As India’s vaccination campaign continues to gain momentum, Gujarat-based Cadila Healthcare, owned by billionaire Pankaj R. Patel, has joined the list of companies that have been granted permission to use emergency (EUA) for their Covid-19 vaccines. Last week, Cadila said the Drug Controller General of India approved its India-made ZyCov-D, which he hopes will be on the market by mid-September. The price of the vaccine has not yet been decided.
India has so far administered the vaccine to more than 604 million people, but only 9.6% of India’s population is fully vaccinated against the virus. The country vaccinated an average of 5 to 7 million people every day.
ZyCov-D is a three-dose vaccine, given 28 days apart. The company plans to seek approval for a two-dose regimen of the vaccine.
According to the company, ZyCov-D is also India’s first vaccine for adolescents aged 12 to 18. All currently available vaccines are intended for people over 18 years of age.
In addition to ZyCov-D, the regulatory body has approved five vaccines: Covishield from the Serum Institute, Covaxin from Bharat Biotech, which was the first vaccine made in India, Sputnik V from Russia, Vaccine from Moderna, which is facilitated by Cipla, and the Johnson & Johnson vaccine. vaccine. Johnson & Johnson has also requested permission to study its single-dose vaccine in the country.
The National Immunization Technical Advisory Group will develop a roadmap to include ZyCov-D in the Covid vaccination campaign, and will also prioritize people aged 12 to 18. There are approximately 120 million adolescents in this group.
Zydus Cadila said his vaccine would be administered using a needleless applicator, ensuring painless intradermal vaccination. “This is the first time that a technologically advanced vaccine has been successfully developed on the plasmid DNA platform for human use. The platform, due to its fast plug and play technology, can be easily adapted to deal with mutations in the virus, such as those already occurring. The company plans to manufacture 10 to 12 crores (100 to 120 million) of doses of ZyCov-D each year, ”she said in a recent statement.
ZyCov-D is stored between 2 and 8 degrees Celsius, the company said, and it has shown good stability at temperatures of 25 degrees for at least three months.
According to the company’s 2020-21 annual report, Zydus Cadila has also developed another Covid vaccine, which is a recombinant measles vaccine, ZyCov-MV. He has developed a drug to treat covid-19 patients and has sought approval for clinical trials in patients with mild to moderate symptoms of covid.
The country’s first mRNA-based vaccine developed by Pune-based Gennova Biopharmaceuticals has received approval for Phase II / III trials in the country. The company had submitted provisional clinical data from the Phase I study to the Central Drugs Standard Control Organization, which is the Indian government’s national regulatory authority. An expert panel reviewed the data from Phase I and found that HGCO19 was “safe, tolerable, and immunogenic in study participants.” Gennova will conduct the study in India at 10 to 15 sites in phase II and 22 to 27 sites in phase III.