Zydus Cadila Covid vaccine close to approval in India, says MD Sharvil Patel – fr

Zydus Cadila Covid vaccine close to approval in India, says MD Sharvil Patel – fr

Ahmedabad-based pharmaceutical company Zydus Cadila will likely submit an application for emergency use authorization for its Covid-19 “ZyCoV-D” vaccine candidate in India this month. The company is confident that the vaccine will be approved in May. The company plans to produce one crore of doses of its “painless” Covid-19 vaccine per month.
If approved, ZyCoV-D will be the fourth vaccine to be used as part of the Covid-19 vaccination campaign in India. Made in India, the company plans to increase production of the vaccine to 3-4 crore doses per month and is already in talks with two other manufacturing companies for the same.

Although the vaccine should ideally be stored between 2 and 8 degrees Celsius, it remains stable even at room temperature at 25 degrees Celsius. It is easy to administer, the developers said, and will be administered by intradermal injection.

If approved for emergency use, ZyCoV-D could help India fill the vaccine dose gap currently being tested in the country’s vaccination campaign.

Earlier in April, Zydus Cadila announced that his drug Virafin had received a restricted emergency use authorization of the Drug Controller General of India for the treatment of mild cases of Covid-19.

In an exclusive interview with India Today TV, Sharvil Patel gives details on all aspects of the Covid-19 ZyCoV-D vaccine.

When asked about the status of the Covid ZyCoV-D vaccine candidate and when exactly Zydus Cadila would apply for emergency use authorization in India, Dr Sharvil Patel said the vaccine was close to being approved in the country.

“I am very happy to say that the first DNA vaccine candidate developed locally in India against Covid, which is our ZyCoV-D, is about to be approved,” he said.

“We have almost completed all of our clinical trial recruitments. We have by far recruited the largest number of patients for a Covid vaccine trial in India. The number of volunteers who were vaccinated as part of the trial is 28,000, ”Sharvil Patel said.

Sharvil Patel also said his company also included children ages 12 to 17 for vaccine trials.

He said: “Recruitment represents very important milestones in terms of cohorts because not only have we included the elderly and those with co-morbidities, but also children in the 12 to 17 age range.”

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Sharvil Patel said that as soon as efficacy data is obtained, Sydus Cadila will apply for emergency use authorization. As soon as approval is granted, Zydus Cadila will begin production of Covid-19 vaccines from July, he said.

“We hope to see our efficacy data in mid-May. As soon as we see a strong efficacy which is correlated with the strong immunogenicity of the vaccine in phase 2, we will file an emergency use authorization request. We hope to produce a good quantity of the vaccine. starting in July to make sure it is available to the people. It’s the need of the hour right now, ”said Sharvil Patel.

He said that by May, the company would be able to talk to regulators about the restricted use of the Covid-19 vaccine. “The regulatory process is ongoing. I think the regulators are looking at the data in a short period of time, ”said Sharvil Patel.

“We have already submitted a lot of data to help regulators once we provide them with the efficacy results. So we expect to get approval in May itself, ”said Sharvil Patel.


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