The drug regulator of U.K. has approved the Janssen’s single dose Coronavirus vaccine for emergency use
The Medicines and Healthcare products Regulatory Agency (MHRA), the drug regulator of United Kingdom (U.K.) today, i.e., Friday, May 28, 2021 approved the Janssen’s single dose Coronavirus (COVID-19) vaccine for emergency use.
U.K. has ordered 20 million doses of the vaccine, which is 85% effective in stopping severe illness from COVID-19 in trials. The vaccine will arrive later this year. It is the fourth COVID-19 vaccine to be approved by MHRA. The other three are AstraZeneca, Pfizer-BioNTech and Moderna vaccine.
As of now, U.K. has vaccinated more than 38 million people. The Janssen vaccine could be given to care home residents as a booster jab, ahead of winter season as it can be easily stored and transported at fridge temperatures.
Taking it to twitter, the Prime Minister of U.K. – Boris Johnson tweeted,
This is very welcome news and another boost to our hugely successful vaccination programme.
— Boris Johnson (@BorisJohnson) May 28, 2021
As we encourage everyone to get their jabs, the single-dose Janssen vaccine will play an important role in helping us protect people from the virus.
When you get the call, get the jab. https://t.co/t8nEOR7w4B
Confirming the approval, MHRA tweeted,
The @JanssenUK #COVID19 vaccine has been approved for use.
— MHRAgovuk (@MHRAgovuk) May 28, 2021
This is the first vaccine approved for protection against COVID-19 with a single dose in the UK.
MHRA experts have assessed the safety, quality & effectiveness of the vaccine.
Learn more: https://t.co/Lndwlw6QBn pic.twitter.com/4fDwO4qVg1
The MHRA undertook a thorough review of the conditional marketing authorisation application submitted by Janssen. It also checked on the information on quality, safety and effectiveness. The MHRA also obtained independent scientific advice from the Commission on Human Medicines (CHM) and its COVID-19 Expert Working Group.
The MHRA has approved the vaccine for people above 18 years of age. MHRA said that the decision on whether to use the vaccine to pregnant or breast-feeding women should be made in consultation with a healthcare professional. The U.K.’s Vaccine Committee – the Joint Committee on Vaccination and Immunisation (JCVI) will produce advice on exactly who should receive the Belgian-made vaccine in due course.
The vaccine uses the same technology as that of Oxford University – AstraZeneca but is considered to be more suitable for older adults than younger people. Meanwhile, people under 40 years of age, are being offered an alternative to AstraZeneca in the U.K because of a potential link to a type of rare blood clot in the brain. The U.S. is offering the vaccine to people over 18 years of age, after concluding that the benefits of the vaccine outweighed any risks.
The Janssen vaccine has already been approved by European Medicines Agency (EMA), the United States (U.S.) Food and Drug Administration (USFDA) and the World Health Organization (WHO).