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Hind Al Soulia - Riyadh - Saudi Gazette report
LONDON — The Johnson & Johnson single-dose coronavirus vaccine has been approved for use in the United Kingdom by the country's UK's Medicines and Healthcare products Regulatory Agency (MHRA).
This is the fourth COVID-19 vaccine to be authorized by the UK’s independent regulator and is the first to be approved for protection against COVID-19 with a single dose, the UK government said in a press statement.
The vaccine, developed by Johnson & Johnson's pharmaceutical arm Janssen, has been shown to be 67 percent effective overall at preventing moderate to severe COVID-19, with some studies suggesting it also offers complete protection from admission to hospital and death.
Commenting on the approval, Dr. June Raine, MHRA chief executive, said: "We have undertaken a thorough review of the conditional marketing authorization application submitted by Janssen, including the information on quality, safety and effectiveness. I am pleased to confirm today that this authorization has been granted."
"This is encouraging news for the public and the healthcare sector. We now have four safe and effective vaccines approved to help protect us from COVID-19," he added.
The MHRA also obtained independent scientific advice from the Commission on Human Medicines (CHM) and its COVID-19 Expert Working Group.
Professor Sir Munir Pirmohamed, chair of the UK's independent Commission on Human Medicines, said: "The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the MHRA’s evaluation of the application submitted by Janssen and are pleased to say that we have given the vaccine a positive recommendation."
"This is yet another win for the vaccination program, which has saved thousands of lives so far," Pirmohamed added.
The National Institute for Biological Standards and Control, part of the Agency, is carrying out an independent batch release on all of the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards, and will do so for the COVID-19 Vaccine Janssen.
The MHRA approval authorizes the use of the vaccine in people aged 18 and over. The decision on whether to use the vaccine in pregnant or breast-feeding women should be made in consultation with a healthcare professional after considering the benefits and risks. People who have an allergy to one of the components of the vaccine listed in section 6.1 of the Patient Information Leaflet should not receive the vaccine.
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