All Nordic countries except Finland have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca, pending the EMA investigation.
Events involving blood clots, some with unusual features such as low numbers of platelets, have occurred in a very small number of people who received the vaccine. EMA’s investigation has been continuing over the weekend, and analysis of all the data related to thromboembolic events will be carried out in the coming days, EMA states. EMA’s safety committee (PRAC) will further review the information and has called an extraordinary meeting on Thursday 18 March to conclude on the information gathered and any further actions that may need to be taken.
“EMA’s safety committee (PRAC) will further review the information and has called an extraordinary meeting on Thursday 18 March to conclude on the information gathered and any further actions that may need to be taken.”
Blood clots or brain haemorrhages
On March 11th Denmark was the first Nordic country to decide to pause the vaccination with AstraZeneca’s vaccine, as a precautionary measure over fears of blood clots in vaccinated people. The Danish medicines agency said it had seen “highly unusual” symptoms in a 60-year-old recipient of the AstraZeneca vaccine who later died. The same day, Iceland and Norway took the same decision, temporarily suspending use of all their supply of the vaccine citing similar concerns. Norwegian health officials have also reported blood clots or brain haemorrhages in younger people who received the vaccine, but said they cannot yet say they were vaccine-related. So far there are no evidence that the deaths are connected to the vaccine and the authorities in Norway are now investigating if there is.
A very rare but serious condition
Tuesday March 16th, Sweden also decided to pause its vaccination with the AstraZeneca vaccine. The Swedish Public Health Agency has suspended use of the AstraZeneca COVID-19 vaccine as a ‘precautionary measure’ it stated.
Anders Tegnell, State epidemiologist in Sweden, said during a Swedish press conference March 16th that the decision was mainly based on a new kind of suspected side effect that was discovered, causing some sort of disturbance in the coagulation system, the system that makes sure that we do not bleed to much or too little, explained Tegnell during the press conference. He also stated that it was this condition, not the earlier reports on blood clots, that made them take this decision.
So far 15 cases out of 17 million vaccinated have been affected by this condition in Europe so it is a very rare side effect but it is very serious condition, stated Tegnell at the press conference.
The Swedish halt will remain until Thursday when EMA will report its new evaluation.
Finland is not planning on suspending use of the vaccine
Finland is not planning on suspending use of vaccine by AstraZeneca reports the Finnish Medicines Agency (Fimea). 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.
“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,” said Maija Kaukonen, a chief physician at Fimea to Helsinki Times.
AstraZeneca announces update on the safety of its vaccine
A review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country, states the company in its press release.
“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” says Ann Taylor, Chief Medical Officer, AstraZeneca.
So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines, according to the company. Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group, continues the company. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.
The benefits outweigh the risk of side effects, stated EMA
While its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects. Both EMA and the World Health Organisation (WHO) have recommended countries to continue using the vaccine while the investigation is still ongoing.
EMA also states that anyone who has received the vaccine and has any concerns should contact an appropriate healthcare professional. It is important that people who suspect they may have a side effect after vaccination report this to the national medicines regulator, or to a healthcare professional who can help them do so.