The standard view in the pharmaceuticals industry has been that it takes many years to develop a new drug. And, until recently, that has generally been true.
A McKinsey analysis of all new drugs developed since 2000 shows that the mean development timeline—from the start of clinical testing (Phase 1) to approval—is nearly ten years. The same holds true for new anti-infective vaccines: the development of vaccines for the human papillomavirus, shingles, and pneumococcal infections, for instance, clocked in at between nine and 13 years. Most academics and pharmaceutical-industry stalwarts would consider a development timeline of less than five years to be highly unusual.
It is truly remarkable, then, that three COVID-19 vaccines were granted emergency-use authorization (EUA) or other forms of approval in Europe, the United Kingdom, or the United States by the end of 2020—just 11 months after the SARS-CoV-2 sequence was published and just eight or nine months after the first human doses were administered (Exhibit 1). Previously, the fastest vaccine development was that for the mumps virus, which took four years (from virus sampling to approval) during the 1960s.
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