Head of the EMA Emer Cooke said that the vaccine is safe and the benefits outweigh the risks.
THE EUROPEAN MEDICINES Agency (EMA) has said that the AstraZeneca vaccine is safe and effective and that it is not associated with an increased risk of blood clots.
The agency held an extraordinary meeting today to finalise its conclusions on a small number of blood clotting events that were reported following vaccination.
Head of the EMA, Emer Cooke said that the vaccine is a safe and effective vaccine and that the benefits of vaccination outweigh the risks.
However, the EMA “cannot rule out definitively a link between these cases and the vaccine”. The EMA’s safety committee has instead decided to draw attention to the possible rare conditions by including details within the vaccines leaflets.
“What the committee has therefore recommended is to raise awareness of these possible risks, making sure that they are included in the product information,” said Cooke.
“Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects.”
A number of countries across Europe, including Ireland, paused use of the vaccine in recent days following reports by the Norwegian Medicines Agency of serious events in four patients.
Officials in Ireland had said the decision to pause the use of the vaccine had been made on a precautionary principle.
Cooke said that the EMA was aware that EU member states had suspended vaccination while they awaited the EMA review.
Given that thousands of people in the EU die every day – in fact over 2,500 were reported one day last week – it really was crucial for EMA to review rapidly and thoroughly all the available evidence, so we made this review our highest priority
According to Cooke, the EMA worked closely with the UK’s health regulator the Medicines and Healthcare products Regulatory Agency (MHRA) during the rapid review.
“The scientific conclusions adopted today provide member states with the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns.”
World Health Organization experts yesterday recommended countries continue to use the AstraZeneca vaccine, but said they were looking into its safety.
Following the publication of the EMA review, Italy announced that it will resume administering the vaccine tomorrow. Health officials in Sweden said they need a “couple of days” to evaluate the ruling and the pause will remain in place for now.
Ireland’s Health Products Regulatory Authority (HPRA) said in a statement this evening that close safety monitoring of reports of blood clotting disorders will continue, and further studies are underway to provide more laboratory data as well as analysis of further real-world evidence.
It added that it has not received any reports of cases of these blood clots.
The MHRA said earlier today that available evidence does not suggest that blood clots in veins are caused by the AstraZeneca vaccine.
In a statement, the MHRA said that the advice remains that the benefits of the Covid-19 vaccines outweigh any risks and that people in the UK should continue to get their jab when it becomes available.
“Our review has found that the available evidence does not suggest that blood clots are caused by COVID-19 Vaccine AstraZeneca,” said Professor Sir Munir Pirmohamed, the Chair of the Commission on Human Medicines.
“We have been closely reviewing all reports of blood clots in the vein (venous thromboembolism, or VTE) following vaccination. There is no evidence either that VTE is occurring more often in people who have received the vaccine than in people who have not, for either vaccine.”
The WHO, the EMA and AstraZeneca itself have repeatedly said the vaccine is safe.
The HSE has said the National Immunisation Advisory Committee (NIAC) will assess the advice from the EMA and will issue guidance to the National Public Health Emergency Team (NPHET). NPHET will then make recommendations to the Minister for Health.
It is likely that these recommendations will include updated clinician and patient information in relation to these reported conditions and the symptoms associated with them.
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HSE CEO Paul Reid said it will take “a period of days” to re-start the roll-out of the AstraZeneca vaccine in Ireland once fresh recommendations are issued from public health officials.
He said the health service will attempt to deliver the vaccines – around 30,000 jabs – that were delayed last week as soon as possible. A further 10,000 doses from AstraZeneca are due to be delivered to Ireland next week.
Speaking to reporters yesterday, Taoiseach Micheál Martin said that the HSE will “immediately endeavour” to restart vaccination with the AstraZeneca vaccine when the all-clear is received from the EMA.
“It will take some time, because obviously people have to be notified again, logistics have to be put in place and the venue has to be organised and so on,” said Martin.
“But we will be doing everything we possibly can to accelerate the vaccine, particularly for those who have had their vaccinations postponed as a result of the decision taken last weekend.”