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Johnson & Johnson vaccine submitted for EU approval 'really welcome news' - Donnelly

The Health Minister Stephen Donnelly says it is 'really welcome news' that a coronavirus vaccine ...
Jack Quann
Jack Quann

21.26 16 Feb 2021


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Johnson & Johnson vaccine...

Johnson & Johnson vaccine submitted for EU approval 'really welcome news' - Donnelly

Jack Quann
Jack Quann

21.26 16 Feb 2021


Share this article


The Health Minister Stephen Donnelly says it is 'really welcome news' that a coronavirus vaccine being developed by Johnson & Johnson has been submitted for approval to the European Medicines Agency (EMA).

Ireland has an Advance Purchase Agreement for 2.2 million doses of the drug.

The EMA says it could make a decision on the single-shot vaccine by the middle of next month.

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However, this is assuming the data relating to its efficacy, safety and quality are comprehensive and robust.

The Janssen drug has been shown to be 66% effective against COVID-19.

Johnson & Johnson is the parent company of Janssen, both of which have Irish operations.

The EMA says it will examine the drug 'under an accelerated timetable'.

If the EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend granting a conditional marketing authorisation.

The European Commission will then issue a decision on whether to green light it in all EU states 'within days.'

This is the fourth drug to be put forward for approval - following BioNTech/Pfizer, Moderna and AstraZeneca.

The Janssen vaccine only requires a single dose to be effective, unlike all others approved so far, and can also be kept in a standard fridge.

AstraZeneca in over-85s

It comes as vaccination of those over-85 is underway, although the AstraZeneca vaccine is not being used for that age group.

However, the Tropical Medical Bureau has suggested it is time to re-assess this decision.

Its medical director Dr Graham Fry earlier told Newstalk Breakfast: "I think it is one of the vaccines that we can get out there very easily by comparison to the other alternatives – and that is one of the issues, we need to get this vaccine out to people as quickly as possible".

"There is no question about the safety of the Oxford vaccine, that is not the issue. The issue is whether it works to the same extent in those older age groups – the 65s, 70-plus age group.

"The answer is, maybe it doesn’t, but it still gives some actual cover for the majority of people and the more we can get this out there, the quicker, the better."

astrazeneca A nurse prepares a dose of the AstraZeneca COVID-19 vaccine at a hospital in Lyon, France. Picture by: Olivier Chassignole, Pool via AP

While Professor Luke O'Neill has suggested Ireland will be 'awash' with vaccines by April or May.

The Trinity Immunologist said there is room for Ireland to be a 'bit more bold' in terms of the vaccination programme, and it has to be the Government's 'mission one'.

"You've got to get enough supply in, and mobilise all the vaccinators - GPs, pharmacists, everyone" Prof O'Neill told The Pat Kenny Show.

"I would predict in four weeks' time... we'll have a huge amount of vaccination will have happened in this country and in the community, which would be tremendous.

"The Government has to have this as mission one."

Main image: Picture by: Frank Hoermann/SVEN SIMON/DPA/PA Images

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