THE EU’S MEDICINES regulator has granted authorisation for the use of the Johnson & Johnson one-dose Covid-19 vaccine in people aged 18 and over.
The is the fourth coronavirus vaccine given the green light by the European Medicines Agency (EMA) following the approval of the Pfizer/BioNTech, Moderna and Oxford/AstraZeneca vaccines.
The EMA’s human medicines committee concluded that the vaccine data was “robust and met the criteria for efficacy, safety and quality”.
Because of its one-dose regime and the fact that it can be stored at fridge temperatures – as well as high efficacy results in trials – governments across the EU have been eagerly awaiting its approval as they struggle to roll-out vaccinations on a large scale.
“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said the executive director of the EMA, Emer Cooke.
This week HSE CEO Paul Reid said 3.8 million vaccine doses are expected to be delivered to Ireland in Q2, including 600,000 Johnson & Johnson doses.
This week, however, Reuters reported that Johnson & Johnson has told the European Union it is facing supply issues that may impact on its ability to deliver the level of vaccines expected in the EU in the second quarter of this year.
It is reported that the company told the EU that issues with the supply vaccine ingredients and equipment means it was “under stress” to meet its goal of delivering 55 million doses by the end of June. An EU official said the company had stated it was not impossible to meet the goal, but it showed caution.
Clinical trial results found that this vaccine was effective at preventing Covid-19 in people aged 18 and up.
The trial, which involved over 44,000 people, found a 67% reduction in the number of symptomatic Covid-19 cases after two weeks in people who received this vaccine compared to people given a placebo.
The side effects experienced by people who received this vaccine “were usually mild or moderate and cleared within a couple of days after vaccination”, the EMA said.
The most common side effects were pain at the injection site, headache, tiredness, muscle pain and nausea. These are similar side effects experienced in the other Covid-19 vaccines approved in the EU.
- Additional reporting by Orla Dwyer.
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