Since there is no cure for the disease to date and prevention seems to be the only saviour, the world is waiting with bated breath for a vaccine against the virus.
It’s been more than six months since the dreaded coronavirus hit the world. Over eleven million people, the world over, had been infected with the deadly disease so far and about 5.25 lakh people have lost their lives. In India alone, the figures are huge and are growing leaps and bound every day. Amidst this scare, Bharat biotech shot the headlines yesterday when ICMR’s Balram Bhargava said in a letter to Bharat Biotech, “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.”
What is Covaxin?
Covaxin Is India’s first COVID 19 vaccine candidate, developed by Bharat Biotech India (BBIL) a Hyderabad based biotechnology firm which is working closely with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The Central Drugs Standard Control Organisation (CDSCO) has allowed BBIL to hold Phase I and II of human clinical trials, which are scheduled to start across India from July.
There are a few very pertinent questions arising here:
Whether the vaccine is indigenously developed?
The claim that Covaxin is indigenous by the managing director of Bharat Biotech, Krishna Ella, raises some doubts.
The vaccine seems to have arisen De Novo. There were no prior announcements to this effect earlier by the company, which usually is expected when such a vaccine is developed. Bharat Biotech Claims that it has acquired the strain from NIV, but there isn’t any further information regarding the nature of the vaccine, and how it is developed.
ICMR transferred the strain NIV had isolated to Biotech Bharat on the ninth of May 2020. The company published its press release on June 29. So there were only 50 days in between, during which time the company should have developed the inactivated vaccine, conducted preclinical animal trials (with mice and hamsters, according to the company), and sent its reports to be evaluated and approved by DCGI.
Is the vaccine developed in collaboration with a US company?
There are speculations regarding the origin of COVAXIN, that they develop the vaccine in collaboration with a foreign company. Interestingly, Bharat Biotech has also invested in one other vaccine recently, the CORAVAX, in association with Jefferson Vaccine Centre (JVC).
Coravax uses an inactivated rabies vaccine to carry the spike protein of the novel coronavirus. The benefit is that the ‘carrier’ vaccine has already been rigorously tested and shown to be safe and effective. There are manufacturing plants around the world already running and with the technological know-how to produce large quantities of that vaccine. One can leverage that efficiency and safety record. The spike protein attaches to a host cell and causes an infection, so experts expect this vaccine to trigger a good immune response.
In early 2019, Bharat Biotech acquired Chiron Behring Vaccines Pvt. Ltd. from GlaxoSmithKline and ramped up production of the rabies vaccine Chirorab to 15 million units a year. So the company already has the ability to mass-produce this vaccine.
Were the animal trials compromised?
There are questions regarding the vaccines animal trials as well. Animal trials for COVID-19 can only be conducted with hACE2 transgenic mice, as ‘normal’ mice can’t get infected with the novel coronavirus. These mice need to be shipped from the US, Europe or China, a fact which Ella has also acknowledged. Krishna Ella said in an interview on April 7: “It will take at least three months to do animal trials to establish the safety properly.”
Whether it is possible to launch the vaccine in such a brief span of time?
A vaccine usually goes through three phases of human trials. As per the BBIL’s submission in its application to CTRI the Phase I and II trials will take one year and three months. Phase I alone will take at least a month.
How this can be achieved without compromising safety remains a challenge. Most of the other vaccine companies in the world with their most ambitious projects have kept a longer time frame.
I do believe that during the times of crisis like this pandemic, the trials could be fast-tracked with certain riders to provide additional data in due course, but it still will consume a considerable amount of time.
So, this dream of seeing a COVID saviour vaccine is definitely looking some distance away. And I expect a clarification will follow soon.