HSE plans to catch up on AstraZeneca rollout following EMA approval

A vial of the Oxford/AstraZeneca coronavirus vaccine. File picture

The AstraZeneca Covid-19 vaccine is “safe and effective” – and its benefits outweigh any risks, the European Medicines Agency (EMA) has concluded.

However, the European regulator said it “cannot rule out definitively” a link between “a small number of cases of rare and unusual but very serious blood clotting disorders” and the vaccine, though investigations were ongoing.

The Health Service Executive said it plans to catch up on the 5,000 people in Group 4 who missed out last week when the Astrazeneca vaccine rollout was paused.

Three more deliveries from AstraZeneca are expected this month, but HSE chief Paul Reid said as of Thursday the amounts are not yet confirmed.

Emer Cooke, EMA executive director, said this situation was not unexpected, adding that “when you vaccinate millions of people” such reports of rare events will occur.

The EMA has concluded there is no overall increase in the risk of blood clots with the vaccine, and in fact it is likely to reduce the overall risk of clots.

Ms Cooke told the press briefing: “The committee has come to a clear scientific conclusion.

“This is a safe and effective vaccine. Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.

“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events, or blood clots.” 

It is this type of clot that led Germany to halt its rollout of the AstraZeneca vaccine, prompting other countries across Europe, including Ireland, to follow.

Ms Cooke said the AstraZeneca vaccine “demonstrated at least 60% efficacy in clinical trials in preventing coronavirus disease and, in fact, the real world evidence suggests that the effectiveness could be even higher than that”.

She told a press conference: “We are very much aware that some (EU) member states have paused vaccinations, waiting for EMA’s outcome of a review.

“Given that thousands of people in the EU die every day (from Covid) – 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.”

An extraordinary meeting of the health regulator's safety committee was held this afternoon.

The use of the vaccine was paused last Sunday after reports from Norway of four incidents of serious blood clotting in adults who were inoculated.

A number of other European countries, including Germany, France, Italy, Spain and Denmark also suspended the use of the vaccine.

The EMA has maintained a view that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

On Tuesday, the EMA’s executive director, Emer Cooke, said that there was no current indication that the Oxford/AstraZeneca’s coronavirus vaccine was the cause of the “very rare” reported blood clots.

Earlier today, a senior director for the World Health Organisation (WHO) said the benefits of the AstraZeneca vaccine “far outweigh the risks”.

Dr Hans Kluge, WHO regional director for Europe, said it was “routine to signal adverse events” but reiterated that people should “have confidence” in the protection given by vaccines.

“The Covid-19 vaccination will not reduce death or illness from other causes,” Dr Kluge told a press briefing on Thursday.

“As of now we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors.

“At this point in time, the benefits of the AstraZeneca vaccine far outweigh its risk and its use should continue to save lives.”