I believe Covishield will reach masses by first quarter of next year

In an interview with IANS, Adar Poonawalla, CEO, Serum Institute of India (SII) said as per the arrangement with AstraZeneca, SII will be making one billion doses of Covishield vaccine over the next one year for India and other low-and-middle-income countries (GAVI countries).

“We will start producing a few millions of doses at a personal risk. Based on the success of the trials, we are expecting to launch it by the end of this year. I believe by the first quarter of the next year it will start reaching the masses”, Poonawalla said.

“Once we get necessary regulatory approvals, we will start manufacturing in large volumes. We will manufacture about 60-70 million doses per month (which might stretch to 100 million doses later). With this, we are looking to manufacture around 300-400 million doses by the end of this year”, Poonawalla said.

The Phase 3 clinical trials are expected to commence in India around August 2020. For the Phase 3 trials, we plan to look at 4000-5000 patients in India, he said.

On the pricing of the vaccine, he said, “It is too early to comment on the vaccine’s price. However, we will keep it under Rs 1,000. Having said that, our aim is to provide an efficacious and affordable vaccine. We are certain that it will be procured and distributed by governments without charge”.

Q: When will the India trials for Covishield start?

A: Phase 3 clinical trials are expected to commence in India around August 2020. For the Phase 3 trials, we plan to look at 4,000-5,000 patients in India.

Q: AstraZeneca has mentioned the SII tie up. How many vaccines are licenced?

A: As per our arrangement with AstraZeneca, we will be making one billion doses of COVISHIELD over the next one year for India and other low-and-middle-income countries (GAVI countries). Once we get necessary regulatory approvals, we will start manufacturing in large volumes. We will manufacture of about 60-70 million doses per month (which might stretch to 100 million doses later). With this, we are looking tomanufacture around 300-400 million doses by the end of this year.

Q: What will be the cost?

A: It is too early to comment on the vaccine’s price. However, we will keep it under Rs 1,000. Having said that, our aim is to provide an efficacious and affordable vaccine. We are certain that it will be procured and distributed by governments without charge.

Q: When will the vaccine be available in the Indian market?

A: We will start producing a few millions of doses at a personal risk. Based on the success of the trials, we are expecting to launch it by the end of this year. I believe by the first quarter of the next year it will start reaching the masses.

Q: How do you see the progress of other potential candidates from Pfizer and Moderna?

A: Based on the available information, their trials are progressing at a gradual pace. There is no one-upmanship in a scenario such as this! All of us are just aiming to win the war against the novel Coronavirus and provide an efficacious, effective and immunogenic vaccine to the world at the earliest.

Q: Are there more global trials pending for the Oxford and AstraZeneca vaccine?

A: Following the positive results of the Phase 1/2 trials, the AstraZeneca-Oxford Covid-19 vaccine will go through phase 2/3 trials across various parts of the world, including India. We are in the process to apply for licensure trials across 11-12 hospitals in the country. Following the positive outcome of the trials and once we receive the requisite approvals, we will commence distribution across India and GAVI nations (60-70 countries).

Q: You have said SII will not take profit from this vaccine?

A: In the interest of public health and as one of the largest vaccine producers it is our responsibility to make the vaccine affordable for the public at-large.