The government is readying a document that will chalk out guidelines for companies and institutions working on potential COVID-19 vaccines.
The COVID-19 pandemic has prompted regulators across the world to issue emergency use authorization certain drugs and trials on potential vaccines to accelerate the approval process without compromising on objectively assessing whether the potential vaccine or investigational drug, provides some additional benefit or reprieve, over being defenseless.
“There is likely to be a guidance document for COVID vaccines in a couple of days issued by the Central Drug Standards and Control Organisation,” said Secretary in the Department of Biotechnology Renu Swarup.
There are five promising candidate vaccines from India including Covaxin, from Bharat Biotech, and from Zydus Cadila which were cleared by the Drug Controller General of India for early human trials.
Trials underway in India were “adaptive” trials, Ms. Swarup said. “The guidance document outlines how to maintain rigor while also fast-tracking the process,” Ms. Swarup told.
Adaptive trials have been tried out for HIV vaccines and could include “… vaccinating the placebo group for immune correlate analyses, adding a booster vaccination if vaccine efficacy appears to wane, or expanding the trial design to include a higher risk population,” according to a review article on such trial designs published on April 4, 2013, in the journal Science Translational Medicine. Importantly, they allow investigators to shift goalposts based on data.
While not seen as ideal, researchers consider them acceptable in emergencies.
Last week, scientists and several medical researchers had questioned a letter by Director General, ICMR, Dr. Balram Bhargava, that exhorted institutions involved in the Covaxin trial to ready the vaccine for “public health use by August 15.” The next day the ICMR backtracked from this date.
No process in vaccine development trials would be skipped, said Ms. Swarup. However, it was possible for different phases of the trial to be conducted in parallel. Generally, data from a Phase-1 trial — where a vaccine candidate is tested on a few people to test if it’s safe — informs a Phase-2 trial, where it is again tested on a new group of people to check whether it stimulates the immune system to produce antibodies. It is based on this that companies progress to a Phase-3, where the vaccine is tested on thousands, in real-world settings, to evaluate if it is working. Before each of these phases, usually, investigators must furnish data from the previous phase to regulators. “No phase can be skipped but regulators can give approvals to two phases together,” she added.