Novavax claims its COVID-19 vaccine against all Omicron variants

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Novavax claims its COVID-19 vaccine against all Omicron variants

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Novavax claims its COVID-19 vaccine against all Omicron variants.

Novavax claims its COVID-19 vaccine generates potent immune responses against all Omicron variants.

Biotech company Novavax has revealed that its COVID-19 vaccine is capable of producing an effective immune response against all circulating Omicron variants.

The unexpected data was presented to an advisory panel 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 that ostensibly focused on presentations by Pfizer and Moderna around their work on a new Omicron-specific formulation of an mRNA COVID-19 vaccine.

Although Novavax’s vaccine has not yet been authorized for use in the U.S., it would be great for the company to present the data to help the panel understand how it fits into a booster schedule later this year, said Peter Marks, director of the FDA’s Division of Vaccines. important.

Novavax’s COVID-19 vaccine hits a bumpy road to U.S. authorization. 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 a COVID-19 vaccine.

Development challenges and manufacturing hurdles slowed things down in 2021, but by the end of the year, the new vaccine was on sale around the world.

In the U.S., Novavax has been slow to license its vaccine. The company reportedly submitted data to the FDA back in January, but manufacturing issues continue to hamper authorization.

In early June, an FDA advisory panel recommended emergency use authorization for the vaccine and renewed questions about manufacturing standards, leading to a final approval suspension.

Marks said recently: “We take production very seriously. In manufacturing, we don’t benchmark against other countries, we think we have a very high standard, which is why we are often considered the gold standard in manufacturing, especially in the field of vaccines.”

New data disclosed by Novavax shows that its original vaccine formulation appears to generate a broad immune response, resulting in antibodies that show potent responses to all of the new Omicron variants, including the most immune subtype, BA.5.

In particular, the data showed that Novavax’s vaccine boosted a neutralizing antibody response against the Omicron variant that was comparable to the response to the original SARS-CoV-2 strain at the peak of the initial Phase 3 trial.

Novavax believes its vaccine may be more effective against emerging SARS-CoV-2 variants than mRNA vaccines because it uses a different vaccine technology.

The vaccine is called a protein subunit vaccine, and its production involves initial growth of the coronavirus spike protein in a large-scale manufacturing facility.

These proteins are assembled into nanoparticles designed to mimic the structure of viruses. These nanoparticles are paired with adjuvants, which are molecules that help boost the body’s immune response.

Novavax claims that the unique structural features of its vaccine lead to the production of broad cross-neutralizing antibodies that allow for better detection of emerging SARS-CoV-2 variants.

In support of this hypothesis, Novavax presented data on its latest vaccine formulation, which is designed to more directly target the Omicron BA.1 variant.

The data showed little difference in antibody responses to the Omicron variant when comparing the original vaccine and the newer formulation.

Novavax believes that this means a booster needle program using the original formula could be an effective strategy later this year.

However, ongoing trials of a specific formulation of Omicron should yield results soon, and Novavax has said it can offer an iteration of the vaccine if necessary.

“We believe that our COVID-19 prototype vaccine as a primary series generated broad antibody levels and that boosting with this prototype vaccine would increase the breadth of responses,” said Gregory Glenn, Novavax’s head of research and development. “While we believe in the power of our prototype vaccine data, we are poised to deliver an Omicron-based vaccine this fall as recommended by the health department.”

To date, Novavax’s COVID-19 vaccine has been licensed and distributed in more than 40 countries around the world, including Europe, Canada and Australia.

The company said its supply line is strong enough to immediately begin supplying the U.S. with its original-formulated booster and a target dose of Omicron by the end of the year.

Novavax claims its COVID-19 vaccine against all Omicron variants

(source:internet, reference only)

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