Specialist
Former senior executive at GlaxoSmithKline plc
Agenda
- Vaccine development cycle and key idiosyncrasies for a COVID-19 novel coronavirus vaccine
- R&D pressure points and clinical development optimisation
- Evaluation of technologies – recombinant, mRNA and others
- Comparison of COVID-19 and H1n1 pandemics and key lessons
Questions
1.
There’s a lot of noise out there in the media and industry publications regarding Covid-19 Vaccine development. Just to kick us off, can you give us your view on where we are today, and some of the key development programmes that excite you?
2.
As you mentioned, there is one vaccination programme already in early-stage clinical trials. Could you outline the typical vaccine development cycle, and how this one has been accelerated to the point it’s in the clinic already?
3.
Can you dive deeper into Moderna’s vaccine programme specifically?
4.
Could you elaborate on vaccine failure rates across phases 1, 2 and 3? You highlighted that probably of success is higher than typical pharmaceuticals – why is that?
5.
What is the typical cost for an infectious vaccine programme using attenuated or live inactive platforms?
6.
To what extent do you think players such as GlaxoSmithKline or Sanofi are hesitant to heavily invest in a COVID-19 vaccine? What’s the risk that by the time a vaccine has been developed the disease in question may have died down somewhat and the ROI is compromised?
7.
We’re seeing some evidence of this today, but both with respect to both the coronavirus situation today and future pandemics, do you think that Biotechs or non-profits will be first to bring a vaccine to market?
8.
What are the key characteristics you look for in a Vaccine? Safety, efficacy and stability presumably?
9.
What are the potential vaccination strategies for COVID-19? Are we likely to vaccinate the entire at-risk population? Would there be multiple injections per patient?
10.
So if we look at the at-risk population of 65 years-plus, that would represent 51 million people in the US, 85 million in Europe and 156 million in China. Adding on top health workers, that would result in a significant number of patients. Given the size of this potential patient pool, to what extent is the safety profile of a drug going to be the major hurdle here? Even a 0.01% adverse effect rate here would result in a very large number of patients experiencing side effects. Or, on the other hand, do you think that the regulatory bodies will be prepared to lower the standards for safety given the unmet need?
11.
Could you walk me through some of the idiosyncrasies of COVID-19 vs other viral infections when it comes to developing a vaccine? To what extent should this not be compared to an influenza flu?
12.
With the seasonal flu we see antigenic drift resulting in the need for yearly vaccine development. How prone are Coronaviruses to similar mutations or recombination with other coronaviruses?
13.
What are the major costs involved in updating a vaccine on a yearly basis? You mentioned that for influenza viruses, nine-tenths of the work is already done?
14.
Coronaviruses have spike proteins on the surface, and the specific gene in coding the S protein is has been identified and sequenced very rapidly. Do you think the fact that Coronaviruses typically only have one major antigenic protein by comparison to influenza, which has haemagglutinin, neuraminidase etc, has been instrumental in developing a vaccine?
15.
Respiratory virus vaccines seem to have posed a challenge historically. Can you share any insight into the failures of the RSV [respiratory syncytial virus] vaccines and the key lessons learnt relevant to the development of a COVID-19 vaccine?
16.
What are the most common reasons for clinical trial failures for vaccines more broadly?
17.
Is the time it takes for the immune system to respond and start producing immunoglobulins a key factor in determining efficacy? Is this something that will be looked at closely?
18.
Could you elaborate on the complexity and scalability of manufacturing as a key pressure point?
19.
How easy is it to pass batch release tests, and do you think there will be some leniency from regulatory agencies as we try to develop a vaccine?
20.
What are the pros and cons of inactive vs live attenuated vaccines, considering safety, efficacy, stability and ability to manufacture at scale? How does that compare to some of the DNA vaccines – so subunit or mRNA more broadly?
21.
What cell lines would be used for COVID-19 vaccines to grow on? Could we see a potential supply bottleneck for the Vero, the human embryonic lung diploid cells, the MDCKs [Madin-Darby canine kidney] or others?
22.
What is the risk that inactive vaccines could actually increase the severity of lung disease, as we saw with some Sars [severe acute respiratory syndrome] vaccines?
23.
Genetically engineered vaccines such as recombinant vaccines, where an immunogenetic protein is made in a lab, are delivered using viral vectors. There is a well-known viral vector supply chain bottleneck in gene therapy – is this a key limitation to the large-scale use of recombinants?
24.
Moderna managed to get its mRNA vaccine into phase 1 within three months by my understanding. The first patient was dosed last week. Looking to the future, what key hurdles remain? Will the vaccine be capacity constrained?
25.
Do the big pharma, or otherwise at-scale vaccine players, have the capacity or technology to aid in large- scale manufacturing of mRNA vaccines?
26.
To what extent are mRNA vaccines sill struggling with the ability to deliver an intact strand of mRNA consistently? Presumably this impacts the efficacy of the vaccine? I know there have been a lot of efforts from CureVac, BioNTech, Moderna and others here recently.
27.
What is the potential for using neutralising antibodies from recovered patients as a potential COVID-19 prophylactic as opposed to therapy?
28.
Could you draw parallels to the Mers [Middle East respiratory syndrome], Sars and H1NI epidemics in terms of the timeline we saw before we saw a vaccine on the market and the key lessons?
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