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In its call, EOF explains the operating protocol of the Pharmacovigilance Committee and the way in which all types of incidents are treated, in order to indicate the specific ones:
- ΟΕ / Ε.ΦΑΡ. assess the incident as possible and 2 days before the final Coreper evaluation and 8 days before the AZ letter is sent to healthcare professionals.
- In addition, the data for Greece for the specific incident, from forwarded to Coreper, In accordance with established procedures, it was taken into account in their pertinent meetings, in which it was decided to modify the approved vaccine data and send a relevant information letter to health professionals. by the possibility of thrombocytopenia and bleeding disorders, considered at European level.
- ΟΕ / Ε.ΦΑΡ. operates with strict scientific criteria and with solely for the protection of the health of citizens, through the timely detection of possible AS of vaccines.
- The EOF immediately informs the competent national and international organizations., with whom it is interconnected, in order to know definitively and safely any possible association of SA with a specific vaccine.
With regard to the complainant, the OAS indicates that “the complaints of reluctance have nothing to do with reality. “These reports were issued by a recently appointed alternate member of EFAR, who participated in a single meeting, without even knowing how the committee works, how it is evaluated, nor the number, nor the result of previous evaluations.”
However, it is underlined: “E.FAR. And OE / E.FAR. Takes Decisions with impartiality and absolute freedom in the expression of your scientific thought., and it is unfair to tarnish your work with immoderate behavior. Citizens must be aware that EOF and EFAR work constantly and selflessly to protect the health of all. The information will be made in a coordinated way and based on data or in an extraordinary way, but only if it is considered necessary and always based on the scientific data available until then ”.
EOF concludes by emphasizing that: “The crisis facing the entire planet is unprecedented, as is the effort to confront it. Therefore, it is necessary seriousness and sobriety to return to normal soon “.
The EOF announcement in detail
The EOF, respecting its institutional role, acts with strict scientific criteria and in accordance with the law and ethical standards. However, given the discussion that arose especially after the public and as a derogation of each procedure, positions of a member of the Pharmacovigilance Committee of the EOF (EFAR), the public position of the Organization is considered necessary to establish the truth of the facts.
Pharmacovigilance, according to the World Health Organization (WHO), is the science and activities associated with the detection, evaluation, understanding and prevention of side effects and other drug-related problems. It is a complex and time-consuming process. The EOF has a Department of Adverse Reactions (TAE) in the Directorate of Pharmaceutical Studies and Research and, for many decades, a Pharmacovigilance Committee (EFAR), which is an institutional scientific advisory body with the task of side effects with drugs. and for the safety of citizens. The participation of its members requires a declaration of non-conflict of interest and confidentiality, as well as the evident observance of medical confidentiality.
Since the beginning of December 2020, before the start of vaccinations, a special Working Group (SP) was created in the OAS within the EFAR, with the aim of continuous and exhaustive monitoring of the vaccines against SARS-CoV- two. These are two interdisciplinary organizations, made up of 25 renowned scientists and different specialties from all over Greece, with extensive experience in case evaluation, which is based on international standards, accepted criteria and methodology of the World Health Organization (WHO ), applied by our counterpart Organizations and the European Medicines Agency (EMA), the data available for each case and the international literature. When an unrepresented specialty is required, the opinion of relevant experts is sought.
The OE works on a voluntary, uninterrupted and tireless basis, being constantly alert, contributing to the scientifically based evaluation and with absolute transparency of the possible correlation of the secondary effects of the Yellow Cards (KC) reported with the EE. ΟΕ / Ε. ΦΑΡ. has contributed to the systematic collection of data on vaccine AE and, on its own initiative, statistics have also been obtained from the Statistical Service to compare the observed frequency of vaccine AE with the expected frequency of AE in the general population.
The data is continuously transmitted via the APR to the European database (Eudravigilance) together with the evaluations of severe cases, contributing to the final evaluation of the European data by the competent European Pharmacovigilance Evaluation Committee (PRAC).
Through the TAE and the Directorate of Pharmaceutical Studies and Research (DFME), the National Vaccination Committee is informed daily by a representative of the EOF.
Regarding the specific incident that is the subject of discussion, we believe that the following should be disclosed, in order to restore the distortion observed in recent days, which profoundly affects the prestige, integrity, reputation and credibility of E. ΦΑΡ., Ε. ΦΑΡ. / ΟΕ and ΕΟΦ in general, undermining and nullifying a long-term, arduous, silent, voluntary and very substantial project.
The incident was investigated by OE / E.FAR. on 09/03/21, as soon as the KK was sent and additional information was requested from the treating physicians. On 3/16/21 the OE / E.FAR met again. in a joint meeting with the plenary of E.FAR. After a careful review of all available clinical and laboratory data for the specific case, he considered that it is not possible at this time to exclude the causal correlation of the reported incident with vaccination. According to WHO criteria. called the incident “possible”. If new information emerges, the incident will be reexamined.
The OAS submitted this assessment to the European Adverse Reference Database, which was 2 days before the announcement by the European Medicines Agency (EMA) that it reached the same conclusion on similar rare cases of thrombocytopenia associated with the Astra vaccine. Zeneca (AZ) (Announcement by Coreper on 3/18/2021, the translation of which was published on the OEA website).
On 3/19/2021, the EMA, through the Committee for Medicinal Products for Human Use (CHMP) and on the recommendation of the PRAC (the OEA also participates institutionally in these procedures), requested the update of the approved data of the Astra-Zeneca vaccine ( AZ) and sending a relevant information letter to healthcare professionals. On 3/19/2021, AZ, in compliance, sent the OEA a draft letter “Direct Contact with Health Professionals” (DHPC) about its vaccine and the issue under consideration. ΟΕ / Ε.ΦΑΡ. edited and corrected the critical points of the letter and recommended to send the letter to all Health Professionals without exception, the extensive distribution of which was initiated by AZ on 3/24/21, according to the scheduled schedule.
Therefore,
- ΟΕ / Ε.ΦΑΡ. Assess the incidence as possible already 2 days before the final Coreper evaluation and 8 days before sending the AZ letter to healthcare professionals.
- Likewise, the data from Greece for the specific incident, after being sent to Coreper, in accordance with the established procedures, were taken into account in their relevant meetings, with which it was decided to modify the approved data of the vaccine and send a relevant Information letter to healthcare professionals due to thrombocytopenia and bleeding disorders, currently under examination at the European level.
- ΟΕ / Ε.ΦΑΡ. It operates with strict scientific criteria and with the sole objective of protecting the health of citizens, through the timely detection of possible AEs from vaccines.
- The OAS immediately informs the competent national and international organizations, with which it is related, to know definitively and safely any possible association of AS with a specific vaccine.
Reports of reluctance, therefore, have nothing to do with reality. These reports were issued by a newly appointed alternate member of EFAR, who participated in a single meeting, without even knowing how the committee works, how it is evaluated, nor the number, nor the result of previous evaluations. Regarding the reports of the value system, we believe that respect for personal data, compliance with commitments and respect for interlocutors are fundamental moral values of anyone who wants to contribute in a genuine and substantial way to the common good and the defense of Public Health.
The E.FAR. and OE / E.FAR. he makes decisions with impartiality and absolute freedom in the expression of his scientific thought, and it is unfair to tarnish his work with impartial behavior. Citizens must be aware that EOF and EFAR work constantly and selflessly to protect the health of all. The information will be provided in a coordinated way and on the basis of data or on an ad hoc basis, but only if it is considered necessary and always on the basis of scientific data available until then. For the proper information of citizens, pharmacovigilance issues are systematically published in the relevant EOF announcements. The possibility of electronic submission of possible side effects of medicines and vaccines is remembered through the EOF website.
The crisis facing the entire planet is unprecedented, as is the effort to address it. Therefore, seriousness and sobriety are required to return to normality soon.
The Administration of the National Medicines Agency
