“A Hurried Gamble”
(Gamble: जुआ/दांव पर खेलना; to do something that involves risks and might result in loss of money or failure)
Opacity (अस्पष्टता; unclearness or haziness) in communication is dangerous when there is high vaccine hesitancy (हिचकिचाहट/संकोच; the failure to do something immediately because you are nervous or not certain)
The stage is set for the biggest vaccine rollout in India’s history with the Drugs Controller General of India formally approving two vaccines for restricted use under emergency conditions: Covishield by the Serum Institute of India (SII), and Covaxin by Bharat Biotech. Though other vaccine candidates are in the fray (मैदान/प्रतिस्पर्धा; a fight or competition in which several people take part) too, these two set a precedent (उदाहरण/मिसाल; a previous action or decision that can be used as a reason or example for a similar action or decision at a later time) for how future COVID-19 vaccines will be evaluated and administered.
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India has been long known as a manufacturer of vaccines but less so as one that can develop from scratch (शुरुआत से; completely from the beginning), test and then provide it to the world. The pandemic offers an unprecedented (अà¤ूतपूर्व; never having happened or existed in the past) opportunity to establish those credentials, but already a key step — of establishing the vaccine’s efficacy (क्षमता/प्रà¤ाविता; the quality of being effective; effectiveness) in the Indian population before rollout — has been sidestepped.
A double-blinded phase3 trial (A double-blind clinical trial is a medical study involving human participants in which neither side knows who's getting what treatment and a placebo or vaccine is given to a control group.) — where some volunteers get the vaccine and some do not and the rate of disease in both arms is compared to determine the vaccine’s ability — is among the foundations of evidence-based medicine.
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The SII because of its agreement with AstraZeneca has furnished data from a phase3 trial in the U.K. and Brazil, but nothing publicly on how protective the vaccine was in 1,600 Indian volunteers. All of the leading vaccine candidates — Pfizer, Moderna and AstraZeneca itself — made public at least partial results of the vaccine’s abilities in their own populations before these were given a go-ahead by the respective regulators.
Bharat Biotech, which is conducting such a phase3 trial in India, is yet to furnish (प्रस्तुत करना; to provide something needed or required) similar data because it has not been able to finish recruiting the required number of volunteers. The Indian data furnished by the companies only attest to the vaccine’s safety and its evoking (आह्वान; to cause something to be remembered or expressed) some immune response.
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However, this pandemic has revealed (बताना/प्रत्यक्ष करना; to make known or show something usually secret or hidden) multiple instances of therapies and interventions — from convalescent plasma therapy (CPT is a passive immunization technique where plasma/serum from a recovered person is used in the treatment of the illness in a patient suffering from the same infection.) to a slew of antivirals (ढेर सारे प्रतिविषाणु; a lot of antivirals) — that seemed to work well under idealised lab conditions but did not measurably protect in real world hospital conditions.
The concern from approving an untested vaccine is that it makes it nearly impossible to conduct a proper phase3 trial. It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere.
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Both SII and Bharat Biotech, given the pace of recruitment and potential pool of volunteers, would have been able to generate much more data within mere (केवल/मात्र; only; and nothing more) weeks. So, it is hard to imagine why an emergency use authorisation of these vaccines was hurried through.
Opacity marks the government’s communication strategy in a country where distrust of vaccines remains in spite of years of vaccination programmes and elimination of grave diseases (गंà¤ीर रोग; serious disease). The government neglects this at the country’s peril (संकट; something that is very dangerous).
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