Covovax, the Covid-19 vaccine produced by Serum Institute of India under license from the US-based Novavax, on Friday received approval from the World Health Organisation (WHO) for its emergency use. Calling it a “milestone” in the fight against coronavirus, SII CEO Adar Poonawalla tweeted, “Covovax is now WHO approved for emergency use, showing excellent safety and efficacy.”
In an official statement, the WHO said, “Today, the World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named Covovax, is produced by the Serum Institute of India under license from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.”
This is yet another milestone in our fight against COVID-19, Covovax is now W.H.O. approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration, @Novavax @WHO @GaviSeth @Gavi @gatesfoundation https://t.co/7C8RVZa3Y4— Adar Poonawalla (@adarpoonawalla) December 17, 2021
Dr Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products, said, “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.”
“This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10 per cent of their populations, while 98 countries have not reached 40 per cent,” Dr Simao said.
Last month, Poonawalla had said that children in India will likely be vaccinated with the Covovax Covid-19 vaccine, and not Covishield. He also said that the trials of the vaccine is underway and Covovax should be ready in six months. “Not Covishield… Covovax should be available in six months. (The) trials are on… no safety issues so far. We have gone down to the age of seven (with) good results…” Adar Poonawalla said, NDTV reported.
“Our approach for vaccinating children will be with Covovax – the new vaccine awaiting licencing in India and (this) should be done soon. Our approach (will be) to vaccinate children right down to the age of two with Covovax,” the Serum Institute CEO said.
Earlier in October, Poonawalla had said his company won’t “fast-track” the ongoing trials. “By February 2022, we hope to launch Covovax for children. At present, we are undergoing trials. We would not fast-track the trials for this, especially when there’s no urgency to do so,” he told News18 in an exclusive interview.
The SII had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
In June this year, the Serum Institute said it had begun production of the first batch of the vaccine after clinical trials were launched in India in March. It has spoken about launching the vaccine in India by October even as Novavax has said that the partnership with the Serum Institute has contracts to provide more than 1.1 billion doses to the COVAX Facility, which is working to ensure equitable vaccine access for poorer countries.
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 2 to 8 °C refrigerated temperatures. The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.
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