HomeBusinessNovavax, after delays, files for US authorisation of COVID-19 vaccine

Novavax, after delays, files for US authorisation of COVID-19 vaccine

Novavax mentioned on Monday (Jan 31) it has filed for emergency use authorisation of its COVID-19 vaccine for US adults, a long-awaited step for the corporate following months of struggles with improvement and manufacturing issues.

The submitting relies on information offered to the US Food and Drug Administration final month and outcomes of two late-stage trials within the United States, Mexico and the UK that confirmed the protein-based vaccine had an total efficacy of about 90 per cent, the corporate mentioned.

“We imagine our vaccine provides a differentiated possibility… that may be a substitute for the portfolio of obtainable vaccines to assist struggle the COVID-19 pandemic,” mentioned Novavax Chief Executive Officer Stanley Erck in an announcement.

Novavax’s vaccine makes use of a distinct know-how than the mRNA vaccines from Pfizer-BioNTech and Moderna or the Johnson and Johnson shot.

Novavax has needed to delay its US submission a number of instances on account of improvement and manufacturing setbacks. A report earlier this 12 months mentioned the strategies Novavax used to check the efficacy of its vaccine had fallen quick of regulators’ requirements. 

Data launched in June from a late-stage US trial confirmed the vaccine was greater than 90 per cent efficient in opposition to a spread of regarding coronavirus variants, together with Delta.

Early information revealed in late December suggests the vaccine can also be efficient in opposition to the quick spreading Omicron variant, which is now the dominant model of the virus within the United States and most of the world.

The US submission follows authorisations for the vaccine from the European Medicines Agency and the World Health Organization, clearing the best way for its use in Europe in addition to low- and middle-income international locations.

Novavax and India’s Serum Institute, the world’s largest vaccine producer, had collectively dedicated to offering greater than 1.1 billion doses to the COVAX worldwide vaccine sharing program.



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