Covid-19 vaccine: Serum, Novavax to file for emergency use authorisation, applies to DCGI for approval

Serum Institute of India (SII) and US biotechnology company Novavax on Friday applied for emergency use authorisation to the Drugs Controller General of India to launch Covid-19 vaccine Covovax in India. Novavax is also filing for a WHO emergency use listing this month.

Novavax would be manufacturing and distributing 350 million doses, while SII will manufacture and distribute 1.1 billion doses to low and middle-income countries. As per the agreement, SII would be commercialising the vaccine in India. SII has got exclusive rights for the vaccine in India and non-exclusive rights during the pandemic period in all countries excluding upper-middle/high-income countries.

Novavax has entered into advance purchase agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses to the COVAX facility. The European Commission has also placed an advance order of 200 million doses. SII would be supplying to COVAX countries. SII began manufacturing the Covovax Covid-19 vaccine in June at its Manjari facility in Pune. The Covovax is expected to be launched in the country this September after regulator approvals. The grant of EUL by the WHO would be needed to start SII’s exports to the COVAX Facility.

SII has committed to supply 200 million doses of the Novavax vaccine between September and December 2021. Novavax said they were on track to achieve 100 million dose monthly capacity by the end of the third quarter of 2021 and 150 million dose monthly capacity by the end of the fourth quarter of 2021.

A Novavax statement said they had filed regulatory submissions in partnership with SII for emergency use authorisation in multiple markets, including Indonesia and Philippines. They expect to complete regulatory filing with the UK Medicines and Healthcare products Regulatory Agency in the third quarter of 2021. Filing is also expected in Canada, Australia and New Zealand as well as the USFDA in fourth quarter of 2021.

Novavax’s Covid-19 vaccine is a recombinant nanoparticle protein-based vaccine that is stored at 2° – 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. The vaccination regimen calls for two 0.5 ml doses given intramuscularly 21 days apart.

The Novovax vaccine trials in UK demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha variant and 89.7% efficacy overall. There was an 100% protection against moderate and severe disease, 91.0% efficacy among high-risk populations, 92.6% efficacy against Variants of Concern/Variants of Interest and 100% efficacy against variants.

Novavax also announced that the Covid-19 vaccine booster data demonstrated a four-fold increase in neutralising antibody levels. A single booster dose at six months increased wild-type neutralizing antibodies more than four-fold, the company said. There was a six-fold increase in antibodies to Delta variant compared to primary vaccination series.