Cadila Healthcare MD Sharvil Patel said the company has started stockpiling the ZyCoV-D COVID vaccine, and is in the process of providing additional data to drug regulators and hopes to get the shot approved in one or two weeks.
If approved, ZyCoV-D will become the first vaccine anywhere in the world to use DNA to induce the human body to produce COVID virus structures and trigger an immune reaction.
No other country uses DNA technology for the purpose.
On the other hand, the US and Europe have already seen widespread use of RNA, another form of genetic code, to achieve the same result using the Pfizer and Moderna vaccines. However, the FDA has never approved the use of DNA vaccines for humans, opening the possibility that India may become the first major country to do so.
All the current vaccines currently available in India are based on traditional technologies.
These use dead, inactivated or genetically modified common viruses to trigger immune reactions. Cadila is also developing a traditional vaccine called ZyCoV-MV, using genetically altered measles virus.
Sharvil Patel said it is very difficult to predict when the government may give its approval to the DNA vaccine, given that it’s a rolling review and new data is continuously being generated by the company and being submitted to the regulatory authorities.
The company is still providing data as and when the regulator asks for it, he pointed out.
“By and large, all the other information has already been reviewed. So, if every thing is okay and we also don’t see any issue with the last data and if the data is fine, we can potentially see an approval within the next one to two weeks, maximum,” he said.
TWO DOSES
Patel also said the vaccine is likely to be administered in a two-dose fashion, instead of three doses, as both methods have shown similar efficacy and safety profiles.
The three-dose regimen requires the administration of 2mg of the vaccine at an interval of four weeks between each dose, while the two-dose approach will deliver 3mg of the vaccine with one interval of four weeks.
Patel also said the company started off by giving the 2mg dose to volunteers given the relative novelty of such vaccines.
“We are doing DNA vaccine for the first time,” he pointed out. “That too, obviously, we would not have known how everything moved, and..immunogenicity and other data comes out much later,” he pointed out. “In this development cycle, things kept on happening in parallel and not in sequence..”
However, the company soon realized that the 3mg dose was also equally safe, and may even have better immunogenicity.
“There have been no serious safety events in this arm also. It has better immunogenicity, so it could have better efficacy. But conservatively, saying similar efficacy would be right.”
Patel said the scientists also wanted to test if spreading the dose over a greater period created a stronger immune response.
The company conducted tests among adolescents and has sought approval for the vaccine in adolescents, and not just for adults. “We are also hoping that we will be approved for that,” Patel said.
PRODUCTION STARTED
The company has started manufacturing and stockpiling the vaccine at one of its two plants designated for the production of the vaccine.
The company had earlier been reported to have guided for a production of 3.5 cr doses of the vaccine by December. Patel said it should be possible to achieve that level of output.
Cadila has identified two facilities, a drug substance plant and a drug products plant, for manufacturing the DNA vaccine. Patel said his firm has started commercially manufacturing the DNA vaccine at the smaller facility for the purpose of stockpiling.
He said there’s no problem with demand, given the situation in India. “..even if it’s the adult population, I don’t think the difficulty will be in terms of being able to secure the business for the quarter given the manufacturing capacity that we have,” said the MD in comments soon after the company revealed its quarterly financial results.
India is currently facing an extreme shortage of vaccines. So far, only around 52 cr vaccine doses have been administered, against a requirement of around 180 cr or so to inoculate the entire adult population.
“Our current capacity, if we manufacture to the max, is between 10 mln and 15 mln doses monthly, which is not very large in terms of the overall need of the vaccination,” the MD pointed out.
“We should be able to supply whatever we can make, because we’re talking about 1 cr doses or 1.5 cr doses, which is not very large from an overall requirement point of view.”
Patel said the company is geared up to start the distribution once the nod is given. It has put in place various logistical infrastructure required to do so, such as for supply chain management and patient support.
He said the company has seen expectations from private buyers for more quantities than it can produce, but it cannot commit to them until the government makes it clear how much of the total output it wants. Typically, the government of India buys around 75% of all COVID vaccines produced in India.
“As soon as we get an approval, as soon as our pricing gets approved and as soon the government commits to their quantities, we will then supply to the rest of the market as well.”
NO EXPORTS FOR NOW
The MD said the company has no plans to seek approval for, or export to, any overseas markets right now, given the demand in India.
“For us, the current capacities that we have, we will not have enough capacities to give to India. So, to look at exports is not very practical right now, because we won’t be able to make any supplies,” said the MD.
On the other hand, there have been some interest in the vaccine from outside India, and the company may share its technology with foreign entities without seeking direct entry.
“..we are looking to see whether we can partner for future supplies and may be give the technology to other countries for the manufacturing of this vaccine. A few of them have approached us. So we are in discussion stages.”
Cadila also makes two other COVID-related drugs, remdesivir and Virafin, out of which remdesivir is also being exported.