PUBLISHED:August 14, 2020

Rai, co-authors urge rapid knowledge transfer for vaccine production


Pharmaceutical manufacturing instructions often are not contained in patents or other public findings. That could result in costly production and distribution delays when a vaccine for COVID-19 is finally identified.

As researchers engage in a global race to develop effective vaccines and biological therapeutics for COVID-19, companies and institutions must facilitate the rapid transfer of knowledge on how to manufacture them, say Elvin R. Latty Professor of Law Arti Rai and two co-authors in a paper published online Aug. 13 in Science.

In their paper titled “Knowledge Transfer for Large Scale Vaccine Manufacturing,” Rai and her co-authors argue that it is critical for firms to share information that may not be disclosed in patents or regulatory filings so that manufacturing facilities can spring into action once an effective vaccine is identified — and be able to rapidly produce potentially billions of doses of their own or another firm’s vaccine.

“(M)aintaining pervasive secrecy for manufacturing COVID-19 vaccines during the pandemic could cause dramatic failure,” they write. “Relevant information for quick and effective scale-up must be readily available.”

Rai, who with Douglas B. Maggs Professor of Law Stuart Benjamin serves as faculty co-director of the Center for Innovation Policy at Duke Law, is an internationally recognized expert in intellectual property law, innovation policy, administrative law, and health law. She co-authored the paper with W. Nicholson Price II, professor of law at University of Michigan Law School, and Timo Minssen, professor of law at the University of Copenhagen and founding director of its Center for Advanced Studies in Biomedical Innovation Law.

Lack of transparency could lead to costly delays

Existing barriers to efficient information sharing between companies that produce tightly regulated complex biologics include competitive concerns leading to trade secrecy and failure to enforce the legal requirement that patents for biologic products disclose information on how to manufacture them. Such lack of transparency could lead to costly and deadly delays while firms attempt to reverse engineer vaccine originator firms’ manufacturing processes, the authors write.

Also, vaccine manufacturing lacks standardization, even within manufacturing platforms, the paper notes, while some new vaccine technology platforms such as the messenger RNA vaccine currently being tested by Moderna have never been manufactured at scale.

The authors propose solutions that could facilitate information transfer for individual biologic products, such as creating a license that would include the transfer of proprietary manufacturing knowledge, or building into individual funding contracts a provision for technology transfer to manufacturers. However, they urge broader efforts to ensure that all manufacturers with capacity to produce a vaccine are adapted to produce any one of a number of candidates in various stages of development and testing.

As of Aug. 13, there are 29 candidate vaccines in clinical evaluation and 138 candidates in preclinical evaluation from pharmaceutical companies such as AstraZeneca, Johnson & Johnson, Merck, INOVIO, Sanofi, GlaxoSmithKline and many others, according to World Health Organization (WHO) data. Manufacturing knowledge should at least be shared between the companies actively developing vaccines, the authors state.

“Where knowledge is already explicit and codified, whether in regulatory filings or elsewhere, that knowledge should be shared, at least ... within the universe of major industry players working to develop COVID-19 vaccines. If explicit knowledge is codified in patents, pooling of those patent rights or other licenses should also be pursued.” And where knowledge has not been codified, collaborating companies should share it, they argue.

Pandemic provides opportunity for industry transformation

Signs of collaboration are beginning to emerge as vaccine candidates make their way through the pipeline. Recently six biopharmaceutical firms researching monoclonal antibody (mAb) candidates sought and received approval from the Department of Justice to exchange technical information on manufacturing processes and platforms, the authors note.

Besides the DOJ, other entities that could facilitate knowledge transfer through various mechanisms include international organizations such as the WHO, which has proposed a COVID-19 intellectual property pool; national governments such as the U.S., which could require knowledge sharing among the multiple vaccine manufacturers it has already contracted with to secure hundreds of millions of doses; regional organizations such as the European Union, which has signed a contract with AstraZeneca for 400 million doses of a leading vaccine candidate; and non-governmental organizations such as the Coalition for Epidemic Preparedness that could build provisions into its funding contracts for vaccine development.

New policies and procedures on knowledge transfer that are advanced during the fight against COVID-19 could have broad-ranging, even transformative, implications for the field after the current crisis has waned, the authors write. Still, even a one-time sharing of knowledge between pharmaceutical companies could help to advance the field’s collective understanding and promote standardized best practices, they write

“A focus on rapid information exchange of the sort recently encouraged by the DOJ will not only be critical for the current crisis but could also create the foundation for fewer silos, improved standardization, and less secrecy over manufacturing information in the future.

“Whatever the long-term effects on industry innovation, the most important goal is to make high-quality vaccines for COVID-19 available as quickly and broadly as possible. To pursue that goal and to promote global solidarity and reciprocity, the policymakers and companies jointly engaged in the worldwide race to develop COVID-19 drugs and vaccines should share information about how to actually make them.”