Filenews 8 April 2021
Blood clots should be reported as a 'very rare' side effect of AstraZeneca's vaccine against Covid-19, as the European Medicines Agency (EMA) ruled yesterday, while considering that the benefit/risk balance remains 'positive'.
The EMA estimates that there is "a possible link to very rare cases of abnormal blood clots with low platelets," the Amsterdam-based organisation said, while EMA executive director Emmer Cook noted during a conference call that no specific risk factors were identified. "Specific risk factors such as age, gender or medical history could not be confirmed as rare occurrences occur at all ages," he explained.
"A plausible explanation for these rare side effects is an immune response to the vaccine," Emer Cook added, stressing that the vaccine is "very effective" and "saves lives."
What ema research on AstraZeneca showed
The EMA Safety Committee (PRAC) concluded that unusual blood clots with low platelets should be reported as very rare adverse side effects of Vaxzevria (formerly the COVID-19 AstraZeneca vaccine).
The EMA reminds health workers and people receiving the vaccine to remain aware of the possibility of very rare cases of thrombosis, in combination with low platelet levels, within two weeks of vaccination. So far, most of the reported cases have occurred in women under 60 years of age within 2 weeks of vaccination. On the basis of the available data, specific risk factors have not been confirmed.
The EMA recommends that those who have received the vaccine seek medical attention immediately if they experience symptoms of this combination of thrombosis and low platelets. The reported combination of thrombosis and low platelets is very rare and the overall benefits of the vaccine in the prevention of COVID-19 outweigh the risks of side effects.
The Committee investigated in depth the 62 cases of cerebral thrombosis and 24 cases of visceral arterial thrombosis reported in the European Union since 22 March, 18 of which were fatal. The cases resulted from a total of 25 million people who had the vaccine in Europe and the UK. As for the possible cause of the side effect, experts estimate that it may have something to do with the immune system's reaction to the vaccine.
AstraZeneca: 169 cases of thromboembolism out of a total of 34 million doses in Europe
It is also noted that the European Medicines Agency informed yesterday that it has received reports of 169 cases of rare thromboembolism in people treated with AstraZeneca for Covid-19, but reiterated that the benefits of vaccinations outweigh the risk.
As of April 4, 169 cases of cerebral venous thrombosis (CVST) had been reported, out of a total of 34 million doses of the vaccine administered to the European Economic Area (including EU countries, as well as Norway, Iceland and Liechtenstein), said Sabine Strauss, the head of the EMA's security committee.
Agency executive director Emer Cook, however, stressed that the risk of death from Covid-19 is "much higher" than the risk of death from rare side effects. "It is very important that we use the vaccines we have to try to defeat this pandemic," he said.
Strauss also pointed out that side effects are not unexpected, since vaccines are distributed on a large scale. "What we are trying to do is provide all available information, both on benefits and risks," he noted.
Suspicious symptoms
However, according to the EMA, those who have had the vaccine should seek medical attention immediately if they experience symptoms of a combination of thrombosis and low platelets.
These symptoms are:
- Panting
- chest pain
- swelling in the legs
- persistent pain in the abdomen
- neurological symptoms, including strong and persistent headaches or blurred vision
- small blood stains under the skin, beyond the injection site
WHO: The link between vaccine and thrombosis is not confirmed
For its part, the World Health Organization said in a statement that "a causal link between astraZeneca's coronavirus vaccine and rare cases of low platelet thrombosis is "considered plausible, but has not been confirmed."
The WHO Advisory Committee following the announcements said specialised studies were needed to fully understand the potential link between vaccination and potential risk factors.
"It is important to note that, while worryingly, cases under evaluation are very rare, with low numbers reported among the nearly 200 million people who have received AstraZeneca's Covid-19 vaccine around the world," the committee notes. He added that he would meet again next week to reassess the extra data.
Countries suspend AstraZeneca vaccines
It is noted that following the EMA's announcements, the health ministers of the EU countries met via teleconference yesterday to examine the conclusions.
Following the announcements, some countries made announcements on how to use the AstraZeneca vaccine in vaccinations.
Estonia has suspended its use on people under the age of 60, as has South Korea. In Britain the vaccination committee has proposed that the vaccine should not be used in people under 30, while Spain will only give it to people aged 60 to 65. For its part, Belgium ceases to grant it to persons under the age of 56.
Source: iefimerida.gr
