Specialist
Former VP at Johnson & Johnson
Agenda
- Overview of COVID-19 vaccine supply chain and distribution dynamics
- Near- and long-term dynamics as storage requirements evolve
- Progression from EUA (Emergency Use Authorization) candidates to general availability, and process of scaling supply chain
- Bottleneck analysis and review of manufacturing, distribution and point-of-care dynamics
- 2021 outlook
Questions
1.
Could you outline the vaccine distribution process from release at the manufacturing facility to arriving at the administration point? What do you consider the key potential bottlenecks in those steps?
2.
Do you expect any further stability testing to modify the mRNA COVID-19 vaccines’ storage temperatures? Do you think we’re working with the current temperatures over the next 6-7 months?
3.
How would you break down the availability of -25 to -35 degrees Celsius vaccine storage infrastructure across hospitals, clinics and other administration points vs the shipping boxes and packaging side? Do we have any capacity at all in the -70 to -80 degrees Celsius range, or will that infrastructure have to be built out for Pfizer’s vaccine?
4.
Could aircraft be required in domestic US vaccine shipping as well as trucks? What bottlenecks could potentially be caused by weight limits and related factors?
5.
Do you think it would be optimal to thaw the vaccines prior to arriving at the administration point or once they are there? Would thawing on location require any special staff oversight or training to handle the newer vaccine platforms? How is demand being factored into thawing decisions? How are storage metrics – such as Pfizer sayings its vaccine must be consumed within five days of delivery – affecting decisions to ensure optimal usage and minimal wastage at the point of administration?
6.
How would you segment out rural and urban areas in planning optimal distribution routes? Could the cold storage requirements for the first-generation mRNA candidates mean less well-equipped clinics in lower population areas would lack the capabilities necessary to store and administer these vaccine platforms? Do you expect the first generation to mainly be distributed in more populated zones? Would other areas have to wait on second-generation candidates from players such as Johnson & Johnson, given the potentially simpler storage requirements?
7.
How do you think about any potential bottlenecks with Operation Warp Speed and government-operated distribution? The delineated process seems different from Pfizer’s choice to in-house some of the manufacturing and related elements. Do you think the timeline for Operation Warp Speed is realistic given the need for investment and the dispersed capabilities across networks? Do you think we should expect delays?
8.
A large number of vaccine doses will be manufactured, especially when we think about the first 50 million or first billion doses that go to first responders or the at-risk population. Would you say the government and commercial processes are entirely parallel? Are any partnerships involved?
9.
Could you estimate the investment required to distribute a vaccine across provider locations, especially for ultra-cold storage?
10.
What could happen to investments in freezer farms and ultra-cold storage trucks if there’s further stability testing in 6-12 months that changes the mRNA candidates’ storage temperature requirements? Could there also be other vaccine candidates by that point that have more normal storage temperature requirements? Do you think those investments are a sunk cost or could they be repurposed?
11.
We discussed shipping companies fulfilling the last mile, but how should we think about the packaging and the cryostorage companies? Which players might be better-suited to ultra-cold storage vs regular refrigeration? What role could players such as CSafe and Envirotainer play?
12.
Which packaging and cryostorage players might be particularly well-positioned? Would you say they’re all on the same playing field?
13.
What’s your take on potential vaccine wastage? We’ve heard rates quoted between 5% and 15%. Could there be more vaccine wastage with the mRNAs because they’re newer technologies with more stringent storage requirements?
14.
Do you think the dose release figures being quoted by big pharma players are factoring in vaccine wastage and other potential issues around release testing, lot testing and differing regulatory environments? Should we treat those numbers as the peak of what they could supply?
15.
Are there any other areas around COVID-19 vaccine supply and distribution that we are yet to discuss?
16.
Do you think there could be a federal vaccine mandate, given potential vaccine hesitancy figures loom in the 35-40% range, especially with the mRNA candidates?
17.
What are your thoughts on the UK leading with its purchasing agreements and vaccine administration? Is this a typical time frame, with the EU leading and the FDA [Food and Drug Administration] following suit? Do you think there are more reservations on the FDA side, especially given the scrutiny around how they approved remdesivir?
