New Delhi: The US Monday refused to comment on the request by the Serum Institute of India to lift an embargo on the supply of vaccine raw materials that are essential to ramp up production.
Asked about the specifics of the raw materials required and whether Serum’s concerns would be addressed, Dr Andy Slacitt, the White House Covid-19 response senior advisor, said, “We’ve been a leader in the funding of COVAX, have done several bilateral transfers of vaccines, and are looking very hard and taking very seriously all of these complex issues, we’ll get back to you on the specifics.”
Addressing the same news conference by the White House COVID-19 Response Team, Dr Anthony Fauci, Director at the National Institute of Allergy and Infectious Diseases, said: “We could get back to you on that, I’m sure. But I don’t have anything for you right now.”
Meanwhile, a Biden administration official denied that there were any outright bans. “We reject any statement referring to a U.S. export ban on vaccines. The United States has not imposed any “outright bans” on the export of vaccines or vaccine inputs. This assertion is simply not true,” the official told The Hindu.
India’s Ambassador to the US Taranjit Singh Sandhu has also reportedly brought up the matter with the US administration.
Speaking at an event Tuesday, External Affairs Minister S. Jaishankar also commented on the matter and said, “Today, as foreign minister, I am pushing other countries, particularly some big countries that please keep the raw materials flowing for vaccines to be made in India.”
But how essential are these raw materials to the production of vaccines in India? ThePrint explains.
How it all began
On 5 February 2021, the Joe Biden administration enacted the Defence Production Act (DPA) to bolster the production of the vaccines, increase the availability of testing kits and boost production of protective equipment.
The law grants the president the right to direct domestic manufacturing and production to address and prioritise the nation’s needs.
Then, on 3 March, he promised to make enough vaccines to inoculate the adult American population by the end of May. The White House fixed this timeline after brokering a deal between Johnson & Johnson and the manufacturing firm Merck. The Act was once again imposed to ensure continuous production of the J&J vaccine, 24 hours a day.
The US’ decision to prioritise domestic demand is why certain raw materials — which are manufactured or whose parent companies are based in the US — are not available for India.
The raw materials India needs
According to a report by the World Trade Organization regarding the composition of Covid-19 vaccines, “A typical vaccine manufacturing plant will use in the region of 9,000 different materials sourced from some 300 suppliers across approximately 30 different countries.”
Adar Poonawalla, Chief Executive Officer of Serum Institute of India, which manufactures the vaccine Covishield, had indicated that some of the supplies needed included bags and filters.
“There are lot of bags and filters and critical items that manufacturers need. I will give you an example. The Novavax vaccine that we are a major manufacturer of, need these items from the US… Now the US has chosen to invoke the Defence Act, in which there is a sub-clause which prevents the export of critical raw materials required for their local vaccine manufacturers,” he was quoted as saying in an Economic Times report.
In a tweet, Poonawalla had also requested Biden to lift the embargo.
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. 🙏🙏
— Adar Poonawalla (@adarpoonawalla) April 16, 2021
A report by UK-based think tank Chatham House, in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations, found that shortages in the supply chain could disrupt vaccine manufacturing in a significant way.
Some of the materials in short supply include single-use bioreactor bags, which are used for cell culture and fermentation; cell culture media required for the production of inactivated-virus, viral-vector, protein-subunit-based Covid-19 vaccines, and single-use filters and glass vials.
What does this mean for vaccine supply?
Poonawalla, in a plea, had said, “To develop new suppliers in the eleventh hour will take a bit of time. We will do that. We will not be dependent on the US after six months. The problem is we need it now.”
Simply put, if the components aren’t supplied on time, it could lead to vaccine shortages in the future and disrupt delivery commitments.
While the US isn’t the only supplier of these components, switching to different suppliers from elsewhere could affect various approvals that are currently in place for the manufacturing of Covishield and Covovax — the two products by SII — and Bharat Biotech’s Covaxin.
“Most of these items are standardised, and if manufacturers suddenly switched suppliers, they would have to seek additional approvals which could further complicate the process,” said Dr Chandrakant Lahariya, a public policy and health systems expert.
Considering the US has imposed the DPA, it is under no obligation to lift the embargo anytime soon, and until its own demands are met.