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Novavax NVAX announced that the World Health Organization (“WHO”) has granted an Emergency Use Listing (“EUL”) to NVX-CoV2601, its updated protein-based COVID vaccine, for use in Americans 12 years of age and older.
COVID-19 vaccines that benefit from EUL meet WHO criteria for quality, safety and efficacy. Additionally, this list helps WHO Member States compare vaccines with the aim of accelerating vaccine availability and regulatory approvals.
The EUL is based on knowledge from non-clinical studies in which Novavax’s updated vaccine generated functional immune responses opposed to several circulating Omicron-related sublineages, adding XBB. 1. 5, BA. 2. 86 (also known as “Pirola”), EG. 5. 1 (also referred to as “Pirola”), FL. 1. 5. 1 (also called ‘Fornax’), and XBB. 1. 16. 6.
Novavax shares jumped 5% on Tuesday following the announcement. This will most likely benefit Novavax, whose updated COVID-19 vaccine will be available as an option in all 194 WHO member states. While Novavax is currently suffering from monetary needs, the backlog of COVID-19 vaccines will help the company generate additional financial resources to fund its business operations. In a November SEC filing, control said it had enough liquidity to fund operations for the next 12 months.
So far, Novavax’s inventory is down 44. 3% year-to-date, a 23. 5% drop for the sector.
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Last month, the FDA granted an Emergency Use Authorization (“EUA”) to NVX-CoV2601 in people 12 years of age and older. As a result of the EUA, Novavax’s updated vaccine is the only mRNA-free vaccine option for Americans.
Despite being one of the few corporations with a legal COVID-19 vaccine in the U. S. , it is still a major contributor to the COVID-19 vaccine. In the U. S. , Novavax has largely missed out on the COVID-19 vaccine windfall, which has benefited mRNA vaccine makers Pfizer PFE/BioNTech BNTX and Moderna MRNA. At its peak, Novavax is facing production issues, pushing back its regulatory filing deadline.
In September, the FDA approved updated mRNA vaccines from Moderna and Pfizer/BioNTech for use in people 12 and older. The Moderna and Pfizer/BioNTech vaccines also have an advantage over the Novavax vaccine, as they also received the vaccine. U. S. for ages six months to 11 years and older.
Unlike in times past, when the government controlled the distribution and rollout of COVID-19 vaccines, this year the vaccines were first introduced through an advertisement in retail pharmacies and doctors’ offices. The updated COVID vaccines are intended to be available through personal insurance, Medicare and Medicaid plans.
For those who are uninsured or underinsured, the CDC will temporarily provide loose vaccines through its Bridge Access program.
Novavax, Inc. | Quote from Novavax, Inc.
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