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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

What You Need to Know

Novavax’s COVID-19 vaccine, NVX-CoV2601 (Nuvaxovid), is distinct from many other COVID-19 vaccines as it does not utilize the mRNA platform.

The vaccine incorporates a patented saponin-based Matrix-M adjuvant. The Matrix-M adjuvant enhances both the cellular and humoral arms of the immune system.

The NVX-CoV2601 vaccine has practical advantages in terms of storage and shelf life. It can be stored at temperatures between 2 to 8 degrees Celsius, making distribution and administration more straightforward.

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



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