No indication AstraZeneca vaccine caused blood clots, says EMA director

Regulator reviewing data around ‘very rare’ cases after several countries suspend use of vaccine

Prof. Philip Nolan says that Ireland is in a similar situation to Halloween, 2020, where Covid-19 case numbers rose for about a week to 10 days due to increased social mixing. Video: RTÉ

 

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”.

“They have not come up in the clinical trials and they are not listed as known side events with this vaccine.

“In clinical trials, both vaccinated people and people who received the placebo have shown some very small number of blood clot developments.

“The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.”

The EMA, which last week began an investigation into reports of blood clotting in people who had received the vaccine, met 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.

The World Health Organisation has urged countries to continue using the AstraZeneca vaccine. Its global advisory committee on vaccine safety will hold a meeting on Tuesday.

Dr Soumya Swaminathan, WHO’s chief scientist, told a media briefing “we do not want people to panic”, as she said no association has been found so far between blood clots and Covid-19 vaccines.

Meanwhile, a representative of the Norwegian Medicines Agency, Dr Steinar Madsen, said Norway would make its own decision on the use of the AstraZeneca vaccine.

“We will look to what the EMA is doing and then make our own decision,” Dr Madsen told RTÉ radio’s News at One.

Dr Madsen outlined that there had been four “severe” blood clotting cases in Norway in young people, all aged under 50 and all healthcare professionals. Two of the patients had died and the other two were being cared for in the national hospital in Oslo.

The conditions were “extraordinarily rare” with the patients suffering low platelet counts, internal bleeding and clots.

The four patients were from different parts of Norway and their vaccines had come from different batches, he said. All four were “totally well” with no sign of disease.

Even the specialists in Oslo had never seen anything like this, he said. The only link was that they had all received the AstraZeneca vaccine, he said. They had all become ill within five to seven days of receiving their dose over a two-week span.

The Norwegian Medicines Agency thought it might take a few weeks to conclude their investigation into the vaccine and until there were “clearer answers” the AstraZeneca vaccine would not be used.

On the same programme, immunologist Prof Kingston Mills said the news from the EMA was reassuring.

Prof Mills added that he was hopeful the final report on Thursday would confirm there was no link between the vaccine and the blood clots.

The EMA would have to look at each case to see if there was a clinical link between the cases in Norway. Prof Mills said so far 17 million people had received the vaccine and of the “tens of thousands” involved in the clinical trials there had been only 37 reported “clotting events” which was no more than in the general population.

Coagulation experts were being brought in to assist the EMA in its review, he said and the main focus would be if the patients involved had underlying issues or if there was a consistent pattern.

No medicines or vaccines were without some side effects, he said. “It’s very likely that there won’t be a link.”

Meanwhile, the former president of the Irish College of General Practitioners (ICGP) said the public need to be reassured the Oxford-AstraZeneca 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.

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. – Additional reporting: PA