MHRA Approves Janssen Single Dose COVID-19 Vaccine

Tim Locke

May 28, 2021

A single-dose coronavirus vaccine from Janssen, part of Johnson & Johnson, has been approved for use in the UK by the medicines regulator MHRA. It will become the fourth vaccine to be rolled out in the UK.

The jab, called Ad26.COV2-S [recombinant], has been shown to be 67% effective overall at preventing moderate to severe COVID-19 compared with placebo..

The phase 3 ENSEMBLE trials suggested it gives 87% protection against severe disease.

It is approved for all over-18s but the JCVI hasn’t yet issued recommendations for use, and it may be restricted to older age groups, or used as a booster dose.

The vaccine can be stored for at least 3 months at normal refrigerator temperatures.

Blood Clots

There were concerns raised in the US over links to rare blood clots, and its use was paused for a time by the US FDA before officials said it was safe and effective for the vast majority of people.

In April, the European Medicines Agency said unusual blood clots in combination with low blood platelet levels were identified as avery rare side effect of the vaccine.

The MHRA said healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia after vaccination.

Use of the vaccine in pregnancy should only be considered when the potential benefits outweigh any potential risks to the mother and foetus.

Dr June Raine, MHRA chief executive, 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."

'Further Boost'

The UK had already ordered 20 million doses of the vaccine, which officials said could be useful for harder to reach groups who may not always book an appointment for a second dose.

Commenting via the Science Media Centre, Professor Arne Akbar, president of the British Society for Immunology, said: "Having a range of vaccines against COVID-19 is important in helping us defeat this pandemic, so news that the Medicines and Healthcare products Regulatory Authority (MHRA) has today approved a fourth COVID-19 vaccine for use in the UK is extremely welcome.

"The Janssen vaccine is a viral vector vaccine like the AstraZeneca/Oxford vaccine and works in a similar manner. The main difference between these two vaccines however is that the Janssen vaccine only needs to be given as a single dose.

“The UK has doses of the Janssen vaccine on order for delivery later this year, so while this approval won’t have an immediate impact on the UK’s COVID-19 vaccine rollout, it is reassuring to know that stocks of this vaccine will be delivered in due course.  The Janssen vaccine is part of an ongoing trial looking at the potential need for booster vaccine doses later in the year – the results of this will be important in determining how supplies of this vaccine can be best utilised when they arrive."

England's Health and Social Care Secretary Matt Hancock commented: “This is a further boost to the UK’s hugely successful vaccination programme, which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved to help protect people from this awful virus."


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