WHO clears Serum Institute's Covovax for emergency use

The World Health Organisation (WHO) on Friday issued emergency use listing for anti-COVID vaccine Covovax produced by Serum Institute of India under licence from Novavax, expanding the basket of jabs validated by the global health body against the viral disease.

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.

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 COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally,' it said.

In a joint statement, United States-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.

The EUL pertains to vaccine manufactured and marketed by SII as Covovax, a novel recombinant, adjuvanted SARS-CoV-2 rS vaccine, in India and licensed territories.

An additional EUL filing is under review by the WHO for vaccine to be marketed by Novavax under the brand name Nuvaxovid.

"Today's decision from the WHO is vital to ensuring global access to a protein-based COVID-19 vaccine for hundreds of millions of people around the world," said Stanley C Erck, President and Chief Executive Officer, Novavax.

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.

He tagged Novavax, WHO, Gavi, the Vaccine Alliance, its CEO Seth Berkley and the Gates Foundation in his tweet.

SII already manufactures Covishield in collaboration with AstraZeneca.

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.

Covovax is still awaiting emergency use authorisation from India's drug regulator DCGI.

The grant of EUL was based on the totality of preclinical, manufacturing and clinical trial data submitted for review.

This includes two pivotal Phase 3 clinical trials, which enrolled around 30,000 participants in the US and Mexico, the results of which were published December 15, 2021 in the New England Journal of Medicine (NEJM); and a trial that evaluated the vaccine in more than 14,000 participants in the UK, the results of which were published on June 30, 2021 in NEJM, the joint statement said.

In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.

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 Food and Drug Administration (FDA) by the end of the year.

Novavax has established partnerships for the manufacture, commercialisation and distribution of NVX-CoV2373 worldwide.