UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster

Regulatory NewsRegulatory News
| 15 August 2022 | By Ferdous Al-Faruque 

(Source: Moderna)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s bivalent COVID-19 booster vaccine for adults. The vaccine’s composition is split evenly between components targeting the original 2020 SARS-CoV-2 strain and those targeting the Omicron BA.1 variant.
On 15 August, UK regulators announced they’ve approved the new Moderna mRNA vaccine, known as mRNA-1273.214, that they expect will be even more effective in targeting currently circulating variants of the virus. MHRA is the first regulatory agency to approve the bivalent vaccine, which is also being considered by the European Medicines Agency (EMA), Health Canada, and Australia’s Therapeutic Goods Administration (TGA).
The US Food and Drug Administration has called for the inclusion of an Omicron component in updated vaccines for the fall and winter seasons, though it has called for the bivalent vaccines to include a BA.4/5 component. Last month, Moderna secured a contract with the US government to supply up to 300 million doses of Moderna’s bivalent booster containing the Omicron BA.4/5 strain, known as mRNA-1273-222. The agency’s recommendation follows overwhelming thumbs-up from its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to modify the boosters to include an Omicron component, though the committee was not asked to select specific subvariants. (RELATED: FDA calls for inclusion of Omicron BA.4/5 in future boosters, Regulatory Focus 30 June 2022)
“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives,” said MHRA Chief Executive June Raine in a statement. “What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve.”
The agency based its decision to approve the bivalent vaccines on clinical trial data that showed it triggers a strong immune response to both the original 2020 SARS-CoV-2 strain and the newer BA.1 Omicron strain. The BA.4 and BA.5 strains have become the dominant strains around the world, and based on exploratory analysis of the clinical data, MHRA said the bivalent vaccine was also found to generate a good immune response to those strains.
MHRA said the side effects seen with the bivalent vaccine were the same as those observed for the original Moderna booster vaccine which were typically mild and self-resolving, and the agency said it has not identified any serious safety concerns with the new vaccine.
Munir Pirmohamed, Chair of the Commission on Human Medicines, which advises MHRA on medical products, said it has independently reviewed the bivalent vaccine and agrees with the agency’s decision to approve it.
“The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines,” he said in MHRA statement. “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.”
In June, the EMA said it has started a rolling review of the Moderna bivalent booster vaccine to determine its safety and efficacy. The rolling review is meant to speed up the review of the vaccine so the EMA’s own human medicines committee (CHMP) can decide sooner whether to approve it for its member states.


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