Rushing and Fast-tracking COVID-19 Vaccines: What’s At Stake?

Putting things in perspective: Should we pin all our hopes on a COVID-19 vaccine just yet?

Updated
Putting things in perspective: Can we bank on a COVID-19 vaccine to end the pandemic?
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As the coronavirus takes more people in its grip, the world is placing its bet on a COVID-19 vaccine to put an ‘end’ to the viral outbreak.

Over 160 vaccine candidates are in development right now and at least 23 of them are undergoing human trials. These are being called ‘front-runners’ in the ‘race’ to a potential vaccine against a deadly disease which awaits a proven cure or treatment.

The choice of words has coloured the discourse, making it seem like the single-most priority is to have a vaccine as soon as possible, that speed and urgency are the ultimate endpoints - overshadowing everything else.

While developing a vaccine remains critical in our fight against the pandemic, it is not the silver bullet for COVID-19, a fact even the World Health Organisation (WHO) hasn’t shied away from.

FIT takes you through some pertinent concerns associated with rushing for a vaccine, the potential issues with the first-generation candidates, and why we shouldn’t pin all our hopes on one just yet.

Rushing and Fast-tracking COVID-19 Vaccines: What’s At Stake?

  1. 1. Record-Breaking Speed — and the Concerns

    This is the fastest pace we have ever seen in vaccine development.
    This is the fastest pace we have ever seen in vaccine development.
    (Photo: iStock)

    From the first that we knew of the virus in December, to today, companies and governments across the globe have been on their toes to make a vaccine against it; some using conventional methods, and others, like US-based Moderna, applying newer technologies. To be clear, this is the most expeditious we have ever been in vaccine development. Even the mumps vaccine, which was the fastest-ever approved, took four whole years.

    This explains why many, including Dr Anthony Fauci from the US, are ‘cautiously optimistic’ of having a vaccine in use by early next year. Researchers in Russia are claiming they will have one in a few weeks.

    The operational word here is ‘cautiously’. While early data from animal studies and smaller clinical trials for some candidates has been promising, there is a lot that we are still unsure about. The speed, which must be celebrated on one hand, could also be a reason to worry about in the long-run.

    Public health professionals around the world are concerned that the first-generation vaccine candidates may not be the best. Michael S. Kinch, an expert in drug development and research at Washington University, told The Washington Post, “The realistic scenario is probably going to be more like what we saw with HIV/AIDS. With HIV, we had a first generation of, looking back now, fairly mediocre drugs. I am afraid — and people don’t like to hear this, but I’m kind of constantly preaching it — we have to prepare ourselves for the idea we do not have a very good vaccine. My guess is the first generation of vaccines may be mediocre.”

    Expand
  2. 2. How Does a Compressed Time-Frame Affect Our Knowledge About the Vaccine?

    “When you compress the time frame, you may not be able to sufficiently answer a lot of questions."
    “When you compress the time frame, you may not be able to sufficiently answer a lot of questions."
    (Photo: Aroop Mishra/FIT)  

    In conversation with FIT, Anant Bhan, Adjunct Professor and Researcher in Bioethics at Mangaluru’s Yenepoya University, explains, “The concerns lie with the key aspects of a vaccine. Some questions that need to be answered are: Do we have enough data on safety and efficacy? Do we know enough about the immune response it generates and for how long? How many doses should we administer? Is it effective across age groups?”

    “When you compress the time frame, you may not be able to sufficiently answer these questions. We may not have enough knowledge on the kind and duration of the immune response a vaccine generates. If we look at data in the short term, we will only be able to understand its protective nature and efficacy for that period. Now if you only have evidence for immunity for 2-3 months and you license a vaccine for marketing, questions about its long-term protection will still remain. For that, we will have to wait for a few months, or years.”
    Anant Bhan

    A lot of this uncertainty emerges from the novelty of the virus. Even though we are better equipped to deal with SARS-CoV-2 than we were months ago, much of our knowledge about the virus continues to be incomplete. Questions on the kind of immunity it generates in individuals, the duration these antibodies last for, and the possibility of reinfection loom large in the backdrop of vaccine development.

    Bhan says, “There is a lot that we are still unclear about. Sometimes, you only pick up safety signals much later after administering a vaccine. Large efficacy studies that span a few years help us understand it better. In a shorter time frame, you might or might not pick it up.”

    Expand
  3. 3. Can We Afford to Skip Phase 3 Trials?

    A controversy sparked when an opinion piece published in Forbes suggested putting the vaccine to use, even as phase 3 trials were still being conducted. After facing severe backlash, the author conceded that the move would put many lives at stake.

    But this rush of getting a vaccine on the ground while undermining the necessity of phase 3 trials has been around for a while. The argument given is simple: If we can save lives now, why wait?

    Public health experts have answered this question with multiple reasonings - all centring around the undeniable importance of phase 3 trials which involve thousands of volunteers.

    “There is a reason we do Phase 3 studies, which is to understand larger safety and efficacy implications. In my opinion and in the opinion of most other people who work in this domain, vaccinating people without obtaining evidence from these trials will not be a wise decision. You may not have sufficient knowledge about a vaccine’s impact, safety and utility across different age groups and populations without this evidence.”
    Anant Bhan

    This could also severely undermine people’s trust in vaccines in general. Take this for instance: A survey conducted in May found that only 49 percent of the Americans studied are planning to get the vaccine shot when it’s made available. Closer home, we saw Bajaj Auto Managing Director Rajiv Bajaj saying he would not take a COVID-19 vaccine unless the government made it 100% mandatory.

    Vaccine scepticism would only strengthen with fast-tracked vaccines failing to achieve what they promise. Much of this can be cleared with data from large scale trials which could bring to light issues and adverse effects that smaller trials may have missed.

    Moreover, the possibility of a vaccine failing in these later stages needs to be addressed. What we have so far is initial data from a few animal studies and smaller human trials. The story can change completely once the same vaccine is used on a much larger group of participants. For instance, this FDA document looks at 22 case studies where phase 2 and phase 3 trials had divergent results.

    Columbia University virologist Angela Rasmussen told The Washington Post, “What happens if any of them fail a Phase 3 trial, are people just going to give up? I’m really worried people have been relying on this hope that a vaccine is going to fix everything, and vaccines are not perfect, just like any type of therapeutic. They do fail.”

    How then, would pinning our hopes solely on a vaccine be wise?

    Expand
  4. 4. Is a 50% Effective Vaccine Good Enough?

    A vaccine can look at different end-points.
    A vaccine can look at different end-points.
    (Photo: iStock)

    The World Health Organisation requires a coronavirus vaccine to be at least 50% effective to be used among the population. To put things in perspective, flu vaccines, which are known to be just 40 to 60 percent effective, are still recommended by doctors because they reduce the risk of flu-associated hospitalisation and deaths.

    A vaccine can look at different end-points. It could prevent infection in a person altogether, it could do just enough to protect an individual from severe infection and hospitalisation, or it could do both. Either way, it would help.

    Depending on a particular candidate’s endpoint, decisions regarding the target population and doses would have to be made. For a vaccine that brings down the severity of the disease, for example, older and at-risk people may naturally be prioritised. If a vaccine such as this does not provide complete immunity from the infection and only helps contain critical symptoms, a person would have to be careful in resuming life without caring to follow precautions - as they could still be carriers despite getting vaccinated.

    Further, for the population to attain herd immunity or completely erase the virus, it is estimated that around two-thirds will have to be vaccinated. A 50% effective vaccine, however, would still be of help as it could bring down infection rates and help save lives.

    The key here would be transparency in information dissemination. All this would have to be communicated to the public in order for them to have a clearer and more realistic picture of what a vaccine can and cannot do, and why complacency on their part could be disastrous.

    Besides, if and when we do have a vaccine, uncertainty about the number of neutralising antibodies needed, the duration for which they need to last for, and the possibility of reinfection would be as real as ever - and these are questions we would only get answers for as more time passes.

    Expand
  5. 5. Stick to Basics: Contact, Trace, Isolate, Wear Masks, and Maintain Distance

    In the words of Bhan, “Vaccines are important but we should be not looking at them as some sort of a magical solution.”

    “We know currently that there are a set of interventions that are extremely effective. Masks, maintaining respiratory and hand hygiene, and distancing. We don’t know much about the lasting effects of a vaccine. While the emerging clinical trial data will give some clarity, follow-up will be needed to understand the long term protection it offers.”
    Anant Bhan

    “As we encourage vaccine development and hope for an efficacious vaccine, we must remember that this might be a while away. And even when it comes, it may not be perfect or immediately available for everyone. Given all that, we need to reinforce the importance of public health measures that we know work well,” Bhan added.

    (Subscribe to FIT on Telegram)

    Expand

Record-Breaking Speed — and the Concerns

This is the fastest pace we have ever seen in vaccine development.
This is the fastest pace we have ever seen in vaccine development.
(Photo: iStock)

From the first that we knew of the virus in December, to today, companies and governments across the globe have been on their toes to make a vaccine against it; some using conventional methods, and others, like US-based Moderna, applying newer technologies. To be clear, this is the most expeditious we have ever been in vaccine development. Even the mumps vaccine, which was the fastest-ever approved, took four whole years.

This explains why many, including Dr Anthony Fauci from the US, are ‘cautiously optimistic’ of having a vaccine in use by early next year. Researchers in Russia are claiming they will have one in a few weeks.

The operational word here is ‘cautiously’. While early data from animal studies and smaller clinical trials for some candidates has been promising, there is a lot that we are still unsure about. The speed, which must be celebrated on one hand, could also be a reason to worry about in the long-run.

Public health professionals around the world are concerned that the first-generation vaccine candidates may not be the best. Michael S. Kinch, an expert in drug development and research at Washington University, told The Washington Post, “The realistic scenario is probably going to be more like what we saw with HIV/AIDS. With HIV, we had a first generation of, looking back now, fairly mediocre drugs. I am afraid — and people don’t like to hear this, but I’m kind of constantly preaching it — we have to prepare ourselves for the idea we do not have a very good vaccine. My guess is the first generation of vaccines may be mediocre.”

How Does a Compressed Time-Frame Affect Our Knowledge About the Vaccine?

“When you compress the time frame, you may not be able to sufficiently answer a lot of questions."
“When you compress the time frame, you may not be able to sufficiently answer a lot of questions."
(Photo: Aroop Mishra/FIT)  

In conversation with FIT, Anant Bhan, Adjunct Professor and Researcher in Bioethics at Mangaluru’s Yenepoya University, explains, “The concerns lie with the key aspects of a vaccine. Some questions that need to be answered are: Do we have enough data on safety and efficacy? Do we know enough about the immune response it generates and for how long? How many doses should we administer? Is it effective across age groups?”

“When you compress the time frame, you may not be able to sufficiently answer these questions. We may not have enough knowledge on the kind and duration of the immune response a vaccine generates. If we look at data in the short term, we will only be able to understand its protective nature and efficacy for that period. Now if you only have evidence for immunity for 2-3 months and you license a vaccine for marketing, questions about its long-term protection will still remain. For that, we will have to wait for a few months, or years.”
Anant Bhan

A lot of this uncertainty emerges from the novelty of the virus. Even though we are better equipped to deal with SARS-CoV-2 than we were months ago, much of our knowledge about the virus continues to be incomplete. Questions on the kind of immunity it generates in individuals, the duration these antibodies last for, and the possibility of reinfection loom large in the backdrop of vaccine development.

Bhan says, “There is a lot that we are still unclear about. Sometimes, you only pick up safety signals much later after administering a vaccine. Large efficacy studies that span a few years help us understand it better. In a shorter time frame, you might or might not pick it up.”

Can We Afford to Skip Phase 3 Trials?

A controversy sparked when an opinion piece published in Forbes suggested putting the vaccine to use, even as phase 3 trials were still being conducted. After facing severe backlash, the author conceded that the move would put many lives at stake.

But this rush of getting a vaccine on the ground while undermining the necessity of phase 3 trials has been around for a while. The argument given is simple: If we can save lives now, why wait?

Public health experts have answered this question with multiple reasonings - all centring around the undeniable importance of phase 3 trials which involve thousands of volunteers.

“There is a reason we do Phase 3 studies, which is to understand larger safety and efficacy implications. In my opinion and in the opinion of most other people who work in this domain, vaccinating people without obtaining evidence from these trials will not be a wise decision. You may not have sufficient knowledge about a vaccine’s impact, safety and utility across different age groups and populations without this evidence.”
Anant Bhan

This could also severely undermine people’s trust in vaccines in general. Take this for instance: A survey conducted in May found that only 49 percent of the Americans studied are planning to get the vaccine shot when it’s made available. Closer home, we saw Bajaj Auto Managing Director Rajiv Bajaj saying he would not take a COVID-19 vaccine unless the government made it 100% mandatory.

Vaccine scepticism would only strengthen with fast-tracked vaccines failing to achieve what they promise. Much of this can be cleared with data from large scale trials which could bring to light issues and adverse effects that smaller trials may have missed.

Moreover, the possibility of a vaccine failing in these later stages needs to be addressed. What we have so far is initial data from a few animal studies and smaller human trials. The story can change completely once the same vaccine is used on a much larger group of participants. For instance, this FDA document looks at 22 case studies where phase 2 and phase 3 trials had divergent results.

Columbia University virologist Angela Rasmussen told The Washington Post, “What happens if any of them fail a Phase 3 trial, are people just going to give up? I’m really worried people have been relying on this hope that a vaccine is going to fix everything, and vaccines are not perfect, just like any type of therapeutic. They do fail.”

How then, would pinning our hopes solely on a vaccine be wise?

Is a 50% Effective Vaccine Good Enough?

A vaccine can look at different end-points.
A vaccine can look at different end-points.
(Photo: iStock)

The World Health Organisation requires a coronavirus vaccine to be at least 50% effective to be used among the population. To put things in perspective, flu vaccines, which are known to be just 40 to 60 percent effective, are still recommended by doctors because they reduce the risk of flu-associated hospitalisation and deaths.

A vaccine can look at different end-points. It could prevent infection in a person altogether, it could do just enough to protect an individual from severe infection and hospitalisation, or it could do both. Either way, it would help.

Depending on a particular candidate’s endpoint, decisions regarding the target population and doses would have to be made. For a vaccine that brings down the severity of the disease, for example, older and at-risk people may naturally be prioritised. If a vaccine such as this does not provide complete immunity from the infection and only helps contain critical symptoms, a person would have to be careful in resuming life without caring to follow precautions - as they could still be carriers despite getting vaccinated.

Further, for the population to attain herd immunity or completely erase the virus, it is estimated that around two-thirds will have to be vaccinated. A 50% effective vaccine, however, would still be of help as it could bring down infection rates and help save lives.

The key here would be transparency in information dissemination. All this would have to be communicated to the public in order for them to have a clearer and more realistic picture of what a vaccine can and cannot do, and why complacency on their part could be disastrous.

Besides, if and when we do have a vaccine, uncertainty about the number of neutralising antibodies needed, the duration for which they need to last for, and the possibility of reinfection would be as real as ever - and these are questions we would only get answers for as more time passes.

Stick to Basics: Contact, Trace, Isolate, Wear Masks, and Maintain Distance

In the words of Bhan, “Vaccines are important but we should be not looking at them as some sort of a magical solution.”

“We know currently that there are a set of interventions that are extremely effective. Masks, maintaining respiratory and hand hygiene, and distancing. We don’t know much about the lasting effects of a vaccine. While the emerging clinical trial data will give some clarity, follow-up will be needed to understand the long term protection it offers.”
Anant Bhan

“As we encourage vaccine development and hope for an efficacious vaccine, we must remember that this might be a while away. And even when it comes, it may not be perfect or immediately available for everyone. Given all that, we need to reinforce the importance of public health measures that we know work well,” Bhan added.

(Subscribe to FIT on Telegram)

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