Covid vaccine on In­de­pen­dence Day?

Ex­perts stunned; each trial phase usu­ally takes months, if not years

The Asian Age - - Financial - DEVJYOT GHOSHAL & SACHIN RAVIKUMAR

The chief of In­dia's top clin­i­cal re­search agency said in a leaked let­ter cir­cu­lated on Fri­day it en­vis­aged launch­ing a novel coro­n­avirus vaccine by Au­gust 15, prompt­ing scep­ti­cism from some health ex­perts who ques­tioned the short timeline.

Dozens of vaccine can­di­dates are at var­i­ous stages of de­vel­op­ment around the world to tackle the coro­n­avirus pan­demic.

One, from Bharat Biotech and be­ing de­vel­oped with the In­dian Coun­cil of Med­i­cal Re­search (ICMR), was this week ap­proved for Phase I and Phase II clin­i­cal tri­als.

"It is en­vis­aged to launch the vaccine for pub­lic health use lat­est by Au­gust 15, 2020, af­ter com­ple­tion of all clin­i­cal tri­als," ICMR di­rec­tor gen­eral Bal­ram Bhar­gava said in the let­ter, dated July 2

and ad­dressed in­volved

Phase I and Phase II tri­als typ­i­cally test the safety of a drug be­fore it en­ters Phase III tri­als that test its ef­fi­cacy.

Each phase can last months, if not years, and although reg­u­la­tors glob­ally have been fast-tracking tri­als on medicines and vac­cines to treat the

to in

in­sti­tu­tions the tri­als.

novel coro­n­avirus, the timeline en­vis­aged in the let­ter would be un­prece­dented.

"To my knowl­edge, such an ac­cel­er­ated de­vel­op­ment path­way has not been done EVER for any kind of vaccine, even for the ones be­ing tried out in other coun­tries," Anant Bhan, a doc­tor and pub­lic health re­searcher, said on Twit­ter.

"Even with ac­cel­er­ated time­lines, this seems re­ally rushed, and hence with po­ten­tial risks, in­ad­e­quate at­ten­tion to process."

Sev­eral other health ex­perts also ques­tioned the launch date pro­posed in the let­ter, which was widely shared on so­cial me­dia.

A spokesman for ICMR did not re­spond to phone calls and text mes­sages seek­ing com­ment on Fri­day. How­ever, an ICMR of­fi­cial, who asked not to be iden­ti­fied, said the let­ter was a pri­vate com­mu­ni­ca­tion and was be­ing mis­in­ter­preted.

The of­fi­cial said the aim was to com­plete all tri­als on the vaccine can­di­date by Au­gust 15, and did not say when he thought it might be launched for pub­lic use.

A Bharat Biotech spokesman de­clined to com­ment on the let­ter. But in an emailed state­ment to Reuters, Bharat Biotech's man­ag­ing di­rec­tor Kr­ishna Ella said the com­pany had a tar­get to pro­duce up to 300 mil­lion doses of the vaccine per year if it suc­ceeds in clin­i­cal tri­als.

"En­rol­ment of the co­hort for the phase I is un­der­way," Ella said, adding the com­pany was await­ing ap­provals for hu­man clin­i­cal trial vaccine batches from the In­dian reg­u­la­tor.

—Reuters

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