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The Cabinet approved an advance purchase agreement for 875,000 doses of the Covid-19 vaccine produced by Moderna.
The doses are expected to be delivered early in the new year, as soon as there is approval from the European Medicines Agency.
Ireland is already enrolled in four other vaccines.
The European Medicines Agency (EMA) has said it will hold an extraordinary meeting on December 29 “at the latest” to consider emergency approval for a Covid-19 vaccine developed by BioNTech and Pfizer.
“If the data presented is strong enough to conclude on the quality, safety and effectiveness of the vaccine, the EMA … will conclude its evaluation during an extraordinary meeting scheduled for December 29 at the latest,” said the regulator of the UE in a statement.
The EMA also plans to decide before January 12 whether to approve the vaccine being developed by Moderna.
Meanwhile, a spokesperson for the European Commission said it is likely to grant final authorization for the launch of the Covid-19 vaccines days after the EU drug regulator approves them.
“It will probably be a matter of days. The aim is to do it quickly,” the spokesperson told a news conference, adding that the exact date depends on possible authorizations from the EMA.
Under EU regulations, the EMA recommends authorization of a drug or vaccine and the EU Commission authorizes it on the basis of scientific advice from the EMA, after consultation with the 27 EU states.
Pfizer and BioNTech previously announced that they had formally applied for conditional EU approval for their jab, following a similar request in the United States.
The companies said their candidate, BNT162b2, could be launched in the European Union this month.
“If the EMA concludes that the benefits of the candidate vaccine outweigh its risks in protecting against Covid-19, it will recommend granting a CMA (Conditional Marketing Authorization) that could allow the use of BNT162b2 in Europe before the end of 2020,” they said. . in a joint return.
In their quest for a European launch, the partners are side by side with rival Moderna, which has also submitted a request to the EU regulator to recommend conditional approval of its launch.
Effective immunization is considered the main weapon against the pandemic, which has claimed more than 1.4 million lives.
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About 50 potential vaccines are being tested on volunteers around the world.
US pharmaceutical company Pfizer and Germany’s BioNTech reported final trial results on November 18 showing that their candidate vaccine was 95% effective in preventing Covid-19, with no major safety concerns, increasing the likelihood of approval in United States and Europe from December.
Any authorization in the EU and the US will be “conditional” or for “emergency use”, respectively, which means that developers are obliged to continue testing and provide more testing results as they emerge.
The European submission completes the so-called ongoing review process, which began with the EMA on October 6.
Dr. Anne Moore of the UCC Department of Biochemistry has said that now that Moderna and Pfizer / BioNTech have formally submitted their full data packages to the EMA, she will examine her findings.
Speaking on RTÉ’s Today with Claire Byrne, he said “the regulator will now look at it and decide if it is what the companies say it is.”
Dr. Moore said that if the EMA gives approval to companies for their vaccine to be used in the population, the regulator may decide that it can only be used in specific populations. For example, if the vaccine was not tested in pregnant women or children, then it would not be given to these groups, as there would be no data on its safety on how well it works.
She said the EMA agency process “is the most rigorous process you can have” because these are independent experts who want to protect the public when it comes to safety and how well these products work.
Dr Moore said, “They will really address the risk of using them, and any of those risks, they will define what those risks are and how those risks should be mitigated.”
“I don’t think anyone would have imagined that we would have a vaccine ten months after knowing the sequence of the virus.”
The Moderna and Pfizer / BioNTech vaccines are based on a new technology that uses mRNA (messenger ribonucleic acid) to deliver genetic material to the body that causes human cells to create a protein from the virus.
This trains the immune system to be ready to attack if it encounters the new coronavirus.
But Moderna’s vaccine can be stored long-term at -20 ° C, while Pfizer’s requires -70 ° C.
Pfizer and BioNTech have previously said they expect to make up to 50 million doses of their vaccine globally this year, and up to 1.3 billion doses by the end of 2021.
Additional reporting: Mary Regan
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