A next-generation Covid-19 booster jab targeting two strains of the virus has been approved for adult use in the UK.
The Medicines and Healthcare Products Regulatory Authority (MHRA) has originally approved the Modernas bivalent vaccine targeting both the Covid strain and the Omicron strain.
This dose, known as mRNA-1273.214, is an updated version of the Moderna vaccine already in use for the first, second and booster doses.
The UK was the first country to approve the jab and can be used in booster programs.
Modernas’ chief medical officer, Dr Paul Burton, previously said the new jab raises a person’s antibodies to high levels and may be needed every year.
Moderna CEO Stephane Bancel described the vaccine as the next-generation COVID-19 vaccine that will play an important role in protecting the British from COVID-19 during the winter.
Bancel said: We are delighted with the MHRA approval of Spikevax Bivalent Original/Omicron, our next-generation Covid-19 vaccine.
This marks the first approval of an omicron-containing bivalent vaccine and further underscores the commitment and leadership of UK public health authorities to end the COVID-19 pandemic.
This bivalent vaccine will play an important role in protecting people in the UK from Covid-19 as winter approaches.
Bancel adds that Zap has consistently demonstrated a broad immune response in clinical trials that is superior to other alternatives.
MHRA said vaccine side effects were the same as those seen with the original modder or booster dose and were generally mild.
Chief Executive Dr June Raine described the new booster as a sharp tool in the arsenal to protect the UK from COVID-19.
Dr. Raine said: I am pleased to announce the approval of the Moderna 2 booster vaccine, which has been shown in clinical trials to provide a robust immune response against the Omicron BA.1 variant and the original 2020 strain.
the story goes on
The first-generation Covid-19 vaccine used in the UK continues to provide critical protection against disease and save lives.
What this bivalent vaccine gives us is a sharp tool in our arsenal to help protect us from this disease as the virus continues to evolve.
We are developing a comprehensive safety surveillance strategy to monitor the safety of all Covid-19 vaccines approved in the UK, which will include those approved today.
A new Moderna coronavirus booster jab has been approved in the UK for use by people over the age of 18 (James Manning/PA).
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, an independent DHSC-backed body to advise ministers on the safety, efficacy and quality of medicines, said the vaccine is safe to use.
Professor Pirmohamed said: The Human Medicines Committee and the Covid-19 Vaccine Expert Working Group independently reviewed the data on safety, quality and effectiveness and agree with the MHRA’s decision.
He added that as the coronavirus continues to evolve, constant updates to the zaps are needed to avoid the immunity that vaccines provide.
Professor Pirmohamed said that the coronavirus vaccine prevented up to 20 million deaths in the first year of use, according to a recent paper in the Lancet Medical Journal.
According to Professor Stephen Evans, whether or not to use a jab in a UK booster program depends on factors including cost and clinical efficacy estimates.
A professor of pharmacodynamics at the London School of Hygiene and Tropical Medicine adds that the jab is based on the original moderna jab, which was developed to target the omicron.
The new Moderna vaccine can be used in additional programs after it has been approved for use in the UK (Jane Barlow/PA).
Professor Evans said: This vaccine contains two components. The first is the original Moderna Covid vaccine, which has very large clinical trial data and vast experience since its introduction in the UK and many other countries.
The second is a modification of the original vaccine that targets the new component, the Omicron variant of SARS-CoV-2.
Because these new components are similar to the original, MHRA was able to approve a vaccine based on antibody response rather than demonstrating infection prevention.
We now know from many studies that this antibody response (neutralizing antibody) can to some extent predict the clinical effect of infection prevention and consequent hospitalization or death.
Moderna also said it has completed applications for regulatory approval of Booster in Australia, Canada and the EU.
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