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Covid-19 vaccine ingredients needed from US
Read more on - Polity | Economy | Schemes | S&T | Environment
- Why Adar Poonawala said what he did: The CEO of Serum Institute of India urged US President Joe Biden to lift the US embargo on export of vaccine raw materials. He wants to urgently ramp up production of Covishield and Covovax, the Covid-19 vaccines it is making in India. So there's an embargo, and materials are blocked.
- The US embargo: Exports of critical raw materials used in the production of some Covid-19 vaccines was blocked, to invoke the US Defense Production Act earlier in 2021.
- The 1950 Act was originally passed to help ensure supplies and equipment during the Korean War. Today, its scope extends beyond America’s military to cover natural hazards, terrorist attacks and other national emergencies.
- The Act empowers its President to order domestic businesses and corporations to prioritise federal contracts in such events.
- What Trump did: Early on in the Covid-19 pandemic, then President Donald Trump had invoked the Act for purposes like increasing production of ventilators and limiting exports of medical supplies. But in 2021, President Biden invoked the powers of the Act on January 21 to ensure the availability of “critical” materials, treatments and supplies needed to combat the pandemic, including the resources necessary to “effectively” produce and distribute vaccines “at scale”. Biden said the Act was being invoked to ensure 24×7 manufacturing of the Johnson & Johnson vaccine.
- Blocked: So this decision to ensure that companies on American soil divert their resources to meet the demands of the US population effectively blocks them from meeting export commitments. As an example, Biological E, which is making the J&J vaccine in India as well as a protein subunit vaccine with Houston’s Baylor College of Medicine, had said US suppliers have told global clients that they may not be able to fulfil their orders because of the Act.
- Speficic raw materials blocked: There is no comprehensive list of companies that have been called in to focus on vaccine production in the US, nor is there a list of all the raw materials that cannot be exported from the country as a result of invoking the Act. A typical vaccine manufacturing plant will use around 9,000 different materials, as per WTO. These are sourced from some 300 suppliers across some 30 countries. The US restrictions are expected to hit the output of major suppliers for the world. The continued restrictions may not only cause a fight for limited resources, but also delay regulatory clearances of some products. Plastic bags, filters and cell culture media, especially, are relevant to most vaccines being made to tackle the Covid-19 pandemic. This includes vaccines like Covishield and Covovax, of which SII was expected to supply over a billion doses each this year.
- Hit hard: The US Act seems to be impacting the ability of other Indian companies to make their Covid-19 vaccines in India. For instance, Dr Krishna Ella, the boss of Bharat Biotech that makes Covaxin, said that the restrictions by the US “on some of the materials” have impacted supply logistics for vaccine makers. The US restrictions would not only make the scale-up for Covid vaccines “extremely difficult”, but would also hit the manufacturing of routine vaccines. Biological E is expected to make around a billion doses of the J&J vaccine as well as scale up its production of its recombinant protein vaccine with Baylor College to a billion doses over an unspecified time period. It is not clear how much of its production will be impacted at this stage, as the company is currently still testing the recombinant protein vaccine in India. A meeting among leaders of Quad nations US, India, Japan and Australia last month had also culminated in an agreement to support the company’s scale-up of production of the J&J vaccine.
- Other suppliers: Some capacity for specific input materials exists in other countries as well, but the US does have the major contribution.
- The Johnson & Johnson vaccine is an adenovirus vectored vaccine, and it (the company) has been told to work 24×7 to increase supply.
- So there will be a cutting off of supplies of materials used for cell cultures, which are important for other viral vector vaccines, inactivated vaccines and vaccines that are protein expression systems-based.
- Most of the equipment manufacturing is done in regions like Europe, but for plastics and the bulk of the reagents used in any laboratory, US companies are major suppliers.
- The sterile filters used for 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. Major 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. The US does not have a stronghold on all crucial raw materials. At least 50% of the required buffers and enzymes are imported “largely” from Western European countries like France, Germany, Switzerland and, to some extent, even Italy.
- Import from other countries: Finding alternatives is difficult. Many components flagged by SII, Biological E and Bharat Biotech have also been reported as areas of concern by several other manufacturers around the world. WTO trade statistics suggest that global exports of some particularly critical raw materials (including nucleic acids, amino acid phenols, acyclic amides, lecithins and sterols) grew by 49% in the first six months of 2020 to reach some US$ 15.5 billion in value. Another problem is the complex regulatory processes that vaccine makers have to undergo for seeking approvals in different regions. Vaccine makers have increasingly relied on third parties for the timely supply of goods like raw materials, equipment, formulated drugs and packaging, critical product components and services.
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