Zydus Lifesciences Ltd., a global life sciences business focused on innovation, reported that the Drug Controller General of India (DCGI) had granted emergency use authorization (EUA) for its two dose COVID-19 vaccine, ZyCoV-D. After receiving this approval, the vaccination will now be given on days 0 and 28. The vaccine had previously been authorized for three doses to be given on days 0, 28, and 56.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, commented on the announcement, saying, “The approval of a two-dose regimen for ZyCoV-D is a positive step. This will improve vaccine compliance and cut down on the overall time needed for vaccination to build viral immunity.
Additionally, it will make it easier to distribute the vaccine to a bigger population more quickly, which is always preferable during a pandemic. Three thousand one hundred healthy participants over the age of twelve were tested using the two dose ZyCoV-D regimen.
Earlier, The Lancet, a reputable and well-known medical publication, released the safety and efficacy analysis data from its Phase III clinical trial of its Plasmid DNA COVID-19 vaccine ZyCoV-D (three dose regimen). The Lancet’s EClinical Medicine Journal has also published the findings of the Phase I portion of the Phase I/II clinical study (three dose regimen).
More About ZyCoV-D
ZyCoV-D is a COVID-19 vaccine developed by the Indian pharmaceutical company, Zydus Cadila. It is a DNA vaccine, which uses a small, circular piece of DNA called a plasmid to encode the spike protein of the SARS-CoV-2 virus. Once the vaccine is injected into the body, the DNA from the plasmid enters the cells and instructs them to produce the spike protein. This triggers an immune response, which prepares the body to fight the virus if it is encountered in the future.
ZyCoV-D was granted emergency use authorization by the Drug Controller General of India in August 2021, making it the first COVID-19 vaccine in India that can be administered to individuals aged 12 and above. It requires three doses administered at a gap of 28 days between each dose.
ZyCoV-D has shown promising results in clinical trials, demonstrating an efficacy rate of 66.6% against symptomatic COVID-19 infections in a phase 3 trial involving more than 28,000 participants. The vaccine also showed efficacy against several variants of the virus, including the Delta variant, which is currently dominant in many parts of the world.
ZyCoV-D is stored and transported at standard refrigeration temperatures, making it easier to distribute and administer in many parts of the world. However, like all vaccines, it may cause side effects, which can range from mild to severe. Common side effects include pain and swelling at the injection site, fatigue, headache, fever, and muscle aches. It is important to speak with a healthcare provider if you have any concerns about receiving the vaccine.
How ZyCoV-D operates
ZyCoV-D is a COVID-19 vaccine that works by using a small, circular piece of DNA called a plasmid to encode the spike protein of the SARS-CoV-2 virus. Once the vaccine is injected into the body, the plasmid DNA enters the cells and instructs them to produce the spike protein. This triggers an immune response, which prepares the body to fight the virus if it is encountered in the future.
Specifically, the spike protein is the part of the virus that allows it to enter human cells and cause infection. By producing the spike protein in response to the vaccine, the immune system recognizes it as foreign and mounts an immune response. This response involves the production of antibodies that can neutralize the virus and prevent infection, as well as the activation of immune cells that can attack and destroy infected cells.
ZyCoV-D is administered in three doses, given at a gap of 28 days between each dose. The vaccine is administered as an intradermal injection, which is injected into the skin rather than the muscle. This is believed to help increase the immune response and may also reduce the risk of side effects.
Overall, ZyCoV-D is expected to provide protection against COVID-19 by priming the immune system to recognize and respond to the SARS-CoV-2 virus. While no vaccine can provide 100% protection, ZyCoV-D has demonstrated promising efficacy in clinical trials and is expected to provide a significant level of protection against COVID-19.
More About Zydus Lifesciences Ltd
Zydus Lifesciences Ltd is a subsidiary of Zydus Cadila, an Indian pharmaceutical company that specializes in the development, manufacturing, and marketing of a wide range of healthcare products. Zydus Lifesciences was established in 1995 and is headquartered in Mumbai, India.
The company’s product portfolio includes generic and branded pharmaceuticals, over-the-counter products, animal healthcare products, and medical devices. Zydus Lifesciences also has a strong presence in the global market, with operations in more than 50 countries worldwide.
In addition to its healthcare products, Zydus Lifesciences is actively involved in research and development activities, with a focus on developing innovative and cost-effective healthcare solutions. The company has several research and development centers in India and abroad, where it conducts research in various therapeutic areas, including oncology, immunology, and neuroscience.
Zydus Lifesciences is committed to delivering high-quality, affordable healthcare products to patients around the world. The company’s mission is to become a global leader in the healthcare industry, driven by its passion for innovation, excellence, and social responsibility.
More About Drug Controller General of India (DCGI)
The Drug Controller General of India (DCGI) is the regulatory authority responsible for regulating the pharmaceuticals and medical devices in India. The DCGI is the head of the Central Drugs Standard Control Organization (CDSCO), which is responsible for the approval and regulation of drugs, vaccines, medical devices, and diagnostics in India.
The DCGI is appointed by the Indian government and is responsible for overseeing the safety, efficacy, and quality of drugs and medical devices in India. The DCGI is also responsible for approving the import and export of drugs and medical devices in India and ensuring compliance with international regulations and standards.
The DCGI is responsible for granting permission for clinical trials, approving new drugs and vaccines for marketing, and monitoring the safety and efficacy of drugs and medical devices in the market. The DCGI also plays a key role in coordinating with international regulatory bodies to ensure that Indian pharmaceuticals and medical devices meet global quality standards.
The DCGI plays a critical role in the regulation of the pharmaceutical industry in India, ensuring that drugs and medical devices are safe, effective, and of high quality. The DCGI’s efforts have helped to ensure that the Indian pharmaceutical industry is recognized as a global leader in the development and production of affordable and high-quality drugs and medical devices.
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