The Pune-based Serum Institute of India has already begun manufacturing the Oxford vaccine (ChAdOx1 nCoV-19) for novel coronavirus. The company intends to manufacture two-three million doses by end-August.
The Pune-based Serum Institute of India has already begun manufacturing the Oxford vaccine (ChAdOx1 nCoV-19) for novel coronavirus. The company intends to manufacture two-three million doses by end-August, says Suresh Jadhav, Executive Director of Serum Institute.
According to Mr. Jadhav, the company will begin manufacturing vaccines of such quantity that meets the requirements of a commercial-scale batch for phase-3 trial of the vaccine. The number of doses manufactured per commercial-scale batch would depend on whether the vials will be a single- or multi-dose.
Phase-3 trial in India
While phase-3 trials have begun in the UK, Brazil (June 20) and South Africa (first week of July), Serum Institute will soon be seeking permission to carry out a multicentric phase-3 trial here in India. The trial will recruit a few thousand participants.
“Based on the safety and immunogenicity data of the phase-3 trial carried out in India, we will trigger production of the vaccines even before the results are formally available,” says Mr. Jadhav. It might take up to four months to complete the phase-3 trial.
About manufacturing vaccines even before clinical trials are completed, Dr. Anthony Fauci, Director of NIAID told Reuters: “Normal development process of waiting for a vaccine to be proven effective before manufacturing begins wastes precious time. If the vaccine doesn’t work, the only thing you’ve lost is money.”
Capacity to manufacture
In response to whether the company has the capacity to manufacture millions of coronavirus vaccines without impacting the production of regular vaccines, Mr. Jadhav tells me: “The COVID-19 vaccine production will be separate and will not impact the production of other vaccines we normally manufacture.”
In addition to manufacturing the Oxford vaccine, Serum Institute may take up additional manufacturing of COVID-19 vaccines developed by other entities. “Talks are under way with other developers,” he says. “Besides Oxford vaccine, we have the capacity to manufacture COVID-19 vaccines of other developers too without impinging routine vaccine production.”