Following on from today's scientific opinion from the European Medicines Agency (EMA), it is clarified that, after a thorough investigation, there is no link between the AstraZeneca vaccine and the thromboembolic events reported by EU countries, and that the vaccine is considered safe. effective, the Ministry of Health informs that from tomorrow, March 19, 2021, the vaccinations with her vaccine will resume AstraZeneca.
Therefore, citizens who have a scheduled appointment for vaccination are invited to come to the Vaccination Center where they have arranged their appointment, at the time they have arranged the appointment.
Compared to the appointments that were postponed from March 16-18, more details on how to reschedule them will be given at tomorrow's press conference.
"The benefits outweigh the risks despite the possible association with rare cases of low platelet blood clots"
EMA Safety Committee (PRAC) completes review of blood clot signal in vaccinated individuals COVID-19 AstraZeneca at its extraordinary meeting on 18 March 2021. The Committee confirmed that
- the benefits of the vaccine in combating its still widespread threat COVID-19(which results in coagulation problems in many hospitalized patients) still outweigh the risk of side effects.
- the vaccine is not associated with an increased overall risk of blood clots (thromboembolic events) in those who receive it.
- there is no evidence of a problem related to specific batches of the vaccine or with specific manufacturing areas.
- however, the vaccine may be associated with two very rare cases of thrombocytopenia, ie low platelet counts (elements in the blood that help it to coagulate) with or without bleeding, including rare cases of blood clots developing in blood vessels that remove blood from the brain. venous sinus, CVST).
These are rare cases of around 20 million vaccinations in the EEA and the UK by 16 March, and the EMA had examined only seven cases of blood clots in multiple blood vessels (diffuse intravascular coagulation, DIC) and 18 cases of CVST.
The causal relationship with the vaccine is not proven, but it is possible and worth further analysis.
The PRAC included experts on blood disorders in its review and worked closely with other health authorities, including the UK MHRA, which has experience in administering this vaccine to approximately 11 million people. Overall, the number of thromboembolic events reported after vaccination, in both pre-clinical and pre-licensing studies and post-vaccination reports (469 reports, 191 of which from the EEA), was lower. than expected in the general population. This allows the PRAC to confirm that there is no increase in the overall risk of blood clots. However, in younger patients some concerns remain, particularly related to DIC and CVST.
Commission experts carefully examined the DIC and CVST records reported by the Member States, seven of which resulted in death. Most of them occurred in people under 55 years of age and the majority were women. Because these events are rare and COVID-19 often causes blood clotting disorders in patients, it is difficult to estimate the history of these events in people who have not received the vaccine. However, it was estimated that less than one case of DIC could be expected by March 16 among people under 50 within 14 days of receiving the vaccine, with five reported cases. Similarly, an average of 1,35 cases of CVST were expected among this age group, whereas by the same cut-off date there were 12. A similar imbalance was not visible in the elderly population given the vaccine.
The Commission is of the opinion that the vaccine has been shown to be effective in preventing hospitalization and death from COVID-19 exceeds the extremely low probability of DIC or CVST occurring. However, in light of its findings, health professionals and patients should be aware of the remote possibility of such syndromes and if symptoms suggestive of coagulation problems occur, patients should seek immediate medical attention and inform health professionals about the recent their vaccination. Measures have already been taken to update vaccine product information to include more information on these risks.
PRAC will conduct additional review of these risks, including risk assessment with other types of vaccines COVID-19 (although the preliminary indications are reassuring). Close monitoring of the safety of blood coagulation disorder reports will continue, and further studies are underway to provide more laboratory data as well as factual data. The EMA will update further accordingly.
Patient information:
- The vaccine against COVID-19 AstraZeneca is not associated with an increased overall risk of blood clot disorders.
- There have been very rare cases of unusual blood clots accompanied by low platelet counts (ingredients that help the blood to clot) after vaccination. The reported cases were almost all in women under 55 years of age.
- Because h COVID-19 can be so severe and so widespread, the benefits of the vaccine in preventing it outweigh the risks of side effects.
- However, if you get any of the following after taking the AstraZeneca vaccine:
- shortness of breath,
- chest pain,
Swelling or cold in the arm or leg
- severe or worsening headache more than three days after vaccination
- persistent bleeding
- many small bruises, reddish or purple spots or blood cells under the skin,
seek medical attention immediately and report your recent vaccination.
Information for health professionals:
- Cases of thrombosis and thrombocytopenia, some have been reported as the spread of intravascular coagulation and cerebral vein / cerebral vein thrombosis reported in individuals who have recently received the COVID-19 AstraZeneca, which appeared mainly within 14 days after vaccination. The majority of reports concerned women under the age of 55, although some of them may reflect the higher exposure of such individuals due to the targeting of specific populations for vaccination campaigns in different Member States.
- The number of reported events exceeds expectations and the causality, although not confirmed, cannot be ruled out. However, given the rarity of the events and the difficulty of determining the frequency of occurrence, as the COVID-19 leads to hospitalization with thromboembolic complications, the validity of any association is uncertain.
- The EMA considers that the benefit-risk balance of the drug remains positive and there is no association with thromboembolic disorders as a whole. However, steps will be taken to update the SmPC and the package leaflet with information that DIC and CVST cases have occurred.
- Healthcare professionals should be alert to possible cases of thromboembolism, DIC or CVST occurring in vaccinated individuals.
- Recipients should be warned to seek immediate medical attention for symptoms of thromboembolism, especially signs of thrombocytopenia and cerebral blood clots such as bruising or bleeding and persistent or severe headache, especially after 3 days after vaccination
More about the drug:
The vaccine against COVID-19 AstraZeneca is a vaccine for the prevention of coronavirus disease 2019 (COVID-19) to people aged 18 and over. THE COVID-19 caused by the SARS-CoV-2 virus. The vaccine against COVID-19 AstraZeneca consists of another virus (of the adenovirus family) that has been modified to contain the gene for the production of a protein by SARS-CoV-2. The vaccine against COVID-19 AstraZeneca does not contain the virus itself and cannot cause it COVID-19.
The most common side effects with the vaccine are COVID-19 AstraZeneca is usually mild or moderate and improves within a few days after vaccination.
More about the process:
The review of thromboembolic events with the vaccine against COVID-19 AstraZeneca is conducted as part of a safety signal, with an accelerating schedule. A safety signal is information about a new or poorly documented adverse event that may be caused by a drug such as a vaccine and that requires further investigation.