The European Medicines Agency has concluded its preliminary review of the rare cases of severe blood clots in people vaccinated with the COVID-19 Vaccine AstraZeneca
The European Medicines Agency (EMA) has today published its preliminary review of the safety of the COVID-19 vaccine from AstraZeneca. The vaccine warranted closer investigation because of concerns raised a week ago about a suspected link between the vaccine and reported cases of rare but severe blood clots.
EMA finds, that the vaccine may be associated with very rare cases of severe blood clots in people vaccinated with the COVID-19 Vaccine AstraZeneca.
EMA’s conclusion is, that it cannot rule out that there is a link between the few known cases of rare but severe blood clots and vaccination with the COVID-19 vaccine from AstraZeneca. Therefore, steps have already been taken to update the product information for the vaccine to include a general warning that this type of rare side effect has occurred after vaccination.EMA will also initiate additional studies into these risks. However, EMA’s overall assessment remains that the benefits of the vaccine far outweigh the risk of side effects associated with the use of the COVID-19 vaccine from AstraZeneca.
"Our decision to put vaccination with the COVID-19 vaccine from AstraZeneca on hold until week 12 remains in effect. In the coming day, the Danish Health Authority and the Danish Medicines Agency will assess the impact of EMA's review of the COVID-19 vaccine from AstraZeneca on the Danish vaccination programme against COVID-19," says Søren Brostrøm, Director General of the Danish Health Authority.
"It is the Danish Health Authority's opinion that the risk of these side effects is present primarily within the first 14 days after receiving the vaccine. That assessment is based on the known cases of severe but rare blood clots in people vaccinated with the COVID-19 vaccine from AstraZeneca. At the same time, the vaccine has had a protective effect on those who have been vaccinated," says Director General Søren Brostrøm.
Those Danish citizens who have been vaccinated with the COVID-19 vaccine from AstraZeneca within the last 14 days should continue to be aware of symptoms of blood clots and/or bleeding and contact a doctor if they develop such symptoms. The symptoms are described on the Danish Medicines Agency’s website: Danish Medicines Agency sends out updated letter to people who have received the AstraZeneca vaccine within the last 14 days
The Danish Health Authority and the Danish Medicines Agency invite to a question-and-answer event for the press tomorrow, Friday, 19 March, at 1 p.m. in Eigtveds Pakhus.