Case closed: No legal basis for vaccine mandates

Thanks to the clear and comprehensive answers provided to me by the National competent authority, The Public Agency for Medicinal Products and Medical Devices, in accordance with Article 17 of the Regulation on Administrative Operations (Official Journal of the Republic of Slovenia, No 9/18, 14/20, 167/20 and 172/21), and in accordance with Freedom Of Information Act (Official Journal of the Republic of Slovenia, No. 51/06 – Official consolidated text, 117/06 – ZDavP-2, 23/14, 50/14, 19/15 – Decree of the US, 102/15 and 7/18), any further discussion about vaccine mandate against Sars-CoV-2, should immediately stop, as there is no legal basis for introducing such mandate.

As can be seen from the official replies provided by the JAZMP (Public Agency for Medicinal Products and Medical Devices ), there is currently no vaccine with a standard authorisation not only in Slovenia, but throughout the European Union. Moreover, clinical trials are currently still ongoing for each of the Sars-CoV-2 vaccines currently on the market. The fact is that, unless a member state of European Union wishes to completely dismantle the legal order and overturn international conventions and declarations, it has no valid legal basis for introducing compulsory vaccination against Sars-CoV-2. Indeed, if clinical trials of drugs or vaccines are still under way, any individual wishing to take part in such studies must, at most, be informed of this fact in advance and give his or her informed consent. Such consent must be freely given, without pressure, deception or other defects of will. Otherwise, in legal terms, the vaccination with Sars-CoV-2 vaccines constitutes unauthorised and illegal human experimentation.

More on this in the articles:

https://domengorenseklaw.com/2021/10/03/pogoj-cpt-za-vsako-ceno/ https://domengorenseklaw.com/2021/10/12/varnost-ucinkovitost-in-odgovornost/

The competent regulator has explicitly confirmed that all Sars-CoV-2 vaccines currently available in the territory of the Republic of Slovenia have passed all stages of the clinical trials necessary to obtain a conditional marketing authorisation (emphasis added). Furthermore, the content of the JAZMP replies makes it quite clear what this means and what are the further obligations of the holders of such authorisations. For example, we also officially learn that “for each COVID-19 vaccine, several clinical trials with different research objectives are running in parallel and are at different stages of development” and that “the pivotal clinical studies for the COVID-19 vaccines on which the conditional marketing authorisation is based are in Phase 3 clinical trials“. In view of the above, it is thus obvious that all the claims made by the exposed part of the science and medical profession, have clearly proved to be misleading to say the least, since from a pedestal of authority, we have never been officially told which phase of trials the Sars-CoV-2 vaccines are currently in, but have been treated to endlessly repeated phrases such as “trust the science”, “trust the profession”, “the vaccines are safe and effective”, “the vaccines are approved”. Of course they are, conditionally.

At this point in time, the safety and efficacy of Sars-CoV-2 vaccines can only be hoped for from an objective and legal point of view, as studies are underway to confirm or refute this. This has now finally been officially confirmed by the national regulator, which, alongside the EMA ( European Medicines Agency), is the only authority in the Republic of Slovenia, competent for the licensing of medicines and vaccines.

The “game of blackmail” about introducing any kind of vaccination mandates against Sars-CoV-2 must therefore, in my opinion, be brought to an end immediately. As regards the Comirnaty vaccine (Pfizer), the JAZMP’s reply states quite unequivocally that ‘the study is currently in phase 3‘ (emphasis added). The response further states that “the end of the study is defined as the date of the last visit of the last subject in the study. The study protocol dictates that subjects are followed up for 24 months after the second vaccination in order to determine the long-term safety of the vaccine. Current data indicate an estimated study end date of 2 May 2023” (emphasis added). With regard to Spikevax (Moderna), the JAZMP also explicitly stated that “the study is currently in Phase 3“. However, the end of the study is defined in the same way as the date of the last visit of the last subject in the study. The study protocol for that vaccine dictates that subjects are followed up for 24 months after the second vaccination, … “in order to determine the long-term safety of the vaccine. According to current data, the estimated end date of the study is 27 October 2022” (emphasis added). With regard to Vaxzevria (AstraZeneca), according to the reply of the Agency for Medicinal Products and Medical Devices, the estimated completion date of the study is 14 February 2023. It should be noted that the efficacy and safety study of this vaccine is also currently only in Phase 3.

What about the Janssen (J&J) vaccine? A multicentre, randomised, double-blind, placebo-controlled Phase 3 study is underway in the United States, South Africa and Latin America. The anticipated completion date of this study is 2 January 2023.

Concerning vaccination of pregnant and young women

As can be seen from the JAZMP response, “there are no conclusive clinical data available for the use of covid-19 vaccines during pregnancy, as pregnant women were excluded from participation in the pivotal pre-marketing authorisation clinical studies” (emphasis added). The JAZMP goes on to state that pre-clinical studies have been conducted for each covid-19 vaccine and that “For none of the vaccines have pre-clinical animal data shown effects of the vaccine on female fertility, fetal and embryonic survival, or postnatal growth and development of the offspring“.

So we have preclinical animal studies that are not supposed to show any specific negative effects of vaccinating young women and pregnant women. We also have the hope that this will remain the case in humans. Indeed, the Agency goes on to state that “in view of the reassuring data from the pre-clinical toxicological studies, and taking into account that, according to the data collected so far, pregnant women are two to four times more likely to be at increased risk of a more severe course of covid-19 than non-pregnant women of the same age, an individual assessment of the balance of the benefits of vaccination over the potential risks to mother and foetus seems appropriate“.

With regard to vaccination of pregnant women, the Agency’s response also indicates that the benefit of vaccinating pregnant women should be assessed on an individual basis, particularly with regard to the potential for a more severe course of COVID-19 in each specific case. Furthermore, we learn that dedicated studies on the safety of COVID-19 vaccines in pregnant women were essentially planned in the post-marketing authorisation phase and that some studies are already actively ongoing. We also learn that prospective observational studies will assess pregnancy and birth outcomes in women exposed to covid-19 vaccine during pregnancy. The studies will include pregnant women from the general population who will be followed from enrolment until the end of pregnancy. Live births, stillbirths, terminations or miscarriages will be monitored. Live births will be followed from birth to 1 year of age.

We therefore have not only hope, but also ‘reassuring data’, what it ‘seems’ to be at the moment, preclinical animal studies and studies involving pregnant women from the general population, which are currently under way. In my opinion, given the fact that clinical trials are still ongoing, this is therefore a rather low, practically zero standard of proof on the basis of which anyone, especially the medical doctor or the Minister of Health, could directly call on pregnant women and young women to be vaccinated en masse, calling Sars-Cov-2 vaccines safe and effective for them.

What about children and minors?

The JAZMP has now also given an official answer to the question on the vaccination of minors with Sars-CoV-2 vaccines.
Among other things, the Agency states that “Vaxzevria (AstraZeneca) and COVID-19 Vaccine Janssen are not approved for use in children under 18 years of age“. These vaccines are therefore not even conditionally approved for use in minors.

More interesting answers

“All pivotal clinical trials for these vaccines are still ongoing…” -JAZMP
“All the expected completion dates of the trials are given in the answer to question 3”. -JAZMP
“It should be noted that none of the pivotal clinical trials are conducted exclusively in the European Union, or rather the majority of the clinical trials mentioned are not conducted in the EU, but in the USA, Peru, Chile and the United Kingdom.” – JAZMP
“The sheer volume of notified clinical trials makes it impossible to estimate when clinical trials will be completed in the European Union.” -JAZMP

Conclusion

There is currently no legal basis for introducing any kind of vaccine mandates against Sars-CoV-2- Compulsory vaccination, even indirectly, would legally mean that many rights and freedoms of the citizen are taken away or restricted, if one does not want to be part of phase 3 clinical trials. This is, of course, contrary to Article 18 of the Constitution of the Republic of Slovenia, contrary to the Universal Declaration of Human Rights, contrary to the Oviedo Convention and its protocols, The Declaration of Helsinki and even contrary to the Nuremberg Code itself.

Link to the Agency’s full replies in Slovenian:

https://domengorenseklaw.com/2021/12/18/konec-je-jasna-vprasanja-in-tokrat-povsem-jasni-odgovori/

It is over. The spin of the profession, the media and politics should stop immediately.