- The European Union’s medicines regulator said unusual blood clotting should be listed as a “very rare” side effect of AstraZeneca’s vaccine — though it emphasized that the benefits still outweigh the risks.
- AstraZeneca released updated details of its latest clinical trial results in March. They show strong efficacy against symptomatic infection and very high efficacy against severe COVID-19.
- Results published on March 25 were based on an analysis of data from the phase 3 clinical trial, which included more than 32,000 participants in the United States, Chile, and Peru.
The European Union’s medicines regulator said April 7 that unusual blood clotting with low blood platelets should be listed as a “very rare” side effect of the COVID-19 vaccine developed by AstraZeneca.
However, the agency said the overall benefits of the vaccine still outweigh the risks.
This warning comes after a safety committee of the European Medicines Agency (EMA) reviewed 86 cases of rare blood clots — out of around 25 million people who received the vaccine in EU member countries and the United Kingdom.
The committee was unable to identify “specific risk factors” associated with clotting, but it did note that so far, most of the cases have occurred in women under 60.
Separately, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is recommending that people under age 30 be offered an alternative COVID-19 vaccine.
For most age groups, the benefits of the vaccine clearly outweigh the risk. But the MHRA found that this relationship was less clear for those under 30, who are much less likely to die from COVID-19.
This week, other European countries announced they were restricting use of the AstraZeneca vaccine to older adults, reports BBC News, ranging from those over 55 in France to over 60 in Germany and other countries. Denmark has suspended use of the vaccine entirely.
Scientists aren’t certain what’s specifically causing the blood clots.
One possibility is that the vaccine may cause a certain immune response in some people, similar to what’s sometimes seen in people treated with the anti-clotting medication heparin.
The EMA said people given the AstraZeneca vaccine should seek immediate medical attention if they have any of the following symptoms:
- shortness of breath
- chest pain
- swelling in the leg
- persistent pain in the abdomen
- neurological symptoms, such as persistent headaches or blurred vision
- skin bruising beyond the site of injection
Source: healthline