Transparency Is Vital: The Hindu Editorial With Hindi Word Meaning | 8 December 2020 |

“Transparency Is Vital”

Vital: महत्वपूर्ण/अत्यावश्यक; necessary or extremely important

Safety and efficacy (क्षमता/प्रभाविता; the quality of being effective; effectiveness) data must be known before emergency­-use authorisation for vaccines

A day after Pfizer sought (मांगना; to try to get something or to ask for approval) the Indian regulator’s nod (सहमति/मंजूरी; to show agreement or getting approval) for emergency­-use authorisation for its mRNA vaccine, the Pune­-based Serum Institute of India has approached the regulator for a similar nod for its vaccine, Covishield, developed by Oxford University.

Unlike Pfizer, AstraZeneca, which is carrying out the phase­3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies (नियामक/नियंत्रक संस्था; an organization who checks whether a business is working according to official rules or laws). 

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AstraZeneca recently gave details of the interim (अन्तरिम/अल्पकालीन; temporary and intended to be used or accepted until something permanent exists) safety and efficacy data involving 131 COVID­19 cases in the phase­3 trials in the U.K. and Brazil. But details of the trials in India are not out yet.

The unprecedented (अभूतपूर्व; never having happened or existed in the past) speed in taking the vaccine from the development stage to approval process in less than a year is remarkable, and perhaps necessitated by the toll (क्षति; suffering or damage) the virus has taken on lives and livelihoods.

But this is not without cause for concern at a time when governments are putting pressure on regulatory bodies to fast­track the entire process. Lack of transparency about vaccine safety and efficacy does no good in gaining people’s confidence and willingness to get vaccinated. 

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While Moderna, Pfizer and AstraZeneca took the extraordinary step of publicly sharing the trial protocol (नवाचार/संदेशाचार; set of rules to be followed when doing a scientific study or an exact method for giving medical treatment), the time points at which interim analysis of phase­3 trial in India will be carried out for safety and efficacy is unclear.

While the U.S. FDA has clearly spelt out (स्पष्ट करना; to explain something in a very clear way with details) at least 50% efficacy and stipulated (निर्धारित करना; to say exactly how something must be or must be done) a median follow­up duration of at least two months after completion of the full vaccination regimen (टीकाकरण सम्बन्धी नियम; set of rules about vaccination, especially in order to improve health) to assess a vaccine’s benefit-­risk profile for emergency-­use approval, no such conditions have been mentioned by the Indian regulatory agency.  

The phase­3 trial of Covishield began on September 21 and completed the enrolment on November 12.  Prime Minister Narendra Modi announced a few days ago that a vaccine would be available in the next few weeks bringing some cheer in an otherwise desolate scenario (वीरान/असहाय परिदृश्य; a situation with no people or nothing pleasant in it). 

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The sooner a vaccine is available, the better it is for everyone, but pushing through an ineffective or unsafe vaccine is worse than not having one.

A survey by the London-­based Vaccine Confidence Project revealed (बताना/प्रत्यक्ष करना; to make known or show something usually secret or hidden) that though the intent (उद्देश्य/इरादा; intention to do something) to get vaccinated was 87% in India, 34% respondents were worried about side ­effects while 16% were concerned about fast-moving trials.

While the Indian government is aware of vaccine hesitancy (हिचकिचाहट/संकोच; the failure to do something immediately because you are nervous or not certain) among a certain section of people, the concerns are best addressed when all stakeholders (हितधारक;  a person or group of people who own a share in a business) are transparent at every stage and not by merely (केवल/मात्र; only; and nothing more) sharing guidelines regarding vaccine safety with the States.

It is important that those seeking emergency­-use authorisation share the safety and efficacy data immediately.