After shift on vaccine patents, US backs freer flow of components

The new US position in support of lifting patents on COVID-19 vaccines has taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them.

After having recently taken heat for blocking such exports, Commerce Secretary Katherine Tai said Wednesday that the US government would “work to increase the raw materials needed to produce those vaccines”.

The assertion was hidden at the bottom of the statement unveiling Washington’s remarkable reversal of its position on Covid-19 vaccine patents, which coincides with a shortage of doses in emerging and developing nations as cases surge in some countries.

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Long legal and economic policy debates likely lie ahead about waiving vaccine patents, particularly at the World Trade Organization (WTO).

Meanwhile, the difficulties faced by some laboratories in obtaining components to manufacture vaccines look set to stymie the drive to ramp up production.

Two labs have recently spoken out about their difficulties, laying the blame at Washington’s door.

Germany’s Curevac said it could not secure supplies of certain materials from the United States.

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Several days earlier, India’s Serum Institute, the world’s largest vaccine manufacturer, called on US President Joe Biden to step in.

“Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the US, I humbly request you to lift the embargo of raw material exports out of the US so that vaccine production can ramp up,” the company’s president Adar Poonawalla wrote on Twitter.

There is no actual embargo on exporting vaccine components. Instead, Biden, like his predecessor Donald Trump, invoked the Defense Production Act — which normally concerns wartime — to confront the pandemic.

While it does not explicitly ban exports, it puts the US government first in line to buy certain products made in the country.

US officials have previously played down the possible effect of the law on global vaccine production.

“There’s just more global manufacturing happening everywhere in the world than suppliers can currently support,” a US official told a White House briefing late last month on condition of anonymity.

Over the past two months, a number of public and private actors have noted the shrinking supply of components needed to manufacture vaccines.

At least 50 components, perhaps as many as 100, go into the jabs.

They include items like the glass vials to ship them, as well as certain types of plastics needed for containers used in the manufacturing process. Then there are the ingredients themselves.

Curevac is particularly concerned about nucleotides, a building block for the messenger RNA vaccines like the one it is developing.

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The shortage of raw materials is hardly surprising as the pharmaceutical industry expects to double production to 10 billion doses this year.

Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations (CEPI), which along with the World Health Organization and Gavi co-runs the Covax vaccine distribution initiative, spoke already in March of seeing “increasing signs of strain within supply chains”.

Companies were “beginning to report spot shortages of critical materials, raw materials, critical consumables, even equipment that is necessary for vaccine manufacturing,” he said.

He was speaking at a meeting of the principal actors in the sector, including WHO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Already the consensus was that the free circulation of vaccine components was critical, given that a large number of countries are involved in their production.

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OECD data from 2018 show how thoroughly component production is intertwined across the globe.

China dominates production of the glass storage vials, while the United States leads in the manufacturing of syringes.

France is a major producer of certain stabilisers like sorbitol, while Germany is big in the production of vaccine preservatives, and Mexico and China both are important manufacturers of additives that enhance the effects of vaccines.

Meanwhile, the Netherlands is a leader in the production of dry ice used to transport vaccines that need to be kept at ultra-low temperatures.