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Wednesday, January 26, 2022

WHO issues emergency authorization to Covovax in India to expedite vaccinations in low-income countries

The World Health Organization (WHO) on Friday gave emergency clearance for the Indian-made coronavirus vaccine NVX-CoV2373, also known as Covovax, to vaccinate more people in low-income countries.

“This list aims to expand access, especially in low-income countries, 41 of which have so far failed to vaccinate 10 percent of their population, and 98 countries have not reached 40 percent,” Dr Mariangela Simao, Deputy Director General, WHO , the statement said.

Covovax, manufactured by the Serum Institute of India (SII) under license from the American company Novavax, requires two doses and is stable at refrigeration temperatures of 2 and 8 degrees Celsius.

The vaccine, recently listed by the WHO, uses a new platform and is being produced by creating a modified baculovirus containing the gene for the modified SARS-CoV-2 spike protein.

Adar Punavalla, CEO of the Serum Institute of India, said in a statement that Covovax is “the first protein-based COVID-19 vaccine option” to be produced through the COVAX Center, which distributes and distributes vaccines equitably to participating countries and economy.

“Our partnership with Novavax has been successful in providing global public health leadership and ensuring widespread access to a viable vaccine for all countries,” Punavalla said, adding that Covovax has demonstrated a high profile of efficacy and tolerance.

According to WHO, Covovax was assessed based on quality, safety and efficacy, risk management plan, programmatic suitability and site inspections by the Comptroller General of India’s Medicines before the Emergency Use List was released.

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“A technical advisory group on the emergency use list, convened by WHO and composed of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefits of the vaccine far outweigh any risks, and that the vaccine can be used in all the world, ”the statement said.

SII and Novavax said in a joint statement that the vaccine has been approved for emergency use in Indonesia and the Philippines and is currently under review by several regulatory bodies around the world.

“[Novavax] plans to provide a full package of data on chemistry, manufacturing and control to the US FDA. [Food and Drug Administration] by the end of the year, ”it was reported.

The companies also noted that WHO is reviewing an additional emergency application for a vaccine to be marketed by Novavax under the Nuvaxovid brand name.

“The original product manufactured by Novavax, called Nuvaxovid, is currently being evaluated by the European Medicines Agency (EMA). WHO will complete its own evaluation of this vaccine after the EMA issues its recommendation, ”WHO said.

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