Jamaica seeks Indian COVID-19 vaccine that has not completed human trial.

India COVID Vaccine
India COVID Vaccine

THE Indian and Jamaican Governments are engaged in talks to distribute the India-manufactured COVID-19 vaccine called COVAXIN to Jamaica. Although the vaccine has been approved by the Indian Government and is being administered to the people of India, it has not yet completed human trials.

Even without completion of the human trial, the company behind the vaccine is already seeking approval from the World Health Organization (WHO) to distribute the vaccine to poor countries in Latin America, the Caribbean and Africa.

High Commissioner of India to Jamaica Rungsung Masakui yesterday told members of the media, during a virtual interaction on Zoom, that India’s Ministry of External Affairs is facilitating the bilateral processes which all medical products must go through before agreements are made. He also disclosed that governments across the Caribbean have been provided with data on COVAXIN for use in their own analysis of the product.

Health Minister Dr Christopher Tufton confirmed that the Jamaican Government is in talks with India but did not disclose the extent of the conversations, conditions or whether any agreement had been made.

A year ago, Krishna Ella was simply known for running a small Indian pharmaceutical company with a reputation for scientific rigor. Then came the pandemic that put the scientist and his family at the center of one of the world’s loudest furors over a coronavirus vaccine.

In June last year, India’s drug regulator permitted Ella’s firm, Bharat Biotech International Ltd., to develop a homegrown vaccine in record time. Since then the company has been buffeted by controversies ranging from unrealistic government schedules to sporadic reports of adverse reactions. Matters came to a head last month after the government approved its shot before the completion of final human trials.

That fueled a revolt across the breadth of India with many at the frontlines of the pandemic, particularly health-care workers, refusing the company’s injection. Two weeks in, India’s national vaccine rollout has fallen flat with little over half the targeted number of people coming forward for shots; hesitation that’s largely being blamed on the hasty approval of Bharat Biotech’s shot, which is still deep in Phase III trials.

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From the U.S. to the Norway, vociferous debates over the efficacy and safety of Covid-19 vaccines have beset pharmaceutical giants like Pfizer Inc. and AstraZeneca Plc and governments the world over are battling anti-vaccine sentiment. Yet, experts say India never registered significant resistance to inoculations until now. The stakes are particularly high because the South Asian country is racing to inoculate 1.3 billion people across villages and crowded slums while grappling with the world’s second highest number of infections.

“There are many unanswered questions because of the total opaqueness and lack of accountability,” said Dinesh Thakur, a former pharmaceutical executive known for exposing fraud at the Indian drugmaker Ranbaxy Laboratories Ltd. “One thing is abundantly clear: They have successfully now created a significant anti-vaccine movement in India.”

The use of Covaxin has drawn particular ire because Prime Minister Narendra Modi’s government has distributed it alongside AstraZeneca’s inoculation, which completed final tests. Luck of the draw and location determine which shot India’s frontline workers get, leaving many fearful they could end up taking an injection yet to be fully vetted.

Jamaica could find itself in a similar situation where they have a vaccine like the one from Pfizer that has completed the proper rigors of human testing and one that has not, such as COVAXIN; Jamaicans could end up taking a vaccine where they are not sure whether is has been properly tested or not.

Regarding the clinical trials, a total of 375 subjects have been enrolled in the phase one study, which Bharat Biotech said generated excellent safety data without any adverse reactions. Phase two of the study had 380 participants of 12-65 years and the vaccine led to tolerable safety outcomes.

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In relation to phase three of the trials, the drug company said the first dose of vaccination has been given to all the participants and presently the second dose of either vaccine/placebo is being administered.

The drug company’s joint managing director further stated that in order to prove that COVAXIN has greater than 60 per cent efficacy, the phase three trial data which is just completed will provide a better picture, when the interim data is accessible.

“The trial is double blinded and this is locked up by a third-party clinical research organisation. The third-party entity is completely in control of all the data that is coming from the trial across 26 centres and 25,000 subjects. But we are waiting for that interim data to be broken at a particular time frame. Right now we have satisfied the minimum requirement of 60 per cent efficacy,” she said.

Moreover, Ella said 21 countries, including Brazil, have already registered for procurement of COVAXIN and Bharat Biotech is looking for Caribbean countries to join. Regarding whether Jamaica will receive distributions, Ella said the answer would to be determined by the respective governments.

“I’m sure if Jamaica has approached the Government of India and the Ministry of Eternal Affairs, I’m sure this will definitely be facilitated by both governments. We, as manufacturers, are not going to say no to distributing our vaccines to Jamaica,” she said.

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