Novavax Granted Authorization in United Kingdom for its COVID-19 Vaccine

Last week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it has granted marketing authorization for Novavax’s NVX-CoV2601 (Nuvaxovid) XBB15 COVID-19 vaccine for prevention of COVID-19 in individuals aged 12 years and older.¹

“Today’s MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year,” Novavax CEO John C. Jacobs, said in a statement last week. “We are in ongoing conversations with additional UK partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one. We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the UK.”¹

According to the company, this authorization was based on non-clinical data showing the updated COVID-19 vaccine induced functional immune responses for XBB15, XBB116 and XBB23 variants. Additional non-clinical data demonstrated the vaccine induced neutralizing antibody responses to subvariants JN1—which is the dominant strain in the United States—BA286, EG51, FL151 and XBB1166 as well as CD4+ polyfunctional cellular (T-cell) responses against EG51 and XBB1166. These data indicate Novavax’s vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.¹

Back in late November, the WHO granted Novavax an emergency use listing (EUL) for the same vaccine. The EUL was also based on non-clinical data. ²

The Vaccine’s Novelty

This vaccine does not use the m-RNA technology, but the company’s patented saponin-based Matrix-M adjuvant platform. The vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage. And as previously mentioned, it has demonstrated efficacy against multiple variants. ²

Contagion spoke to Seth Toback, MD, senior vice president, Medical Affairs, Novavax, at last fall’s IDWeek about the novelty of the vaccine.

“Our vaccine is a protein based vaccine; it's really unique in that it uses the entire full length spike protein. It takes that spike protein and arranges it as a three-dimensional shape, which puts it in a very similar shape to the natural wild type SARS-CoV-2,” said Toback. "So when we make antibodies towards that vaccine, the antibodies are more accurately reflecting the wild type virus and gives us a neutralization response. We then take that fully-spiked protein and we add it to our novel adjuvant, which is called matrix M…it enhances both the cellular and humoral arms of the immune system.”²

References

1. Novavax’s Updated COVID-19 Vaccine Authorized in the United Kingdom. Novavax press release. January 24, 2024. Accessed January 31, 2024. https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Authorized-in-the-United-Kingdom

2. Parkinson J. Novavax’s Updated COVID-19 Vaccine is Granted EUL by WHO. ContagionLive. December 2, 2023. Accessed January 31, 2024 Novavax’s Updated COVID-19 Vaccine is Granted EUL by WHO. https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Authorized-in-the-United-Kingdom