Supply chain & logistics
AstraZeneca (AZ) vaccine and Novavax candidate are being made – repeatedly requested that the US lift the DPA export ban on materials like filters, bioreactor bags and single-use systems, so established manufacturers in the rest of the world could ramp up production. Unsurprisingly, a law enacted to help the most powerful country on the planet fight a war is having an adverse impact elsewhere. In spring 2020, the bodies were piling up outside New York’s graveyards; at the time of writing, the people of New Delhi are cremating their suffocated dead by roadsides and in empty lots.
On 25th April 2021, that devastation finally prompted the US to reconsider its use of the DPA. Two days earlier, multiple speakers at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) vaccine manufacturing media briefing had fingered the Act as one of the biggest threats to the global effort to stop the pandemic. Michelle McMurry-Heath, president and CEO of the US-based Biotechnology Innovation Organisation (BIO) contrasted the impact of the DPA with the “positive steps” the Biden administration took in re-engaging with WHO and committing to Covax, which has so far delivered just over 40 million doses to low and middle-income countries. “The Defense Production Act, which was really designed to withhold capacity, expertise, doses and raw materials to the US customer base, was well- intentioned but somewhat misguided at this stage,” she said. “We need to get those raw materials out to the limited manufacturing capacity that exists around the globe and now is the time to act on that. The rate-limiting step is not intellectual property, the rate-limiting step is manufacturing know-how and capacity, and we need to make sure that in every corner of the world that has this great capacity... they have the ability and the means to manufacture as many doses as possible.”
Sai Prasad, executive director for quality operations at Bharat Biotech, makers of Covaxin, an inactivated virus vaccine approved for use in India, and the president of the Developing Countries Vaccine Manufacturing Network (DCVMN), echoed McMurry’s point, listing Europe and China alongside the US as important suppliers of raw materials and production tools. “There is no way that we could get that technology manufactured anywhere else,” he stressed. “We really have to depend on these companies that we have established long-term partnerships with, and [on] countries to enable the free flow of goods between where the manufacturing of these materials is happening and where the vaccine manufacturing is happening.” Crucially, around 55% of the world’s vaccine manufacturing capacity is in East Asia. Prasad linked the risks of misjudged protectionism to those of variants like the multiple strains currently ravaging India. “I don’t think any country... can just
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
protect their population by these kinds of concepts or laws and not expect the virus to come back again, and I think we are seeing this in the waves and waves of the pandemic,” he said. “Policymakers around the world need to think about this. I would request [that] better and cooler heads prevail.”
Cool, calm and collective The US government’s willingness to reconsider its export restrictions is a start, as is the recently announced Covax manufacturing task force, but there are far more examples of missteps. Frustrated by the slow delivery of doses through Covax, a majority of WTO members are now pushing for the Covid vaccine IP waiver proposal initially submitted by India and South Africa in October 2020. Prasad couldn’t offer a view for the DCVMN as a whole but, with the other speakers at the IFPMA conference, cautioned that a focus on sharing IP is no way to solve the more pressing shortages of materials and expertise. It could worsen the situation.
55%
Proportion of the world’s vaccine manufacturing capacity that is in East Asia. IFPMA
“The rate-limiting step is not intellectual property, the rate-limiting step is manufacturing know-how and capacity.”
Michelle McMurry-Heath, BIO
“All our IP is on the internet,” pointed out Moderna CEO Stéphane Bancel. Any interested party can download instructions and ingredients lists but, as Prasad put it, you can’t manufacture vaccines from USBs. The resources that companies like Moderna or Bharat Biotech use for technology transfers, which take six months to a year, are the same they use to make drugs. If they can’t be sure that they’re working with a partner that has the expertise to make vaccines, it’s a dangerous waste of time. The IFPMA has recorded 214 such agreements involving Covid-19 vaccines so far, but every additional manufacturer puts more strain on the raw material supply chain, potentially diverting resources from sites approved to provide doses today. After a certain point, there’s a choice between scaling up and scaling out, between inoculating people now or later. “Trying to diffuse the limited raw materials that we have right now across many more manufacturers that perhaps don’t have experience manufacturing vaccines, could jeopardise the progress we’re on track to make,” explained McMurry-Heath, a former FDA official. “We need to recognise that there are only a handful of manufacturers across the globe who have that expertise at hand, and we need to focus on getting them the materials they need to produce as many doses as quickly as possible.” Technology transfers are difficult enough within single countries and companies. McMurry-Heath
23
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53
