A dose of Oxford / AstraZeneca coronavirus vaccine is being prepared by a member of the Hampshire Fire and Rescue Service at the Basingstoke Fire Station, which has been set up as a vaccination center and where crews still answer 999 calls in Basingstoke on 4 February 2021 . , England.
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LONDON – The European Medicines Agency has ruled that the vaccine against AstraZeneca coronavirus is safe and effective, despite concerns about possible side effects.
The announcement comes on Thursday after more than a dozen EU countries decided to discontinue the use of the AstraZeneca shot, which was developed in conjunction with the University of Oxford, after about 30 cases of blood clots. A few other countries have stopped using individual groups of the vaccine.
The EMA said Thursday that the benefits of the vaccine outweigh the risks. No bundle problems or quality problems were found with the vaccine, although it was not able to definitively rule out a connection with the blood clot incidents.
“It is a safe and effective vaccine,” EMA executive director Emer Cooke told a news conference Thursday.
“The benefits of protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the potential risks. The committee also concluded that the vaccine is not associated with an increase in the overall risk. “for thromboembolic events or blood clots. We still can not rule out a definite link between these cases and the vaccine.”
The regulator said it would continue to study possible links between rare blood clots and the vaccine. It will also update its vaccine guidelines to clarify the potential risks.
Suspensions
The suspensions were not uniform in the 27 member states of the European Union, and a number of countries continued the AstraZeneca shot in their vaccination campaigns.
Austria was the first country to suspend the use of a specific group of AstraZeneca shots last week, following the death of a 49-year-old woman who received the vaccine.
This has been followed by reports of blood clots elsewhere, albeit in a very small number of individuals, which has led other chiefs to interrupt their use and wait for a new assessment by the health authority in the region.
The EMA said in its review that the vaccine could be associated with very rare cases of blood clots associated with thrombocytopenia, that is, low platelet counts, including rare cases of blood clots in the vessels that draw blood from the brain, known as CVST.
“These are rare cases – about 20 million people in the UK and the EEA (European Economic Area) received the vaccine on March 16 and the EMA reviewed only 7 cases of blood clots in several blood vessels and 18 cases of CVST. Causal association with the vaccine has not been proven, but is possible and deserves further analysis, “the EMA added in a statement.
The AstraZeneca vaccine is widely used in the United Kingdom but has not yet been approved by the United States authorities.
The benefits outweigh the risks
The World Health Organization said on Wednesday that “vaccination against Covid-19 will not reduce disease or death due to other causes. It is known that thromboembolic events occur frequently.”
In addition, the WHO said that the response from some EU countries had shown that “the monitoring system is working and that effective controls have been put in place.” Nevertheless, the institution reiterated that it believes that “the benefits of the AstraZeneca vaccine outweigh the risks and recommends that vaccinations continue.”
The British drug regulator also said on Thursday that people should continue to receive the AstraZeneca shot.
Some health experts have expressed greater concern about the interruption of the use of this vaccine. The EMA’s Cooke said earlier this week that the institution was concerned that the suspensions could affect people’s confidence in vaccines.
The recent concern about the side concerns the uncertainty of some EU countries about a perceived lack of data on the efficacy of the AstraZeneca vaccine for the elderly population. However, these countries have decided to continue using the shot for vaccinations.
Situation in Europe is getting worse
The distribution of vaccines is crucial from both a health and economic perspective in Europe.
Ursula von der Leyen, president of the European Commission, said on Wednesday: “The epidemiological situation is getting worse.”
“We are seeing the crest of a third wave form in member states, and we know we need to accelerate vaccination rates,” she added.
The EU aims to vaccinate 70% of its adult population by the end of the summer.
Data presented on Wednesday suggested that the bloc is on track to reach the target, assuming pharmaceutical companies respect their delivery contracts in the next three months and that member states are successful in using them.