Read Editorial with D2G – Ep 519
Efficacious too: On Covaxin
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Vaccine efficacy ( something is how well it works or brings the results you hoped for ) of 80.6% for Bharat Biotech’s Covaxin at the first interim ( in or for the intervening period; provisional ) analysis of phase-3 trials in India is indeed ( used to emphasize a statement or response confirming something already suggested ) promising, though it took two months for the data to become available after the vaccine was approved for ‘restricted emergency use’ by the Indian drug regulator.
The vaccine efficacy was measured based on symptomatic COVID-19 disease — mild, moderate or severe — two weeks after the second dose. The interim analysis undertaken at the first endpoint of 43 COVID-19 cases in the phase-3 trial carried out across 26 sites in India found 36 cases in the placebo ( a medicine or procedure prescribed for the psychological benefit to the patient rather than for any physiological effect ) group while only seven COVID-19 cases in the arm that received two doses of the vaccine given 28 days apart.
The phase-3 trial that began last November recruited 25,800 participants, with one half receiving the vaccine and the other, a placebo. While the phase-3 trial will continue till 130 participants in both groups put together develop COVID-19 disease, another interim analysis will be carried out when there are 87 cases. Covaxin’s efficacy of 80.6% at first interim analysis is higher than AstraZeneca/Covishield vaccine efficacy of 55.1% when the second dose is administered ( manage and be responsible for the running of (a business, organization, etc.) ) less than six weeks after the first; in India, the second dose of Covishield is approved for four-six weeks after the first.
Also, the phase-3 trial recruited ( enrol (someone) as a member or worker in an organization or as a supporter of a cause ) 2,433 participants over the age of 60 and included 4,500 people with comorbidities ( the simultaneous presence of two or more diseases or medical conditions in a patient ). However, those with severe and/or uncontrolled comorbidities were not recruited.
As per the phase-1 data published in The Lancet Infectious Diseases and a preprint ( something that is printed in advance, especially a part of a work printed and issued before general publication of that work ) of the phase-2 trial, Covaxin appears to be safe and highly immunogenic ( relating to or denoting substances able to produce an immune response ), and has also been found to be effective against the B.1.1.7 variant first found in Britain.
While Covaxin accounts for less than 10% of all COVID-19 vaccinations in India, the absolute number of vaccinations as on March 3 stands at over 1.6 crore. No deaths associated with this vaccine have been reported so far. Though the first interim analysis is based on 43 cases, which is smaller when compared with other vaccines that have been approved by other regulators, the vaccine appears safe and efficacious in phase-3 and early stages of human trials and animal studies.
The Indian regulator should therefore revise ( reconsider and amend (something), especially in the light of further evidence or to reflect a changed situation ) the restricted emergency use approval such that Covaxin is treated on a par with Covishield and should no longer seek additional precautions in the form of signed consent ( permission for something to happen or agreement to do something ) before vaccination and also remove the label “clinical trial mode” from the approval; their continuation would send a wrong signal about its safety and efficacy.
With a narrow window of opportunity available to vaccinate people before a second wave probably ( almost certainly; as far as one knows or can tell ) sets in or dangerous variants get established, India can ill ( poor in quality ) afford ( have enough money to pay for ) to have roadblocks ( a hindrance or obstruction ) in the uptake of either vaccine.
