Show Transcript
Fresh optimism about a possible COVID-19 vaccine helped to boost markets. It’s also raising hopes the end of the pandemic may be in sight. Anthony Okolie speaks with Tarik Aeta, Healthcare Analyst, TD Asset Management, about whether recent developments represent a significant step in getting an approved vaccine to market.
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- Markets rallied on news that Pfizer's trial vaccine is more than 90% effective in preventing COVID-19. Tarik, is this a significant step in getting a potential vaccine to market?
- Thanks, Anthony, for having me on. So although the disclosures yesterday were limited, I'd argue the data yesterday is the real deal and takes us a big step forward in finally ending the pandemic. So while there's still some outstanding questions, such as how durable the vaccine is, how effective it is in older adults, despite that, the data is very promising and also bodes well for the other COVID vaccines in development, given most are also targeting the spike protein.
- So what is the data telling us about the effectiveness and, more importantly, the efficacy or the safety of the vaccine?
- Yeah, so the findings from the phase III trial were very important for two reasons. So first, unlike phase I trials, where we generally enroll less than 100 volunteers, phase III vaccine trials enroll tens of thousands of individual. And this allows us to pick up on any rare safety risks that may have been otherwise missed in a small phase I trial. So for the Pfizer vaccine specifically, over 43,000 individuals have been enrolled. And given no major safety risks have been observed thus far, it's probably fair to say that the vaccine is largely safe and effective.
And second, the reason why the phase III results are so important is because it gives us a first real look into how effective the vaccine is. So in contrast to a phase I trial where we only get biomarkers such as antibody production, in a phase III trial, we instead get a real world look into how effective the vaccine is at preventing people from getting sick in their everyday lives.
So all in, the data was strong, with 90% vaccine efficacy after the second dose. And this is well in excess of the 50% minimum hurdle rate rolled out by the FDA back in June. So with this data in hand, Pfizer is well positioned to apply for their emergency use authorization by the end of next week. And I'd expect regulatory approval likely to come in the weeks following that.
- And can you help us explain the difference between Pfizer's mRNA vaccine versus the viral vector vaccine stuff from companies like J&J and AstraZeneca? What's the difference in approaches, as well as the delivery of the vaccine into the system?
- Yeah, that's a great question. So all in, there are five major approaches that are being used by the 200-plus vaccines in development globally.
The first one that will come to market are likely the mRNA vaccines, like the one Pfizer is developing. And the way it works, it basically delivers to the body an instruction manual in the form of mRNA genetic code delivered inside little bubbles of fat. And these basically tell the body what the COVID-19 spike protein looks like. The beauty of this approach is that unlike traditional vaccines, you don't need to grow viruses in the lab. And this allows a vaccine to be developed more quickly, which is partly why Pfizer has been able to reach the finish line before everyone else. And the other benefit is this also means that in the future, if we were to see mutations in the virus, you could easily create a new vaccine within months for that new strain.
Viral vector vaccines, on the other hand, like J&J and AstraZeneca vaccines, work differently. Instead of using little bubbles of fat to deliver those instructions, they instead use the shell of harmless, non-replicating viruses, such as adenovirus. All in, I think both mRNA and viral vaccines, vector vaccines should work decently well, given the phase I data and the animal studies prove that well.
That said, mRNA vaccines did have a slight benefit in terms of efficacy in the phase I data. So it will be interesting to see if that holds up when we get phase III data as well.
- And where do we stand right now with some of the competing vaccines, vaccine trials?
- Yeah. So looking forward over the next two months, we'll be getting actually a bunch of phase III clinical data from the other vaccine developers. First off will be Moderna, given their study is expected to hit, their interim analysis, by the end of November. Their vaccine is very similar to Pfizer's. Both are mRNA vaccines. Both target the full spike protein. So I'd expect them to also be successful.
Moving to December, we're scheduled to get results out of AstraZeneca and possibly even Johnson & Johnson as well. And this comes after both vaccines were temporarily put on pause due to potential safety concerns. However, both have since gotten the all clear to resume their trials and are now enrolling once again.
- OK. So we've talked about the vaccines. I want to talk a little bit about the antibody therapies. And it was just announced that Eli Lilly's experimental antibody drug was just received FDA emergency approval. So I wonder how effective are these treatments, these therapies in treating COVID-19?
- Yeah. So as you mentioned, last night Eli Lilly antibody therapy was the first one that got FDA emergency use authorization. And antibody therapy help by allowing our immune system more quickly identify the virus, in addition to reducing the ability of the virus to bind to cells. While antibody drugs are not very effective for those patients that are already hospitalized, the clinical trials do show, however, that they are effective in keeping high risk patients with mild to moderate symptoms out of the hospital.
So for example, if you're over 65 or if you have a major risk factor, such as diabetes, the clinical trials do show that you're 70% less likely to end up in the hospital or seek additional care if you get an antibody injection. So as such, these antibody therapies can play a key role in bridging the gap and reduce mortality until we're able to get a vaccine that's widely available.
- So despite these positive developments, certainly setbacks can happen which could ultimately delay getting a drug to market. How likely is it that people can get access to these vaccines in early 2021?
- Right. So while I'm very optimistic we'll have several COVID-19 vaccine approvals in the months ahead, you're absolutely right that supplies will be severely limited at first. So for example, by January 1, Pfizer is only expected to have 50 million doses for the whole world, and Moderna only 20 million doses for the whole world. So even though by the end of next year we should have 10 billion doses across all the various vaccine manufacturer-- and that's assuming clinical trials are successful-- supplies will remain constrained likely until the summer and will likely be reserved for high risk individuals.
So for example, in Canada, the National Advisory Committee on Immunization has recommended that vaccines be prioritized for a handful of groups. This includes seniors, those with underlying health conditions, health care workers, caregivers, those providing essential services, and Indigenous communities. However, once next summer rolls along and going into next fall, supplies should start to become plentiful. And I'm optimistic by the end of the year we can have widespread vaccination and we can largely defeat COVID-19 under that scenario.
- What's the latest sense on how much the general population would be willing to take a vaccine once it becomes available?
- Yeah. So based on a survey done by Statistics Canada over the summer, 76% of Canadians are willing to get a COVID-19 vaccine. Personally, I don't think that number is not far from the truth. I think it's very realistic. And the reason I say that is already a third of us get the flu shot every year. And when you start to add on top of that the number of Canadians who would like to expand their social bubble, as well as those who might want to go on vacation abroad, so maybe in the future if you want to go on vacation, countries may have a requirement to get vaccinated to avoid quarantine. So when you take into account all these different scenarios where people may need to get vaccinated, I think it's very realistic that over half the population will ultimately get vaccinated.
- And I just want to finish off by asking you, how are you approaching this from an investment standpoint?
- So the main way we've positioned ourselves at TDAM for a COVID-19 vaccine, at least in our health care investments, has been indirectly through investments in the medical device industry. And these are the companies that make devices such as pacemakers, artificial heart valves, and robotic surgery platforms, to name a few. Since March, many of these companies have been hit hard. And this is because when the pandemic began, most hospitals canceled elective surgeries to make room for COVID-19 patients.
In Ontario alone, for instance, a backlog is over 80 weeks. So with COVID-19 vaccines to be widely available next year, we should see a strong recovery in elective surgeries. And this will benefit the wider medical device industry. So not only can sales return to pre-COVID level, but sales should easily exceed pre-COVID level, as hospitals will need to work through these really big backlogs of patients that need to get their elective surgeries done.
- Tarik, thank you very much for your insights.
- Thanks, Anthony.
[MUSIC PLAYING]
- Thanks, Anthony, for having me on. So although the disclosures yesterday were limited, I'd argue the data yesterday is the real deal and takes us a big step forward in finally ending the pandemic. So while there's still some outstanding questions, such as how durable the vaccine is, how effective it is in older adults, despite that, the data is very promising and also bodes well for the other COVID vaccines in development, given most are also targeting the spike protein.
- So what is the data telling us about the effectiveness and, more importantly, the efficacy or the safety of the vaccine?
- Yeah, so the findings from the phase III trial were very important for two reasons. So first, unlike phase I trials, where we generally enroll less than 100 volunteers, phase III vaccine trials enroll tens of thousands of individual. And this allows us to pick up on any rare safety risks that may have been otherwise missed in a small phase I trial. So for the Pfizer vaccine specifically, over 43,000 individuals have been enrolled. And given no major safety risks have been observed thus far, it's probably fair to say that the vaccine is largely safe and effective.
And second, the reason why the phase III results are so important is because it gives us a first real look into how effective the vaccine is. So in contrast to a phase I trial where we only get biomarkers such as antibody production, in a phase III trial, we instead get a real world look into how effective the vaccine is at preventing people from getting sick in their everyday lives.
So all in, the data was strong, with 90% vaccine efficacy after the second dose. And this is well in excess of the 50% minimum hurdle rate rolled out by the FDA back in June. So with this data in hand, Pfizer is well positioned to apply for their emergency use authorization by the end of next week. And I'd expect regulatory approval likely to come in the weeks following that.
- And can you help us explain the difference between Pfizer's mRNA vaccine versus the viral vector vaccine stuff from companies like J&J and AstraZeneca? What's the difference in approaches, as well as the delivery of the vaccine into the system?
- Yeah, that's a great question. So all in, there are five major approaches that are being used by the 200-plus vaccines in development globally.
The first one that will come to market are likely the mRNA vaccines, like the one Pfizer is developing. And the way it works, it basically delivers to the body an instruction manual in the form of mRNA genetic code delivered inside little bubbles of fat. And these basically tell the body what the COVID-19 spike protein looks like. The beauty of this approach is that unlike traditional vaccines, you don't need to grow viruses in the lab. And this allows a vaccine to be developed more quickly, which is partly why Pfizer has been able to reach the finish line before everyone else. And the other benefit is this also means that in the future, if we were to see mutations in the virus, you could easily create a new vaccine within months for that new strain.
Viral vector vaccines, on the other hand, like J&J and AstraZeneca vaccines, work differently. Instead of using little bubbles of fat to deliver those instructions, they instead use the shell of harmless, non-replicating viruses, such as adenovirus. All in, I think both mRNA and viral vaccines, vector vaccines should work decently well, given the phase I data and the animal studies prove that well.
That said, mRNA vaccines did have a slight benefit in terms of efficacy in the phase I data. So it will be interesting to see if that holds up when we get phase III data as well.
- And where do we stand right now with some of the competing vaccines, vaccine trials?
- Yeah. So looking forward over the next two months, we'll be getting actually a bunch of phase III clinical data from the other vaccine developers. First off will be Moderna, given their study is expected to hit, their interim analysis, by the end of November. Their vaccine is very similar to Pfizer's. Both are mRNA vaccines. Both target the full spike protein. So I'd expect them to also be successful.
Moving to December, we're scheduled to get results out of AstraZeneca and possibly even Johnson & Johnson as well. And this comes after both vaccines were temporarily put on pause due to potential safety concerns. However, both have since gotten the all clear to resume their trials and are now enrolling once again.
- OK. So we've talked about the vaccines. I want to talk a little bit about the antibody therapies. And it was just announced that Eli Lilly's experimental antibody drug was just received FDA emergency approval. So I wonder how effective are these treatments, these therapies in treating COVID-19?
- Yeah. So as you mentioned, last night Eli Lilly antibody therapy was the first one that got FDA emergency use authorization. And antibody therapy help by allowing our immune system more quickly identify the virus, in addition to reducing the ability of the virus to bind to cells. While antibody drugs are not very effective for those patients that are already hospitalized, the clinical trials do show, however, that they are effective in keeping high risk patients with mild to moderate symptoms out of the hospital.
So for example, if you're over 65 or if you have a major risk factor, such as diabetes, the clinical trials do show that you're 70% less likely to end up in the hospital or seek additional care if you get an antibody injection. So as such, these antibody therapies can play a key role in bridging the gap and reduce mortality until we're able to get a vaccine that's widely available.
- So despite these positive developments, certainly setbacks can happen which could ultimately delay getting a drug to market. How likely is it that people can get access to these vaccines in early 2021?
- Right. So while I'm very optimistic we'll have several COVID-19 vaccine approvals in the months ahead, you're absolutely right that supplies will be severely limited at first. So for example, by January 1, Pfizer is only expected to have 50 million doses for the whole world, and Moderna only 20 million doses for the whole world. So even though by the end of next year we should have 10 billion doses across all the various vaccine manufacturer-- and that's assuming clinical trials are successful-- supplies will remain constrained likely until the summer and will likely be reserved for high risk individuals.
So for example, in Canada, the National Advisory Committee on Immunization has recommended that vaccines be prioritized for a handful of groups. This includes seniors, those with underlying health conditions, health care workers, caregivers, those providing essential services, and Indigenous communities. However, once next summer rolls along and going into next fall, supplies should start to become plentiful. And I'm optimistic by the end of the year we can have widespread vaccination and we can largely defeat COVID-19 under that scenario.
- What's the latest sense on how much the general population would be willing to take a vaccine once it becomes available?
- Yeah. So based on a survey done by Statistics Canada over the summer, 76% of Canadians are willing to get a COVID-19 vaccine. Personally, I don't think that number is not far from the truth. I think it's very realistic. And the reason I say that is already a third of us get the flu shot every year. And when you start to add on top of that the number of Canadians who would like to expand their social bubble, as well as those who might want to go on vacation abroad, so maybe in the future if you want to go on vacation, countries may have a requirement to get vaccinated to avoid quarantine. So when you take into account all these different scenarios where people may need to get vaccinated, I think it's very realistic that over half the population will ultimately get vaccinated.
- And I just want to finish off by asking you, how are you approaching this from an investment standpoint?
- So the main way we've positioned ourselves at TDAM for a COVID-19 vaccine, at least in our health care investments, has been indirectly through investments in the medical device industry. And these are the companies that make devices such as pacemakers, artificial heart valves, and robotic surgery platforms, to name a few. Since March, many of these companies have been hit hard. And this is because when the pandemic began, most hospitals canceled elective surgeries to make room for COVID-19 patients.
In Ontario alone, for instance, a backlog is over 80 weeks. So with COVID-19 vaccines to be widely available next year, we should see a strong recovery in elective surgeries. And this will benefit the wider medical device industry. So not only can sales return to pre-COVID level, but sales should easily exceed pre-COVID level, as hospitals will need to work through these really big backlogs of patients that need to get their elective surgeries done.
- Tarik, thank you very much for your insights.
- Thanks, Anthony.
[MUSIC PLAYING]
