South Asian Insider
Opinion and Editorial
Vaccine embargo: Why Modi needs to call Joe Biden
A US embargo on the export of raw materials could upset India's plans to ramp up its Covid-19 vaccination drive
(Insider Bureau)--While the Centre, ramping up its vaccine rollout, has made all Indians aged 18 and above eligible for Covid-19 vaccinations-and allowed vaccine manufacturers to sell much more freely by waiving restrictions-raw material shortages resulting from an embargo by the US may play spoilsport.The US's Defence Production Act (DPA), invoked this February, allows the US President to order US based manufacturers to prioritise the supply of output-in this case, the supply of Covid-19 vaccines and protective equipment-to the American domestic market. One immediate consequence is that the DPA has been used to restrict the vaccine sales of US based medical suppliers Pfizer-BioNTech, Moderna and Johnson & Johnson's unit Janssen to the American market. This decision by the Biden Administration will impact medical companies and vaccine rollouts across the world, with India affected as well.
While the Serum Institute of India (SII) says the US's DPA embargo has not impacted its immediate production schedule for the Covishield vaccine, it says that the needed scale-ups of output could be interrupted or slowed. The SII currently makes 60-70 million doses of Covishield a month and aims to increase production to 100 million doses per month in a few months. The stockpiling of its second vaccine-in-the-making , Covovax-with US biotech firm Novovax, with a planned launch in September-will also be impacted, with current progress at only half of earlier estimates. American DPA restrictions may also impact SII's plan to help Novovax manufacture about one billion doses at Pune and at a facility in the Czech Republic, which SII sold to Novovax last year.
In an April 16 Twitter post, tagging the US President, Adar Poonawalla, CEO of SII, said, 'On behalf of the vaccine industry outside the US, I humbly request you to lift the embargo of raw material exports out of the US so that vaccine production [elsewhere] can ramp up'. Sources say that Indian Covid-19 vaccine manufacturers like SII and Bharat Biotech will be impacted in a number of ways. The trade in many critical, basic items-medical bags, filters, vials, glass, cell culture media, plastic tubing, stoppers and some reagents for production-has been impacted by the US decision, with between 30-40 such products currently being sourced only from the US. It will not be easy to quickly replace suppliers, with manufacturers across the world facing a soaring demand. Vaccine industry experts say it is impossible for any one country to source all its raw materials domestically-the process of making a vaccine involves the use of thousands of raw materials and reagents. Many essential products across the production chain are manufactured by US-based companies like Pall Lifesciences, Baxter, Millipore, ThermoFisher, Cytiva. Many of those products have patent protection. Many of are also not easy to substitute.Bharat Biotech says it has indigenised a key process to ensure that supplies are not restricted by the US embargo. Its vaccine works by using a proprietary chemical, Algel-IMDG, which stimulates the human body's immune response at a cellular level, provoking it into producing more antibodies to kill viruses.
This chemical was being sourced from a US company-Kansas-based ViroVax, which had proved it was an immunity booster in cancer trials-and with the American DPA restrictions, trade had been interrupted.
"The synthesis and manufacture of the IMDG component has been successfully indigenised, and it will be manufactured at commercial scale in India. This is the first instance where [such a medical chemical] has been commercialised in India", says Bharat Biotech. It says that it has secured raw materials, packing materials and single use consumables to meet manufacturing requirements, and the immediate plan is to scale up production to 700 million doses per year. Currently, the company can manufacture 50-60 million doses per year.
It has also partnered with Hyderabad based Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin.
The embargo will also affect Covid-19 vaccine exports from India. SII has to supply 200 million doses in 2021 to the WHO and allied countries under the Covax alliance. Bharat Biotech's Covaxin has received Emergency Use Authorizations (EUAs) in several countries across the globe with another 60 in process. EUAs have now been obtained from Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe and among several other countries. Similarly, Hyderabad-based Biological E has a contract manufacturing agreement with J&J for its vaccine.
On April 19, India Foreign Minister S. Jaishankar tweeted that he had spoken to his US counterpart, Secretary of State Antony Blinken, that they had talked of recent developments in India's immediate and extended neighbourhood, and 'also discussed issues pertaining to our health cooperation'. It is not clear whether their discussion will result in the US lifting its DPA embargo on the export of the medical raw materials, but this will likely remain a significant issue for both India and Indian manufacturers for the time being.
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