COVID-19 vaccine: SII plans to conduct bridging trial for Novavax's candidate in Feb, says CEO1 min read . Updated: 14 Jan 2021, 03:55 PM IST
- The world’s biggest vaccine maker will start stockpiling millions of doses of the Novavax coronavirus vaccine candidate starting around April, said CEO
The Serum Institute of India will try to conduct the bridging trial for Novavax's COVID-19 vaccine candidate in India in February, said CEO Adar Poonawalla on Thursday. Bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.
The world’s biggest vaccine maker will start stockpiling millions of doses of the Novavax coronavirus vaccine candidate starting around April, CEO told the Reuters Next conference.
“Upwards of 40-50 million doses per month is what we are trying to stockpile starting from April," he said.
India's expert panel on coronavirus vaccine, had earlier asked Pune-based drugmaker to submit interim safety data from phase II clinical trial of Novavax vaccine candidate along with the recommendations of Data Safety Board before starting phase III trial in India.
In August, Novavax signed a deal with Pune-based Serum Institute, to produce a minimum of one billion doses of its vaccine candidate, when approved, for low- and middle-income countries and India. Later, the US drug developer doubled its potential COVID-19 vaccine manufacturing capacity to two billion doses annually.
Dubbed NVX‑CoV2373, Novavax's vaccine is currently in mid-stage trials. The early-stage study showed it produced high levels of antibodies against the novel coronavirus.
British-Swedish firm Astrazeneca also signed a deal with Serum Institute of India to manufacture the COVID-19 vaccine developed by the University of Oxford. Dubbed as Covishield, the vaccine already received emergency authorisation in Britain, India and other countries.
The Pune-based drugmaker believed that World Health Organization would soon grant emergency-use authorisation for the Oxford University-AstraZeneca coronavirus vaccine, Poonawalla said.
"The emergency use licensure from the WHO (World Health Organization) should be available and coming through in the next week or two, hopefully, because we have submitted everything," he added.
The Serum Institute CEO said a special purpose vehicle housing its pandemic-related products should be valued at $12 billion to $13 billion.