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FDA lifts hold on Covaxin's clinical trials in US

The FDA’s earlier decision, in April, to put on hold the trials was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

May 24, 2022 / 06:53 PM IST
​(File image: Vial of Covaxin)

​(File image: Vial of Covaxin)

The US Food and Drug Administration which has put on hold the phase 2/ 3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, in USA, has lifted the pause, according to a statement issued by Ocugen Inc, Bharat Biotech’s partner for the jab in USA and Canada.

"We’re extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” Dr Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen Inc said.

The FDA’s earlier decision, in April, to put on hold the trials was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

"Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately,” he further said.

WHO had earlier suspended the supply of Covaxin through US procurement agencies, after its inspectors identified GMP (good manufacturing practice) deficiencies in the Bharat Biotech’s manufacturing plants.

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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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Sources had said the city-based firm however, had not supplied the COVID vaccine to any UN agency and no impact of the suspension would be felt.

OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

After WHO inspection, Bharat Biotech had said it is temporarily slowing down production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees decrease in demand.

The company further said after the recent WHO post Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.
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