India’s largest vaccine manufacturer, Serum Institute of India (SII), the manufacturing partner responsible for producing the Oxford-AstraZeneca vaccine in India, would be distributing 50 percent of its vaccine stockpile to GAVI (Global Alliance for Vaccines and Immunisation) nations once the life-saving vaccine gets approvals, SII CEO Adar Poonawalla told Sputnik.
GAVI, a public-private partnership started by the Bill & Melinda Gates Foundation, aims to ensure equal access to vaccines and healthcare in the world’s poorest countries (about 70-80 nations).
This comes as a significant announcement; fears are rife that most powerful countries will hoard vaccines as they have more purchasing power. The Trump Administration announced on 30 June that it has struck “an amazing deal” by securing 100% stock for July of Remdesivir, a drug made by Gilead Sciences.
Sputnik: The Serum Institute of India is betting big on the UK’s COVID-19 candidate vaccine, developed by Oxford University and AstraZeneca. What made you think that this candidate vaccine is the most potent of all?
Adar Poonawalla: The phase I trials were done by AstraZeneca and Oxford on 1,000 patients while other candidates took the sample size of 60-40 patients only. The T-cell response, if we compare to Chinese vaccine company CanSino, is much better and the vaccine will be able to protect you for a long time based on that. I think that the vaccine candidate holds great potential in becoming the first vaccine to combat COVID-19, based on positive phase I and II trials.
However, we would be able to know the 100% efficacy with phase III trials, which we would be starting in India 3-4 weeks after getting approval.
Sputnik: What would India, the UK and other countries share production of the vaccine? How many dosages would be produced?
Adar Poonawalla: Based on our partnership with AstraZeneca, we will be manufacturing and distributing one billion doses under the name COVASHEILD over the next one year across India and the GAVI nations (about 60-70 countries). Once we get the necessary regulatory approval, 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.
As per our agreement, we are looking at 50% dose distribution in India, while 50% will be distributed to GAVI nations.
Sputnik: What would be the challenges in distributing the vaccine in India, the world's second-most populous country? How will they determine who gets it first?
Adar Poonawalla: During the initial phase, it will be administered under a government vaccine programme. Having said that, I feel that the vaccine should be given to the vulnerable groups to start with; such as healthcare workers, front line staff, children and elderly people with weak immune systems; followed by healthy young adults.
It is important to ensure that the vaccine reaches the most vulnerable and remotest corners of the country. It must be a collaborative effort amongst all the stakeholders involved, buoyed by strengthening our healthcare infrastructure, revisiting our healthcare policies, and fast-tracking regulatory approvals while complying with necessary trials and tests.
Sputnik: How do you compare AstraZeneca’s vaccine to other promising candidates like US drugmaker Pfizer and China's CanSino Biologics, which have yielded positive results so far?
Adar Poonawallah: While each of the companies and their candidates are showing promising results, we can only hope that we will have a vaccine that combats the pandemic soon. Our aim is to provide an efficacious, effective and safe vaccine. But one thing is sure, it’s safe. It has only given mild fever and reactions which are expected of vaccines. It hasn’t resulted in any severe side effects.
Sputnik: The Serum institute has sent the application to Drug Controller General of India (DCGI) run phase III trials in India. What would be the sample size of phase III of the trials and where would it be conducted?
Adar Poonawalla: We will begin with the Phase 3 clinical trials in India around August 2020. For the Phase-III trials, we plan to have 4000-5000 people in India. There are several trial sites across both Mumbai and Pune, since these cities have several hotspots, which will help us understand the efficacy of the vaccine.
