A new coronavirus vaccine candidate could soon be authorized for use, if its excellent clinical results are any indication. Ocugen (OCGN 0.81%) has unveiled the results of a phase 3 clinical trial of the Covaxin vaccine conducted by its co-development partner Bharat Biotech. Most notably, the vaccine demonstrated 100% efficacy against severe COVID-19.
Zooming out, Covaxin's efficacy against mild, moderate, and severe COVID-19 was 78%.
Ocugen made an important and very relevant point about the timing of the study. "The safety and efficacy demonstrated by Covaxin is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial," the company quoted Bruce Forrest, a member of its vaccine scientific advisory board, as saying.
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All told, 25,800 participants were enrolled in Bharat's trial, which took place in India. The age range was 18 to 91; 2,433 subjects were over the age of 60, and 4,500 had co-morbidities.
Covaxin is being developed with the collaboration of the Indian Council of Medical Research-National Institute of Virology.
Ocugen, a biotech that holds the commercial rights to Covaxin in the U.S. (assuming it is either authorized or approved by the Food and Drug Administration), is very much an outlier in the coronavirus vaccine race. It is known for its development of treatments for rare vision conditions, not vaccines, so it was a bit of a surprise when it leaped into the segment with the Bharat deal in February.
Although such strong results bode well for an FDA nod, Covaxin will be very much a latecomer to this market. The regulator has granted Emergency Use Authorization to three other vaccines, two of which (Moderna's mRNA-1273 and Pfizer/BioNTech's BNT162b2) have been widely and successfully administered throughout the country for months.
