Skopje, 6 December 2021 (MIA) – It is being looked into whether deaths have been related to the administration of Covid-19 vaccine. Both reports, from April and September, were submitted by doctors, concerning an 83-year-old and a 53-year-old, but a correlation has not yet been proven, Merjem Hadzihamza of the Agency for Medicines and Medical Devices (MALMED) said at an online meeting with journalists held on Monday. MALMED acting head Lirim Shabani also participated.

She said that the reports were sent to the Uppsala Monitoring Center and the Institute for Public Health where they will be further processed.

Shabani and Hadzihamza said that there is only suspicion and unofficial data, pointing out that the positive effects of vaccination far outnumber the adverse side effects.

“When a vaccine is applied, if a side effect is reported, it does not mean that there is a consequent reaction from the application of the vaccine. The reports that come to them are suspicions of an adverse reaction. There are a number of parameters that need to be examined, such as the patient's medical record, what they have been ill with before, what medications they received. For one of the patients, I saw that he had a lot of comorbidities and I personally doubt that it has anything to do with the use of the vaccine, but this is irrelevant because it should be said by people who have the competence to do so,” Hadzihamza said.

Shabani said that all of the previously mentioned medications that can help in various stages of treating Covid-19 were approved and brought to the country in record time.

“How much they were used and how effective they were is a topic for a time after Covid. The Ministry of Health has some activities for the drug 'Monupiravir', they said that they are negotiating with the manufacturer, we are monitoring the situation and the moment we have a specific request from anywhere we will immediately get involved and we want those drugs in the country. We are currently waiting for an answer from the US Drug Agency for that medicine, there are several other initiatives from other manufacturers, we are ready," Shabani said.

When asked by reporters how many decisions for vaccine destruction have been issued by the Agency for Destruction of Vaccines and which manufacturers got these approvals, he said that approvals for destruction of vaccines have been issued for Pfizer, AstraZeneca and Sinopharm vaccines on several occasions.

In terms of reporting side effects, Shabani said that 133 doctors, 88 pharmacists and 10 healthcare workers have reported side effects.

“We’ve had some reports come in from the citizens, as well. They are all collected, processed in terms of their categorization. As a country, we have an agreement with the Uppsala Monitoring Center in Sweden, a WHO-level side effect center, where side effects are collected from all countries and recommendations and drug monitoring are given. So they are collected here, we share them with Uppsala and give them over for further processing to the Institute of Public Health for examination,” said Shabani.

So far, he pointed out, the reported side effects of all vaccines are within the expected ones, whether it is headache, nausea, dizziness, limb pain or shoulder pain at the site of application.

“These are the most commonly reported side effects. An exception to this I can mention the case of myocarditis from the Pfizer vaccine which was determined after it was released, which was not provided by the manufacturer, it was determined by the European Medicines Agency. They made an appropriate variation and we gave a variation that it’s a possible side effect expected in rare cases. The percentage of side effects in relation to the applied vaccines is very small,” Shabani added. dk/ba/