WHO grants EUL to Covavax produced by SII

The top UN health agency said that COVAX, part of the COVAX facility portfolio, is giving a much-needed boost to ongoing efforts to vaccinate more people in low-income countries.

WHO’s EUL process assesses the quality, safety and efficacy of covid-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to accelerate their own regulatory approvals for the import and administration of COVID-19 vaccines.

Dr Mariangela Simo, WHO’s Assistant-Director-General for Access to Medicines and Health Products, said: “Despite the emergence of new forms, vaccines remain the most effective tools to protect people from serious illness and death from SARS-CoV-2. are one of them.” The purpose of this listing is to increase access, especially in low-income countries, of which 41 are still unable to vaccinate 10% of their population, while 98 countries have not reached 40%,” Simao said.

Kovovax was evaluated under the WHO EUL process based on a review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections conducted by the Drug Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and composed of experts from around the world, has determined that the vaccine meets WHO’s standards for protection against COVID-19, that the benefits of the vaccine may be elsewhere. is more. any risks, and that the vaccine could be used globally.

Kovovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovation (CEPI). It requires two doses and is stable at 2 to 8 °C refrigerated temperatures. The vaccine uses a new platform and is manufactured by creating an engineered baculovirus containing a gene for the modified SARS-CoV-2 spike protein.

The original product manufactured by Novavax, named NuvaxovidTM, is currently being evaluated by the European Medicines Agency (EMA). WHO will complete its evaluation of this vaccine after the EMA issues its recommendation.

The vaccine was also reviewed at the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) meeting this week. SAGE formulates specific policies and recommendations for the use of vaccines in the population (ie recommended age group, interval between doses, specific groups such as pregnant and lactating women) and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days.