The European Medicines Agency (EMA) has found a possible link to very rare cases of unusual blood clots with low blood platelets. This has been communicated by the EMA through a note sent to the press this Wednesday afternoon. Thus, the EMA safety committee (PRAC) has concluded that unusual blood clots with low blood platelets should be included as very rare side effects of Vaxzevria (formerly the COVID-19 AstraZeneca vaccine). In reaching its conclusion, the committee has considered all the available evidence, including the advice of an ad hoc group of experts.
What we know about a possible relationship of the AstraZeneca vaccine to some rare types of thrombi
In any case, the EMA stresses: “The benefits of the vaccine continue to outweigh the risks for the people who receive it. The vaccine is effective in preventing COVID-19 and reducing hospitalizations and deaths.” This was also highlighted by the European Commissioner for Health, Stella Kyriakides.
Emer Cooke, executive director of the EMA; Sabine Straus, president of the EMA Safety Committee (PRAC); Peter Arlett (Head of the Data Analysis and Methods Working Group); and Marie-Agnes Heine, Head of the Communication Department (moderator) to explain the assessment of the European regulator.
The EMA “reminds healthcare professionals and people receiving the vaccine to be aware of the possibility of very rare cases of blood clots combined with low levels of platelets in the blood within 2 weeks of vaccination. So far, the majority of reported cases have occurred in women under the age of 60 within 2 weeks of vaccination. Based on currently available evidence, no specific risk factors have been confirmed. ”
People who have received the vaccine should seek medical help immediately if they develop symptoms from this combination of blood clots and low blood platelets.
The PRAC has noted that blood clots occurred in the veins of the brain (cerebral venous sinus thrombosis, CVST) and abdomen (splanchnic vein thrombosis) and in the arteries, along with low levels of platelets in the blood and, sometimes bleeding.
The Committee has carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of March 22, 2021, 18 of which were fatal. The cases came mainly from the spontaneous reporting systems of the European Economic Area and the United Kingdom, where around 25 million people had received the vaccine.
“COVID-19 is associated with a risk of hospitalization and death,” says the EMA: “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine to prevent COVID-19 exceed those risks of side effects “.
“The EMA scientific evaluation supports the safe and effective use of COVID-19 vaccines,” the statement states: “The use of the vaccine during nationwide vaccination campaigns will also take into account the situation of the pandemic and the availability of the vaccine in each Member State “.
According to the EMA, “A plausible explanation for the combination of blood clots and low platelets is an immune response, leading to a condition similar to that sometimes seen in heparin-treated patients (heparin-induced thrombocytopenia, HIT). PRAC has requested new studies and amendments to those in progress to provide more information and will take the necessary additional measures. ”
“The PRAC,” says the EMA, “highlights the importance of immediate specialized medical treatment. By recognizing the signs of blood clots and low platelet levels and treating them early, health professionals can help those affected in their recovery and avoid complications “.
The head of Vaccine Strategy of the European Medicines Agency, the Italian Marco Cavaleri had affirmed this Tuesday that there is some “relationship” between rare cases of thrombosis and the administration of the vaccine against COVID-19 from AstraZeneca, although he said that he did not the causes had been established. Cavaleri added, in an interview with Il Messagero: “In my opinion, now we can say that it is clear that there is an association. What provokes this reaction, however, we do not know.”
As Cooke has stated, “By recognizing the signs of blood clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications. Patients should seek medical help immediately if they have the symptoms. following symptoms: shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms including severe and persistent headaches or blurred vision, small spots of blood under the skin beyond the injection site ” .
And he added: “Studies show that it is effective in preventing the disease. It also reduces the risk of hospitalization and death from COVID-19. As with all vaccines, the EMA will continue to monitor the safety and efficacy of the vaccine and provide the public the most recent information “.
The EMA acknowledges that “there have been cases of unusual blood clots with low platelets in people who received Vaxzevria (formerly the COVID-19 AstraZeneca vaccine). The probability of this happening is very low, but you have to be aware of the symptoms to receive immediate medical treatment and avoid complications. ”
Thus, the European regulator recommends going “to a healthcare professional” or “contacting the relevant national health authorities” if the patient develops any of the aforementioned symptoms.
The EMA believes that the vaccine “may trigger an immune response leading to an atypical disorder similar to heparin-induced thrombocytopenia. At this time, it is not possible to identify specific risk factors.”
“Healthcare professionals must be aware of the signs and symptoms of thromboembolism and thrombocytopenia in order to quickly treat affected people according to available guidelines,” says the EMA: “And they must inform people receiving the vaccine to look medical attention if they develop the symptoms of blood clots, shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms such as severe and persistent headaches and blurred vision, petechiae beyond the vaccination site after for a few days. ”
In any case, the EMA insists: “The benefits of the vaccine continue to outweigh the risks for the people who receive it. The vaccine is effective in preventing COVID-19 and reducing hospitalizations and deaths.”
On March 18, the European Medicines Agency (EMA) gave its approval to the AstraZeneca vaccine, considering it “safe and effective”, in the words of the EMA, Emer Cooke, in a press conference in which he called continue pharmacovigilance on COVID-19 vaccines. “Our job is to detect incidents and examine them,” Cooke said, explaining that “medical reports, autopsies and all available data” had been examined to come to the “clear” conclusion that the vaccine “is safe.”