Breakwaters for the coming tidal wave

Dec 2, 2020 · 4 min read

Richard Marcil, Chief Customer Officer at conversationHEALTH

COVID-19 vaccines news has been torrid and positive of late, with Pfizer/BioNTech and Moderna posting headline results with circa 95% efficacy. Approval and roll-out of these vaccines is imminent, with the US and UK targeting early- to mid-December distribution. There is also a rich pipeline of vaccines behind these, in addition to antivirals, monoclonal antibodies, immune modulators, etc. Clearly there is a light at the end of the tunnel and it’s no longer a freight train.

But there is still much work ahead for manufacturers in terms of supporting healthcare professionals (HCPs) and the general population through mass vaccination programs that will include massive logistical challenges involving government agencies, healthcare providers and front line staff. The biggest challenge will be the size and speed of vaccination programs in 2021 — truly unprecedented in scale, at country level, globally, and all simultaneously.

Considerations need to be twofold:

1. Safety reporting as the industry deploys rapidly developed vaccines.

2. HCP and engagement of vaccination subjects pre, in-between and post vaccinations.

The former is well covered by MyMeds&Me and Sidley in A Coming Tidal Wave It underscores the need for monitoring vaccines developed through Emergency Use Authorization; the millions of vaccinations taking place every day; early safety and efficacy signals from real-world data gathering; and the need to manage spikes related to broadcast and social media “news”. Ultimately, pharmacovigilance teams for these manufacturers as well as local regulatory authorities must be prepared for large surges in adverse event reporting.

Equally challenging will be the demand for information by everyone administering and receiving these vaccines. Clinical trial populations by their nature are selective whereas real world use will span the breadth of background disease, lifestyle and ethnicity that will raise many questions from HCPs (physician or pharmacist) about what to expect particularly as the first wave of vaccines will be deployed to vulnerable populations with higher levels of morbidity, concomitant medicines and therefore higher risk of adverse events. Given the level of concern about the pandemic and the pressure for rapid vaccination, subjects or their careers will be equally keen to learn about what they might expect from vaccination and if they do experience issues, where to report while receiving reliable approved information. A significant proportion of the population is already hesitant about COVID-19 vaccines given the speed of development and the mis-information propagated by the anti-vaxxer movement. Finally, given the multi-dose regimen of the early vaccines, it will be essential to support vaccinees and ensure compliance with the second dose, irrespective of their first-dose experience.

The magnitude of the issue/opportunity comes to life with simple math. For example — let’s assume the first two vaccines reach 70% of a country’s population over 26 weeks¹; 1% of HCPs and patients have a product inquiry; 0.25% of HCPs and vaccination subjects report an adverse event (this assumes ~40 fold lower AE reporting than seen in trial data where approximately 10% of subject reported severe, grade 3 events); we get the following:

These numbers are multiples greater than the traditional capacity of manufacturer call centers² and Medical Information teams — and all the more for product inquiries. Many call centers are struggling to operate at full capacity due to COVID-19 restrictions either because of staff sickness or because technology is unavailable to work effectively from home. Vaccine inquiries may go to government websites, but as with any product, the manufacturers are considered the primary place to seek information or to complain. In addition, the situation will compounded by large spikes in engagement related to broadcast and social media news and events, whether they happen in country or globally. Call centers will not be able to cope, so vaccination subjects will not have their questions addressed, they will avoid a second dose and will not report their adverse events. The integrity of the vaccination program will suffer and uptake will drop.

In short, successful mass vaccination is a process that goes well beyond market authorization. Proactive and readily available information ensures reassurance of the population, rapid uptake of the vaccinations and prompt reporting of any safety or product quality issues. This means vaccination can scale while providing continual adjustments/refinements to dosing or risk mitigation based on prompt analysis of emerging data. It is imperative that the population and the healthcare community feels engaged with those who have raced to provide the vaccines in record time. This requires meaningful, accessible and transparent materials that drive rapid and sustained uptake of vaccines, and compliance with multi-dose treatment. Advanced technology and interactive digital platforms can play an outsized role in supporting these strategies and, in fact, may be critical given that existing human-intensive processes or “simple” technologies cannot scale quickly and robustly enough to meet the imminent tidal wave of engagement. Only in this way will we preserve public trust and contain the COVID-19 pandemic.

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1. Moncef Slaoui, MD, head of the federal Operation Warp Speed, told CNN that he expects 70% of the U.S. population will be vaccinated by May 2021.



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