A single-shot vaccine to prevent Covid-19 could be cleared for use in Ireland within weeks, after Johnson & Johnson applied for authorisation from the European Medicines Agency (EMA) on Tuesday.
The regulator announced it had received a request for a conditional marketing authorisation (CMA) which would be processed more quickly than usual as the company had already been submitting data on a rolling basis.
“The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust,” the EMA said in a statement.
“If EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend granting a CMA.”
A spokeswoman for Johnson & Johnson confirmed that the company had applied for authorisation for the single-shot vaccine, and said doses could be delivered by summer.
“If authorised, we expect to begin supplying vaccine doses to the European Union in the second quarter of 2021,” the spokeswoman said.
The EU has procured 200 million doses of the vaccine from Johnson & Johnson in advance with the option to buy 200 million more, putting Ireland in line for roughly 2.2 million doses at least based on the size of its population.
Because the vaccine requires only a single dose and can be stored in normal refrigerators rather than requiring deep-frozen logistics chains, it is seen as a potential gamechanger for vaccination campaigns.
Trials indicate that the vaccine is somewhat less effective than the first authorised mRNA vaccines, but is still highly successful at preventing hospitalisation and death.
Trials in the United States showed the vaccine had 72 per cent efficacy in preventing mild to moderate Covid-19 infections. But a large international trial conducted across three continents and covering multiple variants showed a lower efficacy rate of 66 per cent.
Nevertheless, it gave 85 per cent protection against severe illness and complete protection against hospitalisation and death among the trial groups.
