One of the key arguments to capture the public imagination about the Covid vaccines is how they got developed so quickly. I've spent most of my career developing new drugs and vaccines. Here is the short, jargon-free version of how a new vaccine can appear in 12 months without "shortcuts." The number of years saved over the "normal" 10 - 15 year process is listed under four key headings.
(1) Research: 3 - 5 years saved. Research is normally conducted within companies in secret for competitive and patent reasons. For Covid, the genomic sequence was publically available right at the start and nowadays the technology to go directly from a sequence to a vaccine is available. You then need to build a business case for proceeding into a USD400 - 1,000 million program and get that through the budget process of a major pharma. In the case of the Covid vaccines, governments had promised to directly pay for the development programs or guaranteed to buy the vaccines. Literally no risk for the companies to consider.
(2) Preclinical: 2 - 3 years saved. Before drugs/vaccines go into people, they go through tests in test tubes and animals to look for signs they work and are safe. Normally we do those one at a time due to the risk of failure and escalating expenses. For the Covid vaccines, the pharma companies stacked up all the work required (all very standardised work packages) and just did it all at once because there was no financial risk.
(3) Clinical: 2 - 3 years saved. One of the key drivers of speed in clinical trials is patient recruitment. For a vaccine trial in a pandemic, there is literally as many patients as you need and a huge desire from patients to be in trials. Also, the trials were done in quick succession because the financial risks were reduced. Companies were able to contract with clinicians and clinical research organisations ahead of being sure the vaccines would work in previous Phases. So Phase I rolled into Phase II into Phase III without having to convince their companies of the business case for proceeding.
(4) Regulatory: 1.5 - 2 years saved. Normally regulators like the TGA (Australia) and FDA (the US) review information once it is all available. In this case, as it was a global emergency, they reviewed data as they went along so when the last data was available, they were ready to form an opinion and release the vaccines for use in broader populations.
So if my maths is correct, we saved 8.5 - 13 years of a 10 - 15 year process.
Hope that is helpful in understanding how we got the vaccines without the so-called "shortcuts" which are generating vaccine hesitancy.
PS: my whole family had the AZ vaccine, so I've got plenty of skin in the game.
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