The head of the Serum Institute of India (SII), one of the world’s largest manufacturers of coronavirus vaccines, has said its production capacity is “very stressed”.
The SII had been supplying vaccines around the world, including to the Covax scheme for middle and low income countries. But India has put a temporarily halt on these exports.
Can India meet its domestic needs?
India has a major challenge inoculating its own population.
“We are prioritising the needs of India”, said Adar Poonawalla, the head of SII said in an interview on Indian television, but added “we are still short of being able to supply to every Indian.”
As of 7 April, around 85 million doses had been administered nationally, and the programme was recently extended to include all those aged 45 and above.
The government says vaccination will not yet be extended to wider groups because of a “limited supply” until July.
The western state of Maharashtra has been reporting the highest number of cases in the country and it’s health minister has raised concerns about current vaccine stocks running very low.
Similar shortages have been reported elsewhere.
So far, the SII has an agreement to supply 166 million doses to the Indian government, with another firm, Bharat Biotech, supplying 10 million doses.
India also has licensing deals with the Russian Gamaleya Research Institute to produce 200 million doses of the Sputnik vaccine.
These will be produced by Indian manufacturers, for both the Indian market and for export.
Why is capacity ‘stressed’?
Two vaccine producers in India have raised concerns about their ability to meet their production targets.
The largest of these, SII – which produces Novavax and AstraZeneca vaccines – has warned of raw material shortages affecting production.
Its chief executive, Mr Poonawalla, attributed this to US export bans on specific items needed to make vaccines, such as specialised bags and filters.
The firm said it has also faced difficulties importing cell culture media, single-use tubing and specialised chemicals from the US.
“The sharing of these… raw materials is going to become a critical limiting factor — nobody has been able to address this so far,” said Mr Poonawalla.
The SII had written to the Indian government in March asking it to intervene to ensure the uninterrupted manufacture and supply of vaccines globally.
Another Indian manufacturer, Biological E, which is producing the Johnson & Johnson vaccine, has also raised concerns about possible shortages affecting vaccine production.
Mahima Datla, the company’s chief executive, recently said US suppliers were “reluctant to commit that they will stick to their delivery timelines”.
Why is US restricting supplies?
President Biden has asked his administration to identify potential shortfalls in materials required for vaccine production.
He 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.
The DPA allows the US to restrict the export of products which might be needed for domestic manufacturing.
The Biden administration said in February that it would use the act to increase the list of items that US vaccine makers would get priority access to, such as special pumps and filtration units.
- 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
There are currently two vaccines approved in India – the Oxford-AstraZeneca vaccine (known locally as Covishield) and Covaxin, developed in Indian laboratories.
The Indian government says it aims to approve several more vaccines in the coming weeks.
Since early January, nearly 150 million doses of Covishield from the SII have been either exported or used domestically.
Indian pharmaceutical companies have been ramping up production by adding new facilities or converting existing production lines for some months now, both to meet domestic demand and meet global supply requirements.
The Serum Institute said in January it could at that point turn out between 60 and 70 million vaccine doses a month – this includes Covishield and the US-developed Novavax (not yet licensed for use).
Top Indian Covid vaccine makers
Bharat BiotechCovaxin, CoraVax
Biological EJohnson & Johnson
Hetero BiopharmaSputnik V
Dr Reddy’s LabSputnik V
Source: Media reports
The SII told the BBC back then it was aiming to boost production to 100 million doses a month from March – but when we checked with them recently, production was still at 60 to 70 million doses, and had not increased.
Mr Poonawalla has said ramping up to 100 million would happen only by June.
Impact on Covax supplies
Last September, the SII agreed to supply 200 million doses to Covax – the WHO-backed vaccine sharing programme to ensure vaccine availability to low and middle income countries- 100 million each of the AstraZeneca and Novavax vaccines.
India has so far provided 28 million doses to Covax, according to the UN.
However, the halt on exports has meant that 40 million doses expected in March were not received, with further delays expected in April.
India itself has so far received 10 million doses under the Covax agreement, the largest received by any country so far.
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.
The Indian government has also donated vaccines to a number of countries, with a particular emphasis on its neighbours in South Asia.
Until exports stopped, India had donated the most vaccines worldwide. China now holds that position.