Moderna’s bivalent COVID-19 vaccine has been authorised by the US Food and Drug Administration (FDA) for adults aged 18 years and older.

The Emergency Use Authorisation (EUA) issued by the FDA is for a 50µg booster dose of the company’s BA.4/BA.5 Omicron-targeting COVID-19 booster.

The BA.4 and BA.5 strains are currently causing most cases of COVID-19 in the US and are predicted to circulate in the autumn and winter, the FDA reported.

The approval is based on preclinical data and clinical trial data available from a phase 2/3 study evaluating the company’s BA.1 Omicron-targeting bivalent booster candidate.

In the study, the booster met all primary endpoints, including offering a better antibody response against Omicron than a 50µg dose of the currently authorised booster in those who had not previously had Omicron. The booster also offered strong antibody responses against the Omicron subvariants BA.4 and BA.5 when compared to the currently authorised booster, regardless of age or prior infection status.

A phase 2/3 clinical trial of the booster is fully enrolled and currently underway, with initial data expected later this year, Moderna outlined.

In July, Moderna announced the advancement of two bivalent candidates for autumn based on different population health security strategies in different countries.

The Joint Committee on Vaccination and Immunisation (JCVI) has published its advice on which COVID-19 vaccines should be used in this year’s autumn booster programme.

For adults aged 18 years and over, the JCVI’s advised vaccines include Moderna’s mRNA (Spikevax) bivalent Omicron BA.1/original wild-type vaccine, and its mRNA (Spikevax) original wild-type vaccine.

The Pfizer/BioNTech mRNA (Comirnaty) original wild-type vaccine is also advised, and in exceptional circumstances, the Novavax Matrix-M adjuvanted wild-type vaccine (Nuvaxovid) when ‘no alternative clinically suitable UK-approved COVID-19 vaccine is available’, the JCVI stated.

The Pfizer/BioNTech mRNA (Comirnaty) original wild-type vaccine is the only vaccine the JCVI advises for people aged 12 to 17 years, and its paediatric formulation is the only advised for those aged five to 11 years old.

In its latest advice, the JCVI stated that offering a single type of booster vaccine throughout the duration of the autumn programme is preferable for simplicity of deployment.

The autumn booster campaign was due to include all those over the age of 65, but the programme has been expanded in response to the spread of the Omicron variant.

The JCVI noted that studies indicate the Moderna bivalent vaccine produces a ‘marginally higher’ immune response against some variants than the Moderna mRNA original ‘wild-type’ vaccine, but that ‘the clinical relevance of these small differences is uncertain’.

The World Health Organization (WHO), with the support of the Strategic Advisory Group of Experts (SAGE), has released an interim statement concerning COVID-19 vaccines in children and adolescents.

WHO refers to the global inequity in vaccine roll-out, with only 25% of older populations having received a complete primary series of COVID-19 vaccines in lower income countries – the very places where healthcare access is more limited.

To tackle this, WHO published an update of its COVID-19 vaccination strategy last month to increase vaccination targets to 100% of healthcare workers and the highest risk populations with both primary and booster doses, including older populations and those who are immunocompromised or have underlying conditions.

WHO recognised the benefits of vaccinating children and adolescents in terms of reducing the number of infections, hospitalisations, deaths and long COVID cases, as well as minimising disruption to education for children and for overall well-being, health and safety.

It is noted that vaccination that decreases SARS-CoV-2 transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools.

However, WHO stated that ‘the direct health benefit of vaccinating healthy children and adolescents is lower compared with vaccinating older adults due to the lower incidence of severe COVID-19 and deaths in younger persons’.

Valneva’s COVID-19 vaccine, VLA2001, has been recommended by the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) for adults aged 18 to 49.

The vaccine is not recommended for people aged 50 years and over, due to limited data on the immunogenicity of the vaccine in this age group. Similarly, there is no data on efficacy or safety for people below the age of 18 years, and vaccination of this age group is therefore not currently recommended.

Following administration of VLA2001, the spike protein of SARS-CoV-2 and other viral surface antigens stimulate both neutralising and other functional binding antibodies, as well as cellular immune responses directed against the spike and other surface proteins, which are thought to contribute to protection against COVID-19.

The recommendation is supported by a pivotal clinical immunogenicity study, which demonstrated that people 30 years and over who received VLA2001 produced more neutralising antibodies and had about the same seroconversion as people who received the Oxford/AstraZeneca recombinant COVID-19 vaccine following two doses of the vaccine.  Adults aged 18 to 29 who received the Valneva vaccine produced even more neutralising antibodies, following two doses of the vaccine.

WHO also recommended the use of a second booster dose for individuals at high risk of severe disease, administered four to six months after completion of the primary series.

Moderna’s COVID-19 booster vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The booster dose can be used in adults aged 18 years and over to protect against contracting COVID-19.

The MHRA’s authorisation is based on data from a phase 2/3 trial, which showed that mRNA-1273.214 met all primary endpoints. The trial showed a booster dose of mRNA-1273.214 increased neutralising geometric mean titres (GMT) against Omicron approximately eight times above baseline levels.

The booster dose also provided potent neutralising antibody responses against the Omicron subvariants BA.4 and BA.5 when compared against the currently authorised booster – mRNA-1273 – regardless of age or prior infection status.

The conditional authorisation is for mRNA-1273.214 – Spikevax Bivalent Original/Omicron – an Omicron-containing bivalent.

The Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine, containing mRNA-1273 – Spikevax – and a vaccine candidate targeting the Omicron subvariant of concern, BA.1.

The company is working with the Vaccines Taskforce, the UK Health Security Agency and the NHS to make the Spikevax Bivalent Original/Omicron vaccine available in the UK. Moderna has completed regulatory submissions for mRNA-1273.214 in the EU, Australia and Canada and anticipates further authorisations within the next month.