This is the fourth Covid-19 vaccine to be authorised by the UK’s independent regulator and is the first to be approved for protection against the Covid-19 with a single-dose, reports Asian Lite Newsdesk
The Johnson & Johnson single-dose Covid-19 vaccine has been approved in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said on Friday.
This is the fourth Covid-19 vaccine to be authorised by the UK’s independent regulator and is the first to be approved for protection against the Covid-19 with a single dose.
“We have undertaken a thorough review of the conditional marketing authorisation application submitted by Janssen (part of Johnson & Johnson), including the information on quality, safety and effectiveness. I am pleased to confirm today that this authorisation has been granted,” MHRA Chief Executive June Raine said in a statement.
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“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,” Raine added.
The MHRA also obtained independent scientific advice from the Commission on Human Medicines (CHM) and its Covid-19 Expert Working Group.
The MHRA approval authorises 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, the statement reads.
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The MHRA is thought to have held back from early approval of the vaccine after concerns were raised in the US about a link to extremely rare blood clots, similar to those seen in few people having the Oxford-AstraZeneca jab. Earlier, Health Secretary Matt Hancock said that that almost half, and possibly three-quarters, of all new coronavirus cases in the country are of the B.1.617 variant.
Addressing a press conference at Downing Street, Hancock said: “We always expected cases to rise as we rolled out the roadmap, we must remain vigilant.”