Today, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine that targets the Omicron variant JN1 strain (NVX-CoV2705).1 This updated vaccine is approved for individuals aged 12 and older and is designed to offer improved protection against severe COVID-19 outcomes, such as hospitalization and death. The new vaccine features a monovalent component and will replace the previously authorized Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).
Eligible individuals include those aged 12 years and older who are either unvaccinated, partially vaccinated with Novavax, or have received prior COVID-19 vaccines from other manufacturers. The updated vaccine requires 2 doses for unvaccinated individuals, 1 dose for those partially vaccinated with Novavax, and 1 dose for those fully vaccinated with prior COVID-19 vaccines.
"Today's authorization enables Novavax to launch our updated COVID-19 vaccine in the US in prefilled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide," John C. Jacobs, president and CEO of Novavax, said in a statement.2 "Our updated vaccine targets JN1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN1 lineage viruses, including KP23, KP3, KP311, and LB1."
In a recent interview with Contagion, Chijioke Bennett, MD, MPH, MBA, from the Novavax clinical development team, discussed the vaccine’s efficacy. He highlighted that Novavax’s protein-based vaccine provides comparable protection against the latest variants, like previous vaccines.
“As we see this virus drift, we must adapt to where it’s headed. With the new vaccine, our Gen 1 offering—which is what the CDC has recommended—this family of viruses essentially provides clinically comparable efficacy and immunogenicity to what we had originally received approval and authorization for," Bennett said. "These numbers are in the mid-to-high 90s. It’s an effective vaccine. We have no concerns about that, and we’re seeing good immunogenicity across the board, very similar to what we had seen with our original vaccine that we had when the pandemic began.”
What to Know
- Individuals aged 12 and older who have never received any COVID-19 vaccine are eligible to get two doses of the updated vaccine, administered 3 weeks apart.
- Those who have received just one dose of any Novavax COVID-19 vaccine are eligible for a single dose of the updated Novavax vaccine, provided it is given at least 3 weeks after the previous dose.
- People who have been vaccinated with a previous COVID-19 vaccine from another manufacturer or who have had two or more doses of a prior Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax vaccine, given at least 2 months after their last COVID-19 vaccine do
The FDA's decision follows the recent approvals of updated mRNA COVID-19 vaccines for 2024-2025 from ModernaTX Inc and Pfizer Inc. The updated Novavax vaccine is manufactured using a process similar to that of earlier versions, and adverse effects may be like those reported with previous formulations. The most common adverse reactions associated with Novavax's NVX-CoV2373 COVID-19 vaccine included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.
Bennett also emphasized the critical role of healthcare professionals in improving vaccination rates and managing virus spread. “The role of a healthcare provider, a physician, pharmacist, nurse, or anyone people trust with their health decisions is crucial. We should come to these conversations as knowledgeable parties and have scientific discussions. We still have great vaccine options available, and as their healthcare providers, it’s our responsibility to remind them about vaccination to help prevent severe cases of COVID. Healthcare providers need to have these conversations, even if patients are not willing to engage. This personal touch is valuable in guiding patients towards the right decisions, especially as we see the surge in cases,” he stated.
Overall, the FDA has determined that the benefits of the updated Novavax vaccine outweigh its risks, meeting the criteria for EUA. It is now authorized for use in individuals aged 12 years and older.
In late June, the company unveiled promising findings regarding its JN1 COVID-19 vaccine's efficacy against evolving virus strains, including the KP2 and KP3 variants, and filed a type II variation of Marketing Authorization with the European Medicines Agency (EMA) for this NVX-CoV2705 vaccine, targeting the JN1 lineage, aligning with global health strategies aimed at combating seasonal variants expected later in 2024.3
NVX-CoV2705 represents an advanced iteration of Novavax's prototype COVID-19 vaccine (NVX-CoV2373), specifically engineered to target the evolving JN1 variant. This protein-based vaccine leverages recombinant nanoparticle technology, wherein harmless replicas of the SARS-CoV-2 spike protein serve as antigens. Novavax's proprietary Matrix-M adjuvant enhances the immune response by broadening and prolonging its efficacy.
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