COVID-19 Vaccine Availability Raises Critical Policy Issues for Companies

Pharma Communications Expert Mark Senak Raises Questions Needing Answers ASAP           

11/30/2020 – – Moderna today announced that it will be in front of the Food and Drug Administration (FDA) on December 17 seeking emergency use authorization (EUA) for its COVID-19 vaccine. An FDA hearing to review Pfizer’s EUA request has already been scheduled for December 10.

With both vaccines delivering better than 90-percent effectiveness in human trials, there’s plenty of reason to be optimistic about 2021. But before we can issue an “all-clear,” there are challenging vaccination issues that must be considered. All companies and organizations have policy decisions to make regarding their proper role in the vaccination rollout.

Mark Senak, a leading authority on pharmaceutical industry communications, last week posted an insightful article on his “Eye on FDA” blog titled, “As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner.” Mark and I were senior partners together at the PR firm FleishmanHillard. His specialty is counseling FH pharmaceutical and biologic clients working through the process of bringing new drugs and medical treatments to market. No one knows this territory better than Mark.

Getting out ahead of the likely EUA approvals, Mark asks the following questions:

  • Will businesses require a vaccine of employees?
  • Will there be circumstances where access to goods and services by consumers is reliant on vaccination?
  • What sort of documentation will be necessary for an individual?
  • What are the HIPAA and privacy implications?
  • What role, if any, will employers play in the facilitation of vaccinations?
  • Will employers have a role in educating people about the safety and efficacy of vaccines, particularly if there are circumstances where vaccinations may be required?
  • How will this be balanced by the fact that vaccination of the population will be a process, not an event?
  • What are the implications of uneven vaccine implementation by region and geography?
  • What is the contingency plan needed around diminishing effectiveness?

So, before you finalize planning for your virtual holiday party, pull together your leadership team — including operations, HR, legal and communications — to tackle Mark’s questions from your organization’s unique point of view. You’ll be asking your colleagues to scenario plan in a dynamic environment, for sure, but the effort will be well worth the time.  And in the best tradition of crisis prevention, make Mark’s blog post required reading for all. Here’s a link to his wisdom:    

http://eyeonfda.com/

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