Pharmaceutical company Johnson & Johnson is to resume deliveries of its one-shot Covid-19 vaccine to the European Union after the European Medicines Agency (EMA) confirmed its benefits outweighed the risks of blood clots as a very rare side effect.
The vaccine leaflet is to be updated to include information on the diagnosis and treatment after the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed eight reported cases of unusual blood clots combined with low platelets among over seven million people who received the jab in the United States.
It is likely to be several days before the National Immunisation Advisory Committee (Niac) will issue advice on the use of the Johnson & Johnson vaccine and the potential for spacing out between doses.
Addressing an Oireachtas committee after the EMA announcement, Niac chairwoman Prof Karina Butler said it was awaiting further data from the European agency which may impact decisions on restricting access to specific age groups for some vaccines, and from the UK on dose intervals.
This would be studied, along with projections on supplies of other vaccines and the potential impact of any decision on the wider programme, before recommendations were made to Government.
On Monday, the National Public Health Emergency Team said it would not change its advice on extending the interval between doses of the Pfizer and Moderna vaccines until there was clarity on the Johnson & Johnson shot.
Asked about the matter on Tuesday, Prof Butler said spacing out shots allowed to get “some vaccine into more people”, but that it could also favour the emergence of variants, and had to be balanced as it “will necessarily lengthen the time to get everybody fully vaccinated”
“There may be a point that is reasonable that is a benefit without compromise,” she said.
In a statement following the EMA announcement, Paul Stoffels, chief scientific officer at Johnson & Johnson, said: “We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment.
“We strongly believe in the positive benefits of our single-shot, easily transportable Covid-19 vaccine to help protect the health of people everywhere and reach communities in need globally.”
EMA chief Emer Cooke said that vaccines would play a vital role in bringing down Covid-19 rates at a time when infections are surging worldwide and recorded deaths have topped three million.
“These vaccines play an immensely important role in combating this pandemic,” Ms Cooke said. “These vaccines are going to prevent hospitalisation and death from Covid-19.”
In a statement on Tuesday afternoon, the EMA said: “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 vaccine Janssen in preventing Covid-19 outweigh the risks of side effects.
“The cases reviewed were very similar to the cases that occurred with the Covid-19 vaccine developed by AstraZeneca.”
The EMA’s conclusion upholds its prior approval of the Johnson & Johnson vaccine earlier this year, and the regulator did not recommend a new restriction of the use of the vaccine for particular age groups.
Nevertheless, national regulators within the EU are free to make their own recommendations and in the case of AstraZeneca several chose to limit the use of the vaccine for older age groups, who are less at risk of clots and more at risk of severe Covid-19.
“Use of the vaccine during vaccination campaigns at national level will take into account the pandemic situation and vaccine availability in individual member states,” the EMA said.
The eight cases studied by the EMA involved a rare combination of unusual blood clots and low platelet levels in the blood and were all in people aged under 60, mostly women. The conditions involved included cerebral venous sinus thrombosis, splanchnic vein thrombosis, and arterial thrombosis, and one case was fatal, the EMA said.
“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia,” the EMA said in a statement.
The Health Products Regulatory Authority said it was “engaging with Niac and the Department of Health on this matter” and that monitoring would continue.
The Johnson & Johnson vaccine is crucial to inoculation efforts of EU member states which are due to receive 55 million doses by the end of June.
The Republic had been planning to receive about 600,000 doses of the Johnson & Johnson vaccine by the end of June.
