The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has granted authorisation to Janssen ’s single-dose Covid-19 vaccine for adults aged 18 years or older.
The authorisation comes after the vaccine met the required standards of safety, quality and effectiveness. The MHRA’s decision was analysed and recommended by the independent Commission on Human Medicines.
Approximately 20 million doses of the vaccine were obtained via the government’s Vaccine Taskforce for all four nations that are part of the UK. The initial shipment of the doses is anticipated to reach the UK later this year.
The vaccine had demonstrated overall effectiveness of 67% in preventing Covid-19 and 85% effectiveness in averting severe disease or hospitalisation.
It can be stored at fridge temperatures ranging between 2-8°C, facilitating easy distribution to care homes as well as various locations in the UK.
In a statement, the UK government said that a vaccination drive is underway to inoculate all adults by the end of July of this year.
MHRA chief executive Dr 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.
“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.”
The government is communicating with the manufacturers to enhance distribution across its existing vaccine programme and also plans for a possible booster drive later this year.
Currently, the Janssen vaccine is being analysed for safety and effectiveness as a third booster dose in the UK’s Cov-Boost study.
Led by University Hospital Southampton NHS Foundation Trust with £19.3m funding from the UK government, the trial was launched to assess the effect of a third booster dose of seven different Covid-19 vaccines on patients’ immune responses.
Updated advice for the Janssen vaccine will be submitted by the Joint Committee on Vaccination and Immunisation before the vaccines are made available in the UK.
In February this year, the US Food and Drug Administration issued Emergency Use Authorization to the vaccine.