Serum Institute of India CEO Adar Poonawalla Friday urged US President Joe Biden to lift the embargo on export of raw materials needed to ramp up production of Covishield and Covovax, the Covid-19 vaccines it is making in India. In a Twitter post, tagging the US President, Poonawalla said: “Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details.” He later told The Indian Express: “The vaccine industry, outside the United States, needs plastic bags, filters and media solutions which are critical in the manufacturing of Covid-19 vaccine. For a month, we have been asking the US authorities, but they have not responded.” “We are hoping that the Biden administration takes a more global perspective than the previous administration which was looking at only America and America first – that is our hope, our umeed,” he said. Indian government officials have raised the issue with their US counterparts in Delhi and Washington DC to allow ingredients crucial for vaccine manufacturing. Taranjit Sandhu, India’s ambassador to the US, has flagged the issue to officials in the US administration. For a month now, vaccine manufacturers and upstream suppliers have been increasingly reporting shortage of raw and packaging materials, critical consumables and equipment. Over time, such shortages, if left unaddressed, will lead to shortage of vaccines and impact delivery commitments. The SII is currently manufacturing the Covishield vaccine developed by AstraZeneca and Oxford university. The vaccine is not only being used in the country but is also exported to other countries. It also has an agreement with Novavax to make around a billion doses of Covovax, but the Pune firm’s ability to make and stockpile this vaccine has reportedly been halved as a result of the US restrictions. The US restrictions are expected to hit the output of major suppliers for the world. The continued restrictions, a result of the US Defence Production Act that has been invoked frequently throughout the course of the ongoing pandemic, may not only cause a fight for limited resources, but may also delay regulatory clearances of some of these products, according to some experts. The materials flagged by Poonawalla - plastic bags, filters and cell culture media - are relevant to most vaccines being made to tackle the Covid-19 pandemic. Products like the microcarrier beads, used in the process of growing the cell lines to make several vaccines that use a virus, are also in shortage, said an expert requesting anonymity. While some experts have said that the US is not the only supplier of these products - some capacity for specific input materials exists in other countries as well - it does contribute a major role. For instance, the sterile filters used by companies as part of the final process of purification of the protein are majorly supplied by companies like New York-headquartered Pall Life Sciences and Merck Millipore, owned by Germany’s Merck but headquartered in Massachusetts. Most suppliers for the single-use bioreactor systems, which use disposable bags for cell culture and fermentation include American multinational company Baxter Healthcare, Massachusetts-headquartered ThermoFisher and Cytiva. However, Germany-headquartered Sartorius AG also provides such end-to-end disposable systems. Cytiva-owned HyClone and Merck Millipore supply cell culture media and serums used in them, but these are also made by Germany’s CellGenix, India’s HiMedia and Switzerland’s Lonza Group AG. The shortage of crucial inputs like bioreactor bags, cell culture media and filters were flagged as potential roadblocks by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) early in March. Apart from this, chromatography consumables have also been highlighted as a concern. An issue with companies switching to other suppliers also includes the complex regulatory processes that they have to undergo for seeking approvals for their vaccines in different regions.
