European Medicines Agency calls AstraZeneca vaccine "safe and effective"

Sunday, March 21, 2021

The European Medicines Agency (EMA) ruled Thursday, after thirteen European Union (EU) nations suspended rollouts of the Oxford–AstraZeneca COVID-19 vaccine, the jab was "safe and effective" and there was "no indication" of correlation between taking the vaccine and blood clotting.

The review included safety data from over 17 million people vaccinated in the EU and the United Kingdom and focused on cases of uncommon blood disorders.

In a statement on the EMA's website, the Pharmacovigilance Risk Assessment Committee confirmed "the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects", and neither the vaccine, nor "specific batches", nor "particular manufacturing sites" were associated with an increased risk of blood clots. It also stated there may be a relation between "very rare cases of blood clots associated with thrombocytopenia".

Over 469 reports, including 191 from the European Economic Area, it was concluded "[o]verall the number of thromboembolic events reported after vaccination [...] was lower than that expected in the general population."

According to multiple sources, many countries in Europe and elsewhere halted inoculations after reports of blood clots and deaths from those who received the jab, while countries including Austria paused rollout of certain batches.

On Thursday, the World Health Organization said in a press briefing countries should still use the AstraZeneca vaccine. Regional director for Europe Hans Kluge said while "we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors [...] the benefits of the AstraZeneca vaccine far outweigh its risks". The international body was to release the results of its report on Friday.

While nations can choose whether or not to follow EMA advice, many countries said they would only resume inoculations with its approval. On Tuesday, when the preliminary statement was "encouraging", France and Italy said they would "promptly restart" if positive results were found.

AstraZeneca said there is no elevated risk of blood clotting as a result of its vaccine, and of the 17 million inoculated in the EU and the UK, only 37 reports of blood clots were received; "much lower than would be expected to occur naturally" and "similar across other licensed COVID-19 vaccines".

The recent suspensions have only further exacerbated the European Union's vaccine drive, hindered by serious supply shortages. French immunologist Alain Fischer told France Inter France's decision to temporarily halt rollout was "not lost time" and the action was justified by "a few very unusual and troubling cases". Speaking to the BBC, University of Birmingham's drug safety researcher Dr Anthony Cox called it a "cascade of bad decision-making that's spread across Europe".

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Sources

"AstraZeneca vaccine: EU agency says AstraZeneca is 'safe and effective'" — BBC News Online, March 18, 2021
Yuliya Tamazan. "Oxford-AstraZeneca Covid-19 vaccine is safe, European Medicines Agency rules" — NBC News, March 18, 2021
"COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets" — European Medicines Agency, March 18, 2021
Silvia Amaro. "Italy and France ready to restart AstraZeneca vaccinations if regulators give the green light" — CNBC, March 17, 2021
"Which countries have suspended AstraZeneca's Covid-19 vaccine?" — The National (Abu Dhabi), March 16, 2021

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