EMA Approves AstraZeneca Covid Vaccine After Blood Clot Reports

A member of the Hampshire Fire and Rescue Service prepares a dose of the Oxford / AstraZeneca coronavirus vaccine at the Basingstoke Fire Station, which has been established as a vaccination center and where crews continue to respond to calls to the 999 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 injection, which was developed with the University of Oxford, after around 30 cases of blood clots. Some other countries have stopped using individual lots of the vaccine..

The EMA said Thursday that the benefits of the vaccine outweigh the risks. He found no batch issues or quality issues with the vaccine, although he couldn’t definitively rule out a link to the blood clot incidents.

“This is a safe and effective vaccine,” EMA Executive Director Emer Cooke told a news conference 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 overall increased risk of thromboembolic events or blood clots. A definitive link between these cases and the vaccine cannot be ruled out. “

The regulator said it would continue to study possible links between the rare blood clots and the vaccine. It will also update your vaccine guide to explain the potential risks.


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

Austria was the first country to suspend the use of a specific batch of AstraZeneca injections 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 people, prompting other heads of state to stop its use and await a new assessment 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, that is, low levels of blood platelets, including rare cases of clots in the vessels that drain blood from the brain, known as CVSTs.

“These are rare cases: around 20 million people in the UK and EEA (European Economic Area) had received the vaccine as of March 16 and the EMA had reviewed only 7 cases of blood clots in multiple blood vessels and 18 cases of CVST. The link with the vaccine is not proven, but it is possible and deserves a more in-depth analysis, “added the EMA in a statement.

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

The benefits ‘outweigh its risks’

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

In addition, the WHO said that the reaction of some EU nations 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 its risks and recommends that vaccinations continue.”

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

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

Recent concerns about side effects follow uncertainty from some EU nations about an alleged lack of data on the efficacy of the AstraZeneca vaccine for older populations. However, these countries subsequently decided to go ahead with the use of injection for vaccines.

The situation in Europe ‘worsens’

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

On Wednesday, the president of the European Commission, Ursula von der Leyen, said: “The epidemiological situation is getting worse.”

“We see the crest of a third wave forming in the member states, and we know we need to accelerate vaccination rates,” he added.

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

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


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