A day after asking Bharat Biotech to fast-track COVID-19 vaccine, ICMR on Saturday issued a clarification saying the process is in accordance with globally accepted norms.
ICMR had on July 2 asked Bharat Biotech in an internal communication to fast-track clinical trials of the indigenous COVID-19 vaccine.
In an official statement, ICMR Director General Balram Bhargava had stated that ICMR envisages the launch of the indigenous COVID-19 vaccine by August 15. Bharat Biotech recently got a nod for the clinical trial of its vaccine - COVAXIN.
"ICMR’s process is exactly in accordance with globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel," it said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tapes, without bypassing any necessary process, and speed up recruitment of participants," ICMR added.
Several scientists have expressed concerns saying "it is imperative to strike a balance between giving it a high priority and rushing into a process that takes months, even years."
"Fast-tracking a vaccine trial in four weeks for safety, immunogenicity and efficacy are just not possible if things are to be done correctly,” Shahid Jameel, virologist and CEO of the Wellcome Trust/DBT India Alliance, a public charity that invests in building biomedical sciences and health research framework, told PTI.
“The ICMR 'letter' is, to say the least, a deeply inappropriate letter, in tone and content, both in terms of the integrity of due processes of product development, and in terms of technically realistic estimates,” immunologist Satyajit Rath said.
Meanwhile, Opposition leaders have alleged that the ICMR was trying to fast-track the production of a coronavirus vaccine so that Prime Minister Narendra Modi could make the announcement on Independence Day.
"A vaccine would be the most decisive redemption from the pandemic. The world is waiting for a safe vaccine, which is universally accessible. But...scientific advances can never be 'made to order'. Forcing the development of an indigenous vaccine as a cure for COVID-19, bypassing all health & safety norms, to be announced by PM Modi on Independence Day is fraught with horrendous human costs," CPI(M) general secretary Sitaram Yechury tweeted on Saturday.
Congress leader Prithviraj Chavan, too, on Saturday alleged that the ICMR's plans to launch a coronavirus vaccine by August 15 was aimed only at enabling the Prime Minister to make a big announcement from the Red Fort.
(With agency inputs)Click here for Moneycontrol's full coverage of the coronavirus pandemic