FDA Authorizes Novavax’s Updated COVID Jab Based on Data From Previous Versions

The Food and Drug Administration (FDA) on Tuesday granted emergency use authorization (EUA) to an updated version of Novavax’s COVID-19 vaccine based on safety data from previous versions.

The FDA’s latest authorization relied on a combination of previously existing safety and effectiveness data and data from booster studies rather than solely on new clinical trial data specific to this particular vaccine formulation, according to an Oct. 3 authorization letter signed by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

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This differs from previous EUAs for Novavax issued since the summer of last year, which relied on ongoing trials.

For the authorization of the previous version of the Novavax vaccine for people aged 18 and above, which was issued in July 2022 and targeted the “Original monovalent” virus, the FDA reviewed safety and efficacy data from an “ongoing phase 3 trial.” The following month, the FDA authorized the same vaccine for people aged between 12 and 17, relying on data from an expansion of the phase 3 trial for adolescents.

Unlike the previous version of the vaccine, Novavax’s latest jab is designed to target the XBB.1.5 Omicron subvariant, which is closely related to the strains currently in circulation. This is similar to the updated vaccines from Pfizer and Moderna.

However, Novavax’s jab differs from Pfizer’s and Moderna’s by employing a protein-based approach to instruct the immune system on how to combat the coronavirus. Protein-based vaccines have been the standard for decades. The Pfizer and Moderna jabs use mRNA technology.

“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,” Dr. Marks said in a statement.

“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 said it considered safety and effectiveness data from various sources, including data from previous clinical trials with different variants of the Novavax COVID-19 vaccine (such as Original monovalent, Omicron BA.1, Omicron BA.5, and bivalent variants) and data from booster doses administered to different age groups.

In his Oct. 3 authorization letter, Dr. Marks said 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.”

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 a second dose, according to the FDA’s analysis of data from the clinical trials.

However, Dr. Marks notes in his letter that in the FDA’s previous analysis of the original vaccine, “no cases of moderate or severe COVID-19” were reported in participants, whether they received the vaccine “or placebo.”

As a result of the updated vaccine, the FDA said the jab for the original monovalent virus is no longer authorized for use 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, the agency noted in fact sheets that clinical trial data indicated there are increased risks of myocarditis and pericarditis after receipt of the Novavax vaccine.

In the trial data submitted to the regulator, five cases of one or both conditions were reported in the roughly 26,100 people who were vaccinated and zero were reported in placebo recipients. U.S. authorities subsequently cleared a Novavax booster.

In Europe, the regulating agency initially didn’t warn about inflammation after the administration of the Novavax vaccination but later added a warning to its product information.