By: Barbara Laidlaw and Josiah Adams
The COVID-19 pandemic has often created more questions than answers. From the pandemic’s onset in March, public officials, scientists and healthcare providers have searched with frustration for solutions to the virus’ spread, treatments and, above all else, a potential vaccine.
As we enter the fall and winter months, more people will stay indoors, which experts point to as a potential cause for a second surge of the virus. In metropolitan areas like New York City, this could have catastrophic and long-lasting effects on economic and public health. The potential for a second surge, combined with nationwide political pressure leading up to the November election, has led to increased demand for development and deployment of a COVID-19 vaccine.
Unfortunately, developing a vaccine is a process that can only be fast-tracked so much before becoming dangerous and irresponsible. Brands and organizations must understand the facts surrounding a potential vaccine and make the appropriate business decisions based on them. Otherwise, they run the risk of jeopardizing months of precautions and exposing themselves to significant reputational risk.
President Donald Trump’s administration has issued conflicting messages about the COVID-19 vaccine rollout. On Sept. 21, Dr. Moncef Slaoui —the head of the administration’s COVID-19 vaccine program— told reporters the U.S. could immunize those “most susceptible” to coronavirus by December if there is prior vaccine approval. Yet, the FDA recently announced it would roll out higher safety standards for the vaccine approval process that would make approval unlikely before Nov. 3.
Elsewhere, independent health experts have expressed a number of serious concerns about an expedited vaccine. Primarily, their concerns focus on the health risks associated with a potentially faulty vaccine. Experts also worry a fast-tracked vaccine could significantly damage public confidence in the vaccine’s efficacy, which would hobble even a safe vaccine’s ability to immunize key portions of the population. According to, University of Michigan Chief Health Officer Dr. Preeti Malani, “You could have a safe, effective vaccine that no one wants to take.”
A recent KFF poll supports this notion, showing roughly 54% of Americans would not want to get vaccinated ahead of the November election. This mixed messaging and waning confidence could lead to significant issues with returning to an office-based work schedule. Additionally, should cases surge in the coming months, such a return would be even further down the road.
*KFF Health Tracking Poll (conducted August 28-September 3, 2020)
Producing an effective and safe vaccine is a complex process usually comprised of four pre-approval steps that begin with preclinical tests on animals. According to the New York Times, 92 confirmed preclinical vaccines are in active development as of Sept. 23.
Once preclinical testing concludes, Phase 1 safety trials begin with a small group of people to determine if the vaccine is safe and stimulates the human immune system against the COVID-19 virus.
Phase 2 entails expanding trials to hundreds of people from different demographics to confirm the vaccine is effective regardless of key population variants, such as age or gender. Phase 2 trials also expand on safety and efficacy testing.
Phase 3 trials, the final trials before early approval, are efficacy trials comprised of thousands of volunteers, some of whom receive placebo. The goal of Phase 3 is to determine if the vaccine immunizes people against the COVID-19 virus in everyday life. From there, vaccines move on to early approval and final approval.
Current leaders in the race for a vaccine include Johnson & Johnson, AstraZenca, University of Oxford, Pfizer and Moderna, all of which are in Phase 3. Despite this progress, the two front runners Pfizer and Moderna have not expressed confidence in a vaccine becoming readily available any time soon.
On Sept. 17, Modern released its 135-page clinical trial protocol and Pfizer followed suit Sept. 18 with its own 137-page protocol. These complex protocols indicate the first analysis of relevant data may not be conducted until late December. According to the protocol Moderna released, final analyses of the vaccine’s efficacy are projected for March 2021 at the earliest. These timetables cannot be meaningfully expedited because of the waiting periods between initial vaccinations, booster shots and subsequent data analysis.
Despite some Chinese and Russian companies’ decisions to push into early approval without completing this final phase, attempting to cut corners in a Phase 3 trial is a reckless move that carries considerable risk. According to medical experts like NYU’s Langone’s Division of Medical Ethics Director Arthur Caplan, China and Russia’s decision to do so is “[A] really insane and terrible idea… it’s staggeringly hard to comprehend.”
Given this information, weighing your options and planning is the best way to insulate your business from exposing itself to COVID-19 risks. Although many are hopeful sustained low infection rates may spur state and local officials to continue the reopening process, this is a tenuous and fluid situation that should be reviewed week-by-week or month-by-month basis.
Additionally, even if a vaccine came out in the next few months, it would be virtually impossible for a business to force its employees to take it. Notwithstanding the regulatory and legal implications, the reputational impact a brand would expose itself to would be immense.
While a vaccine may instill confidence in a proverbial light at the end of the tunnel, that light is likely further away than it may seem today. These are some of the unfortunate realities we must all face as we try to return to normal business operations.
If you’d like to learn more about how our global reputation + risk management team can support you during this time, get in touch with Barbara Laidlaw at email@example.com
Barbara Laidlaw brings 25 years of experience developing and running programs that help companies prepare, protect, and defend their brand reputation through global and national events, recalls, litigation, data breaches, regulatory issues and labor disputes.
Josiah Adams works on Allison + Partners’ global risk + issues management team and provides federal, state and local policy insights.