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The European Medicines Agency (EMA) states that the benefits of the AstraZeneca-Oxford vaccine outweigh the risks, but continues to study the relationship between the vaccine and the formation of blood clots in people vaccinated with this vaccine.
About 15 EU member states, including Germany, Italy and France, have cautiously discontinued use of the Swedish-British laboratory vaccine following reports of possible side effects, including blood clotting problems and blood clots (thrombosis).
The EMA considers the AstraZeneca vaccine to be “safe and effective” but says it is essential to “keep looking” for possible side effects of the vaccine.
However, EMA Director Emer Cook said she remains “firmly convinced” that the benefits outweigh the risks of using the AstraZeneca-Oxford covid-19 vaccine.
This position was confirmed on Thursday.
The EMA announces that the AstraZeneca-Oxford vaccine is “not associated” with an increased risk of blood clots.
Following the EMA’s announcement, the Ministry of Health issued a press release that read as follows:
The main conclusions of today’s meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency on the evaluation of reported cases of thromboembolic events and thrombocytopenia after immunization with vaccines from the pharmaceutical company AstraZeneca are:
* The benefit-risk balance of AstraZeneca’s COVID-19 vaccine remains unchanged. The benefits of the COVID-19 vaccine outweigh the risks of side effects;
* There is no evidence of problems with specific lots of vaccines or certain production units;
* The vaccine is not associated with an increased overall risk of blood clots (thromboembolic events);
* The vaccine may be associated with the development of two extremely rare conditions: disseminated intravascular coagulation and cerebral venous sinus thrombosis, both conditions associated with a decreased platelet count.
Although a causal relationship between these conditions and vaccine administration has not been demonstrated, this cannot be ruled out at this time, as the available evidence is insufficient to establish causality, and more data will be collected and analyzed. The drug information (Summary of Product Characteristics and Package Leaflet) will be updated to include information on the risk warning for bleeding disorders and thrombocytopenia.
Regarding batch ABV2856, quarantined on March 11, 2021, as an extreme precautionary measure, the CNCAV will make a decision on this decision tomorrow.
Vaccination remains the safe and effective solution to overcome the COVID-19 pandemic, and the vaccines used in Romania are authorized by the European Medicines Agency (EMA), the most rigorous decision-making body, which brings together experts to European level. We promote the monitoring and reporting of all adverse reactions, both by vaccine recipients and health professionals. “
The WHO also recommends the AstraZeneca serum: “The risk / benefit balance tips in favor of the vaccine”
The World Health Organization (WHO) continues to recommend “for now” vaccines with the anti-COVID-19 serum developed by AstraZeneca, whose use has been suspended by several countries due to possible side effects.
“At the moment, the WHO estimates that the risk / benefit balance is in favor of the AstraZeneca vaccine and recommends that vaccinations continue.” The World Health Organization announced Wednesday in a statement cited by Agerpres.
“The WHO Global Advisory Committee on Vaccine Safety is carefully reviewing the latest safety data available for the AstraZeneca vaccine. Once the analysis is complete, WHO will immediately communicate its results to the public.”says the same statement, published a day after the organization’s experts attended a closed-door meeting.
CNCAV: Vaccination with AstraZeneca serum will continue in Romania
Romanian authorities decided on Monday night to continue vaccination with the AstraZeneca serum, although many European states have decided to temporarily stop the use of this vaccine after noting some serious side effects.
“After the analysis of the reports of adverse reactions registered in Romania, the motivation for the decisions of other countries, the events reported internationally, but also the recommendations of the European regulatory authority, the European Medicines Agency (EMA), the representatives of the institutions have decided to continue the vaccination campaign in Romania with all vaccines against COVID-19, currently authorized at European level “Said the CNCAV in a statement.
At the same time, the CNCAV states that, pending the completion of the evaluation of cases reported for blood coagulation disorders by the Pharmacovigilance Committee of the European Medicines Agency (EMA), PRAC (Pharmacovigilance Risk Assessment Committee ) and issuing a recommendation at the extraordinary meeting that will take place on Thursday, March 18, the EMA recommends continuing vaccination, emphasizing that the benefits of vaccination in preventing severe forms of COVID-19 and death outweigh the risk of side effects.
“Cases of bleeding disorders have occurred in a small number of vaccinated patients, not exceeding the reported frequency in the general unvaccinated population. It should be noted that these disorders have different causes and can occur regardless of vaccine administration. Currently, experts at the European level are rigorously analyzing all available data to determine if there is a causal relationship between the administration of the vaccine and these events. Vaccination remains the safe and effective solution to overcome the COVID-19 pandemic. , and the vaccines used in Romania are authorized by the European Medicines Agency (EMA), the most rigorous decision-making body, which brings together experts at European level. We recommend reporting any suspected adverse reactions from both professionals and patients. The CNCAV assures the population full transparency and full responsibility in prompt communication n of all the information of interest, so that the vaccination process is carried out in a favorable and safe environment for all the people who wish to be immunized against COVID-19 “, is also specified in the cited statement.
Chain suspensions in Europe
The WHO licensed the AstraZeneca-Oxford vaccine for emergency use last month, expanding access for developing countries to relatively cheap sera.
Fifteen countries, including Germany, France and Italy, have suspended the use of the AstraZeneca vaccine “as a precaution” this week after reports of blood transmission problems in vaccinated people, such as clotting difficulties or thrombosis, which have shown to date that causal link. .
