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India’s COVOVAX gets WHO approval for emergency use

India’s COVOVAX gets WHO approval for emergency use
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The World Health Organization has listed Covovax, produced by Serum Institute of India under the licence from Novavax, for emergency use.

The ninth Covid-19 vaccine approved for emergency use is part of the COVAX facility portfolio and will be boosting efforts in vaccinating people, especially in lower-income countries.

Approval after due assessment

Covovax was thoroughly assessed for its quality, safety, and efficacy of COVID-19 vaccines before being granted the Emergency Use Listing (EUL). CovovaxTM was assessed under the WHO EUL procedure based on the review of data on quality, safety, and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

According to the Technical Advisory Group, the vaccine meets WHO standards for protection against COVID-19 and is fit for global use as its benefits outweigh any risks.

Vaccines: Best weapon

The listing of Covovax will strengthen the fight against Coronavirus. WHO Assistant-Director General for Access to Medicines and Health Products, Dr. Mariangela Simao said that even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2.

Further, the listing will increase vaccine access in lower-income countries. According to WHO, 41 of these countries have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.

About Covovax

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

In addition to Covovax, India’s Covishield, developed by the Serum Institute of India was issued EUL on 15 February 2021, while Covaxin by Bharat Biotech was given a nod on 3 November 2021.

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