Status on the drug regulatory authorities’ investigation of blood clots after vaccination with the AstraZeneca vaccine

18 March 2021

The European Medicines Agency, EMA, and the drug regulatory authorities in Europe have reviewed reports of the rare and unusual symptoms of low levels of blood platelets, blood clots and bleeding after vaccination with the AstraZeneca’s COVID-19 vaccine. The conclusion is that the AstraZeneca vaccine is generally a safe and efficient vaccine, but that it cannot be ruled out that these symptoms may be caused by the AstraZeneca vaccine.

Last week, several countries including Denmark chose to put the COVID-19 vaccine from AstraZenca on hold on the basis of reports of rare blood clots in younger, healthy individuals, which occurred in combination with low levels of blood platelets and bleeding. Some of these cases had a fatal outcome. The symptoms experienced by these individuals generally presented within 14 days of the vaccinations. The European pharmacovigilance response system was activated, and the EMA launched an accelerated procedure to assess whether it was likely that the vaccine was causing the symptoms.

The results of the EMA investigation has just been published: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets.

The vaccine from AstraZeneca is generally a safe and efficient vaccine that offers protection against COVID-19, but it cannot be ruled out that there may be an association between the vaccine and the rare cases of blood clots, a low level of blood platelets and bleeding. The EMA is therefore launching further investigations.

A warning will be inserted in the vaccine’s product information describing the symptoms and which symptoms to look out for.

The Danish Health Authority will decide on the use of the AstraZeneca vaccine in Denmark when the current pause has ended.

Precautionary principle – an ordinary surveillance practice

Approximately 18 million citizens in the EU and the UK – including more than 140,000 Danes – have until now been vaccinated with the COVID-19 vaccine from AstraZeneca. The most commonly reported adverse reactions from the vaccine in the EU and worldwide are transient, mild and moderate, and they are quite common reactions after vaccination.

“The Danish Medicines Agency and other drug regulatory authorities in the EU have chosen to investigate if these rare, but serious cases could be an adverse reaction to the vaccine from AstraZeneca. One of the reasons for this is a case from Denmark. The symptoms are unusual and they appear right after the vaccinations. It is our job to react on such cases. It is important that we together with EMA and the other drug regulatory authorities take our time to evaluate this type of reports thoroughly”, says Tanja Erichsen, acting Director of Pharmacovigilance at the Danish Medicines Agency.

This is what you should do if you have been vaccinated with AstraZeneca’s COVID-19 vaccine within the last 14 days

If you have been vaccinated with the AstraZeneca vaccine within the last 14 days, you should be observant.

You must react on symptoms of blood clots and a low number of blood platelets and see a doctor.

A low number of blood platelets may occur as signs of skin or mucosal bleeding in the form of easy bruising, small red spots on the skin, or bleeding that does not stop as normal.

Symptoms of blood clots may be a severe headache, severe stomach ache, a leg that turns cold, sudden and unexpected pain in parts of the body, breathing difficulties or paralysis of one side of the body.

It is completely normal to experience transient, mild and moderate adverse reactions such as redness at the injection site, chills and fever after vaccination. It is not necessary to consult a doctor about that.

More detailed symptom descriptions are available in the Danish Medicine Agency’s letter about precautions to be taken after vaccination with the AstraZeneca vaccineUpdated information from the Danish Medicines Agency on your COVID-19 vaccination.

The Danish Health Authority and the Danish Medicines Agency will invite the press to a Q&A session on Friday, 19 March at 1 pm in Eigtveds Pakhus in Copenhagen.