Covid-19: State regulator reports serious clotting events linked to AstraZeneca jab

Fewer than five reports of clotting with low platelets post-jab, regulatory authority says

Chief Medical Officer Dr Tony Holohan has said that he has "real hope and confidence" about the continued easing of Covid-19 restrictions, but has warned that the country is "not yet where we need to be." Video: RTÉ

 

Serious blood clotting events in people who received the AstraZeneca vaccine have been reported by the State’s medicines regulator for the first time.

The Health Products Regulatory Authority says it has received “a small number” (under five) reports of blood clotting-type events combined with low platelets in people who received the jab.

In a vaccine safety update, the authority said these were among a total 29 reports of blood clotting events of all types that it had received.

“In these cases, the individuals concerned sought medical attention, received specialist medical care and are reported to be responding well to treatment.”

Of the report of clotting without low platelets, the authority says the vast majority describe clots typically seen in the general population, such as deep vein thrombosis and pulmonary embolism, and many of those affected had risk factors for clotting. Similar types of clotting – but without low platelets – have been observed with mRNA vaccines, it points out, with 41 such reports received.

A total of 6,616 reports of suspected side effects have been notified so far, arising from the administration of more than 1.15 million vaccine doses.

The authority says the vast majority of side effects are mild to moderate in nature, and that the benefits of Covid-19 vaccines continue to outweigh the risks.

Rare side effect

Two weeks after it concluded that unusual blood clots were a rare side effect of the AstraZeneca vaccine, the European Medicines Agency (EMA) is expected to publish updated European data on Friday.

In Ireland, use of the AstraZeneca vaccine was restricted to over-60s following the EMA decision, thereby further disrupting the overall vaccine rollout.

This was compounded when similar issues arose with the Johnson&Johnson vaccine, a decision on the use of which is due from the National Immunisation Advisory Committee (Niac).

There was disappointment and some anger in Government circles that Niac did not respond to pressure to produce recommendations on the use of the vaccine, before the weekend. Ministers had hoped that the Health Service Executive would be cleared to begin use of Johnson&Johnson shots early next week, but Niac indicated on Thursday that it would not be making any recommendations before next week.

Sources said it was a clear rebuff to Government, with a number criticising Niac for a lack of urgency. One Minister described the delays as “madness”.

Approval expected

Government sources still expect Niac to approve use of the vaccine, which Ireland expects to get 600,000 doses of before the end of June and 2.1 million before the end of the year.

Chief medical officer Dr Tony Holohan, who last night returned to the National Public Health Emergency Team (Nphet) press briefing for the first time in two months, said he expected Niac to provide its advice early next week and that there would not be unnecessary delays to the programme.

HSE chief executive Paul Reid had earlier said that if Niac restricted the use of the Johnson&Johnson vaccine it would “significantly” affect the rollout of the State programme.

New Covid-19 cases on Thursday hit a three-week high of 617, but public health officials hope the increase – driven by school outbreaks, workplace clusters and infections linked to funerals and wakes – will be transient.

Dr Holohan said he still thought “we’re moving in the right direction”. He said there are “reasons for real hope” that Ireland “can confidently move to a point” where an easing of restrictions can be recommended.