EMA approves AstraZeneca Covid vaccine after reporting blood clots

A dose of the Oxford / AstraZeneca coronavirus vaccine is being prepared by a member of the Hampshire Fire and Rescue Service at Basingstoke Fire Station, which has been set up as a vaccination center and where teams are still responding to 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 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 about 30 cases of blood clots. Some other countries have stopped using individual vaccine batches.

The EMA said Thursday that the benefits of the vaccine outweighed the risks. He found no batch or quality problems with the vaccine, although he could not definitively rule out any link to the blood clot incidents.

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

“Its benefits in protecting people against 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 increased overall risk of thromboembolic events or clots. of blood … cannot 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 potential risks.

Suspensions

The suspensions were not uniform in the 27 member states of the European Union, and several nations continued to deploy AstraZeneca firing in their vaccination campaigns.

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

This was followed by reports of blood clots elsewhere, albeit in a very small number of individuals, leading other heads in the state to stop using them and wait for a new assessment by the health authority of the region.

The EMA said in its review that the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, that is, low levels of blood platelets, including rare cases of 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 the EEA (European Economic Area) had received the vaccine as of March 16 and EMA had only reviewed 7 cases of blood clots in various blood vessels and 18 cases of CVST The link to the vaccine has not been proven, but it is possible and deserves further analysis, “the EMA added in a statement.

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

The benefits “outweigh your risks”

The World Health Organization said 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 has reiterated that it believes that “the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations be continued.”

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

Some health experts have expressed broader concerns about the pause in 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 the vaccines.

Recent concerns about side effects follow the uncertainty of some EU countries about an alleged lack of data on the effectiveness of the AstraZeneca vaccine for the elderly. These countries later decided to continue using the shot for inoculations.

The situation in Europe “gets 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 a third wave crest forming in member states and we know we need to speed up vaccination rates,” he added.

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

The data presented on Wednesday suggested that the block is on track to achieve this goal, assuming that pharmaceutical companies honor their delivery contracts in the next three months and that member states are successful in using them.

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