With India attempting to ramp up vaccinations as Covid infections rise rapidly, India’s main domestic vaccine maker is struggling to meet demand at home and globally.
The Indian government has offered financial assistance to its vaccine makers to ramp up production.
How can India meet its domestic needs?
The Serum Institute of India (SII) and Bharat Biotech, the two main vaccine manufacturers, will get $400m and $210m each from the Indian government.
They produce the two vaccines that are currently being used, Covishield (the Oxford-AstraZeneca vaccine) and Covaxin.
The Indian authorities also halted large exports of vaccine in March in an effort to expand the domestic vaccination programme.
However, some smaller donations to other countries are still going ahead, as well as some of the supplies promised to the global Covax vaccine-sharing scheme.
India has now allowed the import of foreign-made vaccines such as Pfizer, Moderna and Johnson & Johnson.
But none of these vaccine makers has applied for an emergency use licence in India as yet.
However, with several states reporting vaccine shortages, India’s drug regulator recently approved the Russian vaccine Sputnik V for emergency use.
India will produce 850 million doses of the vaccine annually with five pharmaceutical companies manufacturing it, according to the Russian Direct Investment Fund, which financed the research and development of Sputnik V.
These will be for both the Indian market and for export, although production has not yet started.
What are the issues facing vaccine makers?
The SII – which produces Novavax and AstraZeneca vaccines – warned in March of raw material shortages, which it attributed to US export bans on specific items needed to make vaccines.
Last week, SII’s chief executive, Adar Poonawalla, appealed to US President Joe Biden to end restrictions on the export of raw materials.
The firm said it has faced difficulties importing cell culture media, single-use tubing and specialised chemicals from the US.
Another Indian manufacturer, Biological E, which is producing the Johnson & Johnson vaccine, had also raised concerns about possible shortages of vital materials affecting vaccine production.
Why is the US restricting supplies?
President Biden has invoked the Defense Production Act (DPA), legislation from the 1950s which gives the US president powers to mobilise the domestic economy in response to emergencies.
This allowed the White House to increase the list of items that US vaccine makers would get priority access to, such as special pumps and filtration units.
Representatives of various global vaccine makers raised concerns in early March, warning that:
Export restrictions from key suppliers could affect global production
Some items lack standardisation and are highly specialised
Replacement with substitutes sourced from elsewhere could take up to 12 months
Dr Sarah Schiffling, an expert on vaccine supply chains at Liverpool’s John Moores University, says the pharmaceutical supply chain is very complex.
“Even when demand is very high, new suppliers can’t spring up as quickly as they would in some other industries, or at least those new suppliers would not be trusted.”
She also says that the US measures are as much a reaction to existing global shortages, as they are the cause of them.
“To some degree, shortages would be unavoidable for materials needed for any kind of product that is suddenly in demand around the world,” she says.
Impact on vaccine production
Since early January, nearly 175 million doses of Covishield produced by the SII have been either exported or used domestically.
The company said then it was turning out between 60 and 70 million vaccine doses a month – this includes Covishield and the US-developed Novavax (not yet licensed for use in India).
But plans to ramp up production to 100 million doses a month by March have now been pushed back to June.
Last September, the SII agreed to supply 200 million doses to Covax – the WHO-backed vaccine sharing programme to ensure availability to low and middle income countries – 100 million each of the AstraZeneca and Novavax vaccines.
The SII was expected to deliver the first 100 million doses between February and May – but has so far delivered only 30 million.
India itself has so far received 10 million doses under the Covax agreement, the largest received by any country so far.
The global vaccine alliance Gavi, a partner in Covax, is reported to have said that the SII is legally obliged to provide vaccines for the scheme.
It’s also warned those countries taking part in Covax to expect delays to deliveries in March and April.
The SII has also made bilateral commercial deals amounting to more than 900 million doses of AstraZeneca vaccine, and 145 million doses of Novavax, according to UN data.