Opinion: Waiving Covid-19 vaccine IP could save lives, but where is the manufacturing capacity?
Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.
At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.
But when you begin to consider how this is supposed to play out in the real world, how the tech transfer will take time and energy and engagement from the very companies that would lose their IP, how the legal challenges and logistics will complicate everything further, and how the manufacturing site numbers don’t really make sense, it’s easy to wonder why there’s such a big push for this.
Take, for instance, Moderna. Back in October 2020, Moderna announced that it would not enforce its Covid-19 related patents against those making vaccines intended to combat the pandemic, even saying it would license its IP.
Sounds great, but no one has come calling.
Some have noted that Moderna doesn’t own every patent used in its vaccine. Tahir Amin, an IP lawyer at the forefront of pushing for the waiver, also has explained at length how manufacturers need more than just the patents, saying other vaccine manufacturers could scale up in about 6 to 8 months.
But where? What other manufacturers? Even Pfizer and Modera took longer than 6 to 8 months to really ramp up.
The publication The Intercept proposed to answer that question recently in an article titled, “Factory Owners Around the World Stand Ready to Manufacture Covid-19 Vaccines.” But the only example provided is Ontario-based Biolyse Pharma, which said it can make 20 million vaccines per year, and another fill-finish facility in Bangladesh that says it has capacity.
So we’re going to disrupt Pfizer and Moderna, which together are producing almost 10 billion doses of Covid-19 vaccines over the next two years in facilities that have been cleared by the top regulators in the world, so Biolyse can make 20 million doses in a year?
Even if there are hundreds of other manufacturing sites like Biolyse (which, by the way, was shut down by Health Canada in 2014) around the world, who’s going to mandate the tech transfer, and who’s going to ensure the sites are built and performing properly?
The US FDA isn’t currently conducting onsite foreign inspections, and many low-income countries don’t even have drug regulators. Cutting corners on vaccine manufacturing can lead to serious health issues, as we’ve seen with contractor Emergent’s site in Baltimore, which is especially important as these vaccines are going to healthy people.
President Biden said Tuesday afternoon that by July 4, the US will donate 10% of its Covid-19 vaccine stockpile to the rest of the world. And earlier this week, Moderna pledged 500 million doses for low-income countries. Biden’s chief medical adviser Tony Fauci told the Financial Times this week that while he’s agnostic on the waiver, he warned it could backfire into a long legal battle.
Right now, the campaigning for the IP waiver in the US seems to be a lot more about bashing Big Pharma than trying to actually increase vaccine doses for the neediest. A long legal battle with companies like Pfizer and Moderna isn’t going to help bring the world more Covid-19 vaccine doses.