India, one among the world’s largest producers of coronavirus vaccines, has temporarily halted all exports of the AstraZeneca vaccine citing the necessity to prioritise its own needs.
Its manufacturers had been supplying vaccines round the world, including many doses of the AstraZeneca jab to the Covax scheme for middle and low income countries.
Why the halt on exports?
India features a major challenge inoculating its own population.
By the top of March, around 65 million doses had been administered nationally, and therefore the programme has now been extended to incorporate all those aged 45 and above.
Two vaccine producers in India have raised concerns about their ability to satisfy their production targets.
The largest of those , the Serum Institute of India (SII) – which produces Novavax and AstraZeneca vaccines – has warned of staple shortages affecting production.
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 has written to the Indian government 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.
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.
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).
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.
The company did not clarify if it already had stockpiles of the vaccines it produces, and how much of its production has been earmarked for domestic use only.
Is India meeting domestic needs?
The Indian government began its vaccination programme on 16 January.
But infections have been increasing in some parts of the country since mid March and the vaccine drive has now been extended to younger age groups.
So far, the SII has an agreement to supply 100 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.
The SII chief, Adar Poonawalla, indicated in January that official approval for Covishield was granted on the understanding that company prioritise Indian domestic needs.
However, the Indian government subsequently made clear there were no restrictions on exports, after Bangladesh queried if a contract to supply Covishield would be honoured.
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.
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.