New Flu and Updated COVID Vaccines Greenlighted by Europe

Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for two vaccines: Fluad (surface antigen, inactivated, adjuvanted) and Flucelvax (surface antigen, inactivated, prepared in cell cultures) for active immunization against influenza. Together, the vaccines can immunize children from 2 years and older, adults, and those with comorbidities — including cardiovascular disease, diabetes, and obesity — against influenza.

The CHMP also recommended a revised composition for Nuvaxovid, an already approved vaccine that targets the JN.1 variant of the SARS-CoV-2 virus. The news follows recommendations by the European Medicines Agency Emergency Task Force to update COVID-19 vaccines for the 2src24/2src25 vaccination campaign.

The committee further recommended updating the composition of Bimervax, a similarly approved vaccine that targets the Omicron XBB.1.16 SARS-CoV-2 subvariant. 

All four recommendations are now pending approval from the European Commission. 

Both Fluad and Flucelvax are administered by injection from pre-filled syringes and contain hemagglutinin and neuraminidase surface antigens that have been purified from 3 inactivated strains: two A subtypes (H1N1 and H3N2) and one B type (Victoria lineage). 

They induce the production of neutralizing antibodies against viral hemagglutinin to protect against influenza viruses. Unlike Flucelvax, however, Fluad also contains the adjuvant MF59C.1, which enhances the immune response and, accordingly, the vaccine’s efficacy. 

Fluad 

The CHMP’s decision on Fluad follows a phase 3 randomized, controlled trial that compared the immunogenicity and safety of Fluad, an adjuvanted quadrivalent inactivated influenza vaccine, with a non-adjuvanted standard dose of Fluarix Tetra. A total of 2src44 adults aged 5src-64 years old were recruited for the trial and given either one of the vaccines. 

Ultimately, Fluad produced a stronger immune response in participants with medical comorbidities and those who had not recently been vaccinated against influenza. Safety data matched that from previous studies of MF59-adjuvanted seasonal and pandemic influenza vaccines. The findings supported the use of Fluad for people aged between 5src-64 years old, and particularly those with comorbidities. 

The most frequent side effects of Fluad included pain and tenderness at the injection site, myalgia, headache, fatigue, and arthralgia. 

Flucelvax

Unlike Fluad, multiple randomized controlled trials show that Flucelvax can protect adults and children from 2 years of age against seasonal influenza. Results from multiple randomized controlled trials  demonstrate that Flucelvax reduces influenza risk by 54.6% and 69.5% among any circulating strains for those aged between 2-17 years old and 18 years and older, respectively.

It was more effective for vaccine-matched strains, reducing risk by 63.6% in those aged between 2-17 years, and 83.8% among those aged 18 and older. Rates of adverse effects varied among different age groups. However, common reactions included tenderness, erythema, pain, and headache. 

Detailed recommendations for both Fluad and Flucelvax will be described in the summary of product characteristics, which will be published in the European public assessment report in all official European Union languages. 

Nuvaxovid

The recommendation of an updated formula for Nuvaxovid comes after  non-clinical datathat showed the updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses such as KP.2.3, KP.3, KP.3.1.1, and LB.1. 

Data from clinical trials show that the vaccine’s most common side effects include vomiting, muscle pain, joint pain, injection site pain and tenderness, fatigue, and malaise. 

The adjuvanted 2src24-2src25 formula has been authorized for emergency use by the United States Food and Drug Administration for individuals aged 12 years and older. 

Bimervax

Bimervax is a COVID-19 vaccine for use among people aged 16 years and older. The vaccine contains a lab-produced protein that carries parts of the SARS-CoV-2 spike protein derived from the alpha and beta variants. It also contains an adjuvant. It can be used as a booster among people who have previously received an mRNA COVID-19 vaccine. 

The vaccine is currently not recommended for people younger than 16 years old. The vaccine has also not yet been studied in immunocompromised people or in pregnant or breastfeeding women. Common side effects to the currently approved version of the vaccine include pain at the injection site, headache, tiredness, and muscle pain. 

Annie Lennon is a medical journalist. Her writing appears on Medscape, Medical News Today, and Psych Central, among other outlets.