Editor’s Note: Isaac Larkin, PhD, has worked on lipid nanoparticle delivery vehicles for RNA and proteins. He is a core developer on the BioBricks Foundation’s Free Genes Project, and a research fellow at the think tank New Consensus. The views expressed in this commentary belong to the author. View more opinion at CNN.
In December, President Joe Biden set a vaccination target of 100 million doses in his first 100 days. During his first week in office, however, healthcare workers were already meeting the goal of administering an average of 1 million doses a day. While Biden has already raised the bar, saying he hopes to get to 1.5 million doses a day, the new administration can and should do more to accelerate the vaccine rollout.
The Trump administration’s abject failure to coordinate a federal strategy means we are facing immediate bottlenecks in vaccine distribution, but in the medium term, manufacturing capacity could become the primary barrier to accelerating vaccinations. The New York Times reported last month that manufacturing limitations make it impossible to increase the supply before April, while the largest vaccine manufacturer in the world estimated in September that it would take until 2024 at the earliest to vaccinate everyone on Earth.
With the spread of Covid-19 expected to accelerate due to new and more transmissible strains, speeding up the vaccine timeline by even a few months could save thousands of lives (as well as hundreds of billions of dollars in recovered economic activity, according to Oxford economist Gregory Daco). The appearance of strains that could partially resist the current vaccines makes scaling vaccine production even more urgent: The longer we wait to vaccinate everyone, the more we risk resistant strains evolving and spreading, prolonging the pandemic and necessitating further rounds of vaccination. It’s time to get much more ambitious about making vaccines.
Now that Pfizer and Moderna have figured out how to set up production lines for their emergency authorized mRNA vaccines, their manufacturing design plans could be replicated to more quickly to ramp up manufacturing capacity in much less time, with much less trial and error.
Unfortunately, no other manufacturers possess the critical proprietary information needed to make these vaccines, including the exact composition and the technical details of their production lines. Without this knowledge and the licenses to the intellectual property (IP) required to act on it, production is currently limited to Moderna, Pfizer/BioNTech, and their partners. Similar IP restrictions will pose a barrier to accelerating worldwide production of the Novavax, Astrazeneca and Johnson & Johnson vaccines, if they are authorized for emergency use. Notably, French pharmaceutical company Sanofi has recognized the need for assistance in getting shots into arms and has agreed to fill and pack millions of vaccine doses from Pfizer. But Sanofi and other companies in the industry could do much more if they were given access to the information needed to produce the life-saving vaccines from start to finish.
In a situation like this, it’s entirely reasonable – and legal – for the US government to step in and help alleviate some of these IP bottlenecks. There’s historical precedent for this. During World War II, the US was cut off from the natural rubber supply from Southeast Asia. To meet the demand for this material, which was critical to the war effort, the US government got a group of companies and academic researchers to share the findings from more than 200 patents in the effort to create synthetic rubber. During World War I, the US government basically forced the two companies that controlled key patents to aircraft technology to pool their IP in order to aid in the wartime scale-up of plane production.
The Defense Production Act (DPA) gives the government the right to request detailed information from both the vaccine manufacturers and their suppliers about their product compositions, manufacturing methods and supply chains. Zain Rizvi and Peter Maybarduk of Public Citizen have observed that the US government has the right under 28 U.S.C. section 1498 to use methods and technical information covered by any US patents for federal vaccine production efforts, as well as the right under DPA section 4555 to disclose publicly any confidential technical specifications obtained from manufacturers deemed essential in the interest of defending the nation.
The new administration can also utilize the Bayh-Dole Act, which allows the government to “march in,” take patents on inventions created with federal funding and grant them, under certain circumstances, to third parties. Since Moderna’s vaccine was developed primarily with public funds, and because mass scale-up is urgently needed to meet health and safety needs, the US government could license the IP for the vaccine’s formulation and manufacturing process to other companies (as well as to any direct federal efforts to build out vaccine production capacity) as part of a publicly driven, ideally global, vaccine manufacturing mobilization.
The Biden administration could then lead a public campaign to recruit every person and company with relevant experience and capacity toward the building and operating of vaccine production lines. Biden has already issued an executive order outlining his intention to create a Public Health Jobs Corps, and expressed his commitment to hire 100,000 people to aid in testing and contact tracing. He should go further and create a Vaccine Production Jobs Corps to enlist Americans in a nationwide effort to help make vaccines and necessary supplies (a similar mobilization for masks and tests would also be helpful).
A primary task for such a corps must be to construct and operate new factories, as some of the vaccine production bottlenecks (particularly for the novel RNA vaccines) require new manufacturing techniques and equipment that few companies currently employ. Ordinarily, building and staffing new pharmaceutical factories according to current Good Manufacturing Practices (cGMP) regulations takes months, or even years. The Biden administration could accelerate those timelines by partnering experts in cGMP facility construction with logistics and manpower from the US Army Corps of Engineers, and by leveraging the detailed information about current vaccine production facilities obtained through the DPA.
The US government could directly pay for, build and own these production lines, pay companies to operate them throughout the pandemic and then repurpose them afterward. This government-owned, contractor-operated (GOCO) factory model was used to build and pay for much of the material in World War II, to great effect.
Covid-19 has now killed more Americans than World War II. The US needs to launch a full-fledged effort to end the pandemic by mobilizing both companies and people to produce more vaccines. We could share the surplus (and freezers, for distribution) with the rest of the world, and perhaps even leverage our manufacturing capacity after the pandemic toward a decade-long research and development push (a moonshot, if you will) to take down existing and emerging infectious diseases around the globe.
At least some members of the Biden team may agree: Vivek Murthy, Biden’s Surgeon General nominee and co-chair of the President’s coronavirus task force, has indicated that the task force has discussed the idea of building out GOCO bioreactor factories that the government could harness for rapid vaccine and therapeutic production in future pandemics. However, according to Murthy, the Biden administration has not yet adopted this proposal. They should do so immediately and utilize those factories to help manufacture enough vaccines for every single person in the world as quickly as possible.
Will this mobilization result in far more vaccine productive capacity than would be profitable for private companies to develop and maintain? Most likely yes, but the faster we end the pandemic, the more lives we save and the sooner our economy can rebound. A recent working paper published by the National Bureau of Economic Research (NBER) suggests there will be dire costs if the vaccine is unevenly distributed throughout the world.
The global economy could suffer losses exceeding $9 trillion if wealthier countries are fully vaccinated by the middle of the year while poorer countries face a lag, with wealthier countries absorbing nearly half of those costs. Given the magnitude of public benefit and the relatively paltry cost (the NBER paper estimates it would cost tens of billions of dollars to manufacture and distribute vaccines globally that would avert trillions in economic losses), a massive vaccine mobilization effort is a more than worthwhile public investment that will benefit both the United States and the rest of the world, now and in the future.
Biden has already committed to using the Defense Production Act to alleviate supply chain and distribution bottlenecks. He should go much further and leverage every available tool in his considerable arsenal toward expanding vaccine productive capacity, now. Only then can we end this pandemic, rebuild our economy and get Americans back to better lives. Let’s mobilize.