The Serum Institute of India (SII) has started at risk production of its second Covid-19 vaccine, Covovax, in India, according to people familiar with the development.
US biotechnology firm Novavax’s protein-based Covid-19 vaccine, NVX-CoV2373, is being locally manufactured by SII under the brand name Covovax.
The firm is already locally producing the Covishield vaccine developed by Oxford University and AstraZeneca.
“The numbers obviously cannot be disclosed but the manufacturing and stockpiling has already begun like it happened for the Oxford-AstraZeneca vaccine last year; in a small way though,” a person at the industry informed on condition of anonymity.
The development, though, was not confirmed by the Union health ministry or the national drugs controller’s office.
In addition, the Covishield vaccine, SII is also committed to sharing Covovax doses with the COVAX facility to be distributed amongst low- and middle-income countries.
In an interview of last month, SII chief executive officer Adar Poonawalla confirmed that they planned to begin stockpiling soon even though manufacturing was impacted somewhat because of curbs that the US had prior put on export of raw materials.
“…we are starting to stockpile and manufacture Covovax this month itself… Right now, we could have been making twice as much if we had the raw materials; having said that, in the next four to five months, we would have made adequate arrangements from other suppliers outside of the US which is good news, so this is only a temporary problem. We just need it for these three months; after that we will be completely self-reliant,” he stated.
In March, Poonawalla had updated that Covovax clinical trials had begun in India.
Covovax, yet, has not got regulatory clearance anywhere so far.
“After Novavax gets approvals abroad with efficacy trials, then we can look at maybe launching it in India. Having said that, I still want to complete my trials in India for Covovax to be absolutely sure that this product we made is identical to Novavax, and we want to adhere to those standards before we launch the product in India, so it’s going to take two-three months. But the good news is that if we can start stockpiling enough quantities, it won’t matter because in three or four months, we can then give those doses to India, and other parts of the world. The key issue is that we are going to establish that the quality of the product that we are making and stockpiling here is identical to standard quality compared to Novavax, and that’s going to take a couple of months,” he added.
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