Specialist
Director at Gavi, The Vaccine Alliance
Agenda
- Availability of supply following US FDA EUA (Food and Drug Administration Emergency Use Authorisation), volume commitment updates and vaccine manufacturers’ ability to scale up supply
- Review of various go-to-market and vaccine allocation strategies
- Supply chain capacity, role of centralised or government entities and remaining logistical bottlenecks
- Timelines for mass-scale immunisation by region and outlook for herd immunity 5. Commercial opportunity for the industry
Questions
1.
Pfizer and Moderna are in talks with the FDA [Food and Drug Administration] for EUAs [emergency use authorisations] for their respective candidate vaccines and the EMA [European Medicines Agency] is conducting a rolling review, meaning a vaccine is likely to be approved by the end of year in Europe too. What are your expectations for the outcomes of these discussions? Should we expect anything other than a straightforward EUA, if such a thing exists? For example, could we see strict labelling language as for the anti COVID-19 antibodies?
2.
Do you think there will be any salient differences in the language or nature of the EUA for the Pfizer, BioNTech and Moderna vaccines?
3.
Is the AstraZeneca vaccine good enough for approval given that its optimal dose has only been given to 2,700 people, or 24% of the trial population? The company has since confirmed it will be running an additional study to confirm the findings.
4.
AstraZeneca only has data for its low dose in 24% of the patients, and those patients were all under the age of 55 – so a low-risk cohort at that. Is that a large enough sample size for approval? The data we have is also from studies conducted in the UK and Brazil, with the US trial still underway. Taken together, this inconclusive data set and no US trial data, is the FDA likely to give an EUA?
5.
There’s a deep and rich pipeline of COVID-19 vaccine candidates in development. Other than the Pfizer BioNtech and Moderna candidates, which do you think are the most promising? What are the timelines there and your expectations for approval?
6.
What are your efficacy expectations for J&J’s vaccine? Some have speculated that immunity to the AAV [adeno-associated virus] itself case may be responsible for curbing the efficacy in AstraZeneca’s trials, hence the 62% efficacy in the high-dose cohorts. Given that J&J is a single dose, might we expect higher efficacy?
7.
You mentioned that the FDA was open to any vaccine which had demonstrated more than 50% efficacy. Is that philosophy still valid given that Moderna and Pfizer have now come out with 90%? According to the American Journal of Preventative Medicine, and assuming a R0 of 2.5, we need 60% population coverage if a vaccine has 80% efficacy to achieve herd immunity, 75% coverage if a vaccine had 70% efficacy, and 100% coverage if the vaccine has 60% efficacy. Do you expect the goalposts to have moved given the better than expected data coming out for the mRNA candidates, and the fact that high population coverage is unrealistic in practice?
8.
I’d like to review some of the latest volume commitments here. By the end of 2020, AstraZeneca has said it is likely to produce 28 million doses and BioNTech Pfizer up to 50 million. By the end of 2021, Pfizer said it will produce 1.3 billion, AstraZeneca two billion, Moderna 500 million, CanSino around 100 million to 200 million. How feasible are these different numbers in practice? Pfizer-BioNtech have already halved their original projections due to logistical issues. What are your expectations for the availability of supply immediately following EUA?
9.
Where do you think the key bottlenecks are beyond cold chain logistics?
10.
Why do you think the concern around cold chain logistics is overblown? Is it because the rollout would be staged given the regulatory requirements, so a limited initial supply would yield time to optimise distribution?
11.
What are the use cases for the Moderna vs Pfizer vaccines given the temperature requirements? Many are speculating that Moderna’s vaccine is best suited for rural communities and BioNTech’s for metropolitan areas given the -20C and -70C requirements respectively and the fact that Pfizer-BioNTech’s cold suitcases only accommodate batches of around 1,000 doses, so it won’t really be amenable for small scale rural immunisation. Do you think that is how it will play out or do you think decision-makers will generally want the Moderna vaccine given that it’s easier to handle?
12.
What role might a centralised or government entity have in the distribution of these vaccines? Could there be a disintermediation of traditional wholesalers and distributors?
13.
There seem to be three phases to think about when considering how demand is going to evolve over the coming years. The acute phase, the vaccination of the priority population as defined by frontline workers and the at-risk population, then herd immunity. How many doses will be needed across those three different phases? Can you run us through some back of the envelope calculations to calculate what demand may look like?
14.
When do you think herd immunity will be achieved at the earliest in advanced economies? Especially given everything we have discussed insofar as limited vaccine supply, vaccines may not be fully effective, there may be durability concerns and people simply may not accept the vaccines.
15.
There have been some worrying surveys conducted among European states suggesting that 34-61% of the populations will choose to get vaccinated. This is compounded by the fact that the first vaccines to hit the market would be mRNA vaccines. To date there have been no other mRNA vaccines approved, so that exacerbates the inertia. Worth also bearing in mind that one-tenth of one-year-old children globally are not immunised against tuberculosis or hepatitis B, both of which have been proven to be very safe and efficacious vaccines. To what extent is this vaccine resistance going to be a major hurdle that means advanced economies will not be fully vaccinated by the end of next year? Is that a plausible scenario?
16.
What are your expectations for demand by vaccine type? What are your thoughts on mRNA vs AAV vs traditional protein subunit vaccines?
17.
Is it safe to assume that traditional vaccines would command the majority of market share?
18.
To what extent do you think that despite the rich pipeline of candidates the COVID-19 vaccine market is going to consolidate around a handful of vaccines similar to what we see when it comes to the influenza market? If that does happen, who do you think will win out?
19.
Do you think manufacturers with a flu vaccine are likely to have some form of competitive advantage?
20.
How can we avoid vaccine nationalism and ensure fair distribution?
21.
Do you think developing markets will have to manufacture their own supply? Presumably from countries such as India and China?
22.
What is the commercial opportunity for the industry, especially for the pharma players themselves? AstraZeneca has committed to selling their vaccine at cost, or around EU at around USD 3 or USD 4, whilst the pandemic lasts. Worth noting that there is interesting language around how AstraZeneca define the ‘pandemic’, suggesting they will look to make a profit at some point. The vaccines developed by J&J, Sanofi, GSK, etc are expected to cost around USD 10 per dose. Given the relatively low ASP, how should we think about the cost of goods and the other costs to estimate respective margins and profit?
23.
What is the commercial opportunity for AstraZeneca or its peers given the high fixed costs, the development timelines and the fact that vaccines are typically low margin?
24.
What do you think are the opportunities for CDMOs [contract development and manufacturing organisations]? Does the limited in-house capacity mean there is a large CDMO market opportunity? If so, how large?
