FDA Authorizes Updated Novavax COVID-19 Vaccine Amid Rising Infections

Technology and Composition: The Novavax COVID-19 vaccine, known as NVX-CoV2373, is a protein-based vaccine. Unlike mRNA vaccines (like Pfizer and Moderna), Novavax uses a more traditional approach, employing recombinant nanoparticle technology to deliver a spike protein that stimulates an immune response. This type of vaccine is similar to those used for influenza and hepatitis B.

The Food and Drug Administration (FDA) has granted emergency use authorization for an updated version of the Novavax COVID-19 vaccine, aimed at countering the recent surge in infections. This new version is designed to better target the current variants circulating throughout the United States, offering enhanced protection against severe outcomes, such as hospitalization and death. The vaccine is now authorized for use in individuals aged 12 and older and is specifically formulated to address the JN.1 strain, according to a statement from the FDA.

An updated COVID-19 vaccine from Novavax got the green light on Friday from the FDA. https://t.co/mSP67LF9lv

— WCCB Charlotte’s CW (@WCCBCharlotte) September 1, 2024

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, emphasized the significant impact COVID-19 vaccines have had on public health, describing vaccination as the most effective strategy for preventing COVID-19. He highlighted that COVID-19 remains a substantial risk for many, urging people to receive the updated vaccine as soon as they are eligible.

“This authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality necessary for emergency use authorization,” Marks added.

The FDA’s approval of the updated Novavax vaccine follows its earlier approval of revised versions of Pfizer and Moderna’s COVID-19 vaccines, which target the KP.2 strain of the SARS-CoV-2 virus. These moves come in response to the ongoing evolution of the virus, which continues to pose a public health challenge despite no longer being classified as a pandemic.

According to the Centers for Disease Control and Prevention (CDC), as of August 16, COVID-19 infections were increasing or expected to increase in 27 states. The CDC reported that the P.3.1.1 strain was the most prevalent, accounting for 42.2% of cases over a two-week period ending on August 31. Meanwhile, the JN.1 strain, which the updated Novavax vaccine targets, was detected in just 0.2% of cases, and the KP.2 strain was found in 3.1% of cases.

FDA authorizes Novavax’s updated COVID-19 vaccine https://t.co/gy3BwaXZh7

— USA TODAY (@USATODAY) September 1, 2024

Health experts from Cedar Sinai, a nonprofit health organization, noted that the primary symptoms of the COVID-19 variants circulating this summer include chills, fever, runny nose, and congestion.

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• Efficacy and Safety: Clinical trials have demonstrated that the Novavax vaccine is effective in preventing symptomatic COVID-19, including severe disease. The trials reported an efficacy of around 90% against COVID-19 infections, including variants like Delta. The updated version aims to target new variants more effectively, although specific efficacy rates against new variants are still being studied. The vaccine has been shown to produce a robust antibody response and has a good safety profile, with most side effects being mild and temporary, such as pain at the injection site, headache, and fatigue.
• Vaccine Authorization and Use: The updated Novavax vaccine has been authorized as a booster dose for adults who have already completed their primary vaccination series with either the Novavax vaccine or another COVID-19 vaccine. The decision to authorize the updated version comes as public health officials continue to encourage booster doses to maintain immunity levels against COVID-19, particularly as new variants emerge.
• Storage and Distribution: One of the advantages of the Novavax vaccine is its storage requirements. It can be stored at standard refrigerator temperatures (2°C to 8°C), making it easier to distribute and store compared to some mRNA vaccines that require ultra-cold storage.
• Target Audience: The Novavax vaccine is recommended for individuals who may have allergic reactions to mRNA vaccines or prefer a non-mRNA option. It is also being positioned as a booster dose option, adding to the diversity of available vaccines to enhance public health resilience against COVID-19.
• Global Impact: Novavax has partnered with various international organizations and governments to supply its vaccine globally. It has been a key player in COVAX, the global initiative aimed at equitable access to COVID-19 vaccines, helping to provide vaccine options to low- and middle-income countries.

i. FDA Authorization: The FDA has authorized an updated version of the Novavax COVID-19 vaccine for emergency use, targeting the JN.1 strain.

ii. Eligibility: The vaccine is now available for individuals aged 12 and older.

iii. Continued Risk: Despite the virus no longer being a pandemic, COVID-19 remains a significant risk, and vaccination is recommended.

iv. Current Virus Strains: The P.3.1.1 strain is currently the most prevalent, but new vaccines also target other emerging strains.

v. Vaccine Impact: Updated vaccines from Novavax, Pfizer, and Moderna are seen as critical tools in combating ongoing COVID-19 infections.

James Kravitz – Reprinted with permission of Whatfinger News