Janssen’s one-shot COVID vaccine approved by MHRA
pharmafile | May 28, 2021 | News story | |
The MHRA has approved the use of Janssen’s one-shot COVID-19 vaccine in the UK, becoming the fourth jab approved for use.
The government have ordered 20 million doses of the vaccine which are expected to arrive later this year.
The jab, COVID-19 Vaccine Janssen, is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
Dr Mohamed Lockhat, Medical Director of Infectious Diseases & Vaccines at Janssen UK, said: “The MHRA authorisation of our single-dose COVID-19 vaccine marks another important step forward in the global effort to end the COVID-19 pandemic. This has only been made possible by the significant contributions from study participants, site investigators, and our research and development teams.”
The approval of the vaccine is based on data from the Phase III Ensemble study, evaluating the safety and efficacy of the one-shot jab in preventing moderate to severe COVID-19 in patients over 18 years old.
The data from the primary efficacy analysis showed that COVID-19 Vaccine Janssen was generally well tolerated and demonstrated 67% reduction in symptomatic COVID-19 disease 14 days after vaccination. Similar results were seen from 28 days after vaccination, in participants who received the vaccine in comparison to participants given the placebo.
The vaccine was 85% effective in preventing severe disease across all regions studied and showed reduction of COVID-19 related hospitalisation from 14 days after vaccination.
In a statement, Johnson & Johnson said they will make their one-shot vaccine available on a not-for-profit basis for emergency pandemic use.
The Conditional Marketing Authorisation permits the supply and use of COVID-19 Vaccine Janssen in the UK, while more data are gathered and while the company files for a full license with the MHRA.
The vaccine has already been authorised by the EMA, FDA, US, and the WHO.
Kat Jenkins
