Serum Institute of India (SII) and US biotechnology business 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, whilst SII will manufacture and distribute 1.1 billion doses to low and middle-revenue nations. 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 through the pandemic period in all nations excluding upper-middle/higher-revenue nations.
Novavax has entered into advance obtain 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 nations. SII started manufacturing the Covovax Covid-19 vaccine in June at its Manjari facility in Pune. The Covovax is anticipated to be launched in the nation this September just after regulator approvals. The grant of EUL by the WHO would be necessary to start off SII’s exports to the COVAX Facility.
SII has committed to provide 200 million doses of the Novavax vaccine amongst September and December 2021. Novavax mentioned they have been on track to reach one hundred million dose month-to-month capacity by the finish of the third quarter of 2021 and 150 million dose month-to-month capacity by the finish of the fourth quarter of 2021.
A Novavax statement mentioned they had filed regulatory submissions in partnership with SII for emergency use authorisation in numerous markets, like Indonesia and Philippines. They count on to full regulatory filing with the UK Medicines and Healthcare merchandise Regulatory Agency in the third quarter of 2021. Filing is also anticipated in Canada, Australia and New Zealand as properly 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 current vaccine provide and cold chain channels. The vaccination regimen calls for two .5 ml doses offered 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 all round. There was an one hundred% protection against moderate and extreme illness, 91.% efficacy amongst higher-danger populations, 92.6% efficacy against Variants of Concern/Variants of Interest and one hundred% efficacy against variants.
Novavax also announced that the Covid-19 vaccine booster information demonstrated a 4-fold boost in neutralising antibody levels. A single booster dose at six months enhanced wild-form neutralizing antibodies more than 4-fold, the business mentioned. There was a six-fold boost in antibodies to Delta variant compared to key vaccination series.