Pharmaceutical Technology

Novavax wins FDA emergency approval for updated Covid-19 vaccine

The US regulatory agency has also approved updated versions of Moderna and Pfizer / BioNTech’s Covid-19 vaccines in the past two weeks.

Novavax has joined its peers and received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the updated version of its Covid-19 vaccine, NVX-CoV2705.

The EUA allows for the updated vaccine use in individuals 12 years and older. In the month, the US regulatory agency approved and granted EUAs to two updated mRNA vaccines, namely Moderna’s Spikevax and Pfizer / BioNTech’s Comirnaty. Both mRNA vaccines were approved for use in aged 12 and above and were granted EUA for use in children aged six months to 11 years.

Novavax’s updated vaccine includes a monovalent component against the Omicron variant JN.1 strain of SARS-CoV-2. The company’s CEO John C Jacobs said: “Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1."

The updated Covid-19 vaccine approvals follow the June FDA's Vaccines and Related Biological Products Advisory Committee meeting unanimous vote to recommend a monovalent JN.1-lineage vaccine composition. The committee also advised the Covid-19 vaccine manufacturers that the new 2024-2025 formula of the vaccines should be monovalent JN.1 vaccines.

The demand for Covid products has seen a huge decline over the past year. Pfizer and Moderna were hit hard by the sales decline. Pfizer’s revenue declined by 42% in 2023, compared to the previous year, forcing the company to institute cost-saving measures of $1bn by the end of last year and an additional $2.5bn this year. Moderna’s drop in revenue was equally as stark, with its full revenue for 2023 coming to just $6.8bn, down 64.8% from $19.3bn recorded in 2022.

Pfizer and BioNTech are also developing a combination mRNA vaccine for treating influenza and Covid-19. However, the combination therapy failed to meet one of its two primary endpoints in a Phase III trial (NCT06178991).

In May, Novavax signed a $1.2bn licensing agreement with Sanofi for its adjuvanted Covid-19 vaccine. The deal grants Sanofi global commercialisation rights to the vaccine except in countries such as India, South Korea, and Japan where Novavax already has existing partnerships in place.