London, United Kingdom (UK)- The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a COVID-19 vaccine made by Moderna that targets both the original strain and the Omicron variant.
It is now up to the Joint Committee on Vaccination and Immunization (JCVI) to decide whether it will, as expected, be used in the planned autumn booster programme, expected to begin in September.
The booster dose, known as Spikevax bivalent Original/Omicron, contains 25 micrograms of Omicron vaccine and 25 micrograms of the original COVID-19 vaccine.
“I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain.
The first generation of COVID-19 vaccines being used in the UK continues to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.
We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this will include the vaccine approved today,” said Dr. June Raine, chief executive of the MHRA.
In addition, Stephane Bancel, the CEO at Moderna, described the vaccine as a next-generation COVID-19 vaccine which will play an important role in protecting people in the UK from COVID-19 over the upcoming winter.
“We are delighted with the MHRA’s authorization of Spikevax Bivalent Original/Omicron, our next generation COVID-19 vaccine.
This represents the first authorization of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic. This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months,” said Bancel.
Prof. Sir. Munir Pirmohamed, the chair of the Commission on Human Medicines, which independently reviewed the vaccine data, said the commission agreed with the MHRA’s decision.
“The Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality and effectiveness and agrees with the MHRA’s decision. The virus, Sars-CoV-2, is continually evolving in order to evade the immunity provided by vaccines.
This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine,” said Prof. Pirmohamed.
