For months, international partners have pressured the United States about intellectual property (IP) concerns and access to SARS-CoV-2 vaccines. As the country emerges from the worst of the pandemic, President Joe Biden now has an opportunity to shift his administrationâs focus to realizing its longstanding promise of making the United States âthe arsenal of vaccines for the worldâ (1). However, the country cannot accomplish that goal just by exporting mRNA vaccines and waiving IP protections. The current generation of vaccines simply cannot be produced, transported, and administered at the scale needed to tackle the COVID pandemic.
In late spring, President Biden announced that the government would begin exporting doses from its national stockpile to countries in need, starting with 20 million doses of the three vaccines that have received emergency use authorization from the Food and Drug Administration (FDA) (2). That announcement followed his decision to side with leaders in South Africa, India, and other middle- and low-income countries in calling for suspension of IP rights for COVID-19 vaccines and treatments. The ongoing debate over IP protections often is cast in black-and-white terms, with drug companies in industrialized countries prioritizing their interests over those of vulnerable populations. But such an assessment glosses over facts on the ground in countries such as India, where the PfizerâBioNTech mRNA vaccine has yet to be approved (3).
To put it bluntly, there is not enough manufacturing capacity to inoculate the worldâs population against SARS-CoV-2 using the currently available vaccines, even if the United States exports its surplus. Production limitations are understandably hard to fathom in light of headlines trumpeting the hundreds of millions of doses that American health authorities already have administrated. However, those limitations become concrete when considering the highly specialized manufacturing facilities that are required to produce mRNA vaccines, the highly specific training required to operate those facilities, and current shortages of requisite raw materials such as polymerases.
The United States indeed could rise to a position of global leadership on COVID-19 vaccination. However, to do that, the country also must take the lead on developing vaccines that can sidestep limitations capping the production of mRNA and viral-vector vaccines. The next generation of SARS-CoV-2 vaccines also must be fit for implementation in countries, rural villages, and other hard-to-reach communities with significant barriers to access. Most of those regions face limitations in refrigeration, electricity, and transportation networks, necessitating that vaccines be easy to transport, store, and administer.
Fortunately, several such vaccines are already under development. Among them is a candidate produced by my company, Akston Biosciences. Our candidate is a âtraditionalâ protein-subunit vaccine based on longstanding technologies that predate the mRNA modality. The vaccine is undergoing phase 1/2 clinical trials in Europe. Many approved vaccines â including those used to inoculate patients against human papilloma virus (HPV), hepatitis B, and shingles â use protein-subunit technology.
Compared with mRNA vaccines, protein-subunit vaccines are developed and tested in far lengthier processes. Monoclonal master cell banks that serve as the basis for such vaccines can require 18 months to produce, and each batch is subject to strict testing and regulatory requirements. But once such development work has finished, the resulting protein-subunit products for SARS-CoV-2 will offer several advantages. They are far less complex and resource-intensive to produce than are the currently available SARS-CoV-2 vaccines, and most can be stored at room temperature for months at a time. My companyâs vaccine remains shelf stable for weeks at temperatures approaching 99 Â°F. Robust temperature stability makes protein-subunit vaccines an ideal choice for public health systems in parts of the world where the âcold chainâ of refrigeration and transportation is unreliable or wholly unavailable.
With world-leading pharmaceutical companies, research institutions, and healthcare providers, the US is positioned well to spearhead development and implementation of a second generation of SARS-CoV-2 vaccines that can fill gaps left by the first. Instead of getting bogged down in debates over the stockpiles and IP of vaccines unfit for use in countries with lower-income economies, the Biden administration should focus on reliable technologies that already have demonstrated their ability to end other public health crises.
1 Wise A. US to Ship 20 Million Additional COVID Vaccine Doses Overseas. NPR 17 May 2021; https://www.npr.org/2021/05/17/997575473/u-s-to-ship-20-million-additional-covid-vaccine-doses-overseas.
2 Stolberg SG, Slotnik DE. Biden Dips into US Vaccine Supply to Send 20 Million Doses Abroad. The New York Times 17 May 2021; https://www.nytimes.com/2021/05/17/us/politics/biden-coronavirus-vaccine.html.
3 India COVID Crisis: Pfizer Pushes for Vaccine Approval. Deutsche Welle 5 March 2021; https://www.dw.com/en/india-covid-crisis-pfizer-pushes-for-vaccine-approval/a-57417960.