EMA offers reassurance on AZ vaccine, while some European authorities pause

Regulatory NewsRegulatory News | 11 March 2021 |  By 

 On the same day that the European Medicines Agency granted conditional marketing authorization to Janssen's one-dose COVID-19 vaccine, administration of another authorized COVID-19 vaccine has been paused in scattered European countries. 

A handful of European national health authorities have announced the pause for AstraZeneca's COVID-19 vaccine following reports of blood clots in the vaccine's recipients. Other regulators, reassured by the fact that pulmonary embolisms and venous thrombo-occlusive events are not occurring more frequently in vaccinated people than in the general population, are continuing apace with AstraZeneca vaccinations.
On Wednesday, European Medicines Agency (EMA) issued a statement following reports from Austria of thromboembolic events following vaccination with AstraZeneca’s COVID-19 vaccine. One individual died 10 days after vaccination and was found to have “multiple” blood clots within unspecified vessels; another individual experienced a pulmonary embolism after vaccination but was reported to be recovering in hospital. Two other clotting events had been reported in Austria for the same batch and are also under investigation, according to the report from EMA.
Austria’s competent authority has suspended use of that batch, whose 1 million doses went to 17 European Union countries. As of Tuesday, 9 March, Estonia, Lithuania, Luxembourg and Latvia had followed suit following the Austrian reports, according to EMA.
“There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine… Although a quality defect is considered unlikely at this stage, the batch quality is being investigated,” according to EMA’s Wednesday statement.
Today, EMA issued an update to reflect actions taken by the Danish Health Authority, which suspended administration of the AstraZeneca vaccine following a thromboembolic-related death of an individual in Denmark who had received the vaccine. Norway, Italy, and, according to an announcement from the UK’s medicines authority, Iceland have also paused administration of the Astra-Zeneca vaccine.
The Danish Medicines Agency today issued its own statement announcing that the “temporal association” between vaccine receipt and clotting events warranted investigation and putting AstraZeneca vaccinations on hold “based on a precautionary principle.”
EMA’s update reiterates the stance of PRAC, its safety committee, that “There is currently no indication that vaccination has caused these conditions.” The committee continues to judge that benefits outweigh risks for administration of the vaccine amid the ongoing investigation.
By 10 March, nearly 5 million people in the European Economic Area had received the AstraZeneca COVID-19 vaccine, with 30 reported cases of thromboembolic events. This rate, according to EMA, is not higher than the background rate expected for that population.
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued the following statement affirming their intention to continue administering AstraZeneca vaccines: “This is a precautionary measure by the Danish authorities. It has not been confirmed that the report of a blood clot was caused by the AstraZeneca COVID-19 Vaccine. People should still go and get their COVID-19 vaccine when asked to do so.”
MHRA’s vaccines safety lead, Phil Bryan, PhD, also noted in accompanying remarks that “Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population.”


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Tags: coronavirus, EMA, EU

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