EMA approves AstraZeneca Covid vaccine following 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 is set up as a vaccination center and where the crew is still answering 999 calls on February 4, 2021 in Basingstoke. , England.

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LONDON – The European Medicines Agency has ruled that the AstraZeneca coronavirus vaccine is safe and effective, despite some concerns about potential side effects.

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

The EMA said on Thursday that the benefits of the vaccine outweighed its risks. It found no batch or quality problems with the vaccine, although it could not definitively rule out an association with the blood clot incidents.

“This is a safe and effective vaccine,” said Emer Cooke, EMA director, at a news conference Thursday.

“Its benefits in 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 of thromboembolic events. or blood clots … can’t rule out 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 guidelines to explain the potential risks.

Suspensions

The suspensions were not uniform across the 27 member states of the European Union, and a number of countries continued to use the AstraZeneca shot in their vaccination campaigns.

Austria was the first country to discontinue use of a specific batch of AstraZeneca injections last week, following the death of a 49-year-old woman who received the vaccine.

This was followed by reports of blood clots elsewhere, albeit in a very small number of individuals, leading other heads to discontinue use and await a new review from 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, i.e. low platelet levels, including rare cases of clots in the blood vessels that drain blood from the brain, known as CVST.

“These are rare cases – about 20 million people in the UK and the EEA (European Economic Area) had received the vaccine on March 16, and the EMA had assessed only 7 cases of multi-vessel blood clots and 18 cases of CVST. A causal link connection with the vaccine has not been proven, but is possible and deserves further analysis, ” the EMA added in a statement.

AstraZeneca’s vaccine is widely used in the UK but has not yet been approved by the authorities in the United States.

The benefits ‘outweigh the risks’

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

In addition, the WHO said that the response from some EU countries showed that “the surveillance system is working and that there are effective controls”. Nonetheless, the institution reiterated its belief that “the benefits of the AstraZeneca vaccine outweigh its risks, and recommends continuing vaccinations”.

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

Some health experts have raised more concerns about discontinuing use of this vaccine. Earlier this week, Cooke of the EMA said the agency was concerned that the suspensions could hurt people’s confidence in vaccines.

Recent concerns about side effects follow uncertainty from some EU countries about an alleged lack of data on the efficacy of the AstraZeneca vaccine in older populations. These countries then decided to use the shot for vaccinations.

Situation in Europe ‘deteriorating’

The distribution of vaccines is crucial from both a health and an economic perspective in Europe.

European Commission President Ursula von der Leyen said Wednesday: “The epidemiological situation is deteriorating.”

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

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

Data presented Wednesday suggested the bloc is on track to achieve that goal, assuming pharmaceutical companies honor their supply contracts in the next three months and member states manage to use them.

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