EMA approves AstraZeneca Covid vaccine after blood clot reports

A dose of the Oxford / AstraZeneca coronavirus vaccine is prepared by a member of the Hampshire Fire and Rescue Service at the Basingstoke fire station, which has been installed as a vaccination center and where crews are still answering 999 calls in 4 February 2021 in Basingstoke, England.

WPA Pool | Getty Images

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

The announcement comes Thursday after more than a dozen EU countries have decided to stop using the AstraZeneca injection, which was developed 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 Thursday that the vaccine’s benefits outweigh the risks. He found no batch or quality problems with the vaccine, although he was unable to definitively rule out a link to blood clot incidents.

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

“Its benefits in protecting people against Covid-19 with the associated risks of death and hospitalization far outweigh the possible risks. The committee also concluded that the vaccine is 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 he would continue to study possible links between rare blood clots and the vaccine. He will also update his vaccine guidelines to explain the potential risks.

Suspensions

The suspensions were not uniform across the 27 member states of the European Union, with several nations continuing to deploy the AstraZeneca vaccine in their vaccination campaigns.

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

There followed reports of blood clots in other places, albeit in a very small number of individuals, which led other chiefs to suspend their 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, 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 – about 20 million people in the UK and the EEA (European Economic Area) received the vaccine on March 16 and the EMA reviewed only 7 cases of blood clots in various blood vessels and 18 cases of CVST. the link with the vaccine has not been proven, but it is possible and deserves further analysis, “added the EMA in a statement.

The AstraZeneca vaccine is being used widely in the United Kingdom, but has not yet been approved by the United States authorities.

The benefits ‘outweigh your 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 its risks and recommends that vaccinations continue”.

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

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

Recent concerns about side effects follow the uncertainty in some EU countries about an alleged lack of data on the effectiveness of the AstraZeneca vaccine for elderly populations. These countries subsequently decided to proceed with the use of the vaccine for vaccines, however.

Situation in Europe ‘getting worse’

The distribution of vaccines is crucial both from a health and an economic point of view 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 forming in the member states and we know that we need to accelerate vaccination rates,” he added.

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

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

.Source