As India’s vaccination drive continues to gather steam, the Gujarat-based Cadila Healthcare, owned by billionaire Pankaj R. Patel, has joined the list of companies that have received Emergency Use Authorization (EUA) for their Covid-19 vaccines. Last week, Cadila said the Drug Controller General of India had approved its Made-in-India ZyCov-D, which it hopes will be available in the market by the middle to the end of September. The vaccine’s price has not yet been decided.
India has so far administered the vaccine to over 604 million people, but only 9.6% of India’s population is fully inoculated against the virus. The country has been vaccinating on average between 5 and 7 million people each day.
The 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, the ZyCov-D is also India’s first vaccine for adolescents between 12 and 18 years of age. All the vaccines that are available now are for those above 18 years.
Apart from ZyCov-D, the regulator has approved five vaccines–Serum Institute’s Covishield, Bharat Biotech’s Covaxin, which was the first Made-in-India vaccine, Russia’s Sputnik V, Moderna’s vaccine, which is being facilitated by Cipla, and Johnson & Johnson’s vaccine. Johnson & Johnson has also sought permission to study its single-dose vaccine in the country.
The National Technical Advisory Group on Immunization will work out a roadmap for including ZyCov-D in the Covid vaccination drive, and also prioritizing those in the 12 to 18 age bracket. There are about 120 million adolescents in this group.
Zydus Cadila said its vaccine would be administered using a needle-free applicator, thus 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 because of its rapid 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 10-12 crore (100-120 million) doses of ZyCov-D annually,” it said in a recent statement.
ZyCov-D is stored at between 2 and 8 degrees Celsius, the company said, and it’s 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 vectored vaccine–ZyCov-MV. It has developed a drug to treat covid-19 patients and has sought approval for clinical trials in patients with mild to moderate covid symptoms.
The country’s first mRNA-based vaccine being developed by the Pune-based Gennova Biopharmaceuticals has received approval for Phase II/III trials in the country. The company had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organization, which is the Indian government’s national regulatory authority. An expert committee reviewed the Phase I data and found that HGCO19 was “safe, tolerable, and immunogenic in the participants of the study.” Gennova will conduct the study in India at 10 to 15 sites in Phase II and 22 to 27 sites in Phase III.