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The situation that has arisen around the Oxford-AstraZeneca Covid-19 vaccine is “not unexpected” when vaccinating millions of people, the head of the European Medicines Agency (EMA) has said.
A number of countries have followed Ireland in temporarily suspending the use of the vaccine, as a precaution following a small number of people developing blood clots after receiving doses in Norway.
Speaking on Tuesday, EMA executive director Emer Cooke said “there is no indication that vaccination has caused these conditions”.
The EMA, which last week began an investigation into reports of blood clotting in people who had received the vaccine, meets on Tuesday to review the evidence and is due to announce a decision on Thursday.
The European regulator was reviewing data around the small number of cases of blood clots, which were “very rare” and needed to be evaluated “very carefully,” she said.
Ms Cooke, who is Irish, said the regulator was working to establish “is this a real side effect to the vaccine or is it a coincidence”.
She said the EMA was still “firmly convinced” that the benefits of the Covid-19 vaccine, in preventing hospitalisation and deaths from the virus, outweighed the risk of side effects.
Sweden, France, Germany, Italy and Spain also temporarily suspended use of the vaccine. Irish health officials are working on contingency arrangements incase the EMA decides to pause or vary the existing authorisation.
Meanwhile, the former president of the Irish College of General Practitioners (ICGP) has said the public need to be reassured the Oxford-AstraZeneca Covid-19 vaccine was “fully safe”.
Dr Mary Favier, former ICGP president, said the decision by the National Immunisation Advisory Committee (Niac) to suspend use of the vaccine in Ireland, awaiting further information, was the correct one.
Dr Favier, who sits on the National Public Health Emergency Team (Nphet), said the blood clots being reported in Norway appeared to be “exceptionally rare”.
For five cases of the blood clots to have been reported in such a short period of time was “very unusual,” so it merited investigation, she told Newstalk Breakfast.
Dr Favier said the EMA was “highly expert” at such reviews, and the use of vaccines were reviewed all the time.
While pausing use of the AstraZeneca vaccine had been the correct approach, the fear of a resulting vaccine hesitancy or scepticism was a real issue, she said.
For Niac the decision had been a case of “damned if you do and damned if you don’t,” but it was better to be cautious and careful, she said.
The vaccine had been seen as a “game changer” in speeding up the rollout, as it is not required to be stored at complex ultra-low temperatures, such as the Pfizer-BioNTech or Moderna vaccines.
Health officials have indicated the pause of its use will mean a delay for thousands of vulnerable patients, including those with cancer, chronic diseases, the immunocompromised, and those with Down syndrome.
The first round of vaccinations for this cohort will now likely not be completed until well into April, officials expect.
Separately, the Garda are preparing a significant policing operation for St Patrick’s Day, ahead of a number of anti-lockdown protests planned for Dublin city centre.
The protests come as public health officials warn progress in suppressing the spread of the virus has stalled, with the numbers of new cases increasing in the last 10 days.
Sinn Féin leader Mary Lou McDonald appealed for people not to gather in protests similar to Reclaim the Streets demonstrations in Britain, following the killing of Sarah Everard.
Speaking on Tuesday, she said there would be time to protest after Covid-19, and “we do not want to see another spike in numbers”.
A left wing feminist group, Rosa, has planned a protest in Dublin city centre on Tuesday, against gender and police violence, with a similar protest planned in Cork on Thursday.