Why have the majority of Covid-19 vaccine doses gone to high and middle-income countries, while only a handful have been administered in low-income nations? At least part of the reason, some activists and academics argue, is that the big pharmaceutical companies producing vaccines, such as Pfizer, have not suspended the patents that they hold over their jabs. This means that other companies cannot manufacture generic versions without leaving them vulnerable to being sued.
On Wednesday 5 May, US President Joe Biden’s administration announced that it would support waiving intellectual property (IP) for coronavirus vaccines, in a move that is bitterly opposed by Big Pharma. The plan, originally floated by India and South Africa at the World Trade Organisation (WTO) last year, is a break from decades of US orthodoxy and, if the proposal passes, it could mean lower profits for vaccine manufacturers. The shares of vaccine manufacturers Moderna, Novavax, BioNTech and Pfizer all fell after the announcement.
Some EU leaders quickly followed Biden’s lead, except for German Chancellor Angela Merkel, whose spokesperson said that the limiting factors in vaccine supply are “production capacities and the high quality standards, not the patents”. Opposition from the EU’s largest economy makes a waiver less likely to pass the WTO, which takes decisions by consensus.
Still, if a waiver is approved, how likely would it be to make a difference to vaccine access in the developing world? In the medium term, it could help, although it might not boost production immediately.
One of the biggest obstacles to producing generic Covid-19 jabs, especially those relying on new mRNA technology, is that the production of vaccines involves a complex manufacturing process. To be replicated, some experts believe that it is not only IP which would need to be shared, but also specialised manufacturing knowledge. In addition, producers are facing a worldwide shortage of some raw materials, such as lipids, which are used to manufacture Covid-19 vaccines.
Indeed, Moderna, the drug manufacturer which produces one of the mRNA Covid-19 vaccines, indicated last year that it would not enforce the patents for its vaccine. That decision, however, does not appear to have resulted in the mass production of a generic mRNA jab.
Even if the vaccine IP is waived, some experts believe, the mass production of generic vaccines could still take months. The timeline could be shortened if the pharmaceutical companies holding patents cooperate with generic manufacturers and share their specialised expertise. Even if they do not, the countries currently likely to be waiting for months or years to receive enough doses to inoculate their entire populations may still be advantaged by waiving IP.
For the Biden administration, which had been under pressure from the left of the Democratic party to waive IP, its decision may be largely symbolic, Marta Bengoa, a professor of economics at City University of New York, told me. “Whether this will remain a purely symbolic move depends in large part on how the pharmaceutical companies behave, as they are the ones whose decisions will really matter for what happens on the ground, given that we not only need their patents, but also their manufacturing know-how.”
However, some pharmaceutical companies in the developing world have argued that they have both the capacity and the expertise to begin making vaccine doses more or less immediately. “If we get the antigen [the part of the vaccine which induces an immune response] then the production can start immediately … we can deliver about 500 million doses a year” said Abdul Muktadir, the chairman of the Bangladeshi pharmaceutical company Incepta, last month.
Waiving patents will probably not, by itself, vaccinate the developing world. Wealthy governments could consider directly subsidising the building of vaccine plants in poorer countries. This would cost trivially little in comparison to their overall fiscal response to Covid (three new production lines with an annual capacity of 100 million doses each were added to one Swiss plant for a reported cost of $210 million, for instance) and would not require diverting doses away from domestic vaccination programmes. It would, however, help many countries to get inoculated.
If vaccine patent waivers are approved, the financial and moral incentives for making them work are huge. With more than 90 per cent of the world still unvaccinated, with figures overwhelming in low and medium-income countries, Biden’s bold move could impact the lives of billions.