The new coronavalirus vaccines are expected to be produced by the end of this year, and they will be manufactured by a firm called CNC Technology, according to sources familiar with the matter.
Sources told ET that CNC Technologies is one of three firms in the Indian orthopedically focused pharma market that has received a $20 million infusion from the US government’s Department of Defense (DOD) for its efforts to make the new vaccines, and the other two firms have a combined $50 million in seed funding from the DOD.
In August, the US Defense Department announced it had awarded a $40 million contract to CNC, and sources told ET, the firm has already been in talks with several government agencies in the US and India.
The sources said CNC is already in discussions with the US National Institutes of Health (NIH) to get a license to produce the vaccines, which have been approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
While the US Department of Health and Human Services has already given the nod to the vaccines to be made by CNC Technologies, CNC Techs first round of funding will be used to create a factory in the USA that will process and package the vaccines.
The new factory is expected to begin operations in the next two to three months.
The government has also provided seed funding for the project, and CNC CEO Vijay Bhaskar told ET he is confident the company will be able to complete the factory in India.
He said the factory will be located in New Jersey and will be ready to manufacture the vaccines by the second half of next year.
“We have been in discussions about getting a US license for manufacturing vaccines and this is a step in that direction,” he said.
The New York-based company will have the capacity to produce up to 100 million doses of the vaccine annually, and its first batch of vaccine is expected for distribution in India by early next year, he added.
While CNC has received the FDA approval, there is still a lot of work to be done in the manufacturing of the vaccines before they can be distributed in India, said an industry official who spoke to ET on condition of anonymity.
The manufacturing of vaccine in India has been fraught with controversy over the last several years.
CNC’s first vaccine, CVR-3, was tested in India only in September 2016, and was found to be ineffective.
In September 2017, CVS, the largest pharmacy in India closed all of its pharmacies because of concerns about the vaccine’s safety.
In November 2017, the government issued an order prohibiting the sale of the drug in pharmacies, but CNC says it will comply.CNC Technologies has also faced criticism for the quality of its manufacturing process, and in March 2018, the company was forced to issue an apology after a batch of the first round vaccine was recalled due to quality problems.CVS, however, was forced by the FDA to stop selling the vaccine after the manufacturer admitted that the batch was not safe.
India’s government has repeatedly pressed the company to manufacture more vaccines, citing safety concerns.