The vaccine has been approved after meeting the required safety, quality and effectiveness standards.
The COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on Human Medicines, which reviewed in depth all the data to ensure this vaccine meets the required standards of safety, quality and effectiveness.
This is the third COVID-19 vaccine to be approved for use by the MHRA and is the second mRNA vaccine (the Pfizer/BioNTech vaccine approved in December 2020 is also an mRNA vaccine).
MHRA Chief Executive Dr June Raine said:
Professor Sir Munir Pirmohamed, Chair of the Expert Working Group of the Independent Commission on Human Medicines said:
This Moderna vaccine works by injecting a small part of the COVID-19 virus’ genetic code, which triggers an immune response and creates antibodies in the human body able to fight the virus. The dosage for this specific vaccine requires two doses to be given. It is recommended to administer the second dose 28 days after the first. It is approved for use in people 18 years and over, and it can be used by pregnant and breastfeeding women following a discussion with their healthcare provider on the benefits and risks. It can be stored at -20°C for up to six months.
The National Institute for Biological Standards and Control, part of the agency, is carrying out independent batch release on all of the approved vaccines, to ensure that every batch meets quality standards, and it will do so for the Moderna COVID-19 Vaccine.
In line with the other COVID-19 vaccines that have been approved, the Moderna vaccine should only be considered for use in pregnancy when the potential benefits outweigh any potential risks for the mother and baby. Women should discuss the benefits and risks of having the vaccine with their healthcare professional and reach a joint decision based on individual circumstances. Women who are breastfeeding can also be given the vaccine after a discussion with their healthcare professional.
Anyone with a previous history of allergic reactions to the ingredients of the vaccine should not receive it, but those with any other allergies such as a food allergy can have the vaccine.