The European Medicines Agency has said the benefits of the Johnson & Johnson Covid-19 vaccine outweigh the risks.
Use of the company's one-dose vaccine was temporarily halted by US regulators last week after a small number of blood clots were reported.
Europe's drug regulator said it had found a possible link between Johnson & Johnson's Covid-19 vaccine and rare blood clotting issues in adults who had received the shot in the United States.
The EMA said its safety committee concluded that a warning about unusual blood clots with low blood platelets should be added to the vaccine's labels.
It said that it had taken into account all the currently available evidence, including eight reports from the US of serious cases of unusual blood clots. One had a fatal outcome.
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The EMA found that all instances had occurred in adults under 60 years, mostly women, within three weeks of vaccination, adding that all available evidence, including eight reports of cases in the United States, were part of its assessment.
It also said that most clots had occurred in the brain and abdomen, similar to AstraZeneca's vaccine, and reiterated that the vaccine's overall benefits outweigh risks.
The National Immunisation Advisory Committee will be examining the findings of the European Medicines Agency in relation to the Johnson and Johnson vaccine 'over the next day or so' according to its chair, Professor Karina Butler | Read more: https://t.co/XVjmD8l4o0 pic.twitter.com/MADK8fBRrk— RTÉ News (@rtenews) April 20, 2021
Concerns over the vaccine and that made by AstraZeneca have dampened hopes that vaccines could offer a swift end to the pandemic.
The EMA said there had been more than 300 cases worldwide of rare blood clotting incidents combined with low platelet counts after use of Covid-19 vaccines.
There were 287 occurrences with the AstraZeneca vaccine, eight with Johnson & Johnson's shot, 25 for Pfizer and five for Moderna, said Peter Arlett, Head of Data Analytics at the EMA.
Johnson & Johnson last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA inquiry.
The news from the European Medicines Agency that the overall benefit versus risk with the J&J jab remains positive will be welcomed by health officials in Ireland.
Ireland is due around 600,000 doses of the single dose vaccine between now and June.
Over 40,000 had been due tomorrow and the Health Service Executive will be looking to establish how soon the first batch will now come.
The National Immunisation Advisory Committee (NIAC) will meet and consider the recommendations and the evidence produced by the EMA, before making recommendations to the Deputy Chief Medical Officer.
It will include consideration of any information relating to different age groups.
Of the eight rare blood clot cases in the US examined by the EMA, all were in people under 60 and most involved women.
The Irish regulator, the Health Products Regulatory Authority (HPRA), said that revised product information for the Johnson & Johnson Covid-19 vaccine will be published by the EMA in the coming days and will be available on its website, www.hpra.ie.
It said the vaccine has not been used to date in Ireland.
The HPRA said it is engaging with NIAC and the Department of Health on the matter and will continue to participate in the EMA's coordinated safety monitoring of Covid-19 vaccines.
Johnson & Johnson said it was ready to resume rolling out the vaccine in Europe.