USFDA official says India-US in very good mutual alignment
A senior official of the US Food and Drug Administration (USFDA) on Monday underlined the role India can play in accelerating COVID-19 vaccine supplies globally and ensuring equitable distribution.
“We will need to collaborate, to do our part in the US to be able to export as much vaccines as we can. But we want India and others to do all of the production that they can to help us globally,” said Peter Marks, director of Center for Biologics Evaluation and Research, USFDA.
Taking questions after his virtual keynote address at BioAsia 2021, Dr.Marks said India and US are in very “good mutual alignment” and ought to use the mutual pharmaceutical capacities to help bring an end to the pandemic.
To another query from Director of Life-sciences, Telangana government, and CEO of BioAsia Shakti Nagappan on how the US managed vaccine hesitancy, he said this was achieved through outreach programmes and by trying to understand the concerns of each group. “We are in a situation where we need to use all the tools we can, provide the information what we need to, rely on social networks we can and also combat disinformation about vaccines,” he said.
A release on his speech said on USFDA’s role in developing vaccine, Dr.Marks said towards ensure public confidence in vaccines “we reference a standard in vaccine production”. The regulator evaluates the manufacturer’s request for vaccine production and commercialisation based on the following aspects — must demonstrate a clear and compelling efficacy in a large, well-designed phase 3 clinical trial; careful evaluation of quality, safety and efficacy; public advisory committee meeting; and enhanced post-deployment surveillance.
“Many people wonder how we have done in less than a year what usually takes at least 4-5 years. One waits till late in the process to scale up manufacturing. But for COVID-19, we did seamless phases of trials without any dead space. Manufacturers have scaled up their processes, it’s a reasonable risk to take,” he said.
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