Filenews 19 March 2021
Of the 107 reports of suspected adverse reactions likely to be related to vaccination in a total of 127,783 (until 17 March) vaccinations, 66 were for Pfizer, 40 for AstraZeneca and one for Moderna.
According to the Deputy Director of Pharmaceutical Services, Elena Panagiotopoulou, of these reports, 9 were mild or moderate and the eight most serious who were not found to be related to vaccination because they related to cases of underlying diseases or were taking medicines. The breakdown by sheet showed that there were more reports from women than in men.
Regarding the rescheduling of AstraZeneca vaccine vaccinations for people whose appointment was postponed from March 16-18, Deputy Director of Medical and Public Health Services Dr Olga Kalakuta explained that the Vaccination Portal will open on Monday, March 22, at 8am and remain open until Tuesday, March 23 , and through it can be reprogramming.
It is recalled that a press conference was held this morning in the wake of yesterday's opinion of the European Medicines Agency on the non-association of thromboembolic events in EU states with the AstraZeneca vaccine. The press conference was attended by Anne. Director of Pharmaceutical Services Mrs Elena Panagiotopoulou, Ann. Director of Medical and Public Health Services Dr. Olga Kalakouta, the Consultant of the Ministry of Health for Vaccines against COVID-19 Mr. Christos Petrou and the President of the Federation of Patients Associations of Cyprus (OSAK) Mr. Marios Kouloumas.
Referring to the way side effects are reported after vaccination, Deputy Director of Pharmaceutical Services Elena Panagiotopoulou explained that "when the drug is approved then we have the real facts. So the drug goes on the market, but it's still being monitored. Here we have pharmaco-vigilance and it is about what we have the monitoring of side effects. The aim is to safeguard Public Health, to guarantee citizens' right to safe and effective medicines, to enrich knowledge of side effects because since in clinical trials we had volunteers who were healthy, we cannot put patients who were in vulnerable groups. So the real data is after the approval of the drug we see what these side effects are."
Also, he continued, the relationship of risk and benefit is monitored, which must always prevail. In the case, said Ms. Panagiotopoulou, where the risk outweighs, then the drug stops being administered.
"The use of adverse reactions is based on the validity of the reports. If indeed the possible side effects, which are reported, are related to the drug. In Cyprus and in Europe in general, pharmacovigilance systems are institutionalised on the basis of legislation, which is fully in line with the European acquis. The Pharmacovigilance Department of Pharmaceutical Services participates in the European Risk Management Committee every month. Adverse reaction information comes either from health professionals or citizens," he noted.
Speaking about the way reports are made through the Yellow Card, Ms Panagiotopoulou explained that "filling out the Yellow Card is simple and exists on the Website of Pharmaceutical Services. There is full protection of personal data. The procedure that is followed after the completion of the Yellow Card is that it is completed by the health professional, by the patient and by the Pharmaceutical Services. Through the platform of the European Medicines Agency, the Agencies are obliged to report all adverse reactions. When these are collected, they are transferred to an information tank at the European Medicines Agency and there they are evaluated and come to certain conclusions."
This procedure, he said, concerns all medicines circulating in the territory of the Republic of Cyprus, with zero exception and those circulating only in Cyprus. "If a serious problem is identified, then a thorough investigation by the European Medicines Agency is launched. If the side effect is confirmed, then there is an organism that is activated immediately and small changes can be made to the sex of the drug until the drug is completely withdrawn from the market," he noted.
He stressed that "we cannot say, however, that by completing the Card we have an adverse effect. To be verified it has to go through all this mechanism."
Finally, Ms Panagiotopoulou said that 'the onset of diseases can occur at any time, the temporal association does not mean a correlation with vaccination'.
Olga Kalakuta: Priority vaccination coverage of vulnerable groups
For her part, Deputy Director of Medical and Public Health Services Dr Olga Kalakuta referred to how the National Vaccination Plan continues, noting that at the moment what is a priority is vaccination coverage for vulnerable groups. The ad hoc committee appointed by the Minister of Health to prioritise vulnerable groups of the population, Dr Kalakuta said, has carried out a very large amount of work and has been able to initially prioritise these groups and then identify them from various sources in order to be gradually notified of vaccination.
Ms. Kalakouta particularly thanked the scientific companies for their contribution to this effort to identify patients, as well as the Cyprus Medical Association for their very good cooperation.
Christos Petrou: There should be no confusion with vaccines of the vector
In turn, the Adviser of the Ministry of Health on vaccination issues against COVID-19 Mr Christos Petrou, referring to the four approved vaccines, clarified that "the vaccines in general that are being developed are several dozen. They belong to viral vector technology, RNA technology, inactivated virus technology and protein subgroup technology. Of the vaccines of live or inactivated viruses, there is no approved. This is the category which is not indicated, vertically contraindicated for people immunosuppressed, transplanted, etc. We do not have such a vaccine in Cyprus, we do not have such a vaccine in Europe and there should be no confusion with vaccines of the same vector as the AstraZeneca, Johnson&Johnson and Sputnik vaccines.
Vaccines are only approved when the benefits outweigh the risks and it is a constant scale and we saw yesterday the AstraZeneca vaccine which was "re-weighed"".
Right now, Mr. Petrou stressed, "the important thing is to make the vaccine immediately without thinking and rethinking what vaccine we are doing. Speed is an important part of the success of vaccinations. We have the example of Israel, after all, where the world has now begun to return to its life. It does not need negative thinking either from the person to be vaccinated or from someone who will take any medicine. Vaccination is very important because it saves lives."
Marios Kouloumas: Aim to protect the health system
Subsequently, the President of the OSAC, Mr. Marios Kouloumas, pointed out that due to the outbreak of transmission of the virus, there is also a lot of pressure on the Health System. "The first objective of the OSAC is to protect our country's health system. The increase recorded in recent weeks certainly reduces access to health services for chronic patients.
Our next goal is to protect vulnerable groups. We therefore welcome the recommendation of the special committee that studies the vaccination of our chronic patients. The biggest concern is to vaccinate our patients, who belong to the high-risk groups", stressed Mr. Kouloumas.
"We have encountered many problems, for example the absence of a patient file or registry. But now with the effort that has been made we have managed to draw up lists. For us vaccination is the key to success. What we say as THEAC is that we respect institutions, experts, we respect scientists and we must follow their recommendations and decisions. And we must also respect the decisions of the European Medicines Agency. And what has now been done with the assessment of the cases has enhanced the safety of the AstraZeneca vaccine which has been re-evaluated," said the President of organized patients.
Mr Kouloumas then sent a very clear message to all our fellow citizens: 'we must not delay vaccination and our lives must not be in danger. So we call on everyone to show seriousness so that we can actually get vulnerable groups vaccinated as quickly as possible."
When vaccinations began, Mr. Kouloumas said, in a meeting with the Minister of Health there was a positive response to patients' requests. "The reason we started vaccinating the vulnerable was because for us it was more important to vaccinate high-risk individuals, but yes there should also be the right to choose vaccines if vaccines are available," noted the President of the OSAC.
Source: eyenews
