Manufacturers May Not Require Large Randomised Trials For Updating COVID-19 Vaccines Against New Variants: USFDA

 Aurobindo Pharma hopes to submit Phase 2/3 data of UB-612 COVID-19...

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The US Food and Drug Administration (USFDA) on February 22 said the vaccine manufacturers who were planning to update their COVID-19 vaccines to make them effective against new variants may not require large-scale randomised clinical trials.

“It will more likely be smaller immunogencity studies,” said Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the USFDA, speaking at BioAsia 2021 virtual event.

Marks said the USFDA was very much thinking about issuing guidance to help manufacturers know how to change their vaccines and what they would need to do in terms of clinical studies.

“We are going to have to address the COIVD-19 variance,” Marks said.

Major vaccine developers like Pfizer, Moderna and AstraZeneca, have begun researching and planning to update their COVID-19 vaccines to combat the global spread of new virus variants.

The AstraZeneca-Oxford University COVID-19 vaccine performed poorly against the South African variant. AstraZeneca-Oxford have indicated that they are working to produce an updated COVID-19 version by winter this year. AstraZeneca-Oxford is widely used globally including India.

It’s not just vaccine makers, even drug regulators across the world are grappling with the problem as to how to allow companies to quickly redesign their vaccines in the backdrop of new variants, that can make the existing vaccines less effective.

Biosimilars reviews to gather pace

Marks said biosimilars reviews that have slowed down due to the pandemic will start gathering pace in the coming months.

“…the pandemic has slowed things down somewhat. The slow down (was due to) people’s (biosimilar makers) ability to bring forward their applications and they were slowed down a little bit at FDA also. We have been working on kind of recovery plans, and I think hopefully within the coming months will start to speed up again, move hopefully to a post-pandemic period,” Marks said.

Indian companies like Biocon, Dr Reddy’s, and Lupin have been trying to crack the biosimilars or generic versions of biotech drugs, as they try to move into more complex and low-competitive drugs. So far it’s been a mixed bag.

Marks said Indian drugmakers need to have “persistence” to succed in the US biosimilar market.

“I think it’s challenging in the biosimilar market for everyone trying to get in it right now. And I think it’s going to become hopefully easier as people become more familiar with biosimilars. I think part of what we’re dealing with here … innovator products have a lot of following and it takes a while. to break into that market,” Marks said.

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