As we near the end of 2020, pharmaceutical companies around the globe are racing to produce safe and scalable vaccines for the COVID-19 virus. In the United States, the federal government’s Operation Warp Speed initiative, which has provided billions of dollars in funding to private companies to date, was launched “to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).” All these U.S. efforts hinge on a given vaccine’s gaining official approval from the U.S. Food and Drug Administration (FDA) through a multiphase process. As the New York Times reports, as of September 25, 2020, 42 vaccines from around the world are currently in clinical trials on humans. Throughout these processes, lawyers are playing an integral role in moving vaccines forward.
While doctors and scientists are understandably at the forefront of these efforts, the legal profession also has a critical role to play. Major U.S. law firms are working closely with pharmaceutical companies on the many regulatory and contract issues at play. “We had long-standing relationships with the companies in the field,” says Dan Kracov, cochair of Arnold & Porter’s life sciences and healthcare regulatory practice, quoted in the American Lawyer. “We have done litigation, deals, regulatory issues and contracts. We were poised with the right skill set. It is not as if the clients came to us at the last minute.” This type of background laid the foundation for working with COVID-19 directly as a legal matter.
While doctors and scientists are understandably at the forefront of vaccine efforts, the legal profession also has a critical role to play.
Arnold & Porter, for example, has announced its partnership with pharmaceutical company AstraZeneca, a previous client, on agreements related to its vaccine efforts in collaboration with Oxford. Other major firms have offered similar peeks into how they are helping pharmaceutical companies in their efforts to produce a vaccine. Latham & Watkins has done cross-border transactional work to get capital to China-based Sinovac. Ropes & Gray has likewise advised U.S.-based Novavax on an agreement that provided an influx of cash to aid in its COVID-19 vaccine development. Hogan Lovells has been advising France-based Valneva on its now-formal partnership with the U.K. government to supply tens of millions of doses of their own vaccine should it prove successful. As Law.com reports, Clifford Chance, Freshfields, and Covington & Burling all advised on an agreement between pharmaceutical companies Pfizer and BioNTech to collaborate on another COVID-19 vaccine. Meanwhile, companies like Johnson & Johnson and Sanofi, both in the process of developing vaccines for COVID-19, have recruited firms like Cravath, Swaine & Moore and Weil, Gotshal & Manges, respectively, to help with multibillion-dollar acquisitions.
These pharmaceutical companies don’t just need their law firms to make progress—they need them when there are setbacks. AstraZeneca and Oxford’s vaccine, for example, had notably halted their clinical trials in early September 2020 due to a participant falling ill. The company is now working with the FDA in the hopes of resuming trials in the United States. “Outside counsel can contact the FDA with representatives of the company and lead those discussions,” says Peter Lindsay, a partner and cofounding member of Paul Hastings’ FDA regulatory practice, quoted in another piece in the American Lawyer. “Some companies may do this themselves, but they do often seek advice on the best way to communicate their information or prepare for those discussions and what questions the agency is likely to raise, both on the safety of the product as well as relating to the investigation itself.”
The race for a COVID-19 vaccine has also seen the rise of new legal and quasilegal roles in pharmaceutical companies. As Bloomberg Law reports, U.S.-based Moderna recently hired John Lepore, former Mastercard general counsel of policy and advocacy, to serve in the newly created role of senior vice president of government engagement. Lepore will operate outside the legal department and report directly to Moderna CEO Stéphane Bancel. “John is joining us at a pivotal time as we enroll the Phase 3 study of our COVID-19 vaccine,” Bancel says in a press release announcing Lepore’s hire.
Of course, much remains to be seen in how lawyers interest with the rush to create usable vaccines to prevent the spread of COVID-19. While further progress and setbacks are to be expected, what exactly they will look like is anybody’s guess, and every turn will require carefully tailored strategy and legal advice. Elsewhere, the courts are likely to become more involved as vaccines are rolled out—whether or not vaccination is mandated—just as plaintiffs’ lawyers and other litigators are sure to engage with the impact of that rollout in the courtroom. Time will tell how all this develops, but lawyers are likely to continue to play a key role in the race for a vaccine.