Filenews 12 March 2021 - by Marilena Panagi
Yesterday morning's news that European countries had withdrawn a specific batch of AstraZeneca vaccines, which was described as potentially 'problematic', following the reporting of two incidents, one involving the death of a 49-year-old woman in Austria, due to blood clotting disorders.
The concern was intensified when it became known that vaccines of this batch, number ABV5300, had also arrived in Cyprus in the previous weeks and the distress of hundreds of citizens who have already received the first dose from this company, lasted for several hours since, from the point of view of the competent authorities, the information that was seeing the light of day was confusing.
As of early morning, of course, the Ministry of Health officially informed that after an investigation of the matter the European Medicines Agency had concluded that the two incidents did not appear to be linked to the vaccination to which the two individuals involved had undergone. However, this news was not enough to reassure citizens who were waiting to be informed of the actions taken by the Cypriot Ministry of Health in relation to this batch of vaccines.
Initially, it became known that the vaccines of this batch that arrived in Cyprus had already been administered in the previous weeks without any "suspicious" incident being recorded, and then the Deputy Director of Pharmaceutical Services Eleni Panagiotopoulou, in a statement said that in Cyprus the batch of vaccines numbered ABV5300 was withdrawn from the vaccination program until further notice.
As "F" was informed after seeking answers from the Ministry of Health, in Cyprus, a small amount had actually been received from this batch of vaccines and some doses were administered through the vaccination program last month. Officially, there was no mention of similar complications in the competent Pharmacovigilance Authority, but, due to reports made by the Austrian authorities, the Ministry of Health had proceeded in good time to suspend vaccinations with these vaccines until there was official information from the European Medicines Agency.
"Citizens should not worry, in Cyprus this lot has been left in a state of suspension, we will not grant it, when people are not worried at all," Ms Panagiotopoulou said in her statement.
Reassuring was presented in his statements to "F" the scientific advisor of the Ministry of Health on vaccination issues for the Crown Deputy Professor of Pharmacology Christos Petrou, which, however, recommended that citizens who have been vaccinated with these vaccines (the batch number is shown on the yellow card of all persons vaccinated), 'as well as all those vaccinated with any vaccine, if they feel that they have any health problems, contact their personal doctor without delay and report any undesirable situation to the competent authorities'.
At the same time, Mr. Petrou pointed out that "the phenomenon of withdrawing batches of medicinal products or even completely withdrawing medicines from the market due to unpleasant incidents recorded during their administration is not at all unusual" and assured that "as in all cases and in this case developments are closely monitored by the competent authorities.
The official position of the European Medicines Agency
In its communication on this subject, the European Medicines Agency stated: "The Austrian national competent authority has suspended the use of a batch of COVID-19 AstraZeneca vaccine (batch number ABV5300) following a diagnosis of a person with multiple thrombosis (formation of blood clots within blood vessels) who died 10 days after vaccination, while another person was hospitalized with pulmonary embolism (obstruction of arteries in the lungs) after vaccination. There is currently no indication that vaccination has caused these conditions, which are not reported as side effects from this vaccine."
The Security Committee, "is looking into this matter. It investigates cases reported with the batch as well as all other cases of thromboembolic events and other blood clot-related conditions reported after vaccination. The information so far available shows that the number of thromboembolic events in vaccinated individuals is not greater than that observed in the general population. Prac will continue its assessment of any potential issue with the lot, as well as its review of thromboembolic events and related conditions."
The 'Janssen' monodosic vaccine has been approved
The green light for its administration and in the EU was yesterday given by the European Medicines Agency the vaccine of the company "Janssen", which until now, is the only monodosic vaccine against coronavirus.
Cyprus will receive 200,000 doses of this vaccine on the basis of the programming, but the timetables have not yet been set.
According to the official announcement of the Ministry of Health, "the COVID-19 Janssen vaccine is a vaccine for the prevention of COVID-19 disease in people aged 18 years and over".
It does not contain the coronavirus itself and cannot cause COVID-19.
It is given as a single injection, usually to the muscle of the upper arm.
It works by preparing the body to defend itself against COVID-19.
It consists of another virus (an adenovirus) that has been modified to contain the gene to produce the spike protein SARS-CoV-2. This is a protein in the SARS-CoV-2 virus which must enter the cells of the body.
The cells can then use the gene to produce the protein spike.
The person's immune system will recognize the protein spike as foreign and produce antibodies and activate T cells (white blood cells) to target it.
Later, if the person comes into contact with the SARS-CoV-2 virus, the person's immune system will recognize the protein spike in the virus and be ready to defend the body from it.
The effect of the COVID-19 Janssen vaccine on the spread of the virus in the community is not yet known.
It is not yet known how much vaccinated individuals may still be able to carry and spread the virus.
Protection with the COVID-19 Janssen vaccine starts about 14 days after vaccination, but it is not currently known how long protection continues.
Clinical studies to date have found a 67% reduction in the number of symptomatic cases of COVID-19 after 2 weeks in people receiving a COVID-19 Janssen vaccine.
