - Synflorix from GlaxoSmithKline or Prevenar-13 from Pfizer).

However, of all vaccinations in children under one year old, the most common medical withdrawal for several months is precisely from hepatitis B. It is especially often given to children who have had prolonged physiological jaundice in newborns. In addition, in the first 24 hours, premature newborns or children resulting from difficult childbirth, with complications. It often turns out that Infanrix Hexa is the ideal solution for children with such a “shifted” hepatitis B vaccination schedule, when it just starts to coincide with a vaccination against 5 infections, including DPT.

What does Infanrix Hexa protect against?

Above, we have already listed the diseases against which Infanrix Hexa helps to develop immunity. These are whooping cough, diphtheria, tetanus, hemophilic infection, poliomyelitis and hepatitis B. Many critically thinking parents have a question: what kind of diseases are these and whether it is necessary to vaccinate a baby under the age of one year from them - after all, any vaccine, whatever one may say, creates a certain load on the body?

This is not done in vain. All diseases, vaccination against which is carried out in the first year of life, are especially dangerous for infants and most often end in death in this age group. Below we provide information about the dangers of each of the listed diseases.

Whooping cough is a highly contagious bacterial infection that maximum amount complications in children under one year of age. The disease manifests itself for a long time painful cough which cannot be stopped by any means. This cough usually continues longer than a week, and as complications, pneumonia, pleurisy, epilepsy, and even cerebral hemorrhage are possible. Deaths have been recorded. A growing incidence of whooping cough is recorded in Moscow every year.

There are cases when vaccinated children still fell ill with whooping cough, but in this case the disease proceeded in mild form and did not cause serious complications.

Diphtheria in children, as a rule, proceeds in the form of diphtheria of the oropharynx. This is dangerous in itself, as it is often accompanied by swelling that can cause suffocation. But besides this, diphtheria is extremely dangerous with complications that almost always accompany the underlying disease - lesions nervous system, brain and especially often - the heart.

Tetanus- a disease with a very high level deaths. Normally, tetanus spores surround us everywhere and are not capable of harming us. However, getting into an open wound, they cause terrible disease. And it is young children who are most traumatic - they often fall, get abrasions, scratches, get splinters and injections from plant thorns. It is very difficult to treat tetanus, and it is extremely painful for the patient, with constant convulsions, and is accompanied by severe complications.

Hemophilus infection caused by Haemophilus influenzae, which belongs to the opportunistic flora and, in principle, is present in most people without causing any disease. However, for a weakened organism, the hemophilic bacillus can become fatal. It is no coincidence that a hemophilic infection often occurs against the background of treatment with strong antibiotics of some other disease. At the same time, the widespread use of antibiotics provokes the emergence of more and more resistant forms of hemophilic infection, which are very difficult to treat. It manifests itself in different ways: most often - pneumonia and other diseases. respiratory tract, but there are also meningitis, and arthritis, and pericarditis, and lesions of the nervous system as a manifestation of hemophilic infection. It is especially difficult for young children to tolerate it.

Polio is not so often fatal and sometimes generally asymptomatic. This is its danger: its spread cannot be limited by quarantine, since it is not always possible to diagnose. At the same time, it is transmitted very easily and often gives paralysis as a complication. Polio poses the greatest danger to children aged one to five.

Hepatitis B affects the liver. Having become ill with it in childhood, a person, even after recovering from the disease, remains a carrier of hepatitis B for life. In about a third of cases, the patient develops cirrhosis of the liver or liver cancer. At the same time, it is very easy to become infected with hepatitis B - it is transmitted even household way, for example, through shared towels, and is resistant to boiling for several minutes. In infants under the age of one year, hepatitis B, as a rule, occurs in severe or moderate form.

Analogues Infanrix Hexa

As a matter of fact, there is no direct analogue, that is, another six-component vaccine, on the Russian medical market. But it is possible, if necessary, to assemble a similar set of other vaccines, especially, as already mentioned, hepatitis B is usually vaccinated on a slightly different schedule.

The closest analogue of Infanrix Hexa is the Pentaxim five-component vaccine, which has gained wide popularity as it has become the first foreign soft analogue of the domestic DTP. It is known that our Russian vaccine is rather difficult for children to tolerate because of the whole-cell pertussis component, which is present in foreign vaccines in a cell-free form. Pentaxim does not provide protection against hepatitis B. However, for a separate vaccination on the Russian market there are about a dozen vaccines against hepatitis B from different manufacturers - for example, GlaxoSmithKline has Engerix.

There is also a five-component Tritanrix vaccine (with hepatitis B, but without polio); on the territory of Russia, it is quite rare.

But most often, three-component vaccines "pertussis-diphtheria-tetanus" are used as analogues. Free of charge in state clinics, children are vaccinated with domestic DTP. Experts agree that this vaccine is quite effective, but the pertussis component can be difficult for children to tolerate, therefore, if possible, it is better to replace it with Infanrix or Pentaxim. Infanrix (without the Hex prefix) contains the same set of antigens - "pertussis-diphtheria-tetanus". In the case of using a three-component vaccine, separate vaccines against hemophilic infection will be required - Hiberix (the manufacturer is the same as that of Infanrix Hexa - GlaxoSmithKline), Act-HIB (manufacturer Sanofi-Pasteur, France) or the domestic "Hemophilus influenzae type b conjugated dry vaccine - as well as from poliomyelitis (Polyorix, Imovax Polio or analogues) and hepatitis B.

How to prepare for Infanrix Hexa vaccination

When using a multicomponent vaccine, the preparation for vaccination is no different from the usual preparation for vaccination. 7-10 days before vaccination and within 7-10 days after it, the child needs a sparing regimen: it is necessary to refrain from visiting crowded places and from introducing new foods to complementary foods. The vaccination should be postponed if the child has recently been ill, if one of the relatives in the family has the flu, SARS, etc. similar diseases, as well as if the child is teething.

It is not necessary to vaccinate on a full stomach and it is very desirable to empty the intestines on the day of vaccination before vaccination. During the week (three days before vaccination, on the day of vaccination and three days after vaccination), it is recommended to give the child antihistamine such as Zyrtec or Zodak. After vaccination, you should carefully monitor the well-being of the child, especially carefully looking at the injection site (swelling is possible), temperature, control sleep patterns - the child can be especially excitable and capricious. In a few days, this will pass, and the child will return to a normal lifestyle.