I have no idea. And I promise, no one else either. It’s a hot time with too much hope, too much fear and too much opportunity for anyone to have a lucid perspective. That said, for me, the fall of 2020 seems too ambitious; even January 2021 is early enough for a safe and effective vaccine to be available to millions of people.
Vaccines usually take years to develop; CanSinoBIO, a leading company in Beijing, recently received praise for getting an Ebola vaccine from concept to approval in just over three years.
Why is it so difficult? After all, the basic approach to vaccine development has remained more or less the same for the past 200 years: inducing the immune system to develop protection against a specific infection, be it smallpox or rotavirus.
Of course, the scientific sleight of hand has radically changed. We have moved from injecting live pathogens to killed pathogens, from weakened but still alive pathogens to injecting genetic fragments of the pathogen using the latest techniques. But the chicanery remained the basic MO.
With all of this know-how and our powerful computers, brilliant vaccine experts, laboratory space and a lot of money, many still wonder why we can’t just keep going.
Alas, it turns out that the modern era, although surely more technological than previous eras, still does not live up to medical miracles on demand. Human biology remains far too complex to be understood by our minds (and our computers).
That said, it’s an exciting time. On April 30, the World Health Organization released an updated inventory of Covid-19 immunization initiatives. The list included eight trials – half of them in China – currently recruiting human volunteers, and 94 trials still in preclinical development.
In addition, health agencies, pharmaceutical and biotechnology companies and researchers have pledged to work closely between countries and scientific communities.
Before digging into the list of vaccines, a quick review of the terminology: The starting point for a clinical trial is “phase 1”, which is designed only to assess the safety of products. If there is no danger sign, the product goes to “phase 2” to determine if the disease reacts to the new product. If things look good, the last one is “phase 3,” usually a large randomized trial involving thousands of people to finally determine safety and effectiveness.
Of the eight trials that are currently recruiting volunteers, only three are in phase 2. Of these, only the Oxford Trial (a phase 1 / phase 2 hybrid) from the UK prevents Covid-19 infection , rather than a laboratory result, as the main desired result.
Why? The Oxford team has the strange advantage of conducting the trial in Britain, where infection rates are still high. However, Germany and China lack sufficient cases to accurately test the effectiveness of the vaccine. And as ethical constraints prevent scientists from infecting participants with a serious illness, a consortium of German, Chinese and American companies is currently developing a product currently being tested only in Germany, which uses substitute markers instead – measures antibody – against the virus. Teams will examine both the amount and the duration of antibodies to the disease created in response to the vaccine.
These groups have had extensive experience in the field of vaccine development. They have already developed certain techniques and theories, which gives them a substantial head start – a glaring endorsement of the long-term value of research that may not seem immediately pressing. As we can see now, what may appear to be an interesting but obscure pathogen today may be the cause of a pandemic tomorrow.
Although many teams are working on a vaccine, many obstacles have been developed to intentionally slow the process in the name of safety. The history of immunization has cast a long dark shadow of side effects, real and imagined. Injecting foreign material into people hoping it will trigger a specific reaction without stirring up anything else is a high-flying medical procedure that has become routine. This is anything but the history of vaccines – and the stopping of vaccines.
Another potential pitfall is the fear that the vaccine will worsen the infection.
It’s more than just a theory. For decades, dengue fever, a common viral infection in tropical climates, has been known to cause a much more serious infection the second time some people develop the disease.
Many clinicians believe that this phenomenon can occur after other respiratory infections – including the coronavirus – although no in-depth investigation similar to working on dengue has been done. Indeed, the increased severity of the “second wave” of the Spanish flu of 1918, with the predominance of deaths among young people, may be due to hyper-inflammation, perhaps due to previous exposure to the flu.
So, some experts fear that if a Covid-19 vaccine does its job by provoking the immune system, the body could go into a destructive overdrive when exposed to the virus itself.
It’s an apocalyptic scenario, yes, but one that gives the scientific community a substantial break as the world rushes headlong into a vaccine. Vaccinologist veterinarians remain haunted by the faux pas of the past and speak up; indeed, emphasizing caution, not speed, is the plea for many who have experienced this.
The appropriate balance between urgent needs and patient safety, they all agree, can be achieved through thorough screening of volunteers and monitoring not only of symptoms, but also of markers of immune activity and overactivity . Regulatory involvement in aggregating all adverse events in a large study population will also be necessary to detect any early group of unexpected symptoms.
In many ways, the new “rush to slow” tension on vaccine development sums up the “anti-lock-in-place” conflict exactly: one party desperate to come back to life before the pandemic at all costs and the other arguing that security should always come first.
And oddly enough, President Donald Trump’s bromide, that the cure should not be worse than the disease, although completely wrong on the issue of home housing, is on the right track for the development of a vaccine. Because the only thing worse than any vaccine during a pandemic is a vaccine that makes things worse.