The Serum Institute of India (SII) is ramping up production of the Oxford vaccine candidate in anticipation of it passing trials. DW spoke with Serum's CEO Adar Poonawalla about when a vaccine could be ready.
Adar Poonawalla (main picture, center), the chief executive officer of Serum Institute of India (SII), is busy these days. SII, the world's largest producer of vaccines by volume, is already starting production on a novel coronavirus vaccine candidate developed by the Jenner Institute at Oxford University.
Researchers at Oxford started testing the candidate vaccine, "ChAdOx1 nCoV-19," on more than 1,110 people last month. Trials determine the efficacy of a vaccine while identifying possible side effects.
Last week, a study showed that the Oxford vaccine was able to prevent SARS-CoV-2-related pneumonia in primates.
In an interview with DW, Poonawalla said he is hopeful India will play a decisive role in manufacturing a vaccine, and, pending successful trials, up to 40 million doses could be ready by October.
Based in the western Indian city of Pune, SII makes 1.5 billion vaccine doses every year, and the company currently produces around 20 vaccines for 165 countries.
DW: Why has the Serum Institute started manufacturing the Oxford vaccine candidate before trials have been completed?
Adar Poonawalla: The decision was made solely to have a head-start on manufacturing and to have enough doses available. The distribution of the doses will only commence once the trials are successful and it is proven the vaccine is effective and safe for use.
We are also working on conducting our own human trials in India this month. The focus of initial tests is to ascertain whether the vaccine works, induces a good immune system response and has no unacceptable side effects.
How confident are you that the Oxford candidate vaccine will work?
More than 100 potential COVID-19 candidate vaccines are now under development by biotech and research teams around the world. At least six of these are in preliminary testing in humans for what are known as Phase 1 clinical trials.
Although the Oxford vaccine, called "ChAdOx1 nCoV-19," has not yet been proven to protect against COVID-19 infection, Serum decided to start manufacturing after it showed promise in the pre-clinical phase and progressed to human trials.
There are several indicators that the vaccine being developed by Oxford will be a good one. The technology of this vaccine has been successful before and we are hopeful this will be safe as well.
We need to be lucky in the clinical trials to get enough people without COVID-19 in the control group to show conclusively that the vaccine is working well.
But the fact that we have a potential vaccine candidate in such a short period of time is definitely something to cheer about.
Even if we are able to create a vaccine soon, what do you think about the challenge of manufacturing billions of doses?
It's too early to comment on what other manufacturers are going to do at this point, but we will surely keep pricing affordable. We aim to manufacture 4 to 5 million doses per month, and then we want to scale up production to 10 million doses a month, based on the success of the trials.
We anticipate manufacturing up to 20-40 million doses by September-October. If the trials are successful, we will make the product available in as many countries as possible, including India. When a vaccine is developed, we plan to sell it for around €12 ($13) per dose.
We are partnering with Indian Council of Medical Research for the clinical trials and are also in touch with the Department of Biotechnology.
I will leave it to the Indian government to decide which countries will get how much of the vaccine and when.
What should be done to boost production for top vaccine candidates so that there's widespread availability in every country after the vaccine is developed?
Both affordability and reliability are key. At this stage, we need multiple companies across the world to try various vaccine trials.
For example, through our association with US-based biotechnology firm Codagenix, we have developed a vaccine-virus strain that is identical to SARS-CoV-2.
We have commenced our pre-clinical trials and hope to progress to the human trial phase by September or October. The aim is to make that vaccine available by early 2021 to combat the novel coronavirus.
Is there a plan B, if trials this year show the vaccine does not work?
Typically, vaccines go through various stages of research, which involve testing on animals and at least three phases of clinical trials. All this can take several years, sometimes up to a decade. But this is an extraordinary situation affecting the world.
A vaccine is the only thing to return normalcy to the world, and this calls for development projects to be accelerated.
However, although there are now around 150 vaccine development projects worldwide, there are only five clinical trials on humans that have been approved across the globe.
Does the coronavirus pandemic point to the need for new vaccine development paradigms?
With COVID-19 being a unique challenge, team work and global partnerships will be crucial in bringing forth a safe and effective vaccine available to all. The big vaccine makers already have distribution networks in place. They will be able to reach across the globe very quickly.
The interview was conducted by Murali Krishnan, DW’s correspondent in New Delhi.