NEW DELHI: The Serum Institute of India (SII), the world’s largest vaccine producer, said on Monday that it has applied for emergency use of Covishield, the first vaccine to be made in India for the coronavirus disease (COVID-19), even as experts questioned the timing of the move.
“As promised before the end of 2020 @seruminstindia has applied for emergency use authorization for the first made in India vaccine, COVISHIELD,” Adar Poonawalla, CEO of the SII, tweeted on Monday.
“This will save countless lives, and I thank the Government of India and Narendra Modi for the invaluable support,” he added.
The announcement followed news on Sunday reporting that Pfizer, an American multinational pharmaceutical corporation, had become the first company to apply for emergency use of its COVID-19 vaccine in India.
With more than 9.7 million infections and 141,000 deaths reported as of Monday, India is racing against time to contain the outbreak and daily spike in new cases and fatalities.
Experts, however, said the timing of the move is highly suspect, especially since the trial is still not complete.
“If a vaccine is used based on a half-baked trial, it is wrong … I don’t think the third stage of the trial is complete. Safety and infrastructure are two important parts in introducing any vaccine into the market,” Dr. Avinash Bhondwe, a doctor in the western Indian city of Pune, told Arab News.
Bhondwe, who is also a member of the Indian Medical Association, a premier medical body, added: “It is only when the trial is complete that you know about the side effects of the vaccine.”
He cited the example of a 40-year-old man, from the southern Indian city of Chennai, who sought $6 million in compensation from the SII two weeks ago, for developing “serious neurological and psychological symptoms” after taking a trial dose of the Covishield vaccine. The complainant also demanded the testing, manufacturing and distribution of the vaccine to be “stopped immediately.”
“If you approve a vaccine after an incomplete trial, it’s like playing with the lives of the people. This should not happen,” Bhondwe said, before questioning the “existing infrastructure in India to handle the vaccine distribution.”
“Both the Pfizer vaccine and the SII one need ultra-cold storage. In India, we don’t have facilities for ultra-cold storage everywhere,” he explained.
“Therefore, this rush to bring in vaccines is very dangerous,” he said.
It is a thought echoed by renowned virologist Dr. Jacob T. John, from the Christian Medical College in the southern Indian city of Vellore.
“The rush to bring vaccines into the market is driven by credit and profit, which I feel is not good,” he said, voicing concerns over the SII’s alleged attempts “to suppress the voice of Chennai-based individuals who claim to have suffered serious side effects after taking the vaccine shot.”
“I don’t know how to trust the SII after the incident. My respect for the institute is shattered after they failed to behave properly with the victim,” John told Arab News.
Pfizer and SII officials were unavailable for comment when contacted by Arab News on Monday.
Both the SII and Pfizer’s moves follow Prime Minister Narendra Modi’s three-city vaccine tour on Nov. 28 to get a “first-hand perspective of the preparations, challenges and roadmap in India’s endeavor to vaccinate its citizens.”
The premier’s tour included a visit to the SII, the Zydus Cadila plant in the western Indian state of Gujarat and the Bharat BioTech company in the southern Indian city of Hyderabad.
John, however, termed the visit a publicity stunt.
“Modi visiting the vaccine companies is just publicity for himself. India has not spent even a single penny in researching for a vaccine, but the Prime Minister of India wants credit for the vaccine,” he said.
Meanwhile, Delhi-based researcher on global health Dr. Anant Bhan drew attention to the lack of studies behind the production of the vaccine.
“Pfizer has done no study in India…If the vaccine is produced in India for Indian people without local (at least bridging) data, it will concern me,” Bhan told Arab News.
“The regulator should have strong control over such vaccines, and everything should be placed in the public domain. How are they addressing safety concerns?” he asked.
Arab News reached out to Dr. Vinod K. Paul, the government’s principal scientific advisor, but he declined to comment.
Bhan also highlighted the fact that the SII data was not in the public domain.
“They have to explain on what basis they are asking permission to produce the vaccine. We want more transparency and data in the public domain,” he said.
Meanwhile, Bhondwe questioned the silence of the country’s political leadership.
“The prime minister and health ministry officials know everything. They know that the vaccine is still in the trial stage. But they want to show the people that they are doing something. It is political grandstanding,” he said.