It's been a few weeks since the Pfizer Vs Serum debate has received immense interest and raised eyebrows at the same time. Who will hit the Indian market first and more importantly, who will be more efficacious.
After Pfizer, Serum Institute of India became the second company to approach India's drug regulator DGCI (Drugs Controller General of India), with Hyderabad-based Bharat Biotech coming a close third. Now the Pune-based SII has approached DGCI once again with updated data seeking authorisation to market its potential Covid-19 vaccine.
As per the reports, the company officials said that they have submitted full dose of efficacy data of the UK trials of the vaccine. They also informed that they have submitted safety data from their own phase 3 trials which are ongoing in India. However, experts say that SII application lacks the immunogenicity data from the Phase III trials which would not have been ready by now as per the timeline.
The first SEC meeting
While the market approval applications of Pune-based SII, and Hyderabad based Bharat Biotech were not cleared at the earlier SEC (Subject Expert Committee) meeting held on December 9, the drug regulator is yet to fix a date for the second SEC meeting. The ten-member committee had asked SII to submit more data and information for emergency use authorisation, particularly outcome of assessment of AstraZeneca trials done by UK regulator. Serum had submitted safety data till November 14 and was asked for updated safety data of the Phase 2/3 clinical trials, immunogenicity data from the clinical trials in UK and India.
Vaccines and the skeptics
While commenting on SII applying once again for emergency use authorisation, remarks a user, "If they approve the 95% efficacy Pfizer vaccine, everyone would want it. No one will prefer Serum's 65% efficacy made in India vaccine. Even a poor man can afford to spend Rs 2,000 for Pfizer instead of Rs 250 for Serum...would create a logistic/economic nightmare," remarks a user.
SII's Covishield and the volunteer incident
Earlier in the month a volunteer's incident came to light when a man had served a legal notice on the company, claiming to have suffered a virtual neurological breakdown and impairment of cognitive functions, seeking Rs 5 crore in compensation. As per the notice, the man suffered acute encephalopathy (a disease affecting the brain) following the vaccine shot and all tests confirmed that it was caused by the vaccine candidate.
Shortly after that, SII has clarified that the incident with one of the volunteers during the clinical trials was not induced by the vaccine and they had sent a legal notice to the man. The company also said that all regulatory, ethical processes and guidelines were followed by them.
