The Task Force’s Brighton Collaboration is a group of more than 750 vaccine experts working on vaccine safety. Through its Safety Platform for Emergency vACcines (SPEAC) project, several Brighton Collaboration experts are monitoring and informing the development of COVID-19 vaccines. Here, Brighton’s Scientific Director and vaccine safety expert Robert “Bob” T. Chen, MD shares insights on questions frequently asked about this work.
- Many companies are racing to develop a vaccine, with more than 150 candidates in various stages of the pipeline (see lists here and here). It is difficult for laypeople to interpret this complex issue. How would you characterize this effort?
This is very much unprecedented in the vaccine field. The Manhattan Project during World War II would be an analogy, where society scientifically mobilized quickly to reach a common goal, in that case, producing nuclear weapons. Likewise, several countries are marshaling all their resources to rapidly develop a vaccine against COVID-19. The US “warp speed” project and the multilateral COVAX initiative are examples of this work.
- Tell us about COVAX and how Brighton Collaboration is involved.
COVAX is an initiative to guarantee fast and equitable access globally to COVID-19 vaccines. The effort is co-led by the World Health Organization (WHO) and Gavi, the vaccine alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI). The aim is to deliver 2 billion doses of effective, approved COVID-19 vaccines by the end of 2021.
CEPI was created to develop potential new vaccine candidates for emerging infectious disease threats around the world. CEPI has funded the Collaboration to harmonize the safety assessment of all its vaccine candidates, including COVID-19, via the SPEAC project. Earlier in the pandemic, CEPI funded approximately 10 COVID-19 developers. Now, there are many more. The tools that the Collaboration developed initially for CEPI are being shared with other developers under COVAX.
- What findings do you see as promising?
The preclinical animal studies so far are promising enough for several vaccine candidates that they are able to move to the phased human trials (phase one and two involve small groups of people). So far there have been no showstoppers. However, the results from the pivotal phase three trials are just getting underway; tens of thousands of people will be tested by receiving a placebo or the experimental vaccine. They will be observed carefully for both safety and efficacy – whether there are fewer COVID-19 cases in the group receiving vaccines or not.
- In this high-stakes, fast-paced race to a vaccine, how can risks be mitigated?
All the stakeholders are doing their best to minimize any risks ahead of introduction; but rare or delayed adverse events will only be visible post-introduction. With potentially multiple COVID-19 vaccines being used, it will be important to track who receives what vaccine and what the results are, to inform ongoing benefit-risk discussions. This ties back into the earlier notion that vigilance is imperative as we have never done anything this large on a global basis before.
- What’s realistic to expect as far as timing for when people could start to get vaccinated on a large scale?
That totally depends on the results of the phase three trials, which Dr. Anthony Fauci, Director of the National Institute of Allergies and Infectious Diseases, believes we will have by the end of the year. As promising as that is, it will still take time to produce enough doses of vaccine, decide which groups get vaccinated first, and so on. With all of these considerations, we’re looking at least a year away at the earliest for full vaccine rollout to all groups.
- Once a vaccine is available, what will be the challenges with ensuring that people everywhere get access to it?
The most important thing is to first know which vaccine is actually safe and effective and is licensed by the Federal Drug Administration (FDA) or its equivalent for use in other countries. Then, we must consider all that goes into delivering billions of doses of a vaccine, such as sterile conditions, enough vials and syringes, refrigerated shipment, contamination problems, enough staff to administer it, costs associated with administering it, etc. These will be challenging areas to address, especially on a global level.
There are also issues of equity. This is an area where our Task Force colleagues from the Focus Area for Compassion and Ethics (FACE) are contributing a lot of good work. FACE Director David Addiss has characterized it well: “Global distribution of COVID-19 vaccines represents one of the most complex and urgent challenges for health equity ever faced by our global community. Marginalized groups and people living in poverty are typically left behind when equity considerations are not made explicit and properly integrated into the design and management of global health programs.”
FACE, collaborating with Emory University professor, James Lavery, PhD, Chair of Global Health Ethics at the Rollins School of Public Health, has proposed an “Equity and Context Allocation Framework.” This would engage a wide-range of stakeholders and partners, including the Collaboration, CEPI, COVAX, WHO, universities, and others to guide decisions regarding vaccine allocation and track the ultimate outcomes of these decisions in terms of equitable distribution and coverage. The framework would provide a means of adjudicating emerging vaccine safety and efficacy data, as well as information on contextual issues such as manufacturing capabilities, cost, intellectual property, cold-chain requirements (for transporting vaccines) and other aspects, with particular emphasis on the links between health and social disparities and COVID-19 prevalence and transmission risk.
This is an important body of work, as there are multiple issues involved. Not only the scientific and technical aspects of developing and delivering a vaccine, but also ensuring that everyone has access.