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EMA 'firmly convinced' benefits of AstraZeneca vaccine 'outweigh the risks of the side effects'

The EMA is continuing to carry out its investigation into the vaccine after reports of rare blood-clotting events.

EMA chief Emer Cooke
EMA chief Emer Cooke
Image: Screengrab via European Commission

THE EUROPEAN MEDICINES Agency (EMA) has said it is “firmly convinced”  that the benefits of the AstraZeneca Covid-19 vaccine “outweigh the risks of the side effects”.

A number of countries including Ireland suspended the use of this particular Covid-19 vaccine amid concerns over blood clots.

Over the past few days, the EMA has been carrying out an investigation into the vaccine after reports of rare blood-clotting events, including some complicated by very low levels of platelets in the blood of younger adults, after vaccination.

In a statement released yesterday evening, the EMA said it is working closely with AstraZeneca and experts in blood disorders, as well as health authorities in the UK where round 11 million doses of the vaccine have been administered.

The statement noted that the EMA “currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects”.

The EMA’s safety committee (PRAC) is set to further review the information today and has called an extraordinary meeting tomorrow “to conclude on the information gathered and any further actions that may need to be taken”.

Speaking at a press conference this afternoon, EMA chief Emer Cooke said that “while the investigation is ongoing, we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risk of the side effects”. 

“I don’t need to remind you all here today that the Covid-19 pandemic is a global crisis with devastating health, social and economic impact, and it continues to be a major burden on EU health systems,” Cooke said.

“Vaccines for Covid-19 help to protect individuals from becoming ill, especially health care professionals and vulnerable populations such as older people and those with chronic diseases, and this is a very important consideration in our assessment of the benefit risk,” she said. 

Cooke reiterated that, while the investigation is ongoing, “anyone who has received the vaccine and has any concerns should contact their appropriate healthcare professional”. 

“It’s important that people who suspect that they have a side effect after vaccination report this to the national medicines regulator or to a healthcare professional who can help them to do so,” she said. 

30,000 fewer doses in Ireland this week

Earlier yesterday, it emerged that 30,000 fewer doses of Covid-19 vaccines than planned are due to be administered in Ireland this week following the pause in the use of the AstraZeneca vaccine.

80,000 vaccines were due to be administered in Ireland this week, according to the HSE. However, just 50,000 are expected to be administered now. 

The people affected by the suspension of the AstraZeneca vaccine will be healthcare workers and the category of people aged 16-69 who have high-risk conditions, Category 4.

The National Immunisation Advisory Committee (NIAC) has recommended that the administration of the Covid-19 AstraZeneca vaccine be temporarily deferred, pending the outcome of the EMA investigation.

The NIAC made its recommendation following a notification from the Health Products Regulatory Authority (HPRA) on Saturday of a new safety alert regarding the vaccine. 

This alert came from the Norwegian Medicines Agency following reports of four new serious, rare blood clotting events, including some complicated by very low levels of platelets in the blood of younger adults after vaccination. 

In a statement yesterday morning, Deputy Chief Medical Officer Dr Ronan Glynn said: “It has not been concluded that there is any link between the Covid-19 vaccine AstraZeneca and these cases.

“However, acting on the precautionary principle, and pending receipt of further information, the NIAC has recommended the temporary deferral of the Covid-19 vaccine AstraZeneca vaccination programme in Ireland.”

To date, the HPRA has received a small number of reports associated with blood clots following vaccination with the AstraZeneca vaccine. However, it has not received any reports of the nature of those described by the Norwegian Medicines Agency. 

The HRPA said it will continue to monitor national reports “very closely”. 

The HPRA said in a statement yesterday afternoon that “there is currently no indication that the vaccine was the cause of these events and there may be alternative explanations for their occurrence that are unrelated to the vaccine”. 

“However, the safety of the public is of the utmost importance, and it is essential that reports of potential safety concerns, even if very rare, are rigorously and swiftly investigated so that the public can be reassured and if required, appropriate action can be taken,” it said. 

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AstraZeneca response

AstraZeneca, an Anglo-Swedish company that developed the vaccine with Oxford University, has defended the safety of its product.

In a statement released yesterday morning, a spokesperson for the company said an analysis of its safety data that covers reported cases from more than 17 million doses of vaccine administered “has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia with Covid-19 vaccine AstraZeneca”.

“In fact, the reported numbers of these types of events for Covid-19 vaccine AstraZeneca are not greater than the number that would have occurred naturally in the unvaccinated population,” the spokesperson said.

“In clinical trials, no trends or patterns were observed with regard to pulmonary embolism, deep vein thrombosis, or events possibly related to thrombocytopenia,” they said.

“A careful review of all available safety data including these events is ongoing and AstraZeneca is committed to sharing information without delay. We also note that the European Medicine Agency (EMA) has asked for an assessment of events related to thrombocytopenia from other COVID-19 vaccine manufacturers (per communication 11 March).”

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