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EMA says benefits of AstraZeneca vaccine 'outweigh the risks of side effects'

Stephen Donnelly hopes vaccine appointments in Ireland will be rescheduled “very quickly”.

Image: DPA/PA Images

Updated Mar 15th 2021, 5:59 PM

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

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

The EMA is currently 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 this 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 said its investigation continued over the weekend, and “rigorous analysis of all the data related to thromboembolic events will be carried out in the coming days”.

“Experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the vaccine might have contributed or if the event is likely to have been due to other causes.”

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

“In the meantime, anyone who has received the vaccine and has any concerns should contact an appropriate healthcare professional. It is important that people who suspect they may have a side effect after vaccination report this to the national medicines regulator, or to a healthcare professional who can help them do so,” the statement added.

30,000 fewer doses in Ireland this week

Earlier 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.

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. 

Germany, France and Italy today halted the use of AstraZeneca’s vaccine, saying that a closer look was necessary. 

“After new reports of thromboses of the cerebral veins in connection with the vaccination in Germany and Europe, the PEI considers further investigations to be necessary,” said the German health ministry, referring to a recommendation by the country’s vaccine authority, the Paul Ehrlich Institute. 

“The European Medicines Agency EMA will decide whether and how the new findings will affect the approval of the vaccine,” it added. 

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 World Health Organization has said no causal link had been established between the vaccine and blood clotting after Denmark, Norway and Iceland Thursday temporarily suspended the use of the vaccine over concerns about patients developing post-jab blood clots.

UK Prime Minister Boris Johnson today said the Covid-19 jab was safe and stressed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) was one of the “toughest and most experienced” in the world.

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. 

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. 

Roll-out impact

It’s currently unclear how long the AstraZeneca vaccine rollout will be suspended.

Speaking on RTÉ Radio One’s This Week yesterday, Dr Ronan Glynn said the EMA is due to meet again on Wednesday or Thursday to discuss data collected regarding the situation. 

With regards to the roll-out of the Pfizer/Moderna vaccine, HSE’s Chief Clinical Officer Dr Colm Henry told the programme that the distribution of those will continue “without disruption”. 

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, Health Minister Stephen Donnelly told RTÉ’s Morning Ireland today. 

Donnelly said he hopes the 30,000 people due to receive the AstraZeneca Covid-19 jab this week will have their vaccinations rescheduled in the next few weeks.

“Hopefully the 30,000 for this week will be rescheduled very, very quickly,” Donnelly said.

When asked if all of the 30,000 people will be vaccinated within the time left in March, he said: “I’d say pretty close, possibly, maybe there may be a bit of spill over into into April, but very, very quickly.

“We should be able to reschedule then and in so doing not have to delay other people. So in other words, do the 30,000 at the same time as people who we were planning on doing in the coming weeks as well.”

From this morning, people over the age of 50 in Northern Ireland can book an appointment for their vaccination. 

Responding to questions regarding the speed of the vaccination roll-out in the Republic, HSE chief Paul Reid told Morning Ireland: “The reality is … this will step up in quarter two. I, like many people in the health system, wish we had more supplies here today. 

“What I can clearly say is, every supply we’re getting, we’re vaccinating with 90% efficiency level within that week, not many European countries are vaccinating to that efficiency level that we are. 

“So, whatever we get, and whatever the EMA decision is clear, those 30,000 will be vaccinated very efficiently and any supply we get we’ll continue in that vein.”

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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).”

Elsewhere, the head of the Oxford University vaccine group has sought to reassure the public over its Covid-19 jab after several countries temporarily suspended its use.

Professor Andrew Pollard said that while it was right that regulators investigated reports of blood clots in people who have had the vaccine, data from millions of people was “very reassuring” that there was no link.

Professor Pollard said “safety is clearly absolutely paramount” but that about 3,000 cases of blood clots occur every month in the UK from other causes.

“So, when you then put a vaccination campaign on top of that, clearly those blood clots still happen and you’ve got to then try and separate out whether, when they occur, they are at all related to the vaccine or not,” he told BBC Radio 4’s Today programme.

With reporting by Órla Ryan, Press Association and AFP

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