Q. What kind of response have you seen in phase 1 and 2 of the clinical trials? When will the Serum Institute conduct trials in India?
A. The phase 1 and 2 trials have been successful in proving the vaccine immunogenic. With that we are now progressing towards the next phase of trials. We seek to apply for licensure trials in a week’s time in India. With the government fast-tracking everything, we are hoping to get approvals soon. After that we will begin phase 3 (human trials) here in India with 4,000-5,000 people.
Q. How will this vaccine work? How helpful will it be in stopping the rise of Covid-19 cases?
A. The vaccine, branded as Covishield, is a viral vector type that uses a harmless virus to deliver the genetic material of a pathogen into cells, which is then supposed to create an immune response against the original pathogen. A chimpanzee adenovirus (a common cold virus) has been used by Gilbert and his team to be the carrier. To trick the immune system to fight back Covid-19, the harmless virus was inserted with the SARSCoV-2 virus’ genetic material.
We can only comment on the efficacy of the vaccine once it clears all the requisite tests and trials. Having said that, so far, the OxfordAstraZeneca vaccine is one of the vaccines which is showing promising results based on ongoing trials and has been cleared for the final phase!
Q. What should be the target and delivery procedure after getting the vaccine?
A. In the initial phase, it will be a government-administered vaccine programme. It is important to ensure that the vaccine reaches the most vulnerable sections and remotest corners of the country. I feel that the vaccine should be given to vulnerable groups to start with, such as healthcare workers, frontline staff, children and elderly people with weak immune systems. Healthy young adults can get it later. It must be a collective effort amongst all the stakeholders involved.
Q. What would be the price of the vaccine in India?
A. It is too early to comment on the pricing, but we would like to keep it under Rs 1,000 initially. However, we are certain that it will be affordable, and hopefully, procured and distributed by governments free of charge in the beginning.
Q. How many doses have you planned to supply? By when will it reach the masses?
A. Once we get the necessary regulatory approvals, we will start manufacturing 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. I believe by the first quarter of the next year it will start reaching the masses.
Q. How do you plan to manage the manufacturing? Do you have enough capacity to manufacture the Covid-19 vaccine?
A. Our facility is well-equipped with state-of-the-art technology to manufacture the Covid-19 vaccine. We have dedicated two facilities within our premises to ensure maximum production capacity for the Oxford-AstraZeneca Covid-19 vaccine. We plan to start production post regulatory approvals.
Q. When are the human trials going to begin in collaboration with Codagenix?
A. The Codagenix candidate is in its pre-trial phase and it is expected to progress to the human trial phase towards the end of this year.