BANJA LUKA, April 8 (FENA) – The Pharmacovigilance Sector of the Agency for Medicines and Medical Devices of BiH has so far received 22 reports of adverse reactions, after the vaccine against COVID-19 received in BiH, and classified as “non serious”.
As the director of the Agency, Aleksandar Zolak, told FENA, the reported symptoms are common reactions to the vaccine, which are fever, rash, pain at the administration site, headache, fatigue, prolonged diarrhea, with recovery without consequences.
“A total of 18 reports of adverse reactions were to the vaccine, received on the basis of the Donation Agreement between the Government of the Republic of Serbia and the Council of Ministers of Bosnia and Herzegovina, from March 2. Four applications were received for the vaccine from the Covax supply program, manufactured by BioNTech Manufacturing GmbH. One application was received, with recovery in progress,” he said.
Director Zolak adds that two reports of adverse effects were received from BiH citizens who were vaccinated in Serbia, for the Covishield vaccine, Serum Institute India.
“Every report of an adverse effect on the vaccine becomes part of the important information for assessing the safety of the vaccine,” said Zolak.
He adds that patients who have been vaccinated and have side effects after vaccination, should report it to a healthcare professional (doctor, pharmacist).
He recalls that the treatment of COVID-19 disease is symptomatic, not causal. This means that there is no medicine that cures the disease, there are medicines that alleviate the symptoms of the disease.
“The medicine used against the disease is a vaccine, as a prophylaxis or prevention of the disease. The vaccine creates passive immunity, which ensures that the human body does not develop the disease after contact with the virus,” he emphasized.
The Agency for Medicines and Medical Devices of BiH is also the National Center for Monitoring the Side Effects of Medicines in Bosnia and Herzegovina. It is a full member of the WHO-UMC network of national adverse reaction centers in the world, and the only one with access to WHO-UMC databases for global reporting and monitoring of adverse reactions from Bosnia and Herzegovina.