Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. Last week Pfizer and BioNTech announced findings from the first interim analysis of the Phase III studies of their candidate vaccine for COVID-19 demonstrating high efficacy levels followed this week by a similar announcement by Moderna. It was a much-craved dose of good news, spawning broad optimism during what is an extremely challenging phase of the pandemic. And while there are many questions left – from efficacy to safety to distribution – given the fact that both of these companies have stated that they will have doses ready in 2020 there appears more of a possibility that there will be more than one vaccine soon – even beginning in December.
But first there will be regulatory rites of passage. During the October 30 meeting of the CDC Advisory Committee on Immunization Practices (ACIP) which focused solely on COVID-19 vaccine development, FDA stated the prior to any approval for an Emergency Use Authorization (EUA) that the agency would reconvene the Vaccines and Related Biologics Advisory Committee tor review data submitted in support of such licensure. It would appear plausible based on the information gleaned from the data announcements that there could be a filing for an EUA very shortly which could in turn mean that limited vaccinations could start being administered very soon. Because the regulatory oversight of COVID became highly politicized, and after some missteps by FDA, some states have indicated that any federal decision will be reviewed, but that does not seem likely to present much a barrier in terms of timeline, if at all.
While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time. These two particular vaccines are two-dose vaccines administered weeks apart. Vaccination may start next month, but the effects will not occur until after a period following the second dose which would occur in 2021.
Nevertheless, the real prospect of a vaccine roll out raises some very practical and important questions for businesses now. This is true for business to consumer or business to business concerns – whether manufacturers or in the service sector. Vaccination for COVID-19 not only requires business planning, but communications planning in support of the decisions. Vaccination will occur in phases, with more and more people being able to access as increasing doses become available. While the initial vaccines may be utilized with very specific populations, over time there will be increasing numbers of people rolling up their sleeves. A post-vaccine world begs some specific questions:
- First and foremost – will businesses require a vaccine of employees? And related – will businesses seek to set themselves apart by making it known that their environmental risk is being addressed with mandatory vaccination of staff? This is particularly relevant for retail establishments for example.
- On the heels of that, will there be circumstances where access to goods and services by consumers is reliant on vaccination? This is particularly relevant for the travel and hospitality industries, but perhaps also for some medical services.
- Related to both of these first two questions – what sort of documentation will be necessary for an individual – either employee or customer – to present evidence of inoculation? And also how will those who do not vaccinate because of medical or religious reasons be considered?
- What are the HIPAA and privacy implications, if any, related to all of these questions?
- What role, if any, will employers play in the facilitation of vaccinations? Currently many employers sponsor vaccines for the flu – will there be a role for COVID vaccination support? Several of the vaccine candidates are administered in two doses, several weeks apart. Will employees need assistance or support in accessing vaccines (and keeping track of which vaccine they have received), particularly if vaccinations are being required?
- Surveys have indicated that many are reticent about taking a vaccine – will that change when vaccination moves from the theoretical to the real? Will employers have a role in educating people about the safety and efficacy of vaccines, particularly if there are circumstances where vaccinations are being required?
- Where vaccines are required as a pre-condition to access to either employment or goods and services how will this be balanced by the fact that vaccination of the population will be a process, not an event, and that there may be many people who for one reason or another, are unable to access vaccination?
- All of these questions may likely have different answers in different regions of the U.S. Companies that are national in scope may have to formulate responses that take into account local or regional conditions. What are the implications of uneven vaccine implementation by region and geography?
- Finally, among the many unknowns connected with the mass production of a vaccine only developed and researched in the past few months is the long-term efficacy and safety. What is the contingency plan needed around diminishing effectiveness?
It may seem like we are a far way away from having to address these types of questions, given the fact that there is no approved vaccine yet and there are considerable distribution obstacles associated with the administration of COVID-19 vaccines to the general public. The fact that vaccination may begin as soon as December does not mean that answers to these questions are needed now. But the process for answering them is. A post-vaccine environment is going to demand business plans and external and internal communications plans that support and consider multiple scenarios and contingencies. If we have learned one thing in this pandemic, reality overtakes everything else – and the environment shifts rapidly. Public facing companies need to act now to consider strategic challenges and support responses with communications approaches that protect and preserve not only credibility, but the well-being and good will of their stakeholders.