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Manufacturers may not require large randomised trials for updating COVID-19 vaccines against new variants: USFDA

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

February 22, 2021 / 05:05 PM IST
Representative image: Reuters

Representative image: Reuters

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.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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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.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Feb 22, 2021 05:05 pm

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