India considers fast tracking Covid-19 vaccine for vulnerable groups

Henrietta Strickland
September 15, 2020

Pfizer is regarded as being among the top three contenders in developing a successful COVID-19 vaccine.

This COVID-19 vaccine, dubbed AZD1222, aka ChAdOx1 nCoV-19, is being developed in association with biopharmaceutical company AstraZeneca and is one of several now in late-stage Phase 3 trials. The voluntary pause was triggered on September 6 after a standard review identified an adverse reaction in one subject.

The Oxford-AstraZeneca study had previously been stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine. AstraZeneca was, and still is, keeping mum on the exact nature of what happened, but according to a New York Times report which cited a person familiar with the situation, a participant based in the United Kingdom was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. It too had "paused" clinical trials in India, albeit a day after AZ announced similar action globally.

Siegel reacted on "Bill Hemmer Reports" to comments from Pfizer CEO Albert Bourla, who said there is a "good chance" he will know by late October if the company's potential vaccine will be effective.

In this instance, a rapid review by the MHRA led to a recommendation the trials be restarted. The trials resumed after the Medicines Health Regulatory Authority confirmed that the trials are safe. In comparison, the AstraZeneca and Oxford University vaccine has been tested on 18,000 people worldwide.

Despite the intense attention on the development of this particular COVID-19 vaccine, it is important to note these kinds of clinical trial pauses are routine.

Hassan Valley, an epidemiologist from La Trobe University, suggests rather than this transitory pause being a cause for concern it should instead offer reassurance that this vaccine trial is being conducted using optimal safety precautions.

Under the COVID-19 vaccine plan discussed at the Cabinet meeting chaired by Prime Minister Chung Sye-kyun, the country will seek to get vaccines for 10 million people from the COVAX Facility, set up by the World Health Organization and global vaccine alliance Gavi, according to the Ministry of Health and Welfare said. "But we don't need to be overly discouraged, as these things happen".

There remains uncertainty in India, where the vaccine candidate is undergoing phase-2 and phase-3 trials simultaneously.

"No date has been fixed for the vaccine launch, it may be ready by the first quarter of 2021", said Mr Vardhan.

Other reports by Click Lancashire

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