India’s Central Drugs Standard Control Organisation (CDSCO) says Pfizer officials failed to turn up to meetings after the company’s application was made in early December and wants India to order its COVID-19 vaccines without any local trials.
Pfizer, a pharmaceutical company based in the United States, was the first to apply for emergency use authorization in India for its Covid-19 vaccine in December 2020. Pfizer officials, on the other hand, skipped the approval meeting, and two other vaccines were approved instead.
Now, Pfizer has told Reuters that they will pursue the approval process if India makes a purchase commitment.
“This request is consistent with the company’s contracts with other countries, where various governments ordered a certain number of doses in advance even before the trials could be complete, bearing the risk,” commented Dr. Shailendra Sawleshwarkar, an infectious disease physician at the University of Sydney.
However, the Indian regulatory body has asked Pfizer-BioNTech to conduct a ‘small trial’ in India to assess the vaccine’s efficacy. Even the Oxford University-Astra Zeneca jab had to undergo clinical trials in India, conducted by the Serum Institute of India, to be approved.
“There’s no set definition for ‘small’ clinical trial. In a standard phase 1 trial with minimum volunteers, there are at least 20-100 recruits,” explained Dr. M. K. Sudarshan, Public Health Expert, who is part of the Karnataka state Covid-19 expert committee.
The regulator has also declined to accept the company’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.
“The data collected has been endorsed by various regulatory agencies (including the most evolved) and they have given EUA [based on] … that data,” Pfizer said in an emailed response to questions, including on India’s demand for a local trial.
According to data from the Vaccine Adverse Event Reporting System (VAERS), at least 181 Americans died from COVID-19 vaccines in just 2 Weeks.
Pfizer has paid $2.3 billion in the largest healthcare fraud settlement in history to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.
Even, the US government paid over $57 million in compensation for vaccine injuries and deaths till March 2020 alone.
That’s a question only time will tell. However, when it comes to the Indian regulator’s demand for a local trial, Dr. Sudarshan says it is a legitimate concern. “Pfizer’s Covid-19 vaccine lacks testing on Asians. A report had also stated the same when the U.S had approved the vaccine. Eighty-three percent of the volunteers for Pfizer’s vaccine were White, only 4.3% were of Asian ethnicity,” he pointed out.
“The vaccine has not been tested sufficiently on Indians at all.” India has not been considering the Pfizer Covid-19 vaccine for approval due to logistical and cost issues. Pfizer vaccine is considerably expensive compared to its Indian competitors – Covishield and Covaxin.
Even if India overcomes regulatory and storage hurdles for accommodating the Pfizer vaccine, it will not be affordable to all.
According to the BBC, a new Russian-made vaccine called Sputnik Light has been approved, despite Pfizer’s failure to break into the Indian market.