January 25, 2024
Questions, Three Years On
About a month ago I put several questions to the Ministry of Health. I wanted to learn, three years after the beginning of vaccination, what its effects are among the population.
Because #WeHaveTheRightToKnow!
I received several answers and a great many silences.
I leave you to understand what there is to understand.
Here are the questions without an answer:
What is the number of strokes (cerebrovascular accidents) in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cases of stroke (cerebrovascular accidents) has not been modified so as to break them down according to the vaccination status of the patients.
What is the number of heart attacks in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cases of heart attack has not been modified so as to break them down according to the vaccination status of the patients.
What is the number of cardiovascular diseases in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cardiovascular diseases has not been modified so as to break them down according to the vaccination status of the patients.
What is the number of cancer cases detected in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cancer cases has not been modified so as to break them down according to the vaccination status of the patients.
What is the number of cases of autoimmune disease found to have been triggered in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording autoimmune diseases has not been modified so as to break them down according to the vaccination status of the patients.
What is the mortality in the period 2021–2023 among unvaccinated persons and among vaccinated persons respectively?
Answer: The methodology for reporting and recording mortality has not been modified so as to break it down according to the vaccination status of the patients.
I leave you one answer as well, perhaps as eloquent as the ministry’s silences:
What is the birth rate in the period 2018–2020 and in the period 2021–2023 respectively?
Answer: The birth rate in the period 2018–2022 was:
Year. Birth rate (live births per 1,000 inhabitants)
2018 9.7
2019 9.7
2020 9.5
2021 8.9
2022 7.8
2023. silence
Below I leave you the full answer as I received it from the ministry.
“No. SRPP 2498 / 23.01.2024
To,
Mr Dan Chitic
Dan.chitic@gmail.com
In view of your request submitted to the Ministry of Health, we communicate to you the following:
1. What is the number of strokes (cerebrovascular accidents) in the period 2018–2020?
Answer: The number of discharges from continuous hospitalisation (public and private sector) with the diagnosis of cerebrovascular accidents, haemorrhagic and ischaemic (ICD 10 code 160-167) in Romania in the period 2018–2020 was as follows:
Year. Cerebrovascular accidents, haemorrhagic and ischaemic (ICD 10 code 160-167)
2018. 108,208
2019 107,095
2020. 62,507
2. What is the number of strokes (cerebrovascular accidents) in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cases of stroke (cerebrovascular accidents) has not been modified so as to break them down according to the vaccination status of the patients.
3. What is the number of heart attacks in the period 2018–2020?
Answer: The number of discharges from continuous hospitalisation (public and private sector) with the diagnosis of myocardial infarction (ICD 10 code 121-122) in Romania in the period 2018–2020 was as follows:
Year. Myocardial infarction (ICD 10 code 121-122)
2018 20,602
2019 20,823
2020 14,872
The number of new cases with the diagnosis of myocardial infarction (ICD 10 code 121-122) in Romania in the period 2018–2020 was as follows:
Year. Myocardial infarction (ICD 10 code 121-122)
2018. 7,823
2019 9,433
2020 8,511
4. What is the number of heart attacks in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cases of heart attack has not been modified so as to break them down according to the vaccination status of the patients.
5. What is the number of cardiovascular diseases in the period 2018–2020?
Answer: The number of discharges from continuous hospitalisation (public and private sector) with the diagnosis of Diseases of the circulatory system (ICD 10 code 100-199) in Romania in the period 2018–2020 was as follows:
Year. Diseases of the circulatory system (ICD 10 code 100-199)
2018. 571,860
2019. 570,851
2020. 304,427
The number of new cases with the diagnosis of Diseases of the circulatory system (ICD 10 code 100-199) in Romania in the period 2018–2020 was as follows:
Year Diseases of the circulatory system (ICD 10 code 100-199)
2018. 820,958
2019. 876,074
2020 788,793
6. What is the number of cardiovascular diseases in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cardiovascular diseases has not been modified so as to break them down according to the vaccination status of the patients.
7. What is the number of cancer cases detected in the period 2018–2020?
Answer: The number of new cases of malignant tumours (ICD 10 code C00-C97) declared by oncologists in the period 2018–2020 was as follows:
Year. Number of new cancer cases declared by oncologists in the period 2018–2022
2018 61,780
2019 59,606
2020 52,350
8. What is the number of cancer cases detected in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording cancer cases has not been modified so as to break them down according to the vaccination status of the patients.
9. What is the number of cases of autoimmune disease found to have been triggered in the period 2018–2020?
Answer: The number of discharges from continuous hospitalisation (public and private sector) with the diagnosis of Autoimmune diseases in Romania in the period 2018–2020:
Year Autoimmune diseases
2018 34,895
2019. 36,442
2020 15,871
10. What is the number of cases of autoimmune disease found to have been triggered in the period 2021–2023, broken down by vaccinated and unvaccinated persons?
Answer: The methodology for reporting and recording autoimmune diseases has not been modified so as to break them down according to the vaccination status of the patients.
11 and 12. What is the mortality in the period 2018–2020 and in the period 2021–2023 respectively?
Answer: General mortality in the period 2018–2022 was:
Year Mortality (deaths per 1,000 inhabitants)
2018 12.00
2019 11.8
2020 13.5
2021 15.2
2022 12.4
13 and 14. What is the birth rate in the period 2018–2020 and in the period 2021–2023 respectively?
Answer: The birth rate in the period 2018–2022 was:
Year Birth rate (live births per 1,000 inhabitants)
2018 9.7
2019 9.7
2020 9.5
2021 8.9
2022 7.8
15 and 16. What is the mortality in the period 2021–2023 among unvaccinated persons and among vaccinated persons respectively?
Answer: The methodology for reporting and recording mortality has not been modified so as to break it down according to the vaccination status of the patients.
17. What are the updated contraindications of each available vaccine, taking into account their leaflets and the adverse effects recorded worldwide to this date?
Answer: The list of contraindications for the vaccines available on the market is set out in the leaflet of each vaccine; these leaflets may be viewed on the site of the National Agency for Medicines and Medical Devices of Romania.
18. What analyses must be carried out before vaccination, according to each particular vaccine and to its specific contraindications?
Answer: Before the administration of a vaccine no medical investigations or analyses are necessary, vaccination being a measure of prevention, not of treatment. The doctor who administers the vaccine, before administering it, takes the patient’s history and carries out a clinical examination in order to know the pathological antecedents (chronic diseases, allergies, medication) of the person concerned and in order to identify any signs of illness at the moment of presentation for vaccination.
19. What is the degree of authorisation by the Ministry of Health of each existing vaccine, and on what basis was that authorisation granted?
Answer: All vaccines are placed on the market following authorisation by the National Agency for Medicines and Medical Devices of Romania (ANMDMR). The procedures for authorising the placing of medicines on the market are regulated in Chapter III of Title XVII of Law no. 95/2006 on the reform in the field of health. In accordance with art. 700 of the law, no medicine may be placed on the market in Romania without a marketing authorisation issued by the National Agency for Medicines and Medical Devices of Romania.
In order to obtain a marketing authorisation for a medicine, an application must be lodged with the National Agency for Medicines and Medical Devices of Romania. According to the provisions of art. 702 para. 4 of Law no. 95/2006, the application for marketing authorisation must be accompanied by the following information and documents: the name and registered office of the applicant and, as the case may be, of the manufacturer; the name of the medicine; the qualitative and quantitative characteristics of all the constituents of the medicine, including the international non-proprietary name recommended by the World Health Organisation; the assessment of the risks the medicine might present for the environment; the description of the manufacturing method; the therapeutic indications, the contraindications and the adverse reactions, the posology, the pharmaceutical form, the manner and route of administration, as well as the presumed shelf life; a copy of each marketing authorisation of the medicine obtained in another state, accompanied by the list of the member states of the European Union in which the application for authorisation is under examination, in accordance with Directive 2001/83/EC establishing the Community code relating to medicinal products for human use.
As for the COVID-19 vaccines, these were authorised by the European Medicines Agency (EMA).
20. Which doctor is to follow the medical course of vaccinated persons after vaccination, and for what period?
Answer: The medical supervision of a vaccinated person is the responsibility of the doctor who administered the vaccine and is carried out over a period of 15 minutes after vaccination. Thereafter, medical supervision falls within the duties of the family doctor, respectively of the paediatrician.
21. Is there at this date a set of medical procedures / treatment schemes established for each type of adverse side effect, according to each vaccine on the market?
Answer: For the undesirable adverse reactions appearing after the administration of the vaccine, symptomatic treatments are administered according to the manifestations.
22. Who assumes the civil (respectively the criminal) liability for a possible malpractice, that is, for the adverse effects occurring after injection with a vaccine as a consequence of an erroneous recommendation to administer a vaccine in disregard of the undersigned’s medical problems?
Answer: Vaccination is carried out after a medical consultation confirming the state of health and establishing the absence of contraindications to vaccination, whether temporary or absolute. The administration of the vaccine is carried out by the family doctor after he has, before administering the vaccine, taken the patient’s history with a view to detecting in the antecedents a history of adverse reactions arising either from the composition of the vaccine or from the associated comorbidities.
23. Given the number of suspected side effects of the vaccines recorded in the European database of reports on suspected adverse drug reactions, are there at this date joint working teams with specialists of the ministry of health and of the manufacturers of the vaccines proposed by the ministry?
Answer: The activity of surveillance of undesirable post-vaccination adverse reactions (Order of the Minister of Health no. 964 of 31 March 2022 on the approval of the Technical norms for carrying out the national public health programmes, as subsequently amended and supplemented) is provided for within the National Vaccination Programme, the National Institute of Public Health, through the National Centre for Surveillance and Control of Communicable Diseases, being the national technical body responsible for the surveillance of cases of undesirable post-vaccination adverse reactions.
Where side effects appear after the administration of the vaccine, these are reported on the site of the National Agency for Medicines and Medical Devices of Romania, as well as to the National Institute of Public Health; subsequently all cases reported as undesirable post-vaccination adverse reactions are analysed by a commission, namely the National Commission for the Classification of Cases of Undesirable Post-Vaccination Adverse Reactions (established by Order of the Minister of Health no. 83/12.01.2023, as subsequently amended and supplemented), which includes specialists of various specialities from the specialist Commissions of the Ministry of Health, namely the Commission of Epidemiology, the Commission of Infectious Diseases, the Commission of Microbiology, the Commission of Paediatrics, the Commission of Neonatology, etc.
Thus, the specialists of the National Commission for the Classification of Cases of Undesirable Post-Vaccination Adverse Reactions analyse whether there exists a causal link between the adverse reaction appearing after vaccination and the administration of the vaccine.
24. What is the sum earmarked for the compensation owed by the Romanian State to the victims of the adverse effects of the vaccines, borne by the manufacturers of the vaccines that protect against COVID?
Answer: There is no legal framework providing for the amount of the compensation that may be borne by the Romanian state in the event of confirmation of cases of serious adverse reactions occurring in vaccinated persons.
Yours faithfully,
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Public Relations and Press Service
MINISTRY OF HEALTH
Post scriptum
How I answered the “silence” of the Ministry of Health:
“Good day!
Thank you for your answer registered with the Ministry of Health under No. SRPP 2498 / 23.01.2024.
However, in view of your answer to questions 2, 4, 6, 8, 10, 15 and 16, by which you informed me that “The methodology for reporting and recording cases of … (of the conditions and diseases I asked you about — our note) has not been modified so as to break them down according to the vaccination status of the patients”,
I ask you to bear in mind that the undersigned did NOT ask you whether or not you have a methodology for the information requested; I asked you for statistical information which I have the right to know, information which the whole population of Romania has the right to be made aware of.
Thus, if in order to supply the requested information you find yourselves obliged to draw up a new “methodology”,
the legal obligation you have to supply the requested data (information of the highest public interest) puts you in the position of having to adapt or update the methodologies so as to integrate the data at your disposal in order to provide the requested information.
I point out by this means that every vaccinated person appears in the registers of the ministry of health, which is why it is simple to integrate that information with the person’s current state of health, with the appearance or otherwise of the conditions mentioned in our request, or at least with the fact of whether or not that person is still alive.
Not least, I ask you to bear in mind that you have not supplied me even with the raw, unbroken-down data for the years 2021–2023, as I requested, a fact which makes any analysis of the effects of the vaccination of the population from December 2020 onwards impossible.
For all these reasons, I return to you with the request and the firm demand that you supply me with the data requested, whatever effort that may require on the part of your institution.
At the same time, I ask you to provide me with the requested information integrated into a single document, in the order in which the information was requested, so as to make the systematic study of these data, integrated into a single document, simpler.
I ask you by this means that the document be placed at my disposal in writing and in electronic format.
I state that, should you not supply me with the information you are obliged to make available under Law 544/2001, I shall appeal to the competent courts in order to compel you, on the basis of art. 4⁹ of Law 544/2001, to supply the requested information of public interest and to pay moral and/or patrimonial damages.
Thanking you in advance for your solicitude and for the promptness of your answer,
I greet you cordially,
Dan MV Chitic”
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