Bharat Biotech has become a known name in the last few days. It is, after all, the indigenous company to get the Drugs Controller General of India’s (DCGI) approval to go ahead with clinical trials for its coronavirus vaccine candidate COVAXIN.
In various interviews that its Managing Director and Chairperson Dr Krishna Ella has given in the days following the news, he was asked questions that are on many people’s minds – from when the vaccine will be available to how it works and how much it could cost.
The Indian Council of Medical Research (ICMR) on Friday said that it would be carrying out clinical trials of COVAXIN at 12 labs, and has set the launch deadline as August 15, 2020. However, there are concerns about whether this fast-tracking will impact the safety and efficacy of the vaccine.
Incidentally, Dr Krishna himself told The New Indian Express that they hope to have the vaccine ready for public use by early 2021 only.
In an interview to India Today, Dr Krishna had said that phase one of the clinical trial will take 30 days. He explained that they will recruit 1,200 people who will take RT-PCR test and will have to be coronavirus negative. “On day zero, we inject the recruits with the first dose. The second dose will be given on day 14. And on day 28, the blood sample will be drawn. Then we have the serology study which will be done by National Institute of Virology (NIV), Pune as well as Bharat Biotech,” Dr Krishna said.
He added that phase two will begin immediately after phase one. Both phase one and phase two combined, in the best case scenario, will take around three-and-a-half months.
When TNM spoke to two of the 12 institutes selected to carry out COVAXIN’s trials – Jeevan Rekha Hospital in Belagavi and Nizam’s Institute of Social Sciences, Hyderabad – on Friday, representatives said that they will only begin work next week.
With August 15 less than a month-and-a-half away, the possibility to have COVAXIN launch by the said date seems unlikely, experts had told TNM, with one suggesting that the ICMR letter could have had a typing error
where they actually meant to write August 15, 2021.
COVAXIN is made from an inactivated vaccine developed from a strain of the novel coronavirus, which was isolated by NIV, Pune. After receiving the virus strain from NIV, Bharat Biotech developed the first GMP (good manufacturing practices) of COVAXIN within 40 days of this, and started pre-clinical trials.
“COVAXIN was evaluated in animals on Schedule Y Guidelines from India and WHO Guidelines. Covaxin was reported to be safe and immunogenic in all animals,” Dr Krishna told Firstpost.
Speaking about how the human trials will work, Dr Krishna told India Today, “Since it’s a killed virus in the vaccine, it does not multiply. But the body thinks that there is a virus and starts producing antibodies. Once the immune response is produced, we draw the blood sample.”
Once the blood sample is drawn from the person who was administered COVAXIN on the 28th day of phase one trials, the blood sample is then sent to their lab. “At the lab, [active] virus is introduced in the blood sample. The virus shouldn’t multiply at all. This means that it has been neutralised,” Dr Krishna explained.
He also appeared quite confident about COVAXIN and the fact that it employs the tried and tested route of using a killed virus. He said that American company Moderna Therapeutics’s vaccine, as well as Oxford University’s vaccine are both using RNA (Ribonucleic Acid) and viral vector techniques respectively. While RNA vaccines have not been approved for human use yet, inactivated vaccines are a tried and tested form of vaccines which have a good success rate, said Dr Krishna.
When asked about cost, Dr Krishna said that their focus would be towards keeping it affordable. Giving the example of Rotavirus vaccine that Bharat Biotech supplies to 120 countries including India, Dr Krishna said in the India Today interview that while this vaccine is sold for up to $85 by some companies, they sell it for $1 per dose. However, he refrained from giving an estimate on how much COVAXIN could cost.
“As a socially inclined organisation and a company that is focussed on public health, we endeavour to deliver world-class vaccines at affordable prices,” he told Firstpost and TNIE.
In terms of capacity, Dr Krishna said that his vision is to manufacture up to 200 million doses. He did not answer how long it will take to reach that capacity. In another interview though, he said that the company has built capacity to manufacture up to 300 million doses per year. Dr Krishna added that Bharat Biotech will need other companies to also set up manufacturing facilities to serve the demand for the vaccine.
The manufacturing will also depend on whether the vaccine can be administered intra-muscularly or intra-dermally. He explained that intra-dermal vaccine requires a lower quantity of dosage per unit (1/10th of intra-muscular), which can scale up their production. It remains to be seen which of these the coronavirus vaccine would be.
When asked who would get the vaccine first, Dr Krishna said that this decision was up to the government.