VP & Health Minister Answer Judges About Safety After Promoting Yearly mRNA & Insisting "covid vaccines have been developed following all quality standards"
"W.H.O. PQ Unit (FDA + EMA) Implicated As The Sole Source of Safety Data For Newly Approved - "YEARLY" mRNA Covid Injection
A couple months back we heard the Health Minister on the news shilling for the mRNA covid injections to be given YEARLY and lying the covid vaccines were developed following all quality standards. Gulp! Time to spring into action!
Yes, Yearly mRNA! You heard us right.
This made us ask questions in hopes to find info to prove there is no reason to say they are developed following all quality standards and use good manufacturing practices.
Below is the FULL ABSURD answer to the following important questions we asked:
Snarky excerpts are also below to help you avoid the pain of reading such tripe, unless you really have the time or are that curious.
Health Ministry: Ummm Uh… Duh… BLAME W.H.O., FDA & EMA Not Us!
“However, since these are vaccines that would be used for the first time in humans, Costa Rica made the decision to include within its selection criteria for COVID-19 vaccines that they had the approval of a Strict Regulatory Authority or is approved in the List of Emergency Use of WHO” - CR Health Minister
This saga began here, immediately after we saw the Minister trying to trick people:
INTEREST OF JUSTICE REQUESTS PROOF OF COVID VACCINE SAFETY
“We have insisted on the importance of getting vaccinated. The vaccines have been developed following all quality standards and have been shown to significantly reduce the severity of the disease,” the minister stressed.
Our Question 1a: Please provide concrete proofs with datasets, not mere assertions by WHO or regulators, that are relied on for that statement.
Our Question 1a: presumptive fact: Please provide concrete proofs with datasets that the vaccines have been developed following quality standards such as 1. "Completion of all standard preclinical trials"
Adherence to Good Manufacturing Practices, which include documentation on production quality, oversight, and quality assurance protocols.
3.Detailed regulatory filings submitted to health authorities (the WHO, FDA, EMA) with transparency regarding any expedited or Emergency Use Listing (EUL) processes and how these aligned with established quality standards.
Thank you,
Interest of Justice,
Dustin Bryce
Lady Xylie
contact@interestofjustice.org
GOVERNMENT ANSWERS THE COURT:
Long story short: Government of Costa Rica testified under oath that all safety for the experiment was on the WHO PQ unit - which is WHO, FDA & EMA. This testimony also admits covid vaccines are imported as INVESTIGATIONAL (EXPERIMENTAL).
Go to the source: Humanity needs to hold W.H.O. Pre-qualification unit responsible for the covid vax which is really unreasonably unsafe gene therapy authorized for mass use to healthy humans through their global EUL (emergency use listing).
ALWAYS REMEMBER: It was the WHO partnered with FDA’s CEBR & EMA to bring you the “safe” and “effective” biological agent poison.
If you think we are doing a good job please support by becoming a donor or paid subscriber. This work is 100% non profit and IMPOSSIBLE without support of our readers like YOU! Together with love and PERSISTENCE they stand NO chance!
READ THE RESPONSE TO THE COURT BLAMING WHO, FDA & EMA FOR ALL!
WE CAN SURELY TRUST W.H.O. TO ENSURE GLOBAL RELIANCE FOR SAFETY FOR “FIRST TIME USE IN HUMANS”
Our governments are so Pollyanna and trusting of the Philanthropaths…
If you want to see the FRICKING GAMES we have to deal with to confront the government on SERIOUS topics of safety standards, please feel free to read the circular gibberish response from the derelict government of Costa Rica below.
Its amazing how these corrupt Public Serpents will delay to give us and the Judges PAGES OF GIBBERISH GOBBLY-GOOK TO SAY ABSOLUTELY NOTHING. It’s obscene. Well below is what they had to say.
It does prove covid injections are a WHO authorized experiment used for 1st time in humans only because WHO promises it’s safe.
Health Ministers response to court:
Health Minister Mary Munive - who is a vax shill clearly, BUT was the only BAD ASS Health Minister in the world last WHA to tell W.H.O. her country will choose to REJECT & REFUSE THE PANDEMIC TREATY. W.H.O.’s side is she on?
Subject: Criteria for resolving queries made by Interest of Justice –
In reference to the processing sheet CARTA-MS-DGS-HT-024-2025, in which the query made by Interest of Justice is transferred, so that the corresponding inputs are provided to address said query, after carrying out the review and analysis of the letter in accordance with the technical competencies of this Directorate, the following is indicated:
Our question 1a: Please provide concrete evidence with data sets, not just claims from WHO or regulators, on which this claim is based.
Our Question 1a: Alleged Fact: Please provide concrete evidence with data sets that the vaccines have been developed following quality standards such as: 1. “Completion of all standard preclinical trials.” 2. Adherence to Good Manufacturing Practices, including documentation on production quality, oversight, and quality assurance protocols. 3. Detailed regulatory submissions submitted to health authorities (WHO, FDA, EMA) with transparency on any Emergency Use Listing (EUL) or expedited processes and how these aligned with established quality standards.
To answer these questions we will begin with a series of clarifications and background information that we consider necessary to clarify the doubts raised since it has been seen that due to the rapid development of COVID-19 vaccines and their early approval has raised concerns among some people about whether all safety and efficacy standards for the vaccines have been met. We begin by clarifying the research phases of the vaccines and a bit about the approval process for vaccines by the FDA and EMA, which are founding members of the International Council on Harmonization of Technical Requirements for Pharmaceutical Substances for Human Use and meet the definition of WHO Strict Regulatory Authority (available at https://www.who.int/initiatives/who-listed-authority-reg-authorities/SRAs ).
The phases of vaccine development and the different research studies that prioritize the safety of use of a vaccine and its efficacy (information taken from the World Health Organization website, available at https://www.paho.org/es/documentos/covid-19-fases-desarrollo-vacuna) are as follows:
• Preclinical phase: Experimental results on efficacy and tolerance in animal models support subsequent research in humans. Preclinical studies use tissue culture systems or cell cultures and tests on animals, which can be mice or monkeys, to evaluate the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response.
• Phase I: This usually involves testing a new experimental vaccine in a small number of humans, usually fewer than 100 adults, with the aim of initially evaluating its safety and biological effects, including immunogenicity. This phase may include studies of dosage and routes of administration.
• Phase II: Testing a vaccine that was deemed safe in Phase I requires a larger group of humans (usually between 200 and 500) to monitor safety and also trials that will determine the vaccine's efficacy. The goals of Phase II trials are to study the candidate vaccine for safety, immunogenicity, proposed dosage, and method of administration.
• Phase III: These are intended to more fully evaluate safety and efficacy in preventing disease and involve a larger number of volunteers participating in a properly controlled, multi-center study. They may include hundreds to thousands of humans in one or more countries. Phase III trials are randomized and double-blind, and involve the candidate vaccine being tested against a placebo (the placebo may be saline, a vaccine for another disease, or some other substance). This is generally the step prior to a vaccine being approved.
• Phase IV: These are studies that occur after a vaccine has been approved in one or more countries. These studies aim to evaluate how the vaccine works in the “real world.” In general, these are effectiveness studies and they also continue to monitor adverse events.
When the World Health Organization (WHO) elevated the public health emergency situation caused by COVID-19 to an international pandemic on March 11, 2020, given the rapidity of the evolution of events, it caused health authorities at the national and international level to adopt immediate and effective measures to deal with these extraordinary circumstances of an unprecedented health crisis of enormous magnitude, both due to the very high number of people affected and the extraordinary risk to their lives and rights.
The different regulatory authorities for products of health interest around the world implemented existing national mechanisms or began to develop special mechanisms to address this global state of emergency and allow access to diagnostic tests, medical devices and medicines to treat COVID-19 disease that have demonstrated a quality, safety and efficacy profile appropriate for human use.
For these purposes, the FDA has the figure of Emergency Use Authorization (EUA), which as described on the FDA website (available at: https://www.fda.gov/vaccines-blood-biologics/vaccines/explanation-of-the-emergency-use-authorization-for-vaccines ), is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions, when certain regulatory criteria have been met, including that there are no adequate, approved, and available alternatives. Based on input from the FDA, manufacturers decide whether and when to submit an EUA request to the FDA.
Taking into account the above, in the case of most COVID-19 vaccines, they began as new investigational vaccines (or vaccine candidates), which passed preclinical studies to begin their use in clinical research in phase I, II, III studies and could only be used within the framework of clinical studies.
When Phase II/III or Phase III studies of the experimental vaccine begin to show positive safety and efficacy results with at least 2 months of follow-up after the application of the complete vaccination schedule, the FDA's Emergency Use Authorization (EUA) can be requested (the guide is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19 ). The FDA may issue an EUA when certain criteria are met, which this includes the absence of acceptable, approved, and available alternatives. In addition, the FDA's decision is based on the totality of available scientific evidence showing that the product may be effective in preventing COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh its known and potential risks (adverse effects). This allows for widespread use of the vaccine, not just in clinical trials like experimental vaccines, and is generally in effect as long as emergency use of the vaccine is justified. This was the case with the Pfizer-BioNTech vaccine.
In the case of formal approval or authorization of a vaccine by the FDA, it is required that all quality information, nonclinical studies and phase I, II and III clinical studies with at least 6 months of follow-up after the completion of the proposed vaccine regimen be submitted. And if after the analysis of the information, a balance of the risks and benefits of the use of the drug is made for the authorization of the drug. This is why the FDA authorization for the Pfizer-BioNTech vaccine was only authorized for the vaccination of those over 16 years of age since they are the only studies that have completed 6 months of follow-up, vaccination in adolescents from 12 to 15 years of age and the one recently approved in children from 5 to 11 years of age is under the figure of emergency use authorization, since as previously clarified for formal authorization in these populations, a 6-month follow-up is required (information from the Fact Sheet for Recipients and Caregivers on the Pfizer-BioNTech COVID-19 Vaccine available at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#translated).
The emergency use authorization supports the evaluation of all the information that these are quality, safe and effective vaccines to prevent a disease for which there is currently no other approved effective therapeutic option.
And, just as the FDA in the United States is considered a Strict Regulatory Authority by the WHO, so is the European Union agency, the European Medicines Agency (EMA), which since December 21 granted authorization to the Pfizer-BioNTech COVID-19 vaccine, and on January 29, 2021 approved the AstraZeneca COVID-19 Vaccine, not under the Emergency Use Authorization figure, in this case EMA used the "rolling review" process, which is an exceptional mechanism by which the authority evaluates the data as it comes in, and since the information is complete and robust enough to reach a conclusion about the quality, safety and efficacy of the vaccine, conditional authorization was granted.
As explained in different EMA communications and I quote the following communication from the Spanish Agency for Medicines and Health Products (AEMPS): “EMA's conditional marketing authorization is an instrument contemplated in European legislation that allows an authorization in the event of an unmet medical need, to the extent that the benefit to public health of its immediate availability is greater than the uncertainty derived from the limitation of the available data.
This type of authorization is not specific to this situation; it has been granted outside and within the pandemic and requires more data than an authorization for emergency situations such as the one granted (available in Others regions “regulatory”
Once conditional authorisation’s have been granted, they can be marketed in all member states of the European Union, as is the case with all authorised medicines; only in this case, the COVID-19 vaccines have not been able to be marketed at the national level. private pharmacies, because the production of these vaccines is still compromised to comply with the marketing agreements that the laboratories made with the different governments for national vaccination campaigns.
It is important to mention that the COVID-19 vaccines authorized by the FDA, EMA, as well as other Strict Regulatory Authorities, have been authorized based on the quality, safety and efficacy results available at the time of the authorization decision (non-clinical studies, and phase I, II and III clinical studies), but the clinical studies Phase III studies continue to be conducted to obtain data on the duration of protection shown over time and to document efficacy in special populations (e.g. children, pregnant women) as well as clinical studies to demonstrate effectiveness against newly identified variants of the virus.
The WHO, for its part, has the Emergency Use Listing mechanism that we already mentioned above, where an external committee of experts convened by the WHO analyzes the results of clinical trials and recommends the vaccines that should be used.and how to use them.
It is then up to the authorities of each country to authorize or not the use of each vaccine in their jurisdictions and to develop policies for administering them, based on WHO recommendations.
In the case of Costa Rica, article 117 of the General Health Law indicates that: The Ministry of Health, the Costa Rican Social Security Fund and any other state entity, with public health or social security functions, may acquire unregistered medicines, at any time or under any circumstances. In case of urgency or public need, the Ministry may authorize the importation of unregistered medicines.Thus, by declaring, through Executive Decree No. 42227 - MP - S, of March 16, 2020, the stat of national emergency throughout the territory of the Republic of Costa Rica, due to the health emergency situation caused by the disease caused by COVID-19, both the CCSS and any other state entity may import COVID-19 vaccines without health registration.
Executive Decree No. 42571-S Regulations for the sanitary authorization for the clearance and acquisition of unregistered medicines by state entities with public health or social security functions and for the authorization of clearance in case of 'public necessity, details the import requirements for medicines in cases of public necessity such as in the case of vaccines against COVID-19.
Similarly, Executive Decree No. 38414-COMEX-MEIC-S Central American Technical Regulation 11.03.59:11 Pharmaceutical Products, Medicines for Human Use, Requirements for Sanitary Registration, applicable to the sanitary registration of Medicines, in its article 13 states that: The Regulatory Authority may authorize the importation and use of medicines without sanitary registration in the following cases: … 13.2 National emergencies and officially declared public need.
However, since these are vaccines that would be used for the first time in humans, and to ensure the population rapid access to vaccines and safeguard the health of the Costa Rican population, the National Vaccination and Epidemiology a Strict Regulatory Authority or approved in the List of Use ofWHO Emergency, so we made sure that the expert committees of these authorities that have quite strict regulations and robust regulatory processes, reviewed the information and gave their recommendation and Costa Rica would provide an authorization based on the recognition made by these Strict Regulatory Authorities as described in administrative resolution DM-RM-7905-2020 of December 3,2020.
We would like to review some of the regulatory approvals that the vaccine against Pfizer-BioNTech COVID-19, which is the vaccine that has been used the most in the vaccination campaign in Costa Rica until obtaining the corresponding health registration with the Ministry Health: at any time or under any circumstances. In case of urgency or public need, the Ministry may authorize the importation of unregistered medicines. Thus, by declaring, through Executive Decree No. 42227 - MP - S, of March 16, 2020, the state of national emergency throughout the territory of the Republic of Costa Rica, due to the health emergency situation caused by the disease caused by COVID-19, both the CCSS and any other state entity may import COVID-19 vaccines without health registration.
Executive Decree No. 42571-S Regulations for the sanitary authorization for the clearance and acquisition of unregistered medicines by state entities with public health or social security functions and for the authorization of clearance in case of public necessity, details the import requirements for medicines in cases of public necessity such as in the case of vaccines against COVID-19.
Similarly, Executive Decree No. 38414-COMEX-MEIC-S Central American Technical Regulation 11.03.59:11Pharmaceutical Products, Medicines for Human Use, Requirements for Sanitary Registration, applicable to the sanitary registration of Medicines, in its article 13 states that: The Regulatory Authority may authorize the importation and use of medicines without sanitary registration in the following cases: … 13.2 National emergencies and officially declared public need.
However, since these are vaccines that would be used for the first time in humans, and to ensure the population rapid access to vaccines and safeguard the health of the Costa Rican population, the National Vaccination and EpidemiologyCommission made the decision to include within its selection criteria for COVID-19 vaccines that they had the approval of a Strict Regulatory Authority or approved in the List of Use of WHO Emergency, so we made sure that the expert committees of these authorities that have quite strict regulations and robust regulatory processes, reviewed the information and gave their recommendation and Costa Rica would provide an authorization based on the recognition made by these Strict Regulatory Authorities as described in administrative resolution DM-RM-7905-2020 of December 3, 2020.
We would like to review some of the regulatory approvals that the vaccine against Pfizer-BioNTech COVID-19, which is the vaccine that has been used the most in the vaccination campaign in Costa Rica until obtaining the corresponding health registration with the Ministry Health:
• On December 2, 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized temporary supply.
• On December 15, 2020, the Ministry of Health of Costa Rica authorizes the use of the vaccine based on the recognition of the emergency use authorization granted by the FDA.
• On August 23, 2021 (prior to the filing of the lawsuit), the FDA formally approves the Pfizer-BioNTech COVID-19 vaccine under the brand name COMIRNATY to prevent COVID-19 disease in people 16 years of age and older.
• On February 16, 2024, the Ministry of Health of Costa Rica formally approved the vaccines COMIRNATY (known as Original since it was the initial one), health registration MB-BE-24-00002 and COMIRNATY Original/Ómicron BQ.4-5 (known as Bivalent), health registration MB-BE-24-00003 and subsequently the COMIRNATY Omicron vaccine was authorized XBB.1.5, health registration MB-BE-24-07632 and MB-BE-24-07535.
By having a current registration with the Ministry of Health, we can ensure that said vaccines met the requirements established by the Technical Regulation: RTCR 440: 2010. Regulations for the Registration and Control of Biological Medicines, Executive Decree No. 37006-S in force and the Central American Technical Regulation RTCA 11.03.59:18 Pharmaceutical Products. Medicines for Human Use. Sanitary Registration Requirements Executive Decree No. 43259-COMEX-S-MEIC and, therefore, they presented the complete preclinical studies and the certificates of compliance with Good Manufacturing Practices, as well as all the quality information of the vaccine production process and quality verification, which refers to questions 1 and 2 of your consultation.
However, much of the technical and scientific information supporting the quality of this vaccine, as with other medicines, is protected by the Undisclosed Information Act, Law No. 7975 of January 4, 2000, and cannot be shared without the express authorization of the holders of said information. Therefore, the information you request cannot be provided.
Regarding question 3, the information can be found on the corresponding pages of the EMA, FDA and WHO. The following links are provided where you can enter relevant information specifically for these vaccines:
• EMA:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty#assessment-history . In the Initial marketing authorization documents section, you will find a public and summarized report of the information submitted by the laboratory for the initial authorization of the vaccine and you can find a similar report for all the changes that the vaccine has undergone since the initial authorization.
• FDA: https://www.fda.gov/vaccines-blood-biologics/comirnaty, In this link you will find information about the authorization of the COMIRNATY vaccine in the United States, with the documents that support the initial authorization and subsequent changes to the vaccine.
• WHO pre-qualification: Vaccines | WHO - Pre-qualification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control), There is information about the pre-qualification process followed by the WHO for vaccines, as well as the list of prequalified vaccines, among other relevant information.
Without further ado, he says goodbye.
Directorate for the Regulation of Products of Health Interest
MS-CS-011-2025
This response pissed us off! Wait til you hear what we did & what happens next
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If you think we are doing a good job please support by becoming a donor or paid subscriber. This work is 100% non profit and IMPOSSIBLE without support of our readers like YOU! Together with love and PERSISTENCE they stand NO chance!
Never Ever believe what the WHO says! Gates, a full fledged psychopath & mass murderer should be imprisoned by now for vast crimes against humanity. The fact he is still pushing his deadly shots is MONEY- lots of it to pay for suppression of the truth.This monster must arrested NOW!
May be worthwhile providing these ignorant people with the Pfizer Report papers? Surely Dr Naomi Wolff would assist there? or refer the paid Researchers and their employers - the Costa Rican government to Dr Wolffs site and many others written by well credentialled people - throughout the World about this "health" scenario.
I fear for the Costa Rican people, not only in the Vaccine area but other matters pertaining to the Governments reach. This incredibly low level of knowledge of current and past History, in what has now become a well researcheds area and statistics is mind blowing. Let alone the proof of WHO and their mismanagement history that is a matter of public record.
Never Ever believe what the WHO says! Gates, a full fledged psychopath & mass murderer should be imprisoned by now for vast crimes against humanity. The fact he is still pushing his deadly shots is MONEY- lots of it to pay for suppression of the truth.This monster must arrested NOW!
May be worthwhile providing these ignorant people with the Pfizer Report papers? Surely Dr Naomi Wolff would assist there? or refer the paid Researchers and their employers - the Costa Rican government to Dr Wolffs site and many others written by well credentialled people - throughout the World about this "health" scenario.
I fear for the Costa Rican people, not only in the Vaccine area but other matters pertaining to the Governments reach. This incredibly low level of knowledge of current and past History, in what has now become a well researcheds area and statistics is mind blowing. Let alone the proof of WHO and their mismanagement history that is a matter of public record.