BackSII seeks emergency nod for jab with 62% efficacy
Drugmaker submits application to DCGI along with data from UK and Brazil trials
PremiumSerum Institute of India (SII) has submitted an application seeking emergency use of Covishield—its version of the Oxford-AstraZeneca covid-19 vaccine—but for the less effective double-dose regimen, a person familiar with the development said.
In phase 3 trials conducted with the Oxford vaccine in Brazil and the UK, the double-dose regimen had shown a lower efficacy rate of 62%, whereas an accidental regimen of one-and-a-half doses revealed an efficacy rate of up to 90%.
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In the UK, AstraZeneca and Oxford University have applied for emergency use of both regimens. To be sure, the more effective one-and-a-half dose regimen was the result of an accident, or “serendipity" as researchers have called it.
SII has Indian data for the full double-dose regimen—under which two doses are given a month apart—from its own tests. It did not conduct any tests for the one-and-a-half doses—a full dose followed by a half dose a month later.
The Pune-based drugmaker submitted its application to the Drug Controller General of India V.G. Somani on Sunday, along with data from the UK and Brazil trials conducted by Oxford and AstraZeneca.
In its interim analysis of trials in the UK and Brazil released last month, British drugmaker AstraZeneca showed that across the two regimens, its vaccine was on an average 70.4% effective in preventing covid-19 symptoms.
However, the lower dosing regimen has been controversial; the interim analysis included 2,741 participants on the lower dosage, which is about a fourth of the volunteers on the regular two-full dose regimen. This led to criticism from experts that there wasn’t enough data to get regulatory clearance.
SII, the world’s largest vaccine manufacturer, itself conducted its trial with two full doses, and since it is a bridging study showing that its contract manufactured vaccine is similar to AstraZeneca’s, it can only base its submission on the full-dose regimen, said the person cited above. SII, however, is yet to complete a final analysis of its 1,600-participant phase 3 clinical trial and is instead relying on interim data, this person said.
On Monday, SII CEO Adar Poonawalla tweeted that the company had submitted its application. “As promised, before the end of 2020, Serum Institute of India has applied for emergency use authorization for the first made-in-India vaccine, Covishield," he tweeted.
SII is the second company to seek an emergency licence for its vaccine from the DCGI, coming a day after Pfizer made its own submission for its mRNA vaccine that has 95% efficacy but requires ultra-cold storage. On Monday, Bharat Biotech also applied for an emergency authorization of its vaccine, the third in as many days.
Neetu Chandra Sharma contributed to this story.
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