AstraZeneca vaccine now limited to over-60s as those who got first dose must wait an extra month for second jab

The Oxford AstraZeneca vaccine is being limited to people over 60 years, the National Immunisation Advisory Committee (NIAC) confirmed this evening.

It said the decision was taken in light of the outcome of the recent investigation by the European Medicines Agency (EMA).

The decision will come as a major blow to the Government's vaccine rollout, as AstraZeneca was to make up around a fifth of doses with a target of having 80pc of the population vaccinated by June.

In a further move it said people under 60 without a very high risk or high-risk medical condition who have already had a first dose should have the scheduled interval between doses extended from 12 to to 16 weeks to allow further assessment of the benefits and risks as more evidence becomes available.

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.

A number of EU states and other countries have issued revised advice regarding this vaccine. NIAC has consulted widely with EU colleagues, specialists in blood clotting and HIQA for input to these recommendations.

It said the benefits versus the risks of this vaccine may vary by age and as alternative Covid-19 vaccines are available in Ireland.

The recommendations said:

Any authorised Covid-19 vaccine, including AstraZeneca, is recommended for those aged 60 years and older including those with medical conditions with very high or high risk of severe Covid-19 disease.

AstraZeneca is not recommended for those aged under 60 years including those with medical conditions with very high or high risk of severe Covid-19 disease.

A second dose of AstraZeneca should not be given to anyone who developed unusual blood clots with low platelets after the first dose.

Advice for those who have received a first dose of AstraZeneca is:

• Those aged 60 and older should receive their second dose 12 weeks later as scheduled.
• Those aged under 60 years with a very high risk or high-risk medical condition should receive their second dose 12 weeks later as scheduled.
• Those aged under 60 years without a very high risk or high-risk medical condition should have the scheduled interval between doses extended to 16 weeks to allow further assessment of the benefits and risks as more evidence becomes available.

NIAC chair Prof Karina Butler said: “All the authorised Covid-19 vaccines - Pfizer, Moderna and AstraZeneca, and the newly approved Janssen - are highly effective in preventing hospitalisation and severe Covid-19 disease. Vaccination with Vaxzevria Covid-19 AstraZeneca vaccine is highly effective and substantially reduces the risk of severe Covid-19 disease across all age groups.

“NIAC realises the need to balance the significant benefits of a national vaccination programme with the very rare risk of these reported 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. As the risk/benefits of Vaxzevria Covid-19 AstraZeneca vaccine may vary by age and as alternative Covid-19 vaccines are available NIAC has revised the recommendations for use of this vaccine.

“In developing these recommendations, NIAC is informed by the available scientific evidence and the risk/benefits of the vaccines. New evidence will be reviewed once available and any further required recommendations will be notified to the Department of Health.”

Prof Butler concluded: “We strongly encourage everyone to accept the Covid-19 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.”

In response to the decision, AstraZeneca said reviews from the regulatory authorities in the EU and UK have reaffirmed the vaccine offers a high level of protection from Covid and that 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,” it said in a statement. “In addition the World Health Organisation last week noted that, whilst concerning, the events under assessment are 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.”

“AstraZeneca has worked closely and quickly with regulators to implement changes to the product information and understand the epidemiology and possible mechanisms that could explain these extremely rare events.

“We will continue to collaborate with the NIAC in order to provide all available data to inform their decisions.”

Online Editors