[Editor’s note: This story originally was published by Real Clear Health.]
By Todd Zion
Real Clear Health
The Biden administration last week joined the chorus of countries calling for the suspension of intellectual property protections for Covid vaccines and pandemic-related treatments. This is unfortunate, as waiving IP rights won’t do much to get more shots in arms, but it will undermine the very system that made the rapid vaccine developments of the past year possible.
What’s more, the vaccines that are currently approved for use in America and Europe will likely never be rolled out to the least-developed nations — precisely the countries this move is intended to help. Consider that the best-case forecasts for production of the vaccines currently approved for emergency use is that we may be able to produce and distribute two billion doses by the end of this year. Some of those vaccines require two doses each, which will leave at least five to six billion people unvaccinated world-wide.
This is not an intellectual-property problem. It’s a production and distribution problem. Waiving patent rights will not help.
The vaccine that the world’s poorest populations need is shelf-stable at room temperature, easily transported and capable of being produced cheaply and by the billions without highly specialized manufacturing facilities.
In other words, that vaccine does not exist. Or more precisely, there are a number of candidates, but they are still in testing or clinical trials. Novavax’s candidate is probably the best known, but there are others, including one in development by my own company. Clinical trials will determine safety and efficacy, but this is not about any one vaccine candidate. It’s about how we vaccinate the next five billion people—and possibly produce tens of billions of doses going forward, if annual boosters prove necessary.
Although they’ve taken longer to develop than the mRNA vaccines from Pfizer and Moderna or the viral vector vaccines from Johnson & Johnson and AstraZeneca, this class of so-called protein subunit vaccines builds on well-established and proven vaccine technologies. The vaccines we use for shingles, HPV, Hepatitus B and others are all protein subunit vaccines.
In general, these types of vaccines don’t require deep sub-zero refrigeration—or any refrigeration at all. Many can retain efficacy for weeks even at temperatures as high as 98 degrees. They can be mass produced without highly specialized production facilities—it would take less than 1% of global bioreactor capacity to produce enough vaccines for the entire world each year.
So if all that is true, why are all the vaccines currently approved in the West either viral vector vaccines or mRNA vaccines? Ironically, it’s in part because, being novel, these newer vaccine technologies haven’t acquired a long list of regulatory approval requirements that would have delayed their testing and introduction. Protein subunit vaccines are produced from so-called monoclonal master cell banks that can take 18 months to produce and test, and each production batch is itself subject to testing requirements that may be unique to the particular molecule and must meet regulatory approval.
None of this is bad in itself. It’s vitally important, especially if we’re giving these shots to nearly everyone in the world, that we know what’s in them and they do what they’re supposed to. But it’s simply a fact that these novel vaccines were able to come to market so fast because they’re being manufactured in ways that bypasses the regulatory hurdles to which most other vaccines are subject.
As a result, the protein vaccines have taken longer to launch. But there’s every reason to believe some of them will prove safe and effective. And when they come, they are very likely to be less expensive to make at scale and easier to transport, distribute and administer than the vaccines currently being deployed.
In other words, the shots for the next five billion people won’t come from waiving the patent rights of Pfizer and Moderna, but from the grunt work of testing and verifying more “conventional” protein vaccines. That’s a good news story for most of the world, but you’re not likely to hear it from those arguing that drug-company greed is what’s slowing vaccination in many countries.
The fact is that waiving IP protections will hurt the very people the idea is intended to help.
Todd Zion is Chairman and CEO of Akston Biosciences
[Editor’s note: This story originally was published by Real Clear Health.]
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