"Over 117 thousand COVID-19 vaccines were defective. They were administered to Poles. Where is the prosecution?"
There were eight reports of the occurrence of quality defects or suspicions of quality defects in COVID-19 vaccines, out of which two reports were significant.
On April 23, 2021, the Main Pharmaceutical Inspectorate received information through the Rapid Alert system from the European Medicines Agency regarding a suspected quality defect in one of the series of COVID-19 vaccines already being used in Polish patients. The report concerned a suspicion of a class II defect, which could cause illness or improper functioning. The Main Pharmaceutical Inspectorate did not issue a decision to suspend or withdraw this batch of vaccine from circulation. However, in April 2022, the Federal Agency for Medicines and Health Products in Belgium informed the Main Pharmaceutical Inspectorate of the withdrawal of this batch from the market. Upon receiving the report, the Main Pharmaceutical Inspectorate forwarded the information to the Rapid Alert System, requesting actions to identify distribution channels and notify recipients about the situation. These actions were unnecessary, as the entire quantity of this batch of vaccine had already been administered to patients.
In the second case, a report of a quality defect in a vaccine batch was received on April 7, 2022, from the Spanish Agency for Medicines and Medical Products (AEMPS). The quality defect in the vaccine could pose a threat to the lives and health of patients (class I defect), which obliged the Main Pharmaceutical Inspectorate to withdraw the faulty product from circulation.
In both cases, the Main Pharmaceutical Inspectorate not only did not recall these batches of vaccines from circulation but also did not know their whereabouts. After receiving the report, the information was passed on to the Rapid Alert System, requesting the identification of distribution channels and notification of recipients about the situation. The Chief Pharmaceutical Inspector explained that, according to the interpretation of the Minister of Health, vaccines against COVID-19 are not considered as being in circulation but are subject to a different type of distribution, which made it impossible to issue a recall decision for a product that was not in circulation. This information was also communicated to the Rapid Alert System.
As a result of the control findings at the Main Pharmaceutical Inspectorate, an assessment indicating the unfounded nature of Ewa Krajewska's position as the Chief Pharmaceutical Inspector was included. The President of the Supreme Audit Office informed the Prime Minister of the Republic of Poland and the Minister of Health in writing about the assessments and conclusions formulated in the control findings from the Main Pharmaceutical Inspectorate.
According to the responses, the Main Pharmaceutical Inspectorate acted correctly in terms of supervision over National Immunization Program vaccines.
source: https://www.nik.gov.pl/aktualnosci/zmarnowane-szczepionki-covid-19.html
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There were eight reports of the occurrence of quality defects or suspicions of quality defects in COVID-19 vaccines, out of which two reports were significant.
On April 23, 2021, the Main Pharmaceutical Inspectorate received information through the Rapid Alert system from the European Medicines Agency regarding a suspected quality defect in one of the series of COVID-19 vaccines already being used in Polish patients. The report concerned a suspicion of a class II defect, which could cause illness or improper functioning. The Main Pharmaceutical Inspectorate did not issue a decision to suspend or withdraw this batch of vaccine from circulation. However, in April 2022, the Federal Agency for Medicines and Health Products in Belgium informed the Main Pharmaceutical Inspectorate of the withdrawal of this batch from the market. Upon receiving the report, the Main Pharmaceutical Inspectorate forwarded the information to the Rapid Alert System, requesting actions to identify distribution channels and notify recipients about the situation. These actions were unnecessary, as the entire quantity of this batch of vaccine had already been administered to patients.
In the second case, a report of a quality defect in a vaccine batch was received on April 7, 2022, from the Spanish Agency for Medicines and Medical Products (AEMPS). The quality defect in the vaccine could pose a threat to the lives and health of patients (class I defect), which obliged the Main Pharmaceutical Inspectorate to withdraw the faulty product from circulation.
In both cases, the Main Pharmaceutical Inspectorate not only did not recall these batches of vaccines from circulation but also did not know their whereabouts. After receiving the report, the information was passed on to the Rapid Alert System, requesting the identification of distribution channels and notification of recipients about the situation. The Chief Pharmaceutical Inspector explained that, according to the interpretation of the Minister of Health, vaccines against COVID-19 are not considered as being in circulation but are subject to a different type of distribution, which made it impossible to issue a recall decision for a product that was not in circulation. This information was also communicated to the Rapid Alert System.
As a result of the control findings at the Main Pharmaceutical Inspectorate, an assessment indicating the unfounded nature of Ewa Krajewska's position as the Chief Pharmaceutical Inspector was included. The President of the Supreme Audit Office informed the Prime Minister of the Republic of Poland and the Minister of Health in writing about the assessments and conclusions formulated in the control findings from the Main Pharmaceutical Inspectorate.
According to the responses, the Main Pharmaceutical Inspectorate acted correctly in terms of supervision over National Immunization Program vaccines.
source: https://www.nik.gov.pl/aktualnosci/zmarnowane-szczepionki-covid-19.html
…
Check out the videos:
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