Rajkotupdates.News : Zydus Needle Free Corona Vaccine Zycov D, Rajkotupdates.News: Zydus Needle Free Corona Vaccine Zycov D, Rajkotupdates News Zydus Needle Free Corona Vaccine Zycov D
In a significant development, the Indian medicines regulator’s expert committee has recommended granting emergency use authorization (EUA) to Zydus Cadila’s ZyCoV-D, a needle-free three-dose COVID-19 vaccine.
The committee’s decision marks a milestone as ZyCoV-D becomes the first plasmid DNA vaccine approved for use in humans, offering a promising antidote against the SARS-CoV-2 virus.
Promising Efficacy and Approval Process
Zydus Cadila, a leading generic medication manufacturer, submitted an application for EUA on July 1, highlighting a robust efficacy rate of 66.6% from a late-stage trial involving over 28,000 volunteers across India. Upon receiving approval, ZyCoV-D will join the ranks of other authorized vaccines, including Covishield, Covaxin, Sputnik V, and Moderna, expanding India’s arsenal against COVID-19. Notably, this breakthrough vaccine is the first DNA-based vaccination to gain regulatory approval anywhere in the world.
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Clinical Trials and Two-Dose Regimen
Zydus Cadila conducted extensive clinical trials for ZyCoV-D, involving more than 50 locations throughout India. Notably, it was the largest clinical trial conducted in the country to date, encompassing participants across a broad age range, including teenagers aged 12 to 18. Alongside the recommended three-dose regimen, the company also submitted data for a two-dose regimen, which will be evaluated by the regulatory authorities.
Understanding ZyCoV-D: A DNA Vaccine
ZyCoV-D is a plasmid DNA vaccine designed to activate both the cellular (T lymphocyte immunity) and humoral (antibody-mediated immunity) arms of the human immune system, offering comprehensive protection against SARS-CoV-2 infection.
Clinical trials have shown a 100% success rate in preventing mild disease and a 66.6% success rate in preventing symptomatic cases of COVID-19. Notably, ZyCoV-D is administered intradermally using a needle-free injector, which aims to minimize adverse effects and provide a painless vaccination experience.
Technological Advantages and Manufacturing Capacity
Utilizing the genetic material of SARS-CoV-2 proteins, ZyCoV-D leverages DNA technology to induce an immune response in human cells, stimulating the production of SARS-CoV-2 antigens. The vaccine demonstrates stability between 2 and 8 degrees Celsius, aligning with India’s existing cold-chain infrastructure.
Additionally, ZyCoV-D’s intradermal administration provides a simpler and more convenient alternative to intramuscular injections. Furthermore, DNA vaccines offer the advantage of adaptability, enabling swift modifications to counter evolving virus strains.
Dosage and Manufacturing Readiness
ZyCoV-D’s three-dose immunization course is efficiently delivered using a needle-free applicator called PharmaJet, ensuring painless intradermal vaccine administration. Interestingly, results from a two-dose regimen at 3 mg/dose have shown comparable efficacy to the existing three-dose regimen, prompting Zydus Cadila to explore this option further.
The company aims to make the vaccine available within 45-60 days, pending necessary permits and production scaling. With a manufacturing capacity of 4.5 million doses at present, Zydus Cadila plans to produce 10-12 crore doses per year. Exploring partnerships, they aim to increase the annual output to 200 million doses.
Conclusion
Zydus Cadila’s ZyCoV-D represents a significant breakthrough in the fight against COVID-19, securing emergency use authorization as India’s first plasmid DNA vaccine. With its robust efficacy, needle-free administration, and manufacturing readiness, ZyCoV-D holds promise in bolstering the vaccination drive and providing protection to millions of individuals across the nation. As India continues its battle against the pandemic, the approval of ZyCoV-D marks a major stride in safeguarding public health and mitigating the impact of the SARS-CoV-2 virus.
Visit also: https://covid19.who.int/
