COVID-19 vaccine: Scientists strike note of caution

New Delhi Indias COVID19 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 monthThere was hope but caution too as the Indian Council of Medical Research on Friday said it aims to launch the worlds first COVID19 vaccine by August 15 The same day Ahmedabadbased Zydus Cadila announced it has got the Drugs Controller General of Indias DCGI nod for human clinical trials for a potential vaccineFast 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 TrustDBT India Alliance a public charity that invests in building biomedical sciences and health research framework told PTIImmunogenicity 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 explainedVirologist 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 muchWe 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 CSIRIICB Kolkata told PTIIndias premier medical body ICMR has said 12 clinical trial sites for the indigenous Covaxin being developed in collaboration with the Hyderabadbased Bharat Biotech and the National Institute of Virology NIV have been identifiedIt asked medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7It 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 sitesThe 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 processThe 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 PTIVaccine development is a multiphase process Phase 1 trials are smallscale 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 efficacyThe final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time and can last several monthsRay added that a vaccine normally takes at least 1218 months to pass all necessary clinical trial phasesFrom now till August 15 the company has just over a months time to wrap up everything that normally a vaccine development process requires for releasing a vaccine for clinical use she saidHow can such a sharp timeline be even decided Where does the evidence come from that by such a short time all the essential steps will be completed What about the safety and efficacy the fundamental steps of any drug development Have even the preclinical studies been completed Too much rush comes with possible risks she saidRay noted that there are some broad mandatory steps for developing a vaccine Preclinical tests in small animals and mammals she stressed are essential to assess neutralising antibody titers and that itself can take at least a month or twoA titer is a laboratory test that measures the presence and amount of antibodies in bloodNext we check for safety Then is the human trial Even if we are in a deep rush we have to wait for some time for immunised individuals to start generating antibodies After that a population needs to be monitored over time to investigate if people are still being infected she explainedSkipping steps could either be dangerous or lead to poor product Ray saidWe must not compromise with the standard the quality We dont need to be the first to launch a drug but what we need is a Made in India vaccine that the entire world can rely on she addedThe vaccine landscape in India has been also bolstered after the approval for Zydus Cadilas vaccine candidate It was fasttracked following a recommendation by the subject expert committee on COVID19 considering the emergency and unmet medical need during the pandemicDCGI Dr V G Somani has given approval for the phase I and II clinical trials on humans of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd on Thursday after its animal studies were found to be successful an official source saidJameel winner of the 2000 Shanti Swarup Bhatnagar Prize for Science and Technology one of the highest Indian science awards noted that it is a vaccine funded by Biotechnology Industry Research Assistance Council BIRAC and the Department of BiotechnologyCongratulations to Cadilla BIRAC and DBT We would look forward to properly conducted trials and good news in due course he told PTII am glad that a locally made vaccine candidate is making the same progress that others elsewhere in the world are making not just with SARSCoV2 vaccine candidates but with DNAbased SARSCoV2 vaccine candidates and I will look forward to the resultsiquest added Rath from Delhis National Institute of Immunology NIIGautam I Menon professor from the Departments of Physics and Biology at Ashoka University said Zydus Cadilas vaccine appears to have shown safety and efficacy in animal trials and so they have been allowed to go to the next step to human trialsThis is the standard procedure It is the human trials that are timeconsuming and it is important to get this right Menon told PTIIn another development Serum Institute of India SII CEO Adar Poonawalla told The Tribune newspaper that the Covid19 vaccine being developed at the University of Oxford will hit the market by the yearendChAdOx1 nCoV19 is made from a virus ChAdOx1 which is a weakened version of a common cold virus adenovirus that causes infections in chimpanzees and has been genetically changed so that it is impossible for it to reproduce in humansI think it is likely that the ChAdOx1S vaccine candidate which has entered a phase 3 clinical trial in Brazil will give at least somewhat promising results by late this calendar year Rath saidWhether this will lead to the vaccine becoming available in the market and in the public health system more importantly by the end of this calendar year in India is much more uncertain Mr Poonawalas welcome optimism notwithstanding he addedCatch up on all the latest Crime National International and Hatke news here Also download the new midday Android 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