The newly disclosed data came as a surprise at a conference that ostensibly focused on presentations from Pfizer and Moderna surrounding their studies of their mRNA COVID-19 vaccines targeting the new Omicron specific formulation.

Biotech company Novavax has revealed that its COVID-19 vaccine is able to generate an effective immune response against all circulating Omicron variants. The unexpected data was presented to an advisory group convened by the U.S. Food and Drug Administration (FDA) to recommend a booster vaccine schedule later this year.

The newly disclosed data came as a surprise at a conference ostensibly focused on Pfizer and Moderna's presentations surrounding their studies of new Omicron specific formulations of their mRNA COVID-19 vaccines. Peter Marks, director of the FDA's Division of Vaccines, said that although Novavax's vaccine has not yet been authorized for use in the United States, it would be interesting for the company to present the data to help the panel understand how it might fit into a booster shot schedule later this year. important.

Novavax's COVID-19 vaccine has had a bumpy road to authorization in the United States. It was originally part of Operation Warp Speed ​​in early 2020, the first wave of funding in the U.S. government's push to develop COVID-19 vaccines. Development challenges and manufacturing hurdles kept things moving slowly in 2021, but by the end of the year, the new vaccine began to be sold around the world.

In the United States, the authorization of Novavax's vaccine has been slow. The company reportedly submitted data to the FDA back in January, but manufacturing issues continued to hold up authorization. In early June, an FDA advisory panel recommended emergency use authorization for the vaccine and again raised questions about manufacturing standards, leading to a pause in final approval.

Marks recently said: “We take production very seriously. We don’t benchmark ourselves against other countries when it comes to manufacturing, we believe we have a very high standard, which is why we are often considered the gold standard in manufacturing, esp. In the field of vaccines."

Novavax has revealed new data showing that its original vaccine formulation appears to generate a broad immune response, resulting in antibodies that show effective responses to all new Omicron variants, including the most immunogenic BA.5 subtype. type. In particular, data showed that Novavax's vaccine boosted neutralizing antibody responses against the Omicron variant that were comparable to responses against the original strain of SARS-CoV-2 at the peak of the initial Phase 3 trial.

Novavax believes its vaccine may be more effective against emerging SARS-CoV-2 variants than its mRNA vaccine because it uses a different vaccine technology. The production of the vaccine, known as a protein subunit vaccine, involves initially growing the coronavirus spike protein in a large production facility. The proteins are assembled into nanoparticles designed to mimic the structure of viruses. The nanoparticles are paired with the adjuvant , which are molecules that help boost the body's immune response.

Novavax claims that the unique structural features of its vaccine result in the generation of broadly cross-neutralizing antibodies that can better detect emerging SARS-CoV-2 variants. To support that hypothesis, Novavax presented data on its latest vaccine formulation, which is designed to target the Omicron BA.1 variant more directly.

The data showed little difference in the antibody response to the Omicron variant when comparing the original vaccine and the newer formulation. Novavax believes this means a booster shot program using the original formula could be an effective strategy later this year. However, ongoing trials of a specific formulation of Omicron should have results soon, and Novavax says it will be able to offer iterations of this vaccine if necessary.

"We believe that our COVID-19 prototype vaccine as a primary series generated a broad range of antibody levels and that boosting with this prototype vaccine will increase the breadth of the response," said Gregory Glenn, Novavax's head of research and development. "While we believe in the strength of the data from our prototype vaccine, we are prepared to offer an Omicron-based vaccine this fall as recommended by health authorities."

Novavax's COVID-19 vaccine has been authorized in more than 40 countries around the world to date and distribution, including Europe, Canada and Australia. The company said its supply lines are strong enough to begin supplying boosters of its original formulation to the U.S. immediately and target doses of Omicron by the end of the year.