COVID-19 Vaccine Development – 6 Conditions For Success
by Dr. Nashya Haider, May 12, 2020
On March 3rd 2020, National Institutes of Allergy and Infectious Diseases Director, Dr. Anthony Fauci stated that it would take at least twelve to eighteen months to get a COVID-19 vaccine approved for use in the USA, and that estimate according to some experts maybe very optimistic. There are many unknowns this early in the game. How the early vaccine candidates will perform, which will be advanced to later stages of clinical development, what safety issues might arise, and how a successful vaccine will be mass produced are among the questions that are now getting attention and funding. Here are 6 conditions that are imperative for successful development and distribution of a COVID-19 vaccine.
Massive Investments : Hundred of Millions of Dollars At Play
The Coalition for Epidemic Preparedness Innovations (CEPI), a non-profit dedicated to the development of vaccines against emerging infectious diseases, has been one source of funding for this effort, with a total of nearly US$30 million so far invested in several candidates, including the first to be injected into trial participants. The organization plans to advance the top six of these candidates into larger efficacy trials with thousands of participants.
Another infusion of funds comes from the Biomedical Advanced Research and Development Authority (BARDA), which is contributing hundreds of millions of dollars to two top vaccine candidates: one made by Johnson & Johnson’s Janssen division and another developed by Moderna in collaboration with the US government that was injected into the first trial participants last month at the Kaiser Permanente Washington Health Research Institute in Seattle. J&J and BARDA said that the funds would be put toward both ushering the potential vaccines through clinical development and setting up manufacturing capacity simultaneously.
Diversity in Research : China, US, UK, Germany Leading The Race Currently
Below, The Scientist rounded up those vaccine candidates that appear to be furthest along. But there are dozens more in preclinical development, and it’s still very early days. “Nobody knows which vaccines are going to work,” Moderna CEO Stéphane Bancel told Science on March 31.
Rethink The Approval Process : Bypass traditional protocols
The global vaccine R&D effort in response to the COVID-19 pandemic is unprecedented in terms of scale and speed. Given the imperative for speed, there is an indication that vaccines could be available under emergency use or similar protocols, to bypass traditional trial approval processes by early 2021. This would represent a fundamental step change from the traditional vaccine development pathway, which takes on average over 10 years, even compared with the accelerated 5-year timescale for development of the first Ebola vaccine, and will necessitate novel vaccine development paradigms involving parallel and adaptive development phases, innovative regulatory processes and scaling manufacturing capacity.
Scale Laboratory Capacity : International Coordination Essential
Industry benchmarks for traditional vaccine development paradigms cite attrition rates for licensed vaccines of more than 90%. The approaches being applied for COVID-19 development — which involve a new virus target and often novel vaccine technology platforms and novel development paradigms as well — are likely to increase the risks associated with delivering a licensed vaccine, and will require careful evaluation of effectiveness and safety at each step. In order to assess vaccine efficacy, COVID-19-specific animal models are being developed, including ACE2-transgenic mice, hamsters, ferrets and non-human primates. Biosafety-level 3 containment measures are needed for animal studies involving live-virus testing, and the demand for these capabilities is likely to require international coordination to ensure that sufficient laboratory capacity is available.
Multi Stakeholder Cooperation: For Speed, Manufacture and Deployment
Finally, strong international coordination and cooperation between vaccine developers, regulators, policymakers, funders, public health bodies and governments will be needed to ensure that promising late-stage vaccine candidates can be manufactured in sufficient quantities and equitably supplied to all affected areas, particularly low-resource and low income regions of the world. CEPI has recently issued a call for funding to support global COVID-19 vaccine development efforts guided by three imperatives: speed, manufacture and deployment at scale, and global access. “We maintain a dynamic portfolio management approach, and will make our enabling science resources available globally. We urge the global vaccine community to collectively mobilize the technical and financial support needed to successfully address the COVID-19 pandemic through a global vaccination programme, and provide a strong base to tackle future pandemics.”
Private and Public Funding: For Balancing Risk and Supply Pipeline
Government funding and private foundation donations in vaccine research is needed because pandemic products are extraordinarily high-risk investments; public funding will minimize risk for pharmaceutical companies and get them to jump in with both feet. In addition, governments and other donors will need to fund — as a global public good — manufacturing facilities that can generate a vaccine supply in a matter of weeks. These facilities can make vaccines for routine immunization programs in normal times and be quickly refitted for production during a pandemic. Finally, governments will need to finance the procurement and distribution of vaccines to the populations that need them.
Availability and Affordability of Vaccine Is At The Heart of Success
Billions of dollars are needed for anti-pandemic efforts and that is the scale of the investment required to solve the problem. Looking at the economic pain that an epidemic can impose — we’re already seeing how Covid-19 can disrupt supply chains and stock markets, not to mention people’s lives — it will be a bargain. Finally, governments and industry will need to come to an agreement: during a pandemic, vaccines and antivirals cannot simply be sold to the highest bidder. They should be available and affordable for people who are at the heart of the outbreak and in greatest need. Not only is such distribution the right thing to do, it’s also the right strategy for short-circuiting transmission and preventing future pandemics.
About Nashya Haider
Founder and Director of Innotech Consultants, Nashya Haider is an internationally experienced Program & Applications Manager having delivered across multiple continents in a number of market sectors including Life-Sciences, Bio-Sciences, and academic research environments. She has lived, studied and worked in multicultural environments which have added to the breadth and depth of her expertise.