While the US has restricted export of vaccine ingredients to help its domestic COVID-19 vaccine manufacturers Pfizer-BioNTech and Moderna, an Indian company is supplying a crucial and rare ingredient required for manufacturing their m-RNA technology based COVID-19 vaccines. It's a lever India could use as a bargaining chip to get US to lift curbs on supplies to Indian vaccine makers from the country.
Using a wartime law, Defence Production Act (DPA), US throttled supplies of key raw materials like bags, filters, vials, glass, cell culture media, plastic tubings, stoppers and some reagents. It directly impacted Indian vaccine makers. US invoked the law to give priority to the production of COVID-19 vaccines and Personal Protective Equipment (PPEs) for domestic use. It forced US raw material suppliers to restrict supplies in favour of Pfizer-BioNTech, Moderna and Johnson & Johnson's unit Janssen.
Mumbai headquartered pharma and nutraceutical specialty ingredient maker VAV Lifesciences and its subsidiary VAV Lipids, through a deal with a US-based multinational contract development and manufacturing organisation (CDMO), is going to supply highly purified 'synthetic phospholipids' required for vaccine manufacturing. The CDMO is using lipids made by VAV to produce gene-based lipid nanoparticles (LNPs) for exclusive use in the COVID-19 vaccines of Pfizer-BioNTech and Moderna.
"LNP technology is considered a medical breakthrough in vaccine-based delivery systems. It has enabled the development of mRNA-based Covid-19 vaccines at a blistering pace. We are proud to be the first and only Indian company to produce high-quality phospholipids that have been approved for use in these novel vaccine delivery systems," said Arun Kedia, Managing Director, VAV Lifesciences.
Phospholipids, which are synthetic lipids and are used in the formulation of lipid nanoparticles (LNPs), are crucial biomolecules used in the manufacturing of m-RNA based COVID-19 vaccines. It is the first time vaccines made using this technology are being used in humans. Phospholipids are very tiny lipid particles which enclose submicroscopic mRNA strands in the vaccine. There are only 3-4 manufacturers of this in the world, and VAV Lifesciences is the only manufacturer in India. These LNPs effectively deliver the mRNA to the target cellular sites and help bind these to the relevant cells. Since mRNA is extremely sensitive to degradation and rapid breakdowns, LNPs ensure the protection of the mRNA until its uptake in cells. This results in a better cellular response and efficacy against virus replication, significantly enhancing the overall immunogenic response of vaccines, said sources.
VAV has already initiated commercial supply of phospholipids for large-scale vaccine manufacturing through its subsidiary VAV Lipids. About 80% of the order quantity already has been either delivered or is in the supply process and new orders are already under discussion. VAV will manufacture all its synthetic phospholipids at its EU current good manufacturing practice (cGMP) certified facility at Ratnagiri in Maharashtra. The volume of lipids utilised in vaccine delivery is very small and are measured in micrograms. Each order volume is about 250 kg and is roughly valued at Rs 50 lakh (approximately USD 67,000), said sources.