Indian pharmaceutical company Zydus Cadila may apply the Corona vaccine ZyCoV-D to the Central Drugs Regulator for emergency approval this week. If approved, it would be the world’s first DNA-based vaccine.
With this, the number of vaccines available in the country will increase to four. So far, Covishield of Serum Institute, Covaxin of Bharat Biotech, and Sputnik-V of Russia are being used in India.
Is this a single dose vaccine or a double?
All three vaccines currently being administered in India are double dose vaccines, while there are also single dose vaccines such as Johnson & Johnson and Sputnik Light available in different countries, which may arrive in India in the coming months. But the ZyCoV-D vaccine is different from all this. Not one or two, but three doses of this Indian vaccine will be given.
The vaccine keeps immunity stronger and longer when administered in three doses during Phase-1 and Phase-2 trials. However, Cadila is also testing two doses. The results of this may also come soon.
How does ZyCoV-D vaccine work?
ZyCoV-D is a DNA-plasmid vaccine. This vaccine uses genetic material to boost the body’s immunity. This plasmid-DNA is used in the same way that Pfizer and Moderna vaccines in many countries, including the United States, uses mRNA to increase immunity.
The mRNA is also called messenger RNA, which sends a message to the body to make antibodies against the coronavirus, while the plasmid is a small DNA molecule in human cells, different from normal chromosome DNA. Plasmid-DNA is usually found in bacterial cells and can be replicated independently.
Plasmid-DNA is converted into a viral protein by entering the human body. This helps the body to develop a strong immune response to the virus. This stops the virus from growing. If a virus changes its shape, that is, a mutation occurs, the vaccine can be changed in a few weeks.
How many doses of ZyCoV-D vaccine are needed?
ZyCoV-D is different from others. It requires three doses for its best results.
What is the interval between three doses of ZyCoV-D vaccine?
The second dose of ZyCoV-D will be given 28 days after the first dose. While the third dose will be taken 56 days after the first dose, that means each dose will have an interval of 4-4 weeks. More than 28,000 people have been enrolled for the third phase trial of ZyCoV-D. It also includes children between the ages of 12 to 18.
Cadila has conducted the third phase trial at 20 centers across the country. 20-20 children between the ages of 12 and 18 were also part of the trial at each center. The centers involved in the trial said the vaccine had no side effects on children. It is hoped that the country will soon get its first vaccine for children.
It is being said that the company may soon trial the vaccine on children between the ages of 5 to 12. Vaccination coverage could increase if trial results remain encouraging.
How is ZyCoV-D administered?
ZyCoV-D is a needle free vaccine. This will be administered from the jet injector. Jet injectors are the most widely used in the United States.
This allows the vaccine to be injected into the skin of the hypertensive lock. The fluid or medicine injected into the muscles, when the needle injection is usually used. Jet injectors use compressed gas or springs for pressure.
The device was invented in 1960. The WHO approved its use in 2013. Jet injectors have been widely used in the United States since 2014. It is also used in some countries in Europe, Africa and Asia.
What is the benefit of vaccinating with a jet injector?
The first benefit is that it reduces pain. Because it does not go inside your muscle like a normal injection. Another advantage is that the risk of spreading the infection is much lower than with needle injection. Companies like Pharmajet, Spirit International, Valeritas Holdings, Injex, Entris Pharma are making jet injectors.
When ZyCoV-D can get approval?
Cadila may apply to DCGI for ZyCoV-D emergency approval this week. Data analysis of the phase-3 trial of the vaccine is almost ready. The company has informed the government about this. The vaccine is being tested on adults as well as children between the ages of 12 to 18. The vaccine is also being tested on people who are already suffering from serious illnesses.
“We hope to start mass production of the vaccine by July,” Dr Sharwin Patel, managing director of Zydus Cadila, said a few days ago. It is clear that the company hopes to get approval by the end of this month or early July.
What is the production capacity of the Cadila company for this vaccine?
Zydus Cadila is talking about producing 240 million doses a year. The company is preparing to hit the market a few days after the approval. The company will produce 20 million vaccines per month. At the same time, talks are underway with other manufacturers to increase production. The company will make about one crore doses in the first month. After this, the production will be doubled from next month.
How XyCov-D vaccine is stored?
It is easier to maintain than any other vaccine. It can be stored at a temperature of 2 to 8 degrees Celsius. It does not deteriorate even at a room temperature of 25 degrees. For this reason, a hectic cold chain is not required for its maintenance. It can even be modified more easily than the rest of the vaccines for the new COVID-19 variant.
What is the price of ZyCoV-D vaccine?
The price of the vaccine is not yet decided. The company officials said that as it is new technology, the price will be decided accordingly.
ZyCoV-D Vaccine updates
Before the third wave in the country, the Delta + variant of coronavirus had spread its legs. This wave can target young children. The corona vaccine for children is also expected to launch the market in July. At present, in India Biotech’s Covexin, Pfizer and Zydus Cadila vaccines can be approved for children.
The Chairman of the Covid Working Group, Dr. Anke Arora said on Sunday that trials of the Zydus Cadila vaccine were almost complete. By the end of July or in August we will be able to start vaccinating children between the ages of 12 and 18.
Aim to apply 10 million doses daily
He said the ICMR had conducted a study in which it was said that the third wave had not started. We have 6-8 months to vaccinate everyone in the country. Our goal in the coming days is to give 10 million doses of injections daily.
AIIMS Chief Dr. Randeep Guleria said that the corona vaccine for children would be the biggest achievement. This will pave the way for schools to reopen and start outdoor activities. Guleria made the remarks during a conversation with news agency PTI on Saturday.
Three vaccines option for children
The results of Phase 2 and 3 trials of Bharat Biotech’s Covexin on children aged 2 and 18 will be available by September. Vaccines for children in India may be available within that time interval after approval by the drug regulator.
If the Pfizer vaccine is approved before this, it will also be a suitable option for children.
According to a senior government official, Zydus Cadila may also soon apply to the Drug Controller General of India for approval to use its corona vaccine ZyCoV-D on an immediate basis.