Open access article
The first single-dose COVID-19 vaccine has been approved for use in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
Johnson & Johnson’s Janssen vaccine — an adenoviral vector vaccine, the same type as the Oxford/AstraZeneca vaccine — is the fourth COVID-19 vaccine to be given regulatory approval in the UK. It has been approved for use in people aged 18 years and over. Decisions on whether the vaccine should be given to pregnant or breastfeeding women should be made in consultation with a healthcare professional.
The vaccine is not expected to be available for use until later in 2021.
June Raine, chief executive of the MHRA, said in a statement on 28 May 2021 that the agency had undertaken a “thorough review” of the conditional marketing authorisation submitted by Janssen, including the information on quality, safety and effectiveness.
During the approval process, the MHRA also obtained independent scientific advice from the Commission on Human Medicines and its COVID-19 expert working group.
“This is encouraging news for the public and the healthcare sector. We now have four safe and effective vaccines approved to help protect us from COVID-19,” said Raine.
“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 National Institute for Biological Standards and Control, part of the MHRA, is carrying out independent batch release checks on all of the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards, and will do so for the Janssen vaccine.
On 20 April 2021, the European Medicines Agency’s safety committee concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for the Janssen vaccine, after reviewing four cases of blood clots and low platelets among vaccine recipients in clinical trials and the vaccination programme in the United States. However, the committee also concluded that these events should be listed as “very rare side effects” of the vaccine.