Covovax approval delayed in India as DCGI expert panel asks for more data: Sources

US-based biotechnology firm Novavax's application to the Drugs Controller General of India seeking the approval of its COVID-19 vaccine 'Covovax' has faced a roadblock, sources revealed on Sunday. While the submission took place in August, the expert panel of DCGI has sought additional data from the firm before taking a call on this vaccine's approval. Moreover, it also highlighted the fact that the US Food and Drug Administration is yet to authorise Covovax for emergency use. 

In June itself, Novavax's Indian partner Serum Institute of India commenced the production of the first batch of this vaccine at its Pune facility. As per the agreement, the SII is responsible for manufacturing and commercializing Covovax in India. Notably, Novavax and SII have pledged to provide over 1.1 billion doses of this vaccine to the COVAX facility.

While Indonesia became the first country to grant Emergency Use Authorization to Covovax, it is yet to be approved by the World Health Organization, the European Union, the UK, Australia, Canada and New Zealand. The emergency use approval can be a gamechanger amid the COVID-19 crisis as it is likely to encourage countries to import the vaccine, facilitate its manufacturing abroad and ease global travel for those vaccinated with it. Until now, the DCGI has accorded emergency use authorization to Covishield, Covaxin, Sputnik V, and Moderna. 

What is Covovax? 

Branded as the first protein-based COVID-19 vaccine, Covavax is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. It was created using recombinant nanoparticle technology and formulated with Novavax's Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. As per the phase 3 trial conducted in the UK, it demonstrated an overall efficacy of 89.7% and 86.3% efficacy against the Alpha (B.1.1.7) variant.

On the other hand, the results of the phase 3 trials in the US and Mexico showed an overall 90.4% efficacy and 100% efficacy against moderate and severe COVID-19 disease. The two doses of Covovax, packaged as a ready-to-use liquid formulation, have to be administered 21 days apart. Most importantly, this vaccine can be stored at 2°- 8° Celsius enabling the use of existing vaccine supply and cold chain channels.

COVID-19 vaccination in India

At present, there are 1,05,691 active novel coronavirus cases in India whereas 3,39,98,278 patients have recovered and 4,68,554 deaths have been reported. The improvement in India's COVID-19 situation has been attributed to the rapid progress in vaccination. Apart from Covishield and Covaxin, the DCGI has approved Sputnik V, Moderna, Johnson & Johnson's Janssen vaccine, and Zydus Cadila's ZyCoV-D. A total of 78,37,52,463 persons have been inoculated whereas 43,69,64,109 of them have received the second dose of the vaccine too.