The EMA approves the AstraZeneca Covid vaccine after reports of blood clots

A dose of the Oxford / AstraZeneca coronavirus vaccine is being prepared by a member of the Hampshire Fire and Rescue Service at the Basingstoke Fire Station, which was set up as a vaccination center and where crews still respond to 999 calls on 4 February 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 concerns about possible side effects.

Thursday’s announcement comes after more than a dozen EU countries decided to stop using the AstraZeneca shot, which was developed in conjunction with Oxford University, after about 30 cases of blood clots. Several other countries have stopped using individual batches of vaccine.

The EMA said on Thursday that the benefits of the vaccine outweighed the risks. He found no batch problems or quality problems with the vaccine, although he could not rule out a blood clot incident.

“This is a safe and effective vaccine,” EMA chief executive Emer Cooke told a news briefing on Thursday.

“Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the possible risks. The committee also concluded that the vaccine is not associated with an increased risk of thromboembolic events or blood clots … no may exclude a definitive 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 guide to explain the potential risks.

suspension

Suspensions have not been uniform across the 27 EU member states, with a number of nations continuing to carry out AstraZeneca fire in their vaccination campaigns.

Austria was the first country to suspend the use of a specific batch of AstraZeneca photos last week after the death of a 49-year-old woman who had received the vaccine.

This was followed by reports of blood clots elsewhere, albeit in very small numbers, which led other chiefs to declare discontinuation of its use and await a new assessment by the region’s health authority.

The EMA said in its review that the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, ie low levels of platelets in the blood, including rare cases of blood clots in the blood vessels known as CVST.

“These are rare cases – about 20 million people in the UK and the EEA (European Economic Area) had received the vaccine since March 16, and the EMA looked at only 7 cases of blood clots in several blood vessels and 18 cases of CVST. the link to the vaccine is not proven, but it is possible and deserves further analysis, “the EMA added in a statement.

The AstraZeneca vaccine is widely used in the UK, but has not yet been approved by US authorities.

Benefits “outweigh the risks”

The World Health Organization said on Wednesday that “vaccination against Covid-19 will not reduce disease or death from other causes. Thromboembolic events are known to occur frequently.”

In addition, the WHO said that the reaction of some EU countries showed that “the surveillance system works and that there are effective controls”. However, the institution reiterated that it believes that “the benefits of the AstraZeneca vaccine outweigh the risks and recommend continued vaccinations”.

The UK drug regulator also said on Thursday that people should continue to receive the AstraZeneca shot.

Some health experts have expressed greater concerns about discontinuing the use of this vaccine. Speaking earlier this week, EMA’s Cooke said the institution was concerned that the suspensions could affect people’s confidence in vaccines.

Recent concerns about side effects stem from uncertainty in some EU countries about the alleged lack of data on the effectiveness of the AstraZeneca vaccine for the elderly. However, these countries later decided to continue using the vaccine for vaccinations.

The situation in Europe is “getting worse”

Vaccine distribution is crucial from both a health and economic perspective in Europe.

Speaking on Wednesday, European Commission President Ursula von der Leyen said: “The epidemiological situation is getting worse.”

“We see the crest of a third wave in the Member States and we know we need to speed up vaccination rates,” she added.

The EU aims to inoculate 70% of its adult population by the end of the summer.

Data released on Wednesday suggested that the bloc is on track to achieve this goal, assuming that pharmaceutical companies comply with their delivery contracts over the next three months and that Member States have managed to use them.

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