The EMA has declared the AstraZeneca vaccine safe to use - here's what happens next

THE EUROPEAN MEDICINES Agency (EMA) yesterday stated that the AstraZeneca Covid-19 vaccine is safe and is not associated with an increased risk of blood clots, following a review of a number of reported incidents following vaccinations.

The agency said it cannot definitively rule out a link between these cases and the vaccine, so it has recommended that health services draw attention to possible rare blood clotting conditions by including details in vaccine leaflets about symptoms associated with them.

A number of countries across Europe, including Ireland, paused use of the vaccine in recent following reports by the Norwegian Medicines Agency of serious events in four patients. It is expected that the HSE will resume using the vaccine in the coming days.

What happens next

Italy has already decided to resume administering AstraZeneca vaccines today, but other countries are taking a more cautious approach.

In Ireland, the next step will be a meeting of the National Immunisation Advisory Committee (NIAC) to assess the advice from the EMA.

At last night’s briefing of the National Public Health Emergency Team (NPHET), deputy chief medical officer Dr Ronan Glynn said he welcomed the clarity from the EMA and said that NIAC would discuss the issue last night and this morning. 

“They’ll be considering it further this evening and tomorrow morning, and the HPRA (Health Products Regulatory Authority) are reviewing the statement and the findings,” he said.

“We’ll be deliberating between the organisations tonight and tomorrow morning, and we’ll issue an update tomorrow once we have come to a position.”

NIAC will issue guidance to NPHET and NPHET will then make recommendations to the Minister for Health.

These recommendations will include a view on whether Ireland should re-commence use of the vaccine. NPHET will also likely advise the roll-out of updated information for vaccinators as well as new patient leaflets that include details of these rare conditions.

HSE CEO Paul Reid yesterday 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 as a result of the decision last week as soon as possible. A further 10,000 doses from AstraZeneca are due to be delivered to Ireland next week.

What we know about the blood clotting conditions

The EMA said its review, conducted by its pharmacovigilance risk Assessment Committee (PRAC), involved days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from clinical trials.

Dr Sabine Straus, who is a member of PRAC, noted that the number of thromboembolic events reported after vaccination is lower than the expected rate in the general population.

“Moreover, because the vaccine is effective in preventing Covid-19 disease, which in itself, of course, is a cause of blood clots, it likely reduces the risks of thrombotic events,” she explained.

She said the committee found no evidence of a quality or batch issue.

Dr Straus said there are still some uncertainties as there have been reports of some very rare cases describing “unusual events of a combination of thrombosis (clotting) and thrombocytopenia (low levels of platelets) and bleeding.

“In a few cases tiny clots developed in multiple blood vessels in the first seven to 14 days after vaccination, a condition called disseminated intravascular coagulation (DIC).

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“Also in a few cases we saw clots developing in blood vessels, draining blood from the brain. And this condition is known as a cerebral venous sinus thrombosis (CVST).

These conditions are linked to low levels of blood platelets, also known as thrombocytopenia, and the evidence we have is, at the moment, not sufficient to conclude with certainty whether these adverse events are indeed caused by the vaccine or not.

As of Wednesday night, seven cases of DIC and 18 cases of CVST were reported out of almost 20 million vaccinated people. She said such cases were not identified in large clinical trials.

Dr Straus said PRAC will continue to gather more information on these conditions, including additional studies.

Speaking at the EMA’s briefing, head of the agency Dr Emer Cooke said the vaccine’s benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.

Because the EMA cannot “definitively” rule out a link between these cases and the vaccine, Dr Cooke said the committee has recommended raising awareness of the possible risks. This should be done, she said, by including details in product information so that healthcare professionals and people who are vaccinated will be able to “spot and mitigate any possible side effects”.

At a European level, additional investigations are to be launched to understand more about these rare cases and the EMA is conducting targeting observational studies.

“When you vaccinate millions of people it’s inevitable that rare or serious instances or illnesses will occur in the time immediately following vaccination,” Dr Cooke said yesterday.

Our role in the EU regulatory system is to rapidly detect these incidents and investigate whether there may be a link to the vaccine or whether they are the result of illnesses which occur by chance close in time to the vaccination.

“We are permitted to ensure that any new suspected adverse reactions are rapidly investigated to support decisions based on science, which can then support competence in vaccines which is so important in dealing with this devastating pandemic that we are facing, and we remain fully mobilised to ensure our public health.”