Plus de 117 000 doses de vaccin Covid étaient défectueuses. Elles ont été administrées aux Polonais. Où est le procureur ?
Eight reports of the occurrence of quality defects or suspicion of quality defects in COVID-19 vaccines were submitted to the GIF, two of which were significant.
On April 23, 2021, the Main Pharmaceutical Inspectorate received information through the Rapid Alert System from the European Medicines Agency regarding the suspicion of a quality defect in one of the series of COVID-19 vaccines that were already being used on Polish patients. The report concerned the suspicion of a Class II defect, which could cause illness or improper functioning. GIF did not issue a decision to suspend or withdraw this series of vaccines from circulation. However, in April 2022, the Federal Agency for Medicines and Health Products in Belgium informed the GIF of the withdrawal of this series from the market. Upon receiving the report, GIF forwarded the information to RARS, requesting action to identify distribution channels and notify recipients of the situation. However, these actions were futile as the entire quantity of this series of vaccines had already been administered to patients.
In the second case, a report of a quality defect in a series of vaccines was received on April 7, 2022, from the Spanish Agency for Medicines and Sanitary Products (AEMPS). The quality defect in the vaccine could pose a threat to the lives and health of patients (Class I defect), which obligated GIF to withdraw the defective product from circulation.
In both cases, GIF not only did not withdraw these series of vaccines from circulation but also did not know where they might be. Upon receiving the report, the information was passed on to RARS, requesting the identification of distribution channels and the notification of recipients about the situation. The Chief Pharmaceutical Inspector explained that due to the interpretation of the Minister of Health stating that vaccines against COVID-19 are not subject to circulation but to another type of distribution, it was not possible to issue a withdrawal decision for a product that is not in circulation. Such information was also conveyed to RARS.
In light of the findings of the control conducted in GIF, an assessment indicating the unwarranted position of Ewa Krajewska - the Chief Pharmaceutical Inspector - was included in the post-control findings. The President of the Supreme Chamber of Control informed the Prime Minister of the Republic of Poland and the Minister of Health in writing about the assessments and conclusions formulated in the post-control findings from the control conducted in GIF.
The response indicated, among other things, that the Main Pharmaceutical Inspectorate acted correctly in the scope of supervision over the National Vaccination Program.
Source: https://www.nik.gov.pl/aktualnosci/zmarnowane-szczepionki-covid-19.html
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Eight reports of the occurrence of quality defects or suspicion of quality defects in COVID-19 vaccines were submitted to the GIF, two of which were significant.
On April 23, 2021, the Main Pharmaceutical Inspectorate received information through the Rapid Alert System from the European Medicines Agency regarding the suspicion of a quality defect in one of the series of COVID-19 vaccines that were already being used on Polish patients. The report concerned the suspicion of a Class II defect, which could cause illness or improper functioning. GIF did not issue a decision to suspend or withdraw this series of vaccines from circulation. However, in April 2022, the Federal Agency for Medicines and Health Products in Belgium informed the GIF of the withdrawal of this series from the market. Upon receiving the report, GIF forwarded the information to RARS, requesting action to identify distribution channels and notify recipients of the situation. However, these actions were futile as the entire quantity of this series of vaccines had already been administered to patients.
In the second case, a report of a quality defect in a series of vaccines was received on April 7, 2022, from the Spanish Agency for Medicines and Sanitary Products (AEMPS). The quality defect in the vaccine could pose a threat to the lives and health of patients (Class I defect), which obligated GIF to withdraw the defective product from circulation.
In both cases, GIF not only did not withdraw these series of vaccines from circulation but also did not know where they might be. Upon receiving the report, the information was passed on to RARS, requesting the identification of distribution channels and the notification of recipients about the situation. The Chief Pharmaceutical Inspector explained that due to the interpretation of the Minister of Health stating that vaccines against COVID-19 are not subject to circulation but to another type of distribution, it was not possible to issue a withdrawal decision for a product that is not in circulation. Such information was also conveyed to RARS.
In light of the findings of the control conducted in GIF, an assessment indicating the unwarranted position of Ewa Krajewska - the Chief Pharmaceutical Inspector - was included in the post-control findings. The President of the Supreme Chamber of Control informed the Prime Minister of the Republic of Poland and the Minister of Health in writing about the assessments and conclusions formulated in the post-control findings from the control conducted in GIF.
The response indicated, among other things, that the Main Pharmaceutical Inspectorate acted correctly in the scope of supervision over the National Vaccination Program.
Source: https://www.nik.gov.pl/aktualnosci/zmarnowane-szczepionki-covid-19.html
...
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