India’s COVID-19 vaccine programme has gained sudden traction but it is imperative to strike a balance between giving it high priority and rushing into a process that takes months, even years, several scientists said on Saturday, a day after the ICMR announced it envisaged a preventive by next month.
There was hope but caution too as the Indian Council of Medical Research on Friday said it aims to launch the world’s first COVID-19 vaccine by August 15.
The same day, Ahmedabad-based Zydus Cadila announced it has got the Drugs Controller General of India’s (DCGI) nod for human clinical trials for a potential vaccine.
“Fast tracking a vaccine trial in four weeks for safety, immunogenicity and efficacy is 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.
Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal, he explained.
Virologist Upasana Ray added that an accelerated launch or promise for launch of a vaccine against the novel coronavirus deserves applause but it is important to ask whether “we are rushing too much”.
“We must rush albeit carefully. Giving this project high priority is absolutely important. However, excess pressure might not necessarily lead to a positive product for public use,” the senior scientist at CSIR-IICB, Kolkata, told.
India’s premier medical body ICMR has said 12 clinical trial sites for the indigenous Covaxin, being developed in collaboration with the Hyderabad-based Bharat Biotech and the National Institute of Virology (NIV), have been identified.
It asked medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7.
“It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials,” ICMR Director General Balram Bhargava said in his letter to the principal investigators of the 12 sites.
The tone of the letter and the haste it indicated had some scientists worried.
They questioned the timeline of the announcement mentioned in the letter, and advised against subverting the due vaccine development process.
“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 told.
Vaccine development is a multi-phase process.
Phase 1 trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans.
Phase 2 trials often involve several hundred subjects, and mainly evaluate the efficacy.
The final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months.
Ray added that a vaccine normally takes at least 12-18 months to pass all necessary clinical trial phases.