On December 2, the United Kingdom became the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine for use.
Northern Ireland’s Department of Health said in a statement issued on December 2: “The approval for the Pfizer/BioNTech coronavirus vaccine has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA). A number of other vaccines are at various stages of development while another is currently being considered by MHRA.
“It is planned to roll-out vaccination from this month, with the JCVI (Joint Committee on Vaccination and Immunisation) determining which population groups will receive the vaccine first. Completion of roll-out will take up much of 2021.
“Health and social care workers – including care home staff - will be amongst the first priority groups as will care home residents. Further groups will then be added to the programme throughout 2021 based on age and clinical vulnerability factors."
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Northern Ireland’s Minister for Health Robin Swann said: “My department has plans and preparations in place to begin the roll-out. This is a hugely significant day for Northern Ireland and the news we were hoping for before Christmas. My thanks go to all those who have worked so hard to make it possible.
“It needs to be remembered that the vaccination process will be a major and long-running logistical exercise. Our rate of progress will depend on available supplies that will be distributed as part of a UK-wide programme.
“We will all need to be patient and allow the priority groups to receive their vaccination first.
“This is not the end of the Coronavirus nightmare but it should represent the beginning of the end.”
This is a hugely significantly day. My Department has the plans and preparations in place. There will still be difficult days ahead, and people must not let their guard down, but there are brighter days ahead.
— Robin Swann MLA : #StopCovidNI (@RobinSwannMoH) December 2, 2020
Minister Swann added: “I need to urge everyone to remain ultra-vigilant in the months ahead as each of us patiently await our turn. It is essential that we keep taking all the steps required to protect each other and stop the virus spreading.
“This does not mean that restrictions on our daily lives will be able to disappear anytime soon. There is still a very tough winter ahead for our health service and society.
“We need to think of vaccination as a long trek to freedom.
“Let’s all of us across Northern Ireland carry each other through this winter, doing all we can to ensure as many people as possible get to enjoy Christmas and live to see a better New Year.”
On December 2, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement: "The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
"The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020.
"This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.
"The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
"The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality."
The first #COVID19 vaccine for the UK, developed by @pfizer/@BioNTech_Group has today been given approval for use following a thorough review carried out by the MHRA.
For more info: https://t.co/V481nNZxuL pic.twitter.com/CAD9TVyCtJ
— MHRAgovuk (@MHRAgovuk) December 2, 2020
Dr. June Raine, MHRA Chief Executive, said: "We have carried out a rigorous scientific assessment of all the available evidence of quality, safety, and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.
Dr. Raine added: "Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly, and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data."
The UK's Department of Health and Social Care said on December 2: "The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable."
It added: "The vaccine will be made available across the UK from next week."
The approval of the Pfizer vaccine in the UK comes less than a month after Albert Bourla, the chairman and CEO of Pfizer, said that his company's vaccine "was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
"The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it."
The news about the COVID-19 vaccine approval in the United Kingdom was revealed the day after Northern Ireland surpassed 1,000 coronavirus-related deaths in the region.
Both Arlene Foster, the First Minister of Northern Ireland, and Michelle O’Neill, the Deputy First Minister of Northern Ireland, welcomed the news on Tuesday but urged caution for the people of Northern Ireland.
Foster said the news is “an early Christmas present for the people of the United Kingdom.” She added that “we will work collectively as an Executive to deal with the large scale logistical challenge to roll the vaccine out.”
— Arlene Foster #We’llMeetAgain (@DUPleader) December 2, 2020
O’Neill said in a video “as of today, we can see a light at the end of the tunnel:”
This is a landmark day as #COVID19 vaccine approved.
Phase 1 will roll-out across the North shortly.
Those over 80yrs, care homes & staff, & our remarkable health & social care workers - are a priority and will be the first to receive vaccine.
Hope will prevail. pic.twitter.com/zPCS8EtTqb
— Michelle O’Neill (@moneillsf) December 2, 2020
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