The Serum Institute of India (SII) on Friday said it has applied for Emergency Use Authorisation (EUA) for US-based company Novavax’s vaccine Covovax in India. Novavax Inc has a vaccine manufacturing agreement with SII who manufactures Covishield vaccine currently administered in India’s vaccination drive.
SII CEO Adar Poonawalla announced he is hopeful that Covovax will be launched in October for adults and for children by the first quarter of 2022. Poonawalla who met Home Minister Amit Shah in Parliament said he is thankful to the government for all the support said the company is always trying to expand its Covishield production capacity to meet the demand.
Poonawala said he is hopeful that for adults Covovax will be launched in October, depending on DCGI approvals. It will be a two-dose vaccine and the price will be decided at the time of launch, he added.
Novovax’s Regulatory Approval
The company has filed for regulatory approval in India, Indonesia and the Philippines. Novovax said it plans to submit the vaccine for emergency use listing at the World Health Organization (WHO) in August. A WHO recognition for Covovax will allow the vaccine to be distributed across the globe through the COVAX facility.
The company announced it also plans to submit applications in Britain soon, followed by Europe, Australia, Canada and New Zealand. However, the company said it will delay the submission of emergency use approval of its vaccine from the US Food and Drug Administration until the fourth quarter.
Novavax CEO Stanley Erck called the submissions an important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic.
The two-dose shot is made with lab-grown copies of the spike protein that coats the coronavirus. The vaccine is very different from other widely used vaccines that deliver genetic instructions for the body to make its own spike protein.
The doses are easier to store and transport than some other options, and have long been expected to play an important role in increasing supplies in poor countries desperate for more vaccine.
In June, Novavax announced the vaccine had proved about 90 per cent effective against symptomatic Covid-19 in a study of nearly 30,000 people in the US and Mexico. It also worked against variants circulating in those countries at the time. Side effects were mostly mild, it had said.
Novovax Booster Shots
Amid growing concerns over the spread of the new Delta variant of coronavirus, the company citing clinical trials said a booster dose provides a four-fold increase in neutralising antibody levels. Additional studies in Britain and elsewhere are testing if the Novavax shot could be used as a booster after other types of Covid-19 vaccines.
A booster shot of a Novavax vaccine six months after completing the second dose of an approved vaccine could provide increased protection against the delta variant and other variants, the trial data said.
The company said it was on track to produce up to 100 million doses a month by the end of the third quarter and 150 million doses a month by the end of the fourth quarter.