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28/07/2021

Pharma company with strong Limerick links seeks EU approval for Covid-19 vaccine

Limerick company applies for EU Covid-19 vaccine approval

Johnson and Johnson employs more than 1,300 people in vision care at the National Technology Park in Plassey | PICTURE: LIAM BURKE/PRESS22

JOHNSON and Johnson has applied for authorisation to the European Medicines Agency (EMA) to use a single shot Covid-19 vaccine.

The firm, which employs more than 1,300 people in vision care at the National Technology Park, applied for the green light from the EMA this afternoon.

It’s hoped that it could be ready for use in the fight against Covid-19 by the middle of March – and delivered to patients by the summer.

In a statement, the regulator announced it had received an application for for conditional marketing authorisation. This will be processed more quickly than usual as Johnson and Johnson 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 Johnson and Johnson spokesperson confirmed the news, adding doses could be delivered by summer.

The EU has procured 200 million doses of the vaccine from Johnson and Johnson in advance with the option to buy 200 million more, putting Ireland in line for at roughly 2.2 million doses at least based on the side of its population.

The vaccine only needs a single dose and can be stored in normal refrigerators rather than requiring deep-frozen logistics chains – something which is seen as a huge benefit.

However, trials have indicated the vaccine is slightly less effective then the two-shot Pfizer jab. It’s efficacy level is 72% in America, with a larger international trial showing a lower efficacy rate of around two-thirds.

It gave 85% protection against severe illness and complete protection against hospitalisation and death among the trial groups.

"Johnson and Johnson embarked on the global effort to combat the Covid-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic," said Alex Gorsky, chairman of the board of directors and the chief executive of the pharmaceutical giant.

"We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere," he added.

Paul Stoffels, the vice-chairman of the executive committee and the firm's chief scientific officer added: "A one-shot vaccine is considered by the World Health Organisation to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe Covid-19 disease and prevention of Covid-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of Covid-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities."

The firm has spent over $1bn in research and development on the vaccine.

It added it is committed to bringing an affordable Covid-19 vaccine on a not-for-profit basis for emergency pandemic use, pending regulatory authorisations.

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