WHO Approves Covovax For Emergency Use: All You Need To Know About India-Made Covid-19 Vaccine

In what is being seen as another gain in India's vaccine manufacturing sector, the World Health Organisation on Friday issued an emergency use listing for anti-Covid vaccine Covovax. The latter is produced by the Serum Institute of India under licence from Novavax. With the new approval, WHO is expanding the basket of jabs validated by the global health body against the viral disease.

The EUL pertains to vaccines manufactured and marketed by SII as Covovax, a novel recombinant, adjuvanted SARS-CoV-2 rS vaccine, in India and licensed territories. As of now, Covovax is still awaiting emergency use authorisation from India's drug regulator DCGI.
Covovax is manufactured by SII, which already manufactures Covishield in collaboration with AstraZeneca. An additional EUL filing is under review by the WHO for the vaccine to be marketed by Novavax under the brand name Nuvaxovid.

WHO approves Covovax

Covovax is the ninth Covid-19 vaccine to be listed for emergency use by the WHO. It is produced by the Serum Institute of India under the licence from Novavax. The approval was given with the aim of providing higher access to vaccines in lower-income countries.

According to WHO, Covovax was assessed under its emergency use listing 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 (DCGI).

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 Covis-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally, the apex health body said,

In a joint statement, US-based Novavax, Inc and SII noted that the approval is for active immunisation of individuals 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2.

How India reacted to WHO approval

The WHO approval was met with cheers and enthusiast from Indian scientists, doctors as well as citizens. Adar Poonawalla, the CEO of Serum Institute of India (SII), hailed WHO's decision as "yet another milestone" in the fight against Covid-19.

"WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax," the world health body said in a tweet on Friday.

The vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology, he added.

"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...", Poonawalla tweeted.

Covovax for children?

Earlier this week, Poonawalla had said that SII planned to launch Covovax in the next six months. He had stated that Covovax would offer protection to children down to three years as it had shown excellent data during the trials. Currently, Covishield and other Covid-19 vaccines are approved for people above the age of 18

Novavax and SII recently received emergency use authorisation (EUA) for Covovax in Indonesia and the Philippines. The vaccine is also currently under review by multiple regulatory agencies worldwide. The company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the US FDA by the end of the year. Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.

Covovax as a booster

Several experts such as Shahid Jameel and members of INSACOG, the government's genome sequencing monitoring agency have agreed that Covovax can be used as a booster shot due to the strong immune response it induces and due to its high safety profile.

(With inputs from PTI)