On vaccine approval

All right-thinking people would readily agree that we need vaccine rollout to overcome the Covid-19 pandemic. But few would disagree that the vaccine approval should not be hastened by bypassing the time-tested protocol laid down for the purpose by the scientific community.

Eyebrows were raised at the nod given by the Drugs Controller General India to Bharat Biotech’s Covaxin, albeit for use in clinical trial mode, in the absence of data on its efficacy from the phase-3 clinical trial. The DCGI did not show patience at the news briefing to elaborate on ‘clinical trial mode’. No amount of rationalisation can justify the hurry.

The proof of efficacy from peer-reviewed phase-3 trial data is an essential precondition for grant of approval for the vaccine. Conjecture cannot substitute evidence. The truth of the conjecture that a vaccine is efficacious has to be confirmed by hard data. The timing must be left to be decided by science.

Safety and efficacy of vaccines against SARS-CoV-2 are what matter; where vaccines are developed or manufactured is immaterial.

Vaccination should not become a subject for the hurly-burly of political debate. But the premature vaccine approval without the needed data cannot go unquestioned. By convincing people that the jab they get is safe and effective they can be persuaded out of vaccine hesitancy.

G David Milton

Maruthancode, TN

Cooperation needed

This refers to the reports ‘Nod for Covaxin in line with rules: Bharat Bio’ and ‘Experts flag lack of transparency’ (January 5). The efforts by various agencies to check the spread of Covid call for total cooperation and encouragement. Negative comments at this juncture are likely to slacken efforts to deal with the virus. The general public should also should cooperate in this effort.

TR Anandan

Coimbatore

 

Safety protocols

Modern-era economics is global and thus movement of people across continents has gone exponential. Not surprising that the speed and breadth of the spread of Covid-19 is so unprecedented. While this has compelled extreme time compression to find vaccines, their safety protocols and checklists are apparently unaltered. Thus deviations are apt to be flagged by the scientific community.

Maybe, the WHO could have used these nine months to clinically recalibrate protocols for reduced time-frames, but then the US of all nations repudiates the WHO when it is needed most.

R Narayanan

Navi Mumbai

Scheduling the shots

Apropos the editorial ‘Injecting confidence’ (January 5), the Centre appears to be in a rush to roll out the Covid vaccine.

The Centre can draw a schedule in such a way that the vaccine be first administered to the patients having positive symptoms now, then to those who had positive symptoms during the peak period of February-April 2019 and later discharged, and finally to frontline field staff. These categories of patients should be monitored closely for 60-90 days before mass roll-out of the vaccine. Of course, this may delay public vaccination by another 2-3 months, which will be a worthwhile wait. All stakeholders — the Drug Controller, Subject Expert Committee, CDSO, ICMR and the Health Ministry — should work in tandem in arriving at a commonly agreed approach in proceeding further.

RV Baskaran

Chennai

Lifting the unorganised sector

This is with reference to ‘Unorganised sectors bore the brunt of Covid lockdowns’ (January 5). Covid-19 is a wakeup call to the government that the unorganised sector in the country needs to be taken care of. There should be more schemes for the benefit of the sector, covering disability, accident insurance, health and maternity benefits, pension, old-age homes, etc.

Big corporate houses should assist the government with funds from their CSR schemes, and citizens should as far as possible buy items made locally.

Veena Shenoy

Thane

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