Janssen coronavirus (COVID-19) vaccine authorised by UK medicines regulator
Janssen's single-dose COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
Government has secured 20 million doses for all of UK
Doses expected to be available from later this year
The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced that the COVID-19 Vaccine Janssen meets the expected standards of safety, quality and effectiveness. The independent Commission on Human Medicines (CHM) has reviewed the MHRA’s decision and endorsed it.
Earlier this year, the single-dose vaccine was shown to be 67% effective overall in preventing COVID-19 infection and 85% effective in preventing severe disease or hospitalisation.
The vaccine can be stored at fridge temperatures, between 2 and 8 degrees, making it ideal for distribution to care homes and other locations across the UK.
Through the UK’s Vaccine Taskforce, 20 million doses of the vaccine have been secured for all 4 nations of the UK and first deliveries are expected to arrive from later this year.
The vaccination programme continues at pace and remains on track to offer a jab to all adults by the end of July.
Health and Social Care Secretary Matt Hancock said:
“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 4 safe and effective vaccines approved to help protect people from this awful virus.
“As Janssen is a single-dose vaccine, it will play an important role in the months to come as we redouble our efforts to encourage everyone to get their jabs and potentially begin a booster programme later this year.”
As with all vaccines, the government is in regular contact with the manufacturers, including exploring how best to optimise supply across the current programme and preparing for a potential booster programme from later this year. Janssen’s COVID-19 vaccine is part of the Cov-Boost study to assess its safety and effectiveness as the third dose of a potential booster programme.
Alongside this, the government is working with the devolved administrations to ensure the vaccine is deployed fairly across the UK.
The Vaccine Taskforce originally secured 30 million doses of the Janssen vaccine last year, based on the predicted clinical need at the time. With the UK’s COVID-19 vaccination programme continuing at an unprecedented scale and pace, the government has decided to amend its original order to 20 million.
The Joint Committee on Vaccination and Immunisation (JCVI) will submit updated advice for the Janssen vaccine before doses become available.
The company continues to explore a 2-dose regimen of their vaccine. The single-dose regimen has also been authorised by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the World Health Organization (WHO).
The government is preparing for a booster programme based on clinical need and will publish further details in due course. The final policy will be informed by advice from the JCVI and take into account the results of clinical trials.
Vaccine Deployment Minister Nadhim Zahawi said:
“The Janssen vaccine will be another weapon in our arsenal to beat this pandemic.
“We are doing everything we can to vaccinate all adults as quickly as possible and I encourage everybody to come forward for a jab as soon as they are eligible.”
Vaccinated people are far less likely to get COVID-19 symptoms. Vaccinated people are even more unlikely to get serious COVID-19, to be admitted to hospital, or to die from it, and there is growing evidence that vaccinated people are less likely to pass the virus to others.
Through the government’s Vaccine Taskforce, the UK has secured early access to over 500 million doses of 8 of the most promising vaccine candidates, including: BioNTech/Pfizer, Oxford/AstraZeneca, Moderna, Janssen, Novavax, GSK/Sanofi, Valneva and CureVac.
The latest data from PHE’s real-world study shows the vaccines are already having a significant impact in the UK, reducing hospitalisations and deaths, saving more than 13,200 lives and preventing more than 39,700 hospitalisations in England up to 13 May.
PHE analysis also shows that individuals who receive a single dose of the Oxford/AstraZeneca vaccine have approximately 80% lower risk of death against the B.1.1.7 coronavirus variant originating in Kent and a second dose of the vaccine can provide 85% to 90% protection against symptomatic disease. Protection against death from the Pfizer/BioNTech vaccine rises from approximately 80% after one dose to 97% after 2 doses against the Kent variant.