India’s drug regulator on Friday granted emergency use approval to Zydus Cadila’s India-developed three dose Covid vaccine ZyCoV-D, the world’s first DNA Covid shot that will be administered to children above 12 years and adults.

On July 1, the Cadila Healthcare Ltd had applied for the authorisation of ZyCoV-D based on 66.6 % efficacy rate in a late-stage trial of over 28,000 volunteers nationwide.

The delivery of vaccines is likely to begin by next month-end and around five crore doses will be in India by December, a senior official said.

ZyCoV, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin.

The DNA-based vaccine will be the sixth vaccine to receive authorisation for emergency use in the India.

The DNA based bases vaccines have broadly three advantages. First, it is a needle-free vaccine system resulting reduction in side-effects such as pain at the injection site. Second, unlike m-RNA vaccines, which need ultra-cold storage systems, the DNA vaccines can be stored at 2-8 degrees Celsius that is best suited for India’s cold storage requirement. Third, the vaccine manufacturing facility does not require the setting up of BSL-3 high containment facility as is required in the production of inactivated virus vaccines like Covaxin.

With ZyCovD, India has now approved six vaccines. Two of them from AstraZeneca and one from Hyderabad-based Bharat Biotech are already being used in the government’s vaccination drive across the country. Russia’s Sputnik V has been administered in small numbers and Johnson & Johnson and Moderna are negotiating for legal indemnity.

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Among the other vaccines in use in India, Covaxin’s overall efficacy is 77.8% while Covishield has a proven efficacy of 70% in India. Sputnik V demonstrates 97.6% efficacy.

Earlier in 2010, Zydus had become the first company to develop and indigenously manufacture a vaccine against swine flu. Earlier, the company had developed the tetravalent seasonal influenza vaccine and the inactivated rabies vaccine.

In other India News, The Gujarat Board of Secondary and Higher Education (GSEB) result has been declared. 

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Prime Minister Narendra Modi paid a visit to pharma major Zydus Cadila at Zydus Biotech Park in Ahmedabad to review the development of its coronavirus vaccine candidate ZyCOV-D. The PM will later visit Bharat Biotech in Hyderabad and Serum Institute of India in Pune to review their Covid-19 vaccine development and manufacturing process.

In a Tweet earlier, the PMO informed that Modi’s visit will help him in getting first hand perspective of the preparations, challenges and roadmap in India’s endeavour to vaccinate its citizens. During his visit to three facilities, the prime minister will also hold discussions with scientists. He will spend around one hour at Bharat Biotech whose vaccine candidate Covaxin is undergoing Phase-3 trials. At around 4: 30 PM, he will pay a visit to Serum Institute of Indian in Pune to review its vaccine candidate being Manufactured in collaboration with Oxford University and Astrazeneca. He will fly back to Delhi later in the evening.

The AstraZeneca-Oxford vaccine is currently the front runner in the race for vaccine followed by Bharat Biotech’s vaccine candidate. The Phase-3 trials of both the vaccines are currently on in India. Earlier, the company had announced that its Phase-3 trials results conducted in other countries showed that effectiveness of vaccine was 90% in preventing coronavirus. For achieving this, an individual will to take half dose of the vaccine followed by full dose. The vaccine showed 62% effectiveness in those individuals who took two full shots.

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However, various concerns had cropped up with the way these results were achieved. Astrazeneca had admitted that a manufacturing had occurred due to which some volunteers received a lower dosage of the vaccine than others. Surprisingly, these individuals seemed better protected than those who received the full doses.

India is currently the second worst affected country in the world after the United States.

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