Autovaccine – is it safe? When can it be used?

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Autovaccine is a preparation prepared individually for the patient using biological material collected from him. Pathogenic microorganisms present in the sample are inactivated and the finished product is administered to the patient. This form of treatment is an alternative treatment therapy that has found application in the treatment of recurrent or chronic staphylococcal infections. When can an autovaccine be used?

What is an autovaccine?

Autovaccine is a preparation that is characterized by vaccine-like effect – is supposed to stimulate the immune system, which cannot cope with infections. The product is prepared individually, based on microorganisms collected from the patient from the area affected by the infection.

However, the autovaccine is not the same as the vaccines known to us, and opinions about the safety and effectiveness of its use are not unequivocal. The autovaccine is not a traditional treatment method, it is rather considered a form of experimental treatment.

See also: Unconventional therapies

The indications for the use of autovaccines are usually chronic and recurrent infections of the upper respiratory tract or skin. Create an autovaccine it consists in taking a sample of biological material with microorganisms causing the disease from a specific patient. On the basis of the sample, a special preparation is developed – pathogens are isolated, then multiplied and their inactivated form is obtained. The autovaccine obtained in this way is administered to the patient. The autovaccine may take the form of:

  1. subcutaneous injections;
  2. aerosol;
  3. orally administered drops.

The use of autovaccines

The first autovaccine was developed at the turn of the 1902th century, and it was first used in XNUMX by the microbiologist Almroth Wright. Since then, autovaccines have been used as an alternative method of treating infections, e.g. with Staphylococcus aureus, mainly in the case of upper respiratory tract infection or skin problems.

Check it out: Superbugs on the attack – when bacteria are resistant to antibiotics

Autovaccines (autogenous vaccines), bacterial and viral, have also been used as a preparation administered to animals, especially farms. The recent increase in popularity of this method is also due to restrictions on the use of antibiotics issued by the WHO and the World Organization for Animal Health (OIE).

Although in practice autovaccines are used to a greater or lesser extent in different places around the world, due to the lack of top-down regulations, the rules of their use differ from country to country. Issue use of autovaccines in medicine raises various doubts. In addition, their production is not allowed in the United States, as well as in some EU countries.

Are autovaccines safe?

There are no unequivocal studies on the effectiveness of autovaccines, as well as their safety. Unlike vaccines, which undergo a multi-stage preparation process before entering the market (they are subjected to numerous tests and quality controls), there are many unknowns about autovaccines. They are prepared by the microbiological laboratory on the basis of an individual order, using a sample taken from a specific patient. The ready agent is also intended for use by this patient.

Doubts about autovaccines also arise from the fact that products of this type are not admitted to trading or subject to serial quality control, there are also no clinical trials that would verify their safety and effectiveness. There are also no recommendations regarding situations in which side effects will occur.

Read also:

  1. Vaccinations for adults. What should we get vaccinated for?
  2. Where did the anti-vaccine movements come from?
  3. Holistic medicine – what is it?

Autovaccines in Poland – when can they be used?

Autovaccines in Poland do not have the status of an authorized medicinal productMoreover, they are not subjected to serial quality control, even though they are an immunological product that should be subjected to such control. In addition, there are controversies regarding the effectiveness of this product and its safety of use. Is it possible to use autovaccines in Poland?

As for the validity of the use of autovaccines, experts from the Association of Medicinal Hygiene published their position on this topic in 2012, pointing to certain legal doubts. Therefore, the possibility of using autovaccines for treatment should be limited to cases medicinal medical experiment. This means that after the consent of all participants in the experiment, the doctor may order the creation of an autovaccine for the patient. The aforementioned doctor must, however, meet all formal requirements related to the conduct of a therapeutic therapeutic experiment.

important

Conducting a therapeutic medical experiment must be approved by both the ordering physician and the patient, laboratory diagnostician, nurse or other person participating in it.

1 Comment

  1. Бактериалните автоваксините не са лекарствени продукт по смисъла Закона за лекарствените продукти в хуманната МЕДИЦИНА (ЗЛПХМ). Този закон представлява на практика превод на съответната Директива на ЕС (поне в Р. България, но е съмнително да се различава драстично в тази му част в други страни от ЕС). Съгласно Директивата, тя се отнася само за лекарствени продукти които се произвеждат промишлено или при производството им се използва промишлен процес.
    Също така не може да се прилагат изискванията за Добрата клинична практика, основания за публикуването на която е споменатата по-горе Директива.
    Не ми е известно да има специална законодателна рамка свързана с лекарствените продукти, която да регламентира по какъвто и да е начин прилагането на бактериални автоваксини.
    Необходимо е да се посочи, че
    има съществена разлика между Бактериалните автоваксини и противотумурните автоваксини, прилагането на които е съгласно съответния Регламент (цитира се в ЗЛПХМ).
    Прилагането на Бактериалните автоваксини е медицински метод при, които не се използват вещества (субстанции) чужди на организма на пациента, така, че ако има някаква законодателна рамка, тя трябва да е свързана с медицината, а не с фармацията. Не ми е известно да има такава (до към 2017-2018 г.).
    В някои страни на ЕС Агенциите по лекарствата са си присвоили без основание (в смисъл противозаконно) правото да се произнасят и да прилагат норми свързани с лекарствените продукти по въпросите свързани с Бактериалните автоваксини.
    В Р. България бактериални автоваксини се изготвяха и се провеждаше лечение с тях до закриването на лабораторията АНастста през 2013 г., като от 2011 г. до 2016 г. Агенцията по лекарствата погрешно ги класифицираше като лекарствени продукт по смисъла на ЗЛПХМ. По тази причина от 2011 г. до закриването на Анаста през 2013 г. в нея не се изготвя ха бактериални автоваксини и много пациенти бяха лишени противозаконно от лечение на хронични стафилококции, чрез единствено ефективния метод.
    Огнян Митов

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