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Covovax data with DCGI, approval expected soon

Approval for Serum Institute of India- (SII-) manufactured Covovax, the Indian version of US major Novavax’s protein sub-unit Covid-19 vaccine, is expected anytime. Sources said the nod may even come as early as December-end after the world’s top health body and the European Medicines Agency (EMA) gave their thumbs up to the vaccine recently.

“Data from the Indian arm of the trials have been submitted and the review is on. With the World Health Organisation (WHO) and EMA giving their nods, the process of approval in India becomes that much easier,” said a source.

Adar Poonawalla, CEO of SII had earlier indicated that the approval for Covovax may come in by December-January. Novavax had applied for an emergency use authorization (EUA) with its partner SII on August 5 with the Drugs Controller General of India (DCGI) and regulatory bodies in Indonesia and Philippines.

India has said any vaccine that has approval from stringent regulatory bodies like the USFDA, UK-MHRA, etc., will be approved for use in India. The WHO and EMA approvals are thus helpful to expedite the approval timelines here.

Poonawalla had said in September that by January-February, the data from the children trials of Covovax may be ready and submitted with the Indian drug regulator. In September, the Subject Expert Committee (SEC), which is advising the Central Drugs Standard Control Organisation (CDSCO), allowed enrolling of candidates seven years and above for Covovax trials.

SII has already started to stockpile the Covovax vaccine, which is expected to see demand as a booster shot for those who have received Covishield, the AstraZeneca vaccine. SII, however, declined to comment on volumes it has stockpiled at its Pune plant.

“Novavax is expecting to produce approximately 2 billion doses of our vaccine in 2022 across our global manufacturing network.”a Nivavax spokesperson said.

The company added that Serum Institute will manufacture and commercialise Covovax for India and several other markets. In partnership with Novavax, they will also produce doses for COVAX.

Novavax said production of doses is ongoing. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.

Poonawalla has said earlier that the targeted production of Covovax is 50 million monthly doses. The numbers could vary if demand is higher. This is one-fifth of the Covishield capacity of 250 million doses a month that SII has. However, the company has reduced its Covishield capacity by half in the wake of slowdown in demand and no fresh orders from the government.

SII has a stockpile of 500 million Covishield doses — half of which are bulk product, and remaining are finished doses. The company can stock 600-700 million doses of the vaccine at its Pune site, and expects exports to pick up soon.

The vaccine, NVX-CoV2373, is a protein-based vaccine candidate that uses nanoparticle technology to generate antigen derived from the Sars-CoV-2 spike protein. It is formulated with Novavax’s patented adjuvant Matrix-M to enhance the immune response.

It has been evaluated in two pivotal phase 3 trials – the UK trial has shown an efficacy of 96.4 per cent against the original virus strain, and 86.3 per cent against the Alpha variant. In the US and Mexico trials, the shot showed 90.4 per cent efficacy overall and 100 per cent success in preventing moderate or severe disease. Business Standard

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