India-made Covovax on Friday became the ninth Covid-19 vaccine to receive WHO’s emergency use listing approval, with manufacturer Serum Institute of India hailing the moment as another milestone.
Serum Institute of India (SII) CEO Adar Poonawalla on Friday hailed WHO’s approval for emergency use of Covovax vaccine “as yet another milestone” in the fight against Covid-19.
The World Health Organization (WHO) on Friday listed the Covovax as the ninth Covid-19 vaccine for emergency use with an aim to increase the access to vaccination in lower-income countries.
It is produced by the Serum Institute of India under the licence from Novavax.
Reacting to the development, Poonawalla tweeted, “This is yet another milestone in our fight against Covid-19, Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration…”
He tagged Novavax, WHO, Gavi, the Vaccine Alliance, its CEO Seth Berkley and the Gates Foundation.
Adar Poonawalla: “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.”
Currently, Covishield and other Covid-19 vaccines are approved for people above the age of 18.
According to WHO, Covovax was assessed under its emergency use listing (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.
Covovax 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. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.
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.
The originator product produced by Novavax is currently under assessment by the European Medicines Agency (EMA).