FINLAND is presently not intent on suspending the use of the vaccine developed by AstraZeneca, a representative of the Finnish Medicines Agency (Fimea) told STT on Monday.
Liisa Näveri, the director of pharmacovigilance at Fimea, said Fimea and the Finnish Institute for Health and Welfare (THL) are in agreement that there is presently no reason for either limiting or suspending the use of the vaccine.
Fimea, she told, has received nine adverse-reaction reports of suspected blood clots following a vaccination after reports of such reactions emerged in certain other parts of Europe.
“There aren’t fatal cases. We’re still waiting for confirmations on whether blood clots have been diagnosed in these cases,” she stated to the news agency, adding that the adverse-reaction reports are no reason to be alarmed or weigh up taking action.
“The reports were made based on a suspicion, for example before an ultrasound and doctor’s diagnosis,” Maija Kaukonen, a chief physician at Fimea, added to Helsingin Sanomat.
Eight European countries have suspended using the vaccine due to the possible blood clot risk. France and Germany, for example, said yesterday they will not use the vaccine until a safety ruling by the European Medicines Agency (EMA).
“Based on all of the information that’s currently available, it’s impossible to identify a causal relationship,” reminded Näveri.
Marco Cavaleri, the director of biological health threats and vaccines strategy at EMA, on Monday said EMA will subject the vaccine to a thorough safety evaluation but added that it “does not see any problem” in continuing using the vaccine in vaccination campaigns. The advantages of the vaccine outweigh the risks, according to EMA.
“We’re scrutinising all the data, particularly the fatal cases that have been reported,” stated Cavaleri.
Maija Kaukonen, a chief physician at Fimea, cast further light on the position of the agency on YLE’s A-studio on Monday, saying it is founded on, for example, experiences of the vaccine in the United Kingdom.
“The vaccine has been used the most in the UK. They have experience of safety monitoring over 10 million vaccinated people. British authorities have communicated that they haven’t detected any signs connected to blood clots,” she reminded, predicting that the uncertainty about the vaccine will not last long.
EMA is expected to deliver its opinion on the issue this week. If a causal relationship between the vaccine and blood clots and coagulation problems is found, the agency would have to investigate whether such reactions are linked to factors such as the age, underlying health condition of medication used by the patient to determine whether the vaccine should be shelved entirely or only for certain groups.
Aleksi Teivainen – HT
