Voluntary, free and informed consent, in five phases – the COVID vaccine plan – Health



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Voluntary, free and informed consent, in five phases: the COVID vaccine plan

© Associated Press

The vaccination plan against COVID-19 in Bulgaria was presented by Health Minister Prof. Kostadin Angelov, after it was approved at an extraordinary meeting of the government on Friday. It includes seven developments by pharmaceutical manufacturers (with Bulgaria participating in agreements for four of them), two of which are awaiting a decision from the European Medicines Agency (EMA) by the end of the year and the rest in 2021.

The plan also includes five phases, in which population groups are vaccinated. The Minister of Health reiterated that the COVID vaccination for all will be voluntary and free. On Friday it became known that people will have to sign an informed consent before placing it.

Since vaccines

According to the plan data, the EMA’s decision on the Pfizer and BioNTech vaccine – until December 29. This is one of the four vaccines for which the National Assembly voted on Thursday that Bulgaria can participate in the agreements.

The first doses of this vaccine for the European Union (EU), if approved for use, are expected to be 200 million units, and from previous statements by Prof. Angelov it is known that 125 thousand of them are for Bulgaria. However, earlier on Friday it became known that this year the company Pfizer together with the German partner BionTech will be able to produce half the doses that were discussed weeks ago.

The Pfizer and BioNTech vaccine should be stored at -70 ° C until distributed, after which it can be kept at 2 ° C to 8 ° C for up to five days until administered, the inspector announced. head of state health. Associate Prof. Angel Kunchev.

The second vaccine pending authorization is by Moderna – until January 12 of next year. So far, Bulgaria has not participated in the agreements for this vaccine, and it has been announced that the first doses for the EU will be 80 million units. According to Professor Kostadin Angelov, in response to a question from Dnevnik on whether there is a possibility of a reaction if the use of Moderna’s vaccine is allowed before the preparations of other pharmaceutical companies in which Bulgaria participates in the agreements, the Minister de Salud said: “When the contracts with the other vaccines will be ready, they will be included again in the National Assembly.”

Refrigerators maintaining a temperature of -20 ° C are required for the distribution and storage of Moderna’s vaccine, and if it is next, Bulgaria will have to “create additional logistics for it as well,” the health minister said.

The plan states that the vaccines will come in the form of vials, but so-called medical devices not supplied by the manufacturer, for example, syringes, needles, solvents. According to the Minister of Health, to provide them, Bulgaria may participate in a joint European procurement of such products, which is expected to be agreed in mid-December. If “this does not happen due to legal impossibilities”, Professor Kostadin Angelov claims that the country has the opportunity to provide them itself.

Who can get vaccinated and when

According to plan c the first stage Medical personnel inside and outside hospitals, healthcare professionals, dentists, and pharmacy personnel may be vaccinated. According to the plan, their total number is 243,600 people.

Professor Kostadin Angelov announced that people in the first phase, who work in hospitals, will be vaccinated in medical institutions, which must prepare in advance lists of those who want to be vaccinated. Workers outside hospitals will be vaccinated by their GPs.

In the second phase The opportunity will be given to immunize people and workers of social institutions, educators and personnel of mink farms. Their total number is estimated at 112,080 people, including 80 people who work on mink farms, but it was not known in the briefing why they are in an earlier phase. “According to a preliminary plan, we plan to put the vaccines for these people,” said Professor Kostadin Angelov, and mobile teams are expected to do so.

The third phase it is for “employees involved in maintaining the functioning of the basic activities of public life.” Examples of those in this phase were the water and sewerage sector, security services, electricity and food providers.

IN the fourth phase The plan is expected to cover adults 65 and older and people with chronic illnesses. According to statistics, there are a total of 1.8 billion people in Bulgaria.

IN fifth phase It lists “vulnerable groups of the population due to the high epidemiological risk of infection associated with their living conditions and lifestyle”.

The plan does not specify periods for each of the phases, probably due to the many unknowns: which ones, how many and when will the pharmaceutical companies receive the marketing authorizations; what will be the desire of the representatives of the different phases to be vaccinated, to know how long it will take, what quantities will Bulgaria receive.

“Whenever an epidemic starts, if there is a vaccine available, it starts immediately with vaccination. This is how we did it in the measles epidemic, in the polio importation 20 years ago. There are no discrepancies here,” said Adjunct Professor Angel Kunchev, with the clarification that to protect society and not individuals, “we must reach a minimum of 70-75%.” His response comes in the context of concerns expressed on social media about whether it is safe to get vaccinated in an epidemic, given that it is unknown if he is infected but he may not yet have symptoms.

If you are in the incubation period and you are vaccinated, it will not get worse. But it will lead to a purely psychological tendency to prescribe the cause of the disease to the vaccine.


Adjunct Professor Angel Kunchev,

state chief health inspector

According to him, people who want to get vaccinated, if they want to be tested earlier with an antigen or PCR method for coronavirus, they should organize. “This is not necessary and it will not be done en masse,” Kunchev added.

Organization and logistics

Professor Kostadin Angelov explicitly noted that the plan can be updated when vaccines and individual product characteristics are approved. “When the answers to many of the questions we ask ourselves are clear regarding: target groups, people eligible for immunization, indications, contraindications, age restrictions, suitable for people without and with chronic diseases, suitable for citizens under 18 years, then this plan will develop further. “

According to him, refrigerators will be installed on Friday at the state-owned company for the production of drugs and medical devices BulBio, which should contain the total amount of 125,000 vaccines ordered by Pfizer and BioNTch, as well as at the Sofia Regional Health Inspection. A vaccine refrigerator is expected to be available at RHI – Burgas on Saturday.

And another headquarters

Professor Krassimir Gigov, the chairman of the new government headquarters, called the National Vaccination Headquarters, announced that the working group he leads will meet for the first time on Friday. According to him, to implement the plan, the tasks are expected to be specified, which is expected to be possible when there is specific clarity for the vaccine supply. Professor Krassimir Gigov mentioned that the new staff includes:

  • – Associate Professor Angel Kunchev, Chief State Health Inspector and Staff Member for Coronavirus
    ch. com. Stoyan Temelakiev, Alternate Secretary General of the Ministry of the Interior
    – Colonel Prof. Andrey Galev, Head of the Center for Research and Application of Epidemiology and Military Hygiene of the Military Medical Academy (MMA)
    – mag. farm. Bogdan Kirilov, Executive Director of the Executive Agency for Medicines
    – Dr. Strashimir Genev, Director of the Hospital Medical Care Directorate of the National Health Insurance Fund (NHIF)
    – Dr. Nikolay Branzalov, General Practitioner and Vice Chairman of the Board of the Bulgarian Medical Union
    – Dr. Galin Kamenov, epidemiologist at the National Center for Infectious and Parasitic Diseases (NCIPD)
    – Dr. Rumen Kofinov, manager of the state company “BulBio”
    – Dr. Kremena Parmakova, Head of the Department of Surveillance and Prevention of Infectious Diseases of the Ministry of Health (MH)
    – Dr. Tsvetolyuba Genkova, Head of Department of the Directorate of Medical Activities of the Ministry of Health
    – Dr. Dancho Penchev, Director of SRZI
    – Prof. Dra. Mariana Mariana Murdzheva, Ph.D. coordinator of the expert council in clinical immunology.

You can read the full plan here
A quick guide to suspecting COVID-19 – here

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