Vaccines regulator would take AstraZeneca Covid-19 jab if offered it

People should still take the AstraZeneca Covid-19 vaccine if offered it, despite the first Irish case of a rare blood clot in a vaccinated person this week, the head of the State's medicines regulator has said.

Dr Lorraine Nolan, chief executive of the Health Products Regulatory Authority (HPRA), said the AstraZeneca vaccine had already saved thousands of lives from Covid-19. She estimated the risk of the unusual blood clot on the brain, which is possibly linked to the vaccine, at one in 200,000.

The “hugely overwhelming benefits of the vaccine” outweigh the risk from the blood clot that has been detected in just 86 people out of 25 million people who have received the jab, she said.

The vaccine’s protection from severe disease and hospitalisation has been “hugely positive”.

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As regulator, Dr Nolan said she appreciated people’s concerns about the AstraZeneca jab but as a 52-year-old woman – fitting the type of profile of person in whom the rare blood clotting has been detected – she would have no hesitation about being vaccinated with it.

“I would absolutely take this vaccine if it was offered,” she said in an interview.

The HPRA is investigating the medical history of a 40-year-old Dublin woman who this week became the first Irish case of cerebral venous sinus thrombosis (CVST) following vaccination with AstraZeneca to be reported to the State’s medicines watchdog.

The woman, who works in health services, is recovering and was discharged from the Mater in Dublin on Friday after a week in hospital. She experienced severe headaches and swelling of the face following vaccination with the AstraZeneca jab.

The regulator is checking for any link to the vaccine, while the National Immunisation Advisory Committee (NIAC) has been consulting with EU counterparts on whether to change the guidance on use of the vaccine in light of a new EU finding of a possible link to the blood clotting.

‘Special interest’

Dr Nolan has described the first reported Irish diagnosis as a “case of special interest”.

HPRA officials plan to contact the woman’s doctors and possibly the woman herself, with her consent, “to get a much more complete picture” and to ensure the accuracy of the reported case.

Until this week, there were 18 reported cases of side effects involving blood clotting following vaccination with the AstraZeneca but the Dublin woman was the first involving the type of blood clotting that has led other countries to restrict the use of the vaccine in certain age groups.

Dr Nolan said the HPRA “feeds regulatory advice” into NIAC but that it weighs up other factors such as public health advice and infection rates in deciding whether to restrict vaccine use.

She encouraged people, particularly younger people, to accept the AstraZeneca jab if offered, despite the reported case of the rare blood clot in the brain that the EU regulator, the European Medicines Agency, concluded this week could be possibly linked to the vaccine.

“If you don’t get vaccinated when you are offered it, you have absolutely no protection at all against Covid-19,” Dr Nolan said.

"Tens of thousands of younger people already in Ireland have got Covid. Some have suffered very severe disease and we are also seeing that young people, even with mild Covid, are suffering with the effects of 'Long Covid' so vaccination is the best way to protect yourself."

The blood clot cases in younger people might be explained by the bias in the AstraZeneca vaccine being given mostly to younger people and healthcare workers, who tended to be younger, she said.

Key role

The British-Swedish vaccine, developed by scientists at the University of Oxford, forms a key part of the Government’s vaccine rollout over the coming months, accounting for about a fifth of the projected four million vaccines to be administered in April, May and June.

“This vaccine really has a hugely important place in vaccination programmes and it definitely continues to be the case that the benefits outweigh the risks,” said Dr Nolan who has a staff of 50 people working on pre-authorisation of vaccines and another 40 involved in safety monitoring.

Medicines regulators would need “high levels of data” to establish whether the vaccine was the cause of the rare blood clotting, she said, and the low number of cases meant there still wasn’t enough evidence at this stage to rule out a link to the vaccine definitively.

“It could take more time because of the level of data that is needed,” she said. “I think it is moving as fast as it possibly can do.”

Policies on use of the AstraZeneca Covid-19 vaccine around Europe:

Austria: no restrictions
Belgium: temporarily restricted to over-55s for one month
Croatia: no restrictions
Cyprus: no restrictions
Denmark: suspended for all ages since March pending local studies
Estonia: over 60s only
Finland: over 65s only
France: over 55s only
Germany: over 60s only
Greece: over 30s only
Hungary: no restrictions
Italy: recommended for over 60s only, but not prohibited
Luxembourg: no restrictions
Malta: no restrictions
Netherlands: over 60s only
Poland: no restrictions
Portugal: over 60s only
Romania: no restrictions
Slovenia: no restrictions
Spain: temporarily suspended for under 60s
Sweden: over 65s for now, assessing evidence
United Kingdom: over 30s

• Naomi O'Leary