Novavax Submits EUA Request for COVID-19 Vaccine Booster


An Emergency Use Authorization (EUA) request has been submitted to america Meals and Drug Management (FDA) for the adjuvanted Novavax COVID-19 vaccine as a homologous and heterologous booster to stop COVID-19 led to by way of SARS-CoV-2 in adults 18 years of age and older.

The Novavax COVID-19 vaccine is engineered from the genetic series of SARS-CoV-2 the use of the corporate’s recombinant nanoparticle era to generate antigen derived from the coronavirus spike protein. The vaccine comprises the corporate’s saponin-based Matrix-M adjuvant era to toughen and extend immune responses. 

The submission is supported by way of knowledge from the randomized, placebo-controlled, segment 3 PREVENT-19 trial (ClinicalTrials.gov Identifier: NCT04611802), which evaluated the efficacy, protection, and immunogenicity of the Novavax COVID-19 vaccine in members 18 years of age and older in the USA and Mexico. Contributors gained a booster dose of the Novavax COVID-19 vaccine a minimum of 6 months after the main 2-dose sequence. Findings confirmed that the booster dose elicited powerful antibody responses related to or exceeding ranges related to the efficacy knowledge in the main sequence of the vaccine.


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Moreover, the EUA submission integrated knowledge from the multicenter, randomized, managed, segment 2 COV-BOOST trial, which confirmed {that a} heterologous booster dose of the Novavax COVID-19 vaccine produced a vital antibody reaction.

As for protection, the Novavax COVID-19 vaccine was once related to native and systemic reactions with an average length of roughly 2 days. The prevalence of medically attended antagonistic occasions, doubtlessly immune-mediated scientific stipulations, and serious antagonistic occasions passed off once in a while following the booster dose.

“It’s essential for other people to have a call as they assessment the best way to keep secure in opposition to COVID-19, and boosters are a useful instrument to construct upon immunity got from earlier vaccinations,” stated Stanley C. Erck, President and CEO of Novavax. “In response to the information offered to the FDA’s VRBPAC and the CDC ACIP, we consider our vaccine provides a vast, long-lasting immune reaction in opposition to a spread of variants.”

The FDA lately granted EUA to the adjuvanted Novavax COVID-19 vaccine as a number one 2-dose sequence for the prevention of COVID-19 led to by way of SARS-CoV-2 in people 18 years of age and older. The vaccine is run intramuscularly as a 2-dose number one sequence (every 0.5 mL), separated by way of 3 weeks.

The Novavax COVID-19 vaccine is equipped as a suspension in a carton containing 10 multidose vials; every vial comprises 10 doses of 0.5 mL every. 

Reference

Novavax submits utility to america FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a booster in adults elderly 18 and older. Information unlock. Novavax, Inc. Accessed August 15, 2022. https://www.prnewswire.com/news-releases/novavax-submits-application-to-the-us-fda-for-emergency-use-authorization-for-novavax-covid-19-vaccine-adjuvanted-as-a-booster-in-adults-aged-18-and-older-301605447.html

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