EMA approves AstraZeneca Covid vaccine after blood clot stories
A dose of the Oxford / AstraZeneca coronavirus vaccine is being made by a member of the Hampshire Fire and Rescue Service of the Basingstoke Fire Station, which has been set up as a vaccination center and where crews are still answering 999 calls on February 4, 2021 in Basingstoke, England.
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LONDON – The European Medicines Agency has decided that the AstraZeneca coronavirus vaccine is safe and effective, despite some concerns about possible side effects.
Thursday’s announcement comes after more than a dozen EU countries decided to stop using the AstraZeneca shot developed with Oxford University after around 30 cases of blood clots. Some other countries have stopped using individual batches of the vaccine.
The EMA said Thursday that the vaccine’s benefits outweighed the risks. No batch or quality problems with the vaccine were found, although an association with the blood clot incidents could not be definitively ruled out.
“This is a safe and effective vaccine,” said Emer Cooke, EMA Executive Director, at 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 was not associated with an increase in the overall risk of thromboembolic events or blood clots. … We still cannot rule out a definitive link between these cases and the vaccine. “
The regulator said it will continue to investigate possible links between rare blood clots and the vaccine. It will also update its guidelines for the vaccine to clarify the potential risks.
The suspensions were not uniform across the 27 member states of the European Union and a number of nations continued to use the AstraZeneca shot in their vaccination campaigns.
Austria became the first country to stop using a certain batch of AstraZeneca shots last week after a 49-year-old woman who received the vaccine died.
Reports of blood clots elsewhere followed, albeit in a very small number of people, causing other leaders to suspend use and await a reassessment by the region’s health authority.
The EMA said in its review that the vaccine may be associated with very rare cases of thrombocytopenia-related blood clots, which are low platelet levels, including rare cases of blood clots in the vessels that drain blood from the brain known as CVST.
“These are rare cases – around 20 million people in the UK and EEA (European Economic Area) had received the vaccine by March 16, and the EMA had only looked at 7 cases of multiple blood clots and 18 cases of CVST. One cause A link to the vaccine has not been established but it is possible and deserves further analysis, “added the EMA in a statement.
AstraZeneca’s vaccine is widely used in the UK but has not yet been approved by the US authorities.
The benefits outweigh the risks.
The World Health Organization said Wednesday that “vaccination against Covid-19 will not reduce disease or death for other reasons. Thromboembolic events are known to be common.”
In addition, WHO said the response from some EU countries had shown that “the surveillance system is working and that there are effective controls in place”. Nonetheless, the institution reiterated its belief that “the benefits of the AstraZeneca vaccine outweigh the risks and recommends that vaccinations be continued”.
The UK Medicines Agency also said Thursday that people should continue to receive the AstraZeneca shot.
Some health professionals have raised major concerns about discontinuing use of this vaccine. Earlier this week, Cooke, of the EMA, said the institution was concerned the suspensions could affect people’s confidence in vaccines.
Recent concerns about the side effects stem from the uncertainty of some EU countries about an alleged lack of data on the effectiveness of the AstraZeneca vaccine in the elderly. However, these countries later decided to use the shot for vaccination.
Situation in Europe “worsening”
The distribution of vaccines is vital in Europe from both a health and an economic perspective.
The President of the European Commission, Ursula von der Leyen, said on Wednesday: “The epidemiological situation is deteriorating.”
“We are seeing a third wave forming in Member States and we know we need to speed up vaccination rates,” she added.
The EU aims to vaccinate 70% of its adult population by the end of summer.
The data presented on Wednesday suggests that the bloc is on track to achieve this goal, provided that drug companies honor their supply contracts over the next three months and member states use them successfully.