Novovax’s Omicron-targeting Covid-19 vaccine obtains WHO emergency listing
Novovax has been granted emergency use listing (EUL) by the World Health Organisation (WHO) for its updated form of the protein-based Covid-19 vaccine Nuvaxovid (NVX-CoV2373). The vaccine is approved for adults and children aged 12 years and above for active immunisation to prevent Covid-19. This EUL is based on non-clinical findings where the vaccine was shown to elicit functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants of the SARS-CoV-2 virus. As per an October update from the US Centers for Disease Control and Prevention (CDC), 99% of circulating SARS-CoV-2 variants are part of the XBB group of the Omicron variant. Under Novavax’s recombinant nanoparticle technology, the non-infectious spike protein acts as the antigen that primes the immune system to recognise the virus. This latest vaccine has been updated to incorporate the viral spike protein from the XBB.1.5 lineage of the Omicron variant. Novavax received full marketing authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for Nuvaxoid last month, based on data from two Phase III studies, the PREVENT-19 (NCT) trial undertaken in the US and Mexico and a Phase III study in the UK, and a Phase IIa/IIb trial in South Africa. Results from the trial indicated the safety and efficacy of the prototype vaccine for individuals aged 12 years and above, as well as safety and immunogenicity as a booster for patients aged 18 years and above. The US Food and Drug Administration (FDA) amended the emergency use authorisation of the vaccine to incorporate the 2023-24 formula last month, however the trade name Nuvaxovid has not been approved by the FDA. In the announcement accompanying the EUL, Novavax president and chief executive officer John Jacobs said: “The WHO emergency use listing of our updated protein-based non-mRNA Covid-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies such as UNICEF, thereby supporting equitable access to our vaccine around the world.” Novavax reported revenues of $19.8bn in 2022, according to Novavax’s 2022 Annual report. This is an increase of 73% over FY 2021, mainly attributed to Nuvaxovid product sales. Novavax also has several ongoing Phase III trials evaluating NanoFlu, a subunit vaccine for influenza virus B; influenza A virus, and H3N2 subtype infections. The revenue for NanoFlu is expected to reach an annual total of $479m by 2037 globally, based on GlobalData’s expiry model. GlobalData is the parent company of Pharmaceutical Technology.
The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.
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