With the nationwide COVID-19 vaccination drive kicking off, NSS BITS Pilani conducted a question-and-answer session titled “Vacc-In-Pilani”, with Dr Swapan K Jana. Dr Jana is the Director of R&D and Manufacturing, Serum Institute of India Pvt Ltd. The objective of the session was to gain an insight into the development of the Covishield vaccine. The vaccine was developed by scientists from Oxford University in collaboration with AstraZeneca and is being manufactured on a large scale by the Serum Institute of India (SII).
Dr Jana started this session by highlighting the differences between Covishield and Covaxin—the vaccine approved by the Government of India for emergencies. Covaxin was developed by Bharat Biotech, a pharmaceutical company. Apart from the well-known Covishield, SII has over five vaccines in the development stage. Where Covishield differs from the other vaccines is that it’s made from the replication-deficient chimpanzee adenovirus. The virus is genetically modified to resemble coronavirus, prompting the body to make antibodies that combat it.
Dr Jana went on to talk about the different approaches taken in developing a vaccine. The traditional approach of using an inactivated virus to prepare the immune system against the virus is ineffective as the change in spike protein due to inactivation by heat may affect the efficacy of the vaccine. However, the Codon Deoptimization technique shows great promise. It uses genome analysis to identify proteins that could be used as a vaccine. He expects this technique to have a significant impact on further vaccination development by the end of the year.
Elaborating on the process of development and immediate effect of the vaccine, Dr Jana pointed out that SII conducted clinical trials on a large number of people in various countries. Dr Jana also pointed out that a single dose of Covishield may have prevented 76% of transmissions in just one month in certain areas. “Breaking transmission to take back control over the coronavirus is the way to go,” explained Dr Jana.
Dr Jana then addressed the potential of Novovax in India. Novovax is another vaccine being developed and manufactured by SII. It has reported higher efficacy compared to the other vaccines in the market in several other countries. Dr Jana added that it is very difficult to estimate how successful it will be in India. ‘Clinical data is just statistical calculation,’ he summarised, as he explained how various factors, ranging from economic conditions to healthcare, affect the efficiency of a vaccine in a country. He advised the audience to not jump to conclusions about Novavax in India until all of the data is made available. Dr Jana is hopeful that Novavax will be one of the best vaccines in human history and estimates that it will be launched by June 2021.
While talking about the Serum Institute, the world’s largest vaccine manufacturer, Dr Jana took pride in the fact that SII’s vaccines were considerably cheaper than their counterparts. In fact, SII is the only institute in the world to have 26 WHO qualified products.
Addressing the topics of half doses of the vaccine and herd immunity, Dr Jana said that the Indian government recommends two full doses with a gap of 12 weeks for the best results, although people are allowed to take the second dose after only four weeks. For herd immunity, the rule of thumb is that 70–80% of the population is to be vaccinated. However, since a huge percentage of the population in cities like Delhi already have COVID-19 antibodies, the burden of vaccinating the majority might ease off a bit. He also pointed out that herd immunity is based on factors such as what vaccine is being used, how the pathogen reacts, and how many people are affected. Dr Jana emphasised that everyone’s immune system is different and reacts differently to the virus.
On being questioned about the possibility that side effects of the vaccine may overshadow the benefits it carries, Dr Jana advised the audience to not worry about the side effects. He likened the side effects to a person walking and hurting their feet due to a sharp object; it might hurt a bit, but it doesn’t stop them from walking altogether. Similarly, the side effects of Covishield are, in most cases, very minor, and should not be a hindrance to the vaccination process. Even in comorbid (patients having other serious medical conditions) cases, they are not lethal. “SII has given a lot of thought to the risk-benefit ratio while developing the vaccine. Thus, some small side effects must not hinder the well-being it provides,” Dr Jana added. According to him, a vaccine that is 50% efficient is still beneficial and should be recommended.
When asked about the relationship between the vaccination drive and the reopening of colleges, he said that the day the government allows the vaccine to be marketed, it will be made available to a large number of people. This will provide further help towards developing herd immunity. He added that more than 50% of the vaccine doses produced by the Serum Institute are lying unused in warehouses at present. As a result, when the vaccine does hit markets, it will have a price range of Rs 500-1000. He also said that a large number of companies and corporate associations are looking to purchase the vaccine in bulk for their employees.
Dr Jana was then asked to elaborate on the development, storage, and wastage of vaccines. He replied that the first step is simply R&D. SII rigorously tests the product under all possible conditions. Once they are satisfied that it works to perfection, they apply to the DCGI (Drugs Controller General of India) for approval. After that, the vaccine is manufactured in phases: the vaccines manufactured in Phases 1 and 2 are normally discarded; it is only during Phase 3 that the vaccine is deemed suitable to be administered. After this, they request the government to allow them to store the vaccine. This is done to ensure that once the vaccine is allowed to hit markets, it will take less than a month to begin distribution. The Serum Institute began manufacturing in bulk around August last year. Money has never been an issue as the Serum Institute is well funded by the Gates Foundation as well as Gavi, a global vaccine alliance.
Another important question that was brought up was whether the vaccines are interchangeable between doses. Dr Jana mentioned that, as of now, this was neither allowed nor recommended by any medical board. He said that while there were theories both supporting and objecting this idea, the lack of exhaustive studies made it impossible to recommend.
Dr Jana then elaborated on the effectiveness of the vaccine, particularly regarding how long it would prevent COVID-19 for. He said that as long as a certain amount of antibodies are present in the bloodstream, immunity from infection is guaranteed. However, due to the current lack of data, he said that there was not a particular time frame that could be given for the effectiveness of the vaccine. He mentioned that the small data set and statistical analyses gave a reasonable estimate of 2–3 years. At the very least, the vaccine would be completely effective for one year.
He also debunked the myth that animal meat is used in the creation of the vaccine. He added that the production process involves the use of a special lab-grown culture and does not have any animal-based components.
Dr Jana concluded by asking all students to cultivate a scientific temperament and to work hard in the field they choose. He added that as long as they stay true to themselves, they will be able to tackle any problem thrown their way. He asked students to stay away from social media and instead use the internet to improve their knowledge. “This is one of the most exciting times to be working in,” he signed off.