The AstraZeneca vaccine should not be given to people aged under 60, including patients that have medical conditions with very high or high risk of severe Covid-19 disease, the State's advisors on immunisation have recommended.
Any authorised vaccine, including AstraZeneca, is recommended for those aged 60 years and older, according to the National Immunisation Advisory Committee (Niac).
Niac's recommendation, which will force a substantial re-organisation of the State's vaccination rollout, is likely to be accepted by chief medical officer Dr Ronan Glynn and the Government.
Niac tonight updated its advice on the AstraZeneca vaccine in light of recent investigations by the European Medicines Agency (EMA). The EMA has added unusual clotting events with low platelet counts as very rare side effects to the vaccine product information. These rare events are estimated to occur between 4 and 10 in every 1 million people, one of whom may die.
In its recommendation for people who have already received one dose of the vaccine, Niac says a second dose should not be given to anyone who developed unusual blood clots with low platelets after the first dose. Those aged 60 and older should receive their second dose 12 weeks later as scheduled, as should under-60s with a very high risk or high risk medical condition.
Those under 60 without a very high risk or high risk condition will have the interval between their doses extended to 16 weeks to allow for further assessment of the benefits and risks of the vaccine, as more evidence becomes available.
Abundance of caution
Acting chief medical officer Dr Ronan Glynn said the change in advice was based on “an abundance of caution”.
“The cut-off could easily have been less than 60 but this was done for an abundance of caution,” he told briefing at the Department of Health.
He said it was difficult to be entirely clear what impact the change would have on the vaccine rollout.
“It will likely have an impact, but the extent of this remains to be seen.”
It was “not necessarily the case that this will have a material impact or delay on rollout”.
Dr Glynn said he appreciated there may be some vaccine hesitancy following the decision but he felt people would be reassured once they understood the reasons for the change.
Professor Karina Butler, chairperson of Niac, the significant benefits of a national vaccination programme had to be balanced against the very rare risk of the reported blood clot events.
“While this is an extremely rare condition, consideration must be given to the fact that it has a very high risk of death or severe outcome,” she said.
The risk-benefit equation for vaccination varies greatly with age, Prof Butler explained. A 60-year-old is 85 times more likely to die from Covid than to have a clotting event of any kind after vaccination. But this factor drops to 48 for 55-59 year-olds and 12 for 45-49 year-olds. People aged between 35 and 44 are six times more likely to die from Covid-19 and those aged between 20 and 34 two time more likely to die.
Dr Glynn said that “hopefully” the new recommendations would not have a significant impact on the rollout of the programme or on the further easing of restrictions in the coming period.
The HSE says all AstraZeneca Covid-19 vaccination clinics planned for tomorrow should be cancelled.
“Following full consideration of the updated guidance, the HSE will advise further in terms of wider implications for the administration of the vaccination programme,” it said.
Well-placed sources said it is expected that as many as 14,000 shots due forTuesday may need to be rescheduled. The State is currently working through the implications of the advice for the vaccine rollout.
Highly Effective
All authorised Covid-19 vaccines are highly effective in preventing hospitalisation and severe illness and death from this disease, Prof Butler said.
“Vaccination with the AstraZeneca vaccine is highly effective and substantially reduces the risk of severe Covid-19 disease across all age groups.
“We strongly encourage everyone to accept the vaccine they are offered. A high uptake of vaccine in every age group is needed if Covid-19 is to be controlled, so that public health restrictions may be safely removed,” Prof Butler said.
Responding to Niac’s recommendation, AstraZeneca said reviews by regulators in the EU and UK had shown its vaccine offers a high level of protection against Covid-19 and that these benefits continue to “far outweigh” the risks.
“Neither agency identified any risk factors, such as age or gender, or a definite cause for these extremely rare blood clotting events.”
The company also pointed out that the World Health Organisation last had noted that, whilst concerning, the events under assessment were extremely rare, “with low numbers reported among the almost 200 million individuals who have received the AstraZeneca Covid-19 vaccine around the world”.
“Of these 200 million people, real-world data has suggested thousands of deaths have been prevented.”
Johnson and Johnson
Elsewhere, it is understood the first consignment of the single-shot Johnson & Johnson vaccine will arrive into the State on Wednesday afternoon. Around 14,000 doses of the vaccine will be delivered.
AstraZeneca makes up around 20 per cent of anticipated doses to be delivered in the second quarter of this year, with some 813,000 due.
A decision will be needed be about which vaccine to give to the cohort who were supposed to have received AstraZeneca. The problem here is that most of the supplies of the Pfizer/BioNTech and Moderna vaccines are being used in the over-70s.
This leaves the 60 to 70 age-group as the one age cohort that could receive large amounts of AstraZeneca. There are about 400,000 people in this cohort, giving a requirement for 800,000 doses. Coincidentally, this is the amount of AstraZeneca doses due to arrive in Ireland this quarter.
But with this latest change being only the latest flip-flop in policy over the AstraZeneca vaccine, there is likely to be considerable consumer resistance from those due to receive this vaccine.
More than 120,000 vaccines doses were administered last week and this was due to increase to 180,000 this week, but this was before any changes in the advice on the AstraZeneca vaccine.
Significant impact
Dr Denis McAuley, the chair of the Irish Medical Organisation’s GP committee, said the impact of the anticipated change on the vaccine rollout will be significant. He estimated there are around 420,000 people aged between 70 and 80 in the State, with 813,000 AstraZeneca vaccines due in the next three months.
If AstraZeneca cannot be given to younger groups, it effectively means “there’s less vaccine available and more people to vaccinate”.
“It confuses an awful lot of things, really,” he said. The issue of second doses for those who have received a vaccine will also need to be addressed. Some 233,000 people have been given their first dose of AstraZeneca so far, and the decisions would be needed for those under 60 in this number. It must be decided whether they are given their second dose, whether a second dose from another manufacturer is given, or whether they are vaccinated with two entirely new shots.
Several EU countries have limited its use to only older people -as the clots have affected younger people - while the UK has confined it to those aged over 30.
