Covovax gets Emergency Use Listing nod from WHO

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Covovax gets Emergency Use Listing nod from WHO


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The WHO released an Emergency Use List (EUL) for NVX-CoV2373 on Friday, or Covovax, the Novovax-licensed anti-Covid vaccine being produced by the Serum Institute of India (SII) in Pune.

“The EU’s World Health Organization (WHO) is a great incentive to make Covid-19 vaccines more accessible. Our partnership with Novavax has been successful in providing global leadership in public health and ensuring that all countries have wide access to a viable vaccine, “said Adar Poonawalla, general manager of SII. “Covovax is the first protein-based vaccine option for Covid-19 with proven efficacy and a well-tolerated safety profile that is made available through the COVAX facility. We thank WHO and look for helping the world control the spread of the pandemic, “Poonawalla said in a statement on Friday.

EUL prequalifies Novavax Covid-19 vaccine as compliant with established WHO quality, safety and efficacy standards. The EUL is a prerequisite for exports to many countries, including those involved in the COVAX facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at cooling temperatures of 2 to 8 ° C. The vaccine uses a new platform and is produced by creating a baculovirus designed to contain a gene for a modified SARS-CoV-2 ear protein.

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The EUL grant was based on all clinical, manufacturing, and preclinical trial data submitted for review. This included two key phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in the New England Journal of Medicine (NEJM) on December 15, and a trial that evaluated the vaccine in more than 14,000 participants in the UK, the results of which were published in NEJM on 30 June.

Novavax and SII recently received emergency use authorization (US) for Covovax in Indonesia and the Philippines. The vaccine is also currently being reviewed by various regulatory agencies around the world. The company expects to submit its complete Chemical, Manufacturing and Controls (CMC) data package to the US FDA by the end of the year.

“Even with the advent of new variants, vaccines remain one of the most effective tools for protecting people from serious illness and death from SARS-VOC-2,” said Dr. Mariângela Simão, Deputy Director General of ‘WHO for access to medicines and health products. “This list aims to increase access, especially to low-income countries, 41 of which have not yet been able to vaccinate 10% of their population …”

Covovax was evaluated according to the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability and site inspections carried out by the Comptroller General of Medicines. ‘India. The Technical Advisory Group for the Emergency Use List (TAG-EUL), convened by the WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards of protection against Covid-19, which far outweighs the benefit of the vaccine. any risk, and that the vaccine can be used globally.

The original product produced by Novavax, called Nuvaxovid, is currently being evaluated by the European Medicines Agency (EMA). The WHO will complete its own evaluation of this vaccine once the EMA has issued its recommendation. A meeting of the WHO Strategic Advisory Group of Experts on Immunization (SAGE) this week also reviewed the vaccine. SAGE, which formulates specific policies and recommendations for the use of vaccines in populations, will issue recommendations for Nuvaxovid / Covovax in the coming days.

“Today’s (Friday) WHO decision is vital to ensuring global access to a protein-based Covid-19 vaccine for hundreds of millions of people worldwide,” said Stanley C Erck. , President and CEO of Novavax. “We believe this vaccine will help overcome barriers to vaccine access to many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while providing an option based on familiar and well-understood technology,” he said. add Erck.

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