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Updated 21 minutes ago
The COVID-19 VACCINE developed by Pfizer / BioNTech has been recommended for use in the European Union, paving the way for people in Ireland to begin receiving the vaccine.
The decision was announced by the European Medicines Agency (EMA) at a press conference this afternoon.
The European Commission will now meet tonight to ratify this EMA recommendation.
In a statement, the EMA said it had completed a rigorous evaluation of the vaccine and that its analysis of the data had concluded “by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a conditional formal marketing authorization “.
EMA CEO Emer Cooke said: “Today’s positive news is an important step in our fight against this pandemic, which has caused suffering and hardship for many.
“We have achieved this milestone thanks to the dedication of scientists, clinicians, developers and trial volunteers, as well as many experts from all EU Member States.
Our comprehensive evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets the necessary quality standards. However, our work does not stop here. We will continue to collect and analyze data on the safety and efficacy of this vaccine to protect people who take it in the EU.
The EMA also said today that there is no evidence that the vaccine does not work against the new strain of Covid-19 reported in England.
Last week, the government said that granting a marketing authorization for the Pfizer / BioNTech vaccine today could mean that the first vaccines will be carried out in this jurisdiction before the new year.
The head of the vaccine working group, Professor Brian MacCraith, said that after approval, the first doses of the 2.2 million Pfizer / BioNTech vaccines allocated to Ireland are expected to take 7-10 days to deliver.
Source: EU Medicines Agency/Twitter
The first people to be vaccinated under the national strategy here will be long-term care home residents over the age of 65, followed by front-line healthcare workers in direct contact with patients.
Reacting to the news, Health Products Regulatory Authority executive director Lorraine Nolan said the expedited approval process would not compromise important standards to ensure the vaccine is safe and works effectively.
“There will be no lowering of the bar on this,” he said.
He added that the vaccines “will serve as an additional measure in our ongoing fight against Covid-19.”
.@EMA_News have recommended the granting of a conditional marketing authorization for #Vaccine for COVID-19 Comirnaty, developed by BioNTech / Pfizer. @TheHPRA Executive Director Lorraine Nolan describes the regulatory process and why vaccines are safe pic.twitter.com/C4ihUoEzQw
– Department of Health (@roinnslainte) December 21, 2020
“Other public health recommendations, including hand washing, wearing masks and social distancing, will continue to be vital in addressing this pandemic,” said Nolan.
The recommendation for approval of the vaccine by European authorities comes after regulators in the UK, US and Canada also approved the vaccine.
Data
In announcing its decision today, the EMA said that a very large clinical trial of the vaccine had found it to be effective in preventing Covid-19 in people 16 years of age and older.
The trial involved 44,000 people in total: half received the vaccine and the other half a placebo. The people at the trial didn’t know which one they were getting. The efficacy test was calculated from more than 36,000 who had no signs of previous infection.
The study showed a 95% reduction in the number of symptomatic Covid-19 cases in people who received the vaccine (eight cases of the 18,198 who received the vaccine developed symptoms of Covid-19).
This compared to people who received the sham injection (162 cases out of 18,325 had symptoms of Covid-19).
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The trial also showed an efficacy of around 95% in participants at risk for severe Covid-19, including those with asthma, chronic lung disease, diabetes, and high blood pressure.
The high efficacy was reflected in all genders, racial and ethnic groups.
The vaccine is given in two injections, at least 21 days apart. Reported common side effects were said to be mild to moderate, and people generally felt better within days of vaccination. They include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills, and fever.
The EMA said it will continue to monitor the safety and effectiveness of the vaccine as it is used in EU member states.
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