New Omicron-specific vaccine from Moderna approved by UK regulator

New vaccine is a ‘sharpened tool in our armoury’ to fight against Covid, says Dr June Raine, chief for the UK medicines regulator

An Omicron-specific Covid vaccine developed by Moderna has been approved for use in the UK after trials showed promising results.

The “next generation” coronavirus booster jab, which may only need administering once a year, has been approved for use in adults.

Known as mRNA-1273.214, the dose is an updated version of the Moderna vaccine which is already in use for first, second and booster doses, and will be the first dose approved in the UK to target Omicron and the 2020 strain of the virus.

The Medicines and Healthcare products Regulatory Agency has granted the use of the booster vaccine, called Spikevax, for people aged 18 and older. The UK is the first country to approve its use.

Moderna’s chief medical officer, Dr Paul Burton, previously said that the new jab could boost a person’s antibodies to such high levels that it may only be needed annually.

MHRA chief executive, Dr June Raine, described the new booster as “a sharpened tool in our armoury” to protect the UK against Covid-19.

In June, Moderna said early clinical trials on 437 people had shown the jab led to an eight-fold jump in the levels of Omicron-specific “neutralising” antibodies compared to people who had not received a booster.

The vaccine, which Moderna has said is its lead candidate for an autumn booster programme, also worked well when compared with a shot of Moderna’s original vaccine.

“We are delighted with the MHRA’s authorisation of Spikevax... This represents the first authorisation of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the Covid pandemic,” said Stéphane Bancel, chief executive officer of Moderna.

The MHRA said that the vaccine’s side effects are the same as those seen in the original Moderna booster dose and were typically mild.

Dr June Raine said: “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.”

Before the vaccine can be used in the UK, the government’s Joint Committee for Vaccinations and Immunisations would have to recommend its use.

Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, an independent body sponsored by the DHSC to advise ministers on the safety, efficacy and quality of medicinal products, said the vaccine was safe to use.

Prof Pirmohamed said: “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.”

He added that since coronavirus is “continually evolving in order to evade the immunity provided by vaccines” constant updates to the jabs are needed.

Prof Pirmohamed added that a recent paper in the Lancet medical journal suggested that coronavirus vaccines have prevented up to 20 million deaths in their first year of use.

Last month, the UK Health Security Agency announced everyone over 50 would be offered a Covid-19 booster vaccine and flu jab in autumn under plans to tackle winter demand.

The news comes as the NHS published its plan to tackle pressures on healthcare services this winter, revealing ambitions to increase bed capacity by 7,000.

The plan warned that even in “optimistic” predictions the NHS is likely to face significant demand for respiratory beds.