A bottle of COVAXIN — a COVID-19 vaccinemanufactured in India
Government in talks with Indian vaccine manufacturer

THE Indian Government and Jamaica are engaged in talks to distribute the India-manufactured COVAXIN vaccine to Jamaica once it gets approval from the World Health Organization (WHO).

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.

India's drug regulator has given the green light to COVAXIN, made by Indian pharma company Bharat Biotech, a 24-year-old vaccine maker, which has a portfolio of 16 vaccines and exports to 123 countries. The vaccine, developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), uses Whole-Virion Inactivated Vero Cell derived platform technology, which means it contains dead coronavirus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.

When administered, immune cells can still recognise the dead virus, prompting the immune system to make antibodies against the virus. Two doses are given four weeks apart. The vaccine can be stored at 2°C to 8°C. Bharat Biotech says it has a stockpile of 20 million doses of COVAXIN, and is aiming to make 700 million doses out of its four facilities in two cities by the end of the year.

But manufacturers are still awaiting WHO approval, which they expect following the interim results of phase three of the trials, anticipated to be available by the end of February.

“I have no doubts, I feel quite confident and hopeful that COVAXIN will also get the WHO's approval once this interim data is available, after we reach a particular number of the infections that haven't been looked at. These are international protocols that have to be kept in mind, so we are just waiting for that and I am sure once that data gets released to the world – hopefully as early as the weekend – with the efficacy data from India coming out, I think COVAX and the WHO will certainly approve COVAXIN, based on its efficacy and safety data that will be proven. I have no doubt in saying this at all; I'm very hopeful of this,” Suchitra Ella, joint managing director at Bharat Biotech, told the virtual meeting.

In addition, Ella said that 60 per cent efficacy of the vaccine has been proven in the phase one and phase two data, which was in a smaller subject population of less than 400 in each one of those studies.

Ella said the efficacy percentage satisfies what is required for the vaccine to be deployed in any population in any country of the world, as per WHO guidelines.

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.

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.

TUFTON... confirms talks are taking place
MASAKUI... India's Ministry of External Affairs is facilitating the bilateral processes
BY KIMBERLEY HIBBERT Senior staff reporter hibbertk@jamaicaobserver.com

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