How Long Should It Take to Develop a Treatment for COVID-19?
[Thursday, April 2, 2020] The burning question in all circles of the society is when and how would a treatment or vaccine for COVID-19 emerge. The politicians and public would want it done in days and weeks, the scientists and developers need months and years. The vaccine is projected to take at least about 12-18 months to be ready for use outside of clinical trials, while the treatment may come in about six months, assuming that at least some of the hundreds of treatments being tested in clinical trials show promise. While the emergency allows some relaxations regarding the amount of data needed to be granted approval to market by the FDA, there still needs to be the minimum supporting data. And it takes time and effort to generate it. Some ways to reduce the time to market are treatments based on strong nonclinical rationale for the mechanism of action, doses, and dosing regimen, followed by a reasonable trial design to evaluate the treatment in the most relevant target population. It is easier said than done. During an emergency, it is common for developers to go for product ideas with scant data, hypotheses based on liberal assumptions, and development plans with reduced due diligence testing. While theoretically it is possible that even an outlandish idea may yield promising results, history tells us that such happenings are rare. Good science needs planning and time. Bad ideas funded by resourceful developers generally suck the initial air out of the systems clogging all funds. Once the first group of products fail, the second and subsequent group of products, that learnt from the mistakes of the first group of products, are tested. The second cycle products generally have a better shot at success. Another factor that comes into play is demand for the treatment. If the pandemic slows down due to movement restrictions and weather, the products intended to treat it also become less attractive. So, it may slow the development of products even more. Such was the fate of previous global outbreaks such as SARS, H1N1, and Ebola. So, coming back to the original questions of how long it should take to develop a treatment or vaccine for COVID-19, it should take at least months for treatments and much longer for vaccines. The good money should be on technologies that were tested in the past on related viruses. Treatments and/or vaccines that showed promised in the earlier SARS virus probably have a better shot than antivirals to unrelated viruses. The truth is no one knows the answer and by any account, the treatments and/or vaccines are at least months away from approval, and all estimates show, will probably come too late to have an impact. It may happen that the pandemic blows over before any viable treatment or vaccine is available. For now, if you have a good product idea for pandemic, you are racing against time to get it out before it become irrelevant or obsolete. |
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