With the pandemic raging across many countries and the demand for a safe, efficacious vaccine being huge, availability of an indigenous vaccine will mean guaranteed availability for Indians, while a significant percentage of the Oxford vaccine manufactured here will be earmarked for local consumption.
India’s first indigenous COVID-19 vaccine (COVAXIN) developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research is all set to be tested on humans. The permission from the Drugs Controller General of India to carry out phase-1 and phase-2 human clinical trials was based on the safety and efficacy results of studies carried out on mice, rats and rabbits.
The phase-1 trial of the candidate vaccine using inactivated (killed) novel coronavirus (SARS-CoV-2) will begin this month on a small number of people to test the safety of the vaccine. The vaccine will altogether be tested on 1,125 volunteers in Phase-1 and Phase- 2. The Phase-1 trial will last for 28 days. The virus used for developing the vaccine was isolated by the Pune-based National Institute of Virology from samples collected from infected people in India.
Vaccines from Serum
Meanwhile, the Pune-based Serum Institute is all set to manufacture two-three million doses of the University of Oxford vaccine (ChAdOx1-S) if the results of the phase-1 clinical trial, which are expected in the first week of July, are encouraging. Millions of doses more will be manufactured if the results of the combined phase-2/3 trial are reassuring. In addition, the two companies are collaborating with universities and a biotechnology company to develop three more COVID-19 vaccines.
Who gets the vaccine first
With the pandemic raging across many countries and appears to be around for some time and no antivirals available to treat severe COVID-19 patients, a vaccine that is even partially effective (FDA has specified at least 50% efficacy for standard approval) and protects for about a year will be highly in demand.
Under these circumstances, an efficacious indigenous vaccine will mean guaranteed availability for Indians, while a significant percentage of the Oxford vaccine manufactured here will be earmarked for local consumption. This is one of the reasons why many countries are earnestly attempting to develop a vaccine.
According to the World Health Organization, 17 candidate vaccines are in various stages of human clinical trial, while 132 are at a pre-clinical trial stage.
First off the block
On June 25, China’s CanSino Biologics COVID-19 vaccine (Ad5-nCoV), which is jointly developed by the company and a research institute at the Academy of Military Science, became the first off the block when it was approved for use by the military for a period of one year. The phase-1 and phase-2 trials found the vaccine to be safe with “potential to protect” against disease. It is unclear if the vaccination will be optional or mandatory.
Risk of speeding up trials
While this is not the first time when countries have made vaccines under development available to the military even before the completion of the trial, there is growing concern that speeding up vaccine development by bypassing certain crucial stages of the trial process may prove counterproductive.
In a poll in the U.S., one-third have said they will not get immunised against COVID-19 even if a vaccine was widely available and affordable. While many expect science to find a quick-fix, experts envisage 12-18 months target to get a vaccine commercialised. But that timeline is already seen as aggressive.
Much to gain, much more to lose
If scientists develop a safe, efficacious vaccine soon, public trust in science could grow substantially but have serious consequences if it fails, particularly on the safety aspect. People opposed to vaccination have seized every opportunity to turn public opinion against vaccines and are now eagerly waiting in the wings.
Regulatory agencies therefore have a huge responsibility to ensure that COVID-19 vaccines, unlike hydroxychloroquine, deliver what they promise.