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President Trump recently announced Operation Warp Speed, an initiative aimed at achieving a completed vaccine for the novel coronavirus by the end of 2020.
Not only does the president want the vaccine to be tested and ready by the end of the year, but also for it to be made available for distribution and administration – all in an affordable way.
The plan, which is to start manufacturing the vaccine while it is being tested for immune response, efficacy and safety, is ambitious. As the president has acknowledged, this will be a risky and highly expensive endeavor – his experts consider it a Herculean task.
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Is it feasible to have millions of doses available by the end of 2020?
The short answer is yes. But the success of this plan hinges on other, more complicated questions. Will these doses be able to actually be used? And can we successfully launch mass vaccination campaigns to immunize the entire population, or will the vaccine initially be used for hospital and front-line workforces?
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Under normal conditions, the process to develop a fully finished vaccine that can be widely administered takes between 10 to 15 years at a cost of up to $5 billion. To ensure safe and efficacious vaccines, it is essential to implement robust and reliable characterization tools across discovery, development, production and quality control.
But COVID-19 has changed everything in a dramatic way – including the way in which we develop vaccines.
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Since China shared coronavirus genomic sequencing data with the world in January, things have moved very quickly. With this information in hand, along with previous experience in vaccine development for SARS, MERS, Zika and influenza, researchers were able to use the same manufacturing process and technology, substituting the genetic code for the novel coronavirus. This enabled us to move the first COVID-19 vaccine into clinical trials within just a couple of months.
With the pandemic causing havoc, the Food and Drug Administration has agreed to speed up the regulatory process by allowing the clinical trial phases to be combined together.
Traditionally, laboratory and animal studies take three to six years and clinical studies with human subjects (Phase I, II, & III) require around six years if everything goes smoothly. The proposed plan is to combine Phase I and II trials together by tracking both safety and immune response in a much smaller population.
Phase II trial participants will be followed into Phase III and tracked to see if the vaccine prevents community infection. This strategy will save years, and a vaccine can be available to the general population in around 18 months.
But just because it’s possible doesn’t mean it’s safe.
One vaccine alone will not be sufficient; my hope is that, with vaccine candidates for COVID-19 in various stages of development globally, multiple vaccines will be developed and approved.
By combining the clinical trials to fast-track advanced development, we risk rushing the vaccine to the market – potentially with serious unforeseen consequences. What if there are significant side-effects that aren’t observed until later? This would be devastating, not only because it would affect all the other vaccines, but also because it would add fuel to a small but very vocal segment of the American population that is against any and all forms of vaccination.
Though a safety test might be accomplished in as little as three months, the vaccine would then need to be given to hundreds or thousands of people at the core of an outbreak to determine the vaccine’s efficacy in protecting its recipients. That could take at least a year.
Furthermore, there is always a possibility that the vaccine does not provide lasting immunity, either because people's immunity wanes quickly or because the virus mutates; RNA viruses like SARS can mutate due to external pressures and evolve. Thus, a perfect vaccine would need to have the antigen that produces immunity against all strains of the virus.
One vaccine alone will not be sufficient; my hope is that, with vaccine candidates for COVID-19 in various stages of development globally, multiple vaccines will be developed and approved.
One thing for sure: If all goes well, we will have a vaccine next year to fight the second wave and not before. In the interim, we will have to rely on safe practices to protect ourselves against the coronavirus and implement stringent testing, tracking and tracing protocols.
There’s no way around it; the world urgently and desperately needs a vaccine. We are in a state of pandemic with over 4.5 million people infected and over 300,000 deaths globally. The U.S., even with restrictions and lockdowns, currently has close to 1.5 million cases and we are expecting close to 100,000 deaths by June 1 and 140,000 deaths by mid-August.
Fortunately, science and technology are constantly evolving – and COVID-19 has served as an accelerator. As Carveth Read wrote in 1898, “it is better to be vaguely right than exactly wrong.”
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I am extremely optimistic that this horrible crisis will yield the highly innovative solutions we need. But to make this happen, we need to follow the science and data we have available and implement a phase-in and phase-out policy. And we must continue observing social distancing, wearing masks and maintaining good hand hygiene – anything we can do to help control transmission. A pandemic is no time for complacency.
We will have a functional vaccine eventually. Until then, stay vigilant, safe, strong and united. And above all, stay hopeful. This, too, shall pass.