The race is well underway to develop a vaccine for the coronavirus, now known as COVID-19.
New pharmaceutical products are time consuming and expensive to develop, and the pharmaceutical companies who dominate the global vaccine industry, Pfizer, MSD, GSK, Sanofi and Johnson & Johnson, typically rely on intellectual property rights, exercised over the long term, to recover the significant investment of often billions of dollars associated with new product development. But things look very different in the middle of a global and immediate health crisis, such as that presented by COVID-19.
Developing new vaccines is particularly challenging. In the case of a vaccine for COVID‑19, both traditional vaccines, where part of the virus is used to mimic an infection and trigger the body’s immune response, and novel vaccine mechanisms, employing messenger RNA to trigger an immune response, are being explored. For either type of vaccine, extensive testing will be required both in animal and then human models to ensure both efficacy and safety, with many vaccines having been associated with unacceptable side effects. For example, the vaccine developed by GSK to respond to the 2009-10 swine flu pandemic was withdrawn from sale after it was discovered to cause narcolepsy in some people.
All of that needs to be done within a timeframe that means the vaccine is still needed. With the typical time-line for developing a new vaccine being two to five years, it is not surprising that in 2002-2003, the SARS outbreak came and went before a vaccine could be produced. This work is, however, now proving useful in developing the COVID-19 vaccine given both SARS and COVID-19 are coronaviruses. Coupled with the RNA sequence of COVID-19 having been sequenced by Chinese scientists shortly after the epidemic began and shared with researchers worldwide, the timeframes for development of a COVID-19 vaccine are seemingly being accelerated beyond what has been achieved previously. This week, for example, the first human clinical trials of a mRNA vaccine developed by the National Institutes of Health and Moderna Inc, commenced in the US. This is record speed for a phase I vaccine trial. Johnson & Johnson is also making fast progress on a vaccine, announcing this week that after starting work on a vaccine in January, it hopes to begin human trials in early November (an extremely short time line, although to many that will seem far too far away).
Given the risks, given the need for speed, and given there is no guarantee that a pharmaceutical company will make much (or any) money from a vaccine, it is perhaps not so surprising and encouraging that we are seeing a number of collaborative efforts emerging, with organisations working together and sharing information freely.
One of the leaders in vaccine development is the Coalition for Epidemic Preparedness Innovations (CEPI), a not-for-profit organisation headquartered in Norway, that brings together public, private, philanthropic and civil organisation to develop new vaccines. Researchers from around the world have now joined CEPI’s effort to develop a Covid-19 vaccine. The first clinical batch of the Moderna vaccine now in human testing was funded by CEPI. Those collaborating with CEPI also include leading researchers from both CSIRO and the University of Queensland in Australia. Researchers at the University of Queensland have already developed a vaccine candidate, which will be tested at CSIRO’s state-of-the-art biologics production facility in Melbourne.
Sanofi Pasteur and Johnson & Johnson have each partnered with the US Biomedical Advanced Research and Development Authority, with BARDA contributing to the costs associated with the research being undertaking by both companies. Pfizer has also this week announced a partnership with BioNTech, a German company, to develop a mRNA-based vaccine and hopes to begin human trials in a few weeks.
Although these collaborations are progressing to human testing at a fast pace, the phase 1 trials involving a limited number of healthy individuals, will take about 3 months to determine if the vaccine is safe enough in those individuals to proceed further. Assuming a successful phase 1 trial, subsequent clinical trial steps would ordinarily mean that a vaccine is still at least some 12 to 18 months away. It is yet to be seen whether regulators can adapt processes, such as running virtual clinical trials, to fast-track promising vaccines.
While the world waits for a vaccine to be developed, a number of companies are also looking to repurpose existing drugs for the treatment of Covid-19. Gilead, for example, is launching two Phase III clinical trials of the antiviral drug, remdesivir, in patients infected with COVID-1 and has been in discussions with Australia’s Therapeutic Goods Administration to allow remdesivir to be used as an emergency treatment. Similarly, AbbVie’s anti-HIV drug, Kaletra, which is already approved for use in Australia, has been used to treat patients in Australia.
All of this underscores the complexities of developing and getting new pharmaceutical products, and particularly vaccines, to market. Pharmaceutical companies will be reluctant to bear the brunt of those complexities and uncertainties on their own, but the adoption of alternative approaches to funding, and collaborative research across the private and public sector, as well as academia, allow the risks associated with those complexities to be shared more effectively. Researchers from around the world are now pulling together, and helping to give hope that an effective vaccine will be developed in time to be of use.
Rebekah Gay is a partner at Herbert Smith Freehills specialising in intellectual property litigation and dispute resolution.
Emma Iles is a senior associate at Herbert Smith Freehills specialising in intellectual property litigation and dispute resolution.
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© Herbert Smith Freehills 2021