Hole is an equity investment director at Capital Group, an investment management firm with roughly $1.9trn in assets under management. Hole is based in London and spoke with Delano via email on Monday evening.
Delano: When is the first covid-19 vaccine likely to come onto the market?
Martyn Hole: This depends on how you define “come onto the market”. Emergency use authorisations for initial use in certain high-risk populations, for example front line workers in high infection areas, could be likely before the end of 2020 in both Europe and the US, based on interim--i.e., partial--data from phase 3 trials. In the US, the [Food and Drug Administration] now wants to see the first interim analysis of efficacy--triggered by a certain number of “events” or symptomatic covid-19 infections--plus at least two months of follow up once at least half of participants have received the second dose.
Full approvals and wider availability won’t come until well into 2021 and it will take time to vaccinate large portions of any population, as polling data indicate that right now only about half the population want to be vaccinated.
The World Health Organization estimates a timeframe of 4-5 years to vaccinate most of the world. Covax--co-led by the Gavi Alliance (formerly Global Alliance for Vaccines and Immunisation), Coalition for Epidemic Preparedness Innovations and WHO that seeks to coordinate pooled procurement of covid-19 vaccines and with the goal of equitable distribution--recently said that they hope to see 20% of the population of participating countries vaccinated by end of 2021.
Which companies are likely to be the first to come up with a vaccine?
This depends on the definition of “come up with a vaccine”. Many companies raced to develop vaccine candidates as soon as the sequence of SARS-CoV-2 virus was released. Today there are 11 vaccine candidates in phase 3 trials (late stage trials) and several hundred candidates in development. Five vaccines have already received emergency use authorisations in Russia and China, but none yet in the US or Europe.
Do you think that multiple vaccines will be approved in a short period of time?
Yes. First interim phase 3 data readouts are all anticipated within weeks of each other for the major US and EU candidates. If the results are positive, they could all file for [emergency use authorisations, EUAs]. We don’t yet know the immune correlates of protection, which is what level of antibody or T-cell response indicates protection, so approvals require efficacy data. In the future, when these immune correlates are established and understood across several vaccines, so called “immunobridging” data may be allowed and approvals may be granted on immunogenicity data alone. [“Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal,” according to Capital Group.]
How do you view the coronavirus vaccines being developed in China and Russia, some of which are already in the third phase?
Five Russian and Chinese vaccines have already received emergency use authorisations globally--Sinovac, Sinopharm and Cansino in China, Gamaleya in Russia, and Sinopharm in UAE, a Chinese vaccine. Large phase 3 trials are ongoing for all of them to prove efficacy after the EUAs were already granted. These EUAs were granted on immunogenicity alone, which is problematic because, as mentioned earlier, we don’t yet know what level of immunogenicity indicates protection.
Will Europe and the US only choose vaccines developed in the West?
This is potentially likely. The 24 companies that have disclosed anticipated vaccine manufacturing capacities will collectively make 13 billion doses in 2021, but remember many of the leading vaccine candidates require two doses each.