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The following excerpt is from the firm’s Top of Mind report published on August 13, 2020.
Allison Nathan, senior strategist for Goldman Sachs Research and creator of Top of Mind, recently interviewed Dr. Richard Hatchett, the CEO of the Coalition for Epidemic Preparedness Innovations (CEPI) to discuss the outlook for a Covid-19 vaccine and whether a vaccine breakthrough will be sufficient to achieve herd immunity.
The views stated herein are those of the interviewee and do not necessarily reflect those of Goldman Sachs.
Q: What is CEPI’s involvement in the pursuit of a vaccine for Covid-19?
A: CEPI is a coalition of countries and philanthropic organizations, including the Gates Foundation and the Wellcome Trust, that was set up in 2017 to focus on vaccine development against emerging infectious diseases.
Before Covid-19, we were involved in the development of about 20 vaccines against high priority emerging infectious diseases like Ebola, Lassa Fever and MERS – another coronavirus.
And with Covid-19, we have funded a diversified portfolio of nine vaccine candidates. Seven of the nine Covid-19 vaccines are now in clinical trials, and an eighth vaccine will be entering clinical trials soon.
Q: When do you expect we'll have a safe Covid-19 vaccine that can be distributed at scale?
A: When we initiated our Covid-19 vaccine development program in late January 2020, we ambitiously set a target of 12 to 18 months for the availability of a vaccine at scale.
Data from preclinical animal trials and early stage human clinical trials have been encouraging.
We’ve seen protection in animal challenge studies and an immune response in humans that is producing neutralizing antibodies to the disease.
And eight vaccines globally are now in Phase III clinical trials only six months in – a truly unprecedented accomplishment, from which we’re hoping to get some definitive results by the end of the year.
That timing will depend on how quickly the tens of thousands of people required for these trials are enrolled, and how long it will take to accumulate enough cases in unvaccinated participants to demonstrate conclusively that the vaccine works.
The prevalence of disease in many countries is unfortunate, but helpful in this regard, so we’re hopeful that we’re on track to have a vaccine available within the next year.
Q: Coronaviruses have been around for a long time, yet a vaccine has never been developed. Why is that?
A: It’s true that we’ve never had a licensed human coronavirus vaccine. Some coronaviruses that are associated with the common cold are highly infectious but cause very mild illness, which doesn’t necessarily warrant a vaccine.
But the SARS virus that took hold in 2002 and the MERS virus that appeared in 2012 are two known coronaviruses that cause even more severe illness and higher mortality rates than Covid-19.
As for why no vaccines for those ever reached licensure, in the case of SARS, the epidemic came and went over a matter of several months and when it disappeared, it was gone.
Although vaccine efforts were initiated in this period, developers encountered challenges with what is called an “immune enhanced disease” response, and, given that the disease was no longer a threat as they ran into these challenges, SARS vaccine development was halted.
Vaccine development efforts were initiated more recently for MERS; in fact, as I mentioned, MERS was one of the first three diseases that we focused on at CEPI, not only because it is a scary disease with mortality rates in excess of 30%, but also because it was the second concerning coronavirus that we had encountered. But, unfortunately, we weren’t that far into the development of a vaccine for MERS when Covid-19 emerged.
Q: Given that we’ve never successfully developed a coronavirus vaccine before, what are the chances that we fail to do so now?
A: There is always a risk that any vaccine development effort will fail. The risks of failure of a new vaccine that hasn't yet entered clinical trials is probably greater than 90%.
On top of that, the biology of some diseases like HIV, tuberculosis, and malaria, presents significant challenges for vaccine development, either because the disease mutates or the targets don't neutralize the virus or the bacteria. But, at least at this point, Covid-19 doesn’t seem to fall into this category.
And there is a very prominent protein on the surface of the virus called the spike protein that is important for binding the virus to its target cells, and is therefore an obvious vaccine target.
Trials so far indicate that targeting the spike protein elicits an immune response, and the immune response produces neutralizing antibodies, which should prevent the virus from being able to infect.
So, the science is encouraging in terms of our ability to develop a vaccine, even if any one vaccine candidate may fail.
Q: Are you concerned that nearly all of the vaccines in development target the same spike protein?
A: I’m not particularly concerned about that, because if such an approach fails to elicit a strong enough immune response, there are other approaches that may be able to induce one, such as targeting more antigens along with the spike protein or employing a live attenuated virus.
So, if this first round of vaccine candidates fails, that doesn’t mean we won’t ultimately develop a successful vaccine. But it does make a strong case for maintaining investment in research and development for backup candidates that use diversified approaches to neutralize the virus.
Even if an effective vaccine is developed in this first round, ongoing research may develop a better one. For example, the first polio vaccine to demonstrate effectiveness was the Salk vaccine, which was an inactivated vaccine that had to be injected.
At the time, it was considered a godsend. But it proved not to be ideally suited for mass vaccination of populations and polio eradication.
The Sabin vaccine, which was an oral vaccine that was easier to administer and produced very effective immunity, came along several years later, and that became the vaccine that we've used for the last 60 years to control polio.
So, the first vaccine may help us end the pandemic, but it may not be the longer term solution that ultimately eradicates the Covid-19 virus.
Q: Even if we get a vaccine, how confident can we be in its safety given the speed of development?
A: Safety is absolutely critical, and developing a vaccine against Covid-19 at speed absolutely does not mean cutting corners with regards to safety.
However, alongside absolutely stringent levels of safety it is crucial that confidence about vaccine safety remains high in the general population because any safety problem – real or perceived – could jeopardize the global immunization effort, which would be tragic.
We must also be mindful that any approved Covid-19 vaccine will likely be initially prioritized for populations at greatest risk, such as elderly populations or people with underlying medical conditions.
These are essentially members of the population that are already at greater risk of death or severe illness regardless of the additional threat that Covid-19 poses.
It is therefore critically important to monitor the vaccinated population to understand baseline rates of predictable health events, such as heart attacks and strokes, given their age and underlying health conditions, in order to avoid mistakenly attributing these events to vaccination.
Case in point: the 1976 swine flu vaccination program was temporarily suspended prior to its termination because three elderly people vaccinated on one day died, although it was ultimately determined that those deaths were unrelated to the vaccine.
Q: Beyond safety, how confident can we be that a Covid-19 vaccine will provide protection against the disease since we’re still learning about immunity to it?
A: The real answer is that only time will tell. We just haven't accumulated enough time or experience with the virus, and we are only beginning to get information about the nature of the antibody response, which may not even end up determining immunity.
It may be the case that another type of immune response—a “cell-mediated” response—might be required instead of or in addition to an antibody response to achieve sustained immunity.
And there’s certainly a chance that Covid-19 will require booster immunizations in the event that the immune response doesn’t prove to be durable for more than a year, or a handful of years.
But all of this remains to be determined and is going to require continued research, monitoring and clinical trials.
Q: Even if an approved vaccine is available next year, will we be able to achieve full herd immunity?
A: We don't expect to have enough vaccine supply to achieve global herd immunity in 2021, meaning that enough people become resistant to the disease through vaccination that the disease is pushed into decline.
But we think we could have enough vaccine next year to protect healthcare workers and the populations at greatest risk globally, which we estimate to be 20% of the global population, requiring two billion doses.
So the near-term aim is to take the sting out of the pandemic by reducing death rates and severe disease and by protecting healthcare systems, which should put the world on the road to restoring normal economic activity.
That said, this will likely only happen with coordinated action. One of the lessons of recent history is that leaving the allocation of a vaccine to general market mechanisms during a pandemic will result in misallocation of supply because some countries will over-buy vaccine supply to ensure their population is protected.
These actions will indeed protect their populations, but won’t end the global pandemic given the resulting scarcity of the vaccine for the rest of the world. We saw this type of behavior during the 2009 H1N1 influenza pandemic, in which over a dozen countries cornered the supply of influenza vaccine globally.
To avoid a repeat of this scenario, CEPI and our partners Gavi, the Vaccine Alliance and the World Health Organization (WHO) have joined together in an entity called COVAX that pools risks through a diversified portfolio of vaccine candidates, actively manages that portfolio, and then oversees vaccine distribution on an equitable basis that will most efficiently help bring the global pandemic under control.
That said, we’ve already seen the US and some EU countries that have formed a buyers group enter into bilateral agreements with companies to procure vaccines for their populations. But, while those efforts are concerning, I don’t think that they will keep COVAX from functioning effectively and efficiently.
Longer term, vaccine supply should be less of a constraint on achieving global herd immunity as vaccine production continues to ramp up. And the question will become one of demand.
Many epidemiologists think that 60-80% of the population needs to be immune to achieve herd immunity. To hit that target through vaccination, most individuals in the community will need to be vaccinated. But we just don’t know what the uptake of the vaccine will be, and it will likely differ between communities, populations, and demographic groups.
The reality is that we don’t know if there will be enough demand for the vaccine to achieve global herd immunity through vaccination.
Q: Given all of the above, is it fair to say that even if we do get an approved vaccine on your accelerated timeline, it won't be a magic bullet?
A: That's absolutely true. There's a lot we don't know about the vaccines. There's a lot we don't know about Covid-19.
Almost every week we're learning something new about the disease; a few months ago, we observed an inflammatory syndrome in children.
Now we're learning that children are probably infected at higher rates than we originally appreciated, just with very mild disease. There will be a period of several years in which we continue to learn about the disease, the vaccines, and the immune response.
And it will also take time and cooperation to produce and distribute any successful vaccine, which some people could ultimately decide not to take. So even if our vaccine timelines are achieved, global herd immunity may still be a long way off.
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