FDA Grants Emergency Use Authorization for Novavax’s Updated COVID-19 Vaccine

On Friday, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for an updated version of Novavax’s COVID-19 vaccine.

This new formulation is now approved for individuals aged 12 and older and is specifically designed to target the JN.1 strain of the virus. The announcement comes amid a fluctuating COVID-19 landscape and varying levels of vaccine uptake.

Key Details of the Authorization

The updated Novavax vaccine is tailored to address the ‘parent strain’ of currently circulating variants, with demonstrated strong cross-reactivity against several lineages of the JN.1 variant, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

According to Novavax’s CEO, John Jacobs, this vaccine aims to offer protection against the evolving virus strains that have been circulating.

Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, highlighted the significance of the authorization, stating, “Today’s authorization provides an additional COVID-19 vaccine option.”

This move expands the range of available vaccines, which is crucial as different variants continue to circulate.

Following the FDA’s announcement, Novavax’s shares experienced a notable increase, rising 2.2% in extended trading after a strong closing that saw a gain of 8.6%. This uptick reflects positive investor sentiment regarding the company’s updated vaccine offering.

Novavax has indicated that doses of the new vaccine could be available as early as the end of next week, subject to distribution logistics. This timely release is aimed at addressing the needs of individuals seeking updated protection against current virus strains.

Comparison with Other COVID-19 Vaccines

Earlier this month, the FDA approved updated COVID-19 vaccines from Pfizer and Moderna, which target the KP.2 variant. JN.1 was the dominant strain in the U.S. earlier in the year but has since decreased in prevalence.

As of August 31, data from the Centers for Disease Control and Prevention (CDC) shows that JN.1 now accounts for approximately 0.2% of COVID-19 cases.

In contrast, the KP.2 subvariant represents about 3.1% of cases, while the KP.3.1.1 subvariant has surged to become the dominant strain at 42.2%.

The evolving nature of the virus has prompted the FDA to request vaccine makers to focus on the KP.2 strain for the 2024-25 vaccine updates.

Vaccine Technology and Public Health Context

Novavax’s vaccine utilizes a traditional protein-based technology, offering an alternative to the messenger RNA (mRNA) vaccines developed by Moderna and Pfizer-BioNTech.

While mRNA vaccines like Moderna’s Spikevax and Pfizer’s Comirnaty have been at the forefront of the pandemic response, Novavax’s approach provides an additional option for those who may prefer or require different technology.

Despite a recent increase in COVID-19-related hospitalizations and deaths in the U.S. over the past three months, the demand for COVID-19 vaccines has significantly declined since the pandemic’s peak.

Novavax has projected that overall vaccine demand will remain consistent with last year’s figures, although it anticipates a better performance for its updated vaccine.

As COVID-19 continues to evolve, the availability of updated vaccines like Novavax’s provides crucial options for maintaining public health protection.

The new EUA for Novavax’s vaccine highlights ongoing efforts to adapt to the changing virus and offer effective solutions to combat it. The coming weeks will be pivotal in assessing the vaccine’s impact and its role in the broader fight against COVID-19.