The US which considers India as a strategic partner in the Indo-Pacific region has banned the export of raw materials like filters, bags, and media solutions which are critical for vaccine manufacturing. POTUS Joe Biden invoked the US Défense Production Act to prevent the export of critical materials required for vaccine production, such as equipment, machinery, and related supplies, from the US. This was done to speed up manufacturing in the US, enable Johnson & Johnson, Merck, Pfizer, and Moderna to expedite delivery of doses to all US citizens above 18 years by May end. The US has already administered 135 million doses and the new administration has set a target of vaccinating another 200 million Americans in the first 100 days of the new administration.

Though this will not affect the production of Covishield, Poonawalla has cautioned that the manufacturing of the second Covid-19 vaccine that SII was working on with US company Novavax would be severely impacted. SII has started work on stockpiling the Covovax vaccine. SII has committed to making 1 billion doses of Covavax and the company has to supply 500 million doses of this globally through GAVI. This export ban has but affected Bharat Biotech in its Covaxin production which is currently being used across India. Also, it must be noted that not single but many vaccines of different companies will be required to vaccinate a country with a large population like India.

“The US has invoked the Defence Act and banned the export of raw materials. This is as good as banning vaccines. All vaccine producers are facing difficulties because of this,” Poonawalla had said. It has already stalled the Novavax vaccine’s production. “Stock-piling of Novavax would happen to the tune of 50 percent more if we had access to US raw materials. Till April, it was not coming in the way. From this month onwards, whatever we stockpile of Novavax would be half of what we could do, had it not been for US restrictions,” he said.

He aslo tweeted:

SII is now working on developing new vendors for raw materials it imports from the US like filters, bags, certain media solutions, etc.

Sources also indicated that Bharat Biotech is facing challenges in procuring the adjuvant used in the vaccine. Bharat Biotech is using an adjuvant from Kansas-based ViroVax for its vaccine. Adjuvants are pharmacological or immunological agents that improve the immune response of a vaccine. They may be added to a vaccine to produce more antibodies and to ensure longer-lasting immunity, thus minimizing the dose of antigen needed.

Vaccine manufacturers can establish a fresh supply chain for raw materials like filters and sterile plastic bags but the disruption in the supply of adjuvant could hamper production for a longer period. Authorised vaccines are made with a certain adjuvant and any change in the vendor of that adjuvant would lead to fresh clinical trials and approvals.