The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine today.
The MHRA has announced that the vaccine meets the ‘expected’ standards of safety, quality and effectiveness, with the independent Commission on Human Medicines (CHM) having also reviewed this decision and endorsed it.
The authorisation was supported by data from J&J’s Phase III ENSEMBLE trial, which demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared to placebo.
The results also showed that the vaccine was 85% effective in preventing severe disease across all regions studied, and also demonstrated protection against COVID-19-related hospitalisation and death, 28 days after vaccination.
The J&J vaccine can be stored at standard refrigerator temperatures – between 2 °C and 8 °C – which makes it ‘ideal’ for distribution to care homes and other locations, the Department of Health and Social Care (DHSC) said in a statement.
The UK’s Vaccine Taskforce has already secured 20 million doses of the J&J vaccine, with the initial deliveries expected to arrive ‘later this year’, although a specific date has not been revealed by the DHSC.
Initially, the Vaccines Taskforce secured 30 million doses of the vaccine last year, although this amount has been amended due to the ‘unprecedented scale and pace’ of the UK’s vaccination programme, the DHSC 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 four safe and effective vaccines approved to help protect people from this awful virus,” said Health and Social Care Secretary Matt Hancock.
The J&J COVID-19 vaccine has also been approved by the European Medicines Agency (EMA), as well as the Food and Drug Administration (FDA) and World Health Organization (WHO).