MHRA approved Covid-19 Vaccine Janssen after meeting the required safety, quality and effectiveness standards
Janssen single-shot Covid-19 vaccine approved in UK. (Credit: Pete Linforth from Pixabay.)
Janssen has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for its single-shot Covid-19 vaccine for use in individuals aged 18 years and above.
Covid-19 Vaccine Janssen is the fourth one to be authorised by the UK regulator and is the first to offer protection against Covid-19 with a single dose.
MHRA is supported by independent scientific advice from the Commission on Human Medicines (CHM) and its Covid-19 expert working group.
The vaccine has been approved after meeting the required safety, quality and effectiveness standards, said the UK regulator.
MHRA chief executive June Raine said: “We have undertaken a thorough review of the conditional marketing authorisation application submitted by Janssen, including the information on quality, safety and effectiveness.
“I am pleased to confirm today that this authorisation 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.
“We are continually monitoring all Covid-19 vaccines in use once they have been approved to ensure that the benefits in protecting people against the disease continue to outweigh any risks.”
Developed by Johnson & Johnson’s pharmaceutical business Janssen, the vaccine leverages the same Viral Vector technology as in the Oxford-AstraZeneca vaccine.
In the Phase 3 Ensemble trial, the vaccine has shown 85% effectiveness in preventing Covid-19 disease, related hospitalisation and death and has met expected safety standards.
Janssen’s single-shot covid-19 vaccine has already been authorised by the World Health Organization (WHO), the US FDA and the EMA.
Last month, the use of the vaccine was halted in the US, South Africa and the EU, after reports of rare blood clots in people who took the jab.
The temporary halt was lifted, and the vaccine was rolled out in the EU after EMA review, and in the US following CDC and FDA Decision.
Furthermore, Britain has reduced its order for the Janssen Covid-19 vaccine to 20 million doses from 30 million as the company has warned of uncertainty over its supplies to Europe, reports Reuters.