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Healthy people without concomitant serious chronic diseases, with no clinical manifestations at this time, and over 16-18 years of age should be vaccinated against COVID-19. This is recommended in a statement from the Bulgarian Academy of Sciences about the upcoming vaccination campaign against COVID-19, sent to the media.
The Bulgarian Academy of Sciences (BAS) includes dozens of the most prominent Bulgarian doctors, biologists, immunologists, virologists, geneticists, mathematicians and other diverse specialists who are involved in the problems of the global pandemic caused by the new coronavirus.
With their research work and active participation in various presentations in the media, where they share the most up-to-date and objective data on the pandemic, they contribute a lot to the adequate awareness of citizens and the scientifically-based guidelines for the fight against the coronavirus. Given all this, we consider it necessary to express our opinion on the next vaccination campaign against coronavirus infection, as a result of the analysis of existing data from the world literature and current practice.
Without dwelling on the very complex medical and economic issues related to the growth of the pandemic and the efforts to control it in our country and around the world, we would like to briefly present information, especially on issues related to available vaccines, their importance and how organizes the vaccination program in our country. We believe this will help to properly understand the great significance of immunization and will help alleviate anxiety in society over the circulation of false, unscientific or contradictory information.
In the absence of a specific and effective drug against coronavirus infection, which modern medicine does not have, except for strict compliance with anti-epidemic measures, the only option is a vaccine. This is proven by the vast experience of many years that humanity has gained in the fight against infectious diseases. A vaccine that is harmless and has an efficacy of at least 50-60% (that is, that creates immunity in a percentage of those immunized) will play a very important role in limiting the infection. Unfortunately, the data we have so far shows that herd immunity to coronavirus is very slow and practically difficult to achieve naturally (which is also associated with great ethical and moral challenges), so vaccines will help a lot. in its construction.
To date, more than 220 coronavirus vaccines have been developed worldwide, of which 56 are in clinical trials and more than 10 are in the third (most important) phase of a clinical trial, which requires, According to the rules accepted worldwide, be administered to 30,000 – 40,000 people to objectively evaluate its safety and efficacy. It should be well known that, under normal conditions, a vaccine develops in 3-5 years or more. But the situation in which the whole world finds itself, a very serious and rapidly spreading infection that takes hundreds of thousands of victims and is a colossal health, social and economic problem, gives rise to the WHO, all the regulatory authorities international and national, state institutions, to allow accelerated introduction of vaccines, subject to all proven safety requirements. No commitment is made in this regard and vaccines must meet well-established high global standards and the expected benefits of their use far outweigh the possible foreseeable risks. Regarding the effectiveness of vaccines and the nature of the immunity they create and their duration, we will be able to give a satisfactory answer no earlier than one year from the start of their application, when we will have enough convincing scientific data as a result of the follow-up. hundreds of thousands immunized. In essence, this is the so-called fourth or “post-marketing” phase of the clinical trial.
We will schematically present the main approaches to the development of vaccines against the COVID-19 virus:
RNA vaccines. On a previously prepared (synthetic) mRNA platform, which is loaded with genetic material from the virus crown included in the liposomes (for greater stability and antigenicity), the synthesis of the viral antigen is stimulated in the human body, which subsequently causes the synthesis of protective viral antibodies and cellular immunity. The vaccines of the Pfizer and BioNTech and Moderna companies were built on this more modern principle. In their study, this mRNA was not found to damage the human genome or to interact with DNA. In addition, it decomposes very quickly and does not circulate through the body.
Vector vaccines. Use of a non-human adenovirus (or other viruses) that is loaded with SARS-Cov-2 genetic material and is used as a vector in immunization. Thus, the Astra Zeneka, Janssen-Cilag, Russian Sputnik and Vector vaccines and others were developed.
Protein vaccines. The protein components are used from the spikes (spikes) of the virus, its shell or body (nucleocapsid), which have proven antigenic (immunostimulatory) activity (Sanofi-GSK).
Adjuvant vaccines. Use of attenuated SARS-Cov-2 virus for immunization. Most often in combination with so-called adjuvant (enhancer) of the immune response. This is how some Chinese and Cuban vaccines were created.
All of these vaccines are given twice every 21 to 28 days. Based on the data presented by the different manufacturers, as a result of the clinical study, they do not cause serious side effects and sufficiently stimulate humoral (antibodies) and cellular immunity.
In the European Union (EU) so far (December 18, 2020) 5 vaccines have been submitted for registration by the European Medical Agency (EMA): Pfizer / BioNtech, Moderna, Astra Zeneka, Janssen-Cilag and Sanofi-GSK , ready to be presented several more. The final decision on their approval, as it became clear, will be made on December 21, 2020, after which it will be possible to implement them in the EU. The Pfizer / BioNtech vaccine was approved a few days ago by UK regulatory authorities and approved for use in the UK. Immunization with the Russian Sputnik V vaccine has been carried out for 1-2 months in selected contingents in the Russian Federation, and the same is the case in China, where immunization is carried out with two different Chinese vaccines approved by the regulatory authorities of Russia and China, respectively. Immunization with the FDA-approved Moderna vaccine in the United States has been ongoing for several days.
According to the general EU action plan against the COVID-19 pandemic, Bulgaria will first import the Pfizer / BioNtech vaccine in a few days and begin its implementation after the expected approval by the EMA. The vaccine will be free and voluntary. For this, a very active organization has been set up to solve important logistical problems related to the application of the vaccine: to ensure its correct storage and transport, since this requires strict compliance with a refrigeration temperature of -70 ° C to -80 ° C; establish an appropriate organization for immunization; determine the places for its implementation and the people who will be in charge of it; the most important: determining the contingents to be immunized and the ways to inform and attract them; carry out a broad awareness campaign on the great importance of vaccines for both individual and public health in order to stimulate collective immunity and limit the spread of infections In this regard, the Ministry of Health has drawn up a detailed work plan, whose implementation has started. All this is imminent and will develop very dynamically, in view of the rapidly changing situation with the coronavirus pandemic in our country and around the world, and will depend on the approval of other vaccines and their importation. This will likely set new requirements in the course of immunization and the way it is carried out.
In conclusion, we allow ourselves to say that it is recommended that all healthy people, without accompanying serious chronic diseases, without clinical manifestations at the moment and over 16-18 years of age be immunized. It is mandatory to first consult with your doctor to discuss this issue, taking into account all the indications and contraindications of the vaccine, described in detail in the call. “Short description”, or your “passport”. This implies the rapid organization of a broad media and institutional campaign so that doctors and citizens are very well informed and convinced of their decision of great personal and public interest.
The opinion was prepared by a team composed of: Academician Bogdan Petrunov, Prof. Radostina Alexandrova – Institute of Experimental Morphology, Pathology and Anthropology with a BAS museum, Prof. Penka Petrova – Director of the BAS Institute of Microbiology, Prof. Iva Ugrinova – Director of the Institute of Molecular Biology of BAS.
Bulgaria
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