COVID Proves It Does Not Take 10 Years to Develop a New Product
[Thursday, August 6, 2020]
We have been told for decades that it takes about 10 years and more than $2 billion to develop a new treatment, so how does one explain that we may have a working vaccine less than 6 months from the start of the first-in-man trials? It may seem like a myth, a conspiracy to deceive the public; but the truth is a lot simpler. The pandemic has exposed a major flaw in the oft-generalized projection for the cost and time needed to develop new medical products: developing new products take time due to the limits in resources, and incentives, and not because of the duration of the individual steps in development. Mathematically it was always possible. If there are unlimited resources and money available, products can be developed at “warp speed”. Let us look at five reasons that sum it up. First, if the background scientific logic is reasonable, things can move fast. All the Covid vaccines being tested are based on technologies that are decades old. Although several are being tested for the first time in human clinical trials, they have been researched extensively on other infectious diseases. The pandemic offered a unique opportunity to test these technologies for Covid at a scale not previously possible. The non-clinical safety data and manufacturing methods were available for most investigational vaccines at the onset of the pandemic making it possible for regulators to allow clinical trial initiation.  Second, the conventional development pathways can be expedited with the right amount of funds and resources. The Covid vaccine programs followed the classical pathways of Phase 1, Phase 2, and Phase 3 clinical trials. There were few shortcuts, or unconventional strategies, hence avoiding prolonged debates. The reason these programs could move so fast is because governments worldwide committed ginormous funds, and medical and regulatory resources, to one goal, find a Covid vaccine. Since most clinical trials for other indications were suspended, it allowed repurposing almost all available clinical trial resources to Covid vaccine trials. Tasks that normally would take weeks and months, could hence be completed in days and weeks. Third, the right timing of the program helps. The declarations of national emergencies and the resulting complete shutdown of normal life activities, along with the seemingly unstoppable infections and deaths, created complete public support for any vaccine efforts. In such times, it should not be surprising that thousands of volunteers can be recruited in very short times. Fourth, the time to biological response determines how long the tests need to be in each volunteer, assuming all other factors are controlled. Vaccines are relatively quick response products. It takes about 2-3 weeks to see initial response in the immunized volunteers, and another 2-3 weeks to see a robust response with a booster dose (assuming the vaccine works). So, mathematically, if we recruit a lot of volunteers on Day 1, we will get results from all those volunteers in 4-6 weeks. Which is what we have been hearing from the developers. There are reports of thousands of volunteers being immunized at hundreds of centers practically simultaneously. So, assuming that all the planned volunteers are recruited and immunized in 1-3 weeks, it should not be surprising if we start seeing results of the entire trial in 2-3 months. Yes, this requires extreme resources and efforts, and that is what was made available. Fifth, business steps up to opportunity. Covid vaccines would be blockbuster products. Even with multiple competing vaccines, it could offer guaranteed quick returns on investment unlike any other product in recent times. For several of the companies developing Covid vaccines, this is the only product they have ever taken this close to market. For those companies the pandemic was the windfall they have been waiting for. Just because it is fast, does not mean it is automatically suspect. Yes, we should vet any claim, but we should judge any vaccine on its data, and not on an antiquated assertion that it should take 10 years to develop a new product. The pandemic products have probably made a big dent on that theory already. There is only one thing that can stop this train; that the vaccines do not work as promised. Excluding that possibility, we should be prepared to see the fastest vaccines in our history.