As discussed in Part I of this article, the fastest and most effective way to increase the supply of vaccines is to rely on vaccine innovators as partners in scaling up. Part II of this article will address the public safety benefits of relying on innovators.
Relying on Innovator Companies Will Increase Safety and Public Acceptance of Vaccines
Producing sufficient supply of vaccine is only one major obstacle in trying to vaccinate the world out of the pandemic. Another major challenge is ensuring that enough people are willing to be vaccinated to create 'herd immunity'. The latter issue is already becoming a serious concern in the vaccine-rich USA. Some experts believe that it is unlikely the US will reach herd immunity. There is going to be a public health battle to try to sway those on the fence to accept a vaccine.These days, every delivery delay or significant rare adverse event with a covid vaccine can become front page news and undermine confidence in vaccines.
Any solution to vaccine shortage has to address both supply and hesitancy. It is not easy to make a massive amount of high quality vaccine. Even with all its experience in manufacturing, AstraZeneca has experienced public relations challenges with its clinical trial data in the US and Europe, as well as its manufacturing. The vaccine originator should therefore be closely involved in this process of building vaccine capacity, to avoid reinventing the wheel. Originators are more likely to successfully transfer technology to licensed manufacturers, minimizing risk of incidents that would undermine public confidence in vaccines. AstraZeneca has created many of its own manufacturing sites, and as of March 2021, it reported having set up manufacturing in 15 countries and 25 sites. That experience has tremendous value when transferred to a licensed partner.
The challenges faced by less-experienced vaccine manufacturers, even after technology transfer, were demonstrated by AstraZeneca stopping use of a US company as a subcontractor to make its vaccine. Overriding AstraZeneca IP to allow other companies to take a shot at making their own version may well backfire if those companies, less experienced with the vaccine, end up with quality problems that create vaccine hesitancy.
IP Licenses Ensure Quality and Control
An IP license agreement can include limited and strict permissions to make, use and sell under an originator company's patents, know-how and trademarks. These license terms allow the originator to effectively control the licensee. If there is no patent or other IP on a vaccine, then no license is needed, and any company can develop its own vaccine formulation, for better or worse. The originator will not be involved and has no control over unauthorized vaccines. If the originator company is involved in the technology transfer as licensor, then the licensee benefits from the originator's knowledge and experience with the product, and problems can proactively be avoided. If problems cannot be resolved, the license can be terminated to revoke permission to make the vaccine.
The WHO recently called for additional licensing efforts to resolve vaccine inequities. This is a more productive approach than patent overrides. A free-for-all of vaccine production by unlicensed vaccine manufacturers may lead to lower quality vaccines and decrease public acceptance of vaccines. Innovator companies that are already licensing their IP will be able to do more licensing, and should be encouraged to do so in a manner that ensures consistently high product quality. Governments and other organizations should investigate how to better support vaccine innovators to undertake rapid technology transfer to capable manufacturers.
Part III of this article will address how licensing and technology transfer for innovative vaccines can help address vaccine equity.
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