Wockhardt, IIL discuss manufacturing tie-up with US vaccine major Moderna

Firms like Indian Immunologicals (IIL) and Wockhardt are in talks for manufacturing tie-ups with US vaccine major Moderna for its mRNA platform-based vaccine, sources said.

“There are two specific steps in vaccine manufacturing. One is making the drug substance, and another is filling the drug substance in vials. If a foreign player supplies the drug substance, then several Indian players have fill-finish capabilities to make the final product. This would typically enhance the vaccine maker’s capacity and reach in this market,” said a person close to the development. Drug substances are the raw material for making vaccines.

Another source confirmed that Hyderabad-based vaccine maker IIL had initiated discussions with Moderna among other players for forging a manufacturing tie-up. “Discussions were initiated last month when IIL had sought data from Moderna on the technology platform the vaccine used to assess compatibility of manufacturing here,” said a source close to the development.

The company, however, did not confirm this. An email sent to Moderna did not elicit an immediate response.

A source indicated that several foreign vaccine makers are in touch with IIL for a tie-up. Around November, IIL had indicated that it was open to discussions with the US major.

Moderna’s vaccine, which is based on mRNA technology, like Pfizer-BioNTech’s vaccine, can be stored for a month at temperatures of 2-8 degree Celsius, and for six months at minus 20 degree Celsius.

Moderna’s vaccine had shown 94.5 per cent efficacy against Sars-CoV-2 in November, after which the US approved it in December and even the UK and France have approved it recently.

The Indian government, too, is engaging with Moderna to see if the vaccine can be brought here.

The health ministry has indicated that India has minus 70-degree cold chain infrastructure (though not equitably distributed) owned by the Department of Agricultural Research and Education (DARE).

Meanwhile, sources also indicated that Mumbai-based Wockhardt was interested in partnering with Moderna for similar opportunities. An email sent to Wockhardt did not elicit an immediate response either.

As such, the firm had indicated that it was in talks with global vaccine makers for contract manufacturing drug substances as well as to fill and finish doses out of its Indian site at Aurangabad. The site has a capacity to make a billion doses.

Wockhardt is already working closely with the UK government, which has reserved one fill-and-finish production line the company has there for its exclusive use for 18 months to guarantee the supply of vaccines required to fight against Covid-19.

Habil Khorakiwala, chairman of Wockhardt, had said last month, “We are in discussions with a number of vaccine developers.” He added that the company is also considering collaborations that involve contract manufacturing and also vaccine distribution in India and some emerging markets.

Khorakiwala had refused to divulge the names of the global players that the firm was in discussions with. At present, there is existing manufacturing capacity to make 5-6 billion doses globally, while there is need for 15 billion doses or so to vaccinate the entire global population. Wockhardt, thus, sees an opportunity in supplying vaccines that have been developed by someone else.

Vaccine industry insiders, however, sounded skeptical. A source said, “Most of the big players have already sealed global partnerships — AstraZeneca and Novavax with Serum Institute, Johnson and Johnson with Biological E, etc. There would not be much opportunity left after this,” the person said.

He also felt that handling a drug substance like Moderna’s would be extremely tricky. “If the finished product has such stringent temperature requirements, then the drug substance would be more unstable. I do not know how this works out easily,” he added. – Business Standard