FDA Approves Novavax’s Updated COVID Vaccine Using Previous Version’s Data
The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to an updated version of Novavax’s COVID-19 vaccine. This exciting development is based on safety data from previous versions.
The Oct. 3 EUA allows individuals aged 12 and above to receive a dose of the new Novavax vaccine, regardless of their prior vaccination history. You can find more information in the official news release.
The FDA’s latest authorization is unique because it combines existing safety and effectiveness data with booster studies, rather than relying solely on new clinical trial data specific to this particular vaccine formulation. This approach was outlined in an Oct. 3 authorization letter signed by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
This marks a departure from previous EUAs for Novavax, which relied on ongoing trials. In the case of the previous version of the Novavax vaccine, authorized in July 2022 for individuals aged 18 and above, the FDA reviewed safety and efficacy data from an ongoing phase 3 trial. The following month, the FDA authorized the same vaccine for individuals aged 12 to 17, using data from an expansion of the phase 3 trial for adolescents.
Unlike the previous version, Novavax’s latest vaccine targets the XBB.1.5 Omicron subvariant, which is closely related to the strains currently in circulation. This aligns with the updated vaccines from Pfizer and Moderna.
However, Novavax’s vaccine differs from Pfizer’s and Moderna’s by utilizing a protein-based approach to instruct the immune system in combating the coronavirus. Protein-based vaccines have been the standard for decades, while Pfizer and Moderna employ mRNA technology.
Dr. Marks, in a statement, expressed his enthusiasm for the FDA’s authorization, stating, “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”
“As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
FDA Authorization Based on Trial Data for Previous Vaccine
The FDA has confirmed that the authorization was based on trial data from previous versions of the Novavax COVID-19 vaccine, including Original monovalent, Omicron BA.1, Omicron BA.5, and bivalent variants. Additionally, data from booster doses administered to different age groups was taken into account.
In his Oct. 3 authorization letter, Dr. Marks explained that ”the data accrued” from the previous versions of the vaccine “are relevant to” the updated version “because these vaccines are manufactured using a similar process.”
“FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of the Novavax COVID‑19 Vaccine, Adjuvanted (2023-2024 Formula) outweigh its known and potential risks for the prevention of COVID-19 in individuals 12 years and older when administered in accordance with the authorized dosing regimen and schedule,” wrote Dr. Marks (pdf).
According to the FDA’s analysis of clinical trial data, the previous version of Novavax was found to be 78.29 percent effective in preventing “PCR-confirmed symptomatic mild, moderate, or severe COVID-19” at least seven days after the second dose. However, Dr. Marks notes in his letter that no cases of moderate or severe COVID-19 were reported in participants who received either the vaccine or placebo.
As a result of the updated vaccine, the FDA has revoked authorization for the original monovalent virus jab in the United States. Last month, the U.S. Centers for Disease Control and Prevention (CDC) approved the updated vaccines, including Novavax’s.
When the FDA authorized Novavax’s shot last summer, fact sheets indicated that clinical trial data suggested an increased risk of myocarditis and pericarditis after receiving the Novavax vaccine.
In the trial data submitted to the regulator, five cases of one or both conditions were reported among the approximately 26,100 vaccinated individuals, while zero cases were reported among placebo recipients. Subsequently, U.S. authorities approved a Novavax booster.
In Europe, the regulatory agency initially did not issue a warning about inflammation following the administration of the Novavax vaccine. However, it later added a warning to its product information.
The vaccine. This includes safety and efficacy data from an ongoing phase 3 trial and expansion of the trial for adolescents. How does the FDA’s consideration of previous versions of the vaccine enhance our understanding of its safety and effectiveness?
Using the same production process and differ only in the specific antigens they contain.” This means that the safety and efficacy data from the previous versions can be applied to the updated version of the Novavax vaccine.
The FDA’s decision to grant emergency use authorization to the updated Novavax vaccine is a significant step in combating the ongoing COVID-19 pandemic. With this authorization, individuals aged 12 and above can now receive a dose of the new vaccine, regardless of their prior vaccination history. This broadens the access to vaccinations and enhances our efforts to achieve widespread immunity.
What sets this authorization apart is the FDA’s unique approach of combining existing safety and effectiveness data with booster studies. Rather than relying solely on new clinical trial data specific to the updated vaccine formulation, the FDA considered data from previous versions and booster doses. This approach ensures that the authorization is based on a comprehensive understanding of the vaccine’s performance.
The Novavax vaccine has undergone rigorous evaluation by the FDA. In the case of the previous version authorized in July 2022, the FDA reviewed safety and efficacy data from an ongoing phase 3 trial. Subsequently, the same vaccine was authorized for individuals aged 12 to 17 using data from the expansion of the phase 3 trial for adolescents. This demonstrates the FDA’s commitment to thoroughly assessing the vaccine’s safety and effectiveness.
The updated Novavax vaccine specifically targets the XBB.1.5 Omicron subvariant, which is closely related to the strains currently in circulation. This aligns with the strategies employed by Pfizer and Moderna in their updated vaccines. However, Novavax’s vaccine differs in its use of a protein-based approach to instruct the immune system in fighting the coronavirus. Protein-based vaccines have been the standard for decades, while Pfizer and Moderna utilize mRNA technology.
Dr. Marks, the director of the FDA’s Center for Biologics Evaluation and Research, expressed his enthusiasm for the FDA’s authorization and emphasized the importance of considering an updated COVID-19 vaccine. As we head into the fall season and prepare for the coming year, it is crucial for eligible individuals to receive the updated vaccine to enhance their protection against currently circulating variants.
The FDA’s authorization of the updated Novavax vaccine is based on trial data from previous versions of
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