Estimating Probabilities of Success of Vaccine and Other Anti-Infective Therapeutic Development Programs (Only 41% of Industry-Sponsored Vaccine Development Programs made it through about 9 years of clinical trials to obtain approval)

Harvard Data Science Review ^ | May 14, 2020 | Andrew W. Lo, Kien Wei Siah, and Chi Heem Wong

[DoodleBob]

Abstract

A key driver in biopharmaceutical investment decisions is the probability of success of a drug development program. We estimate the probabilities of success (PoSs) of clinical trials for vaccines and other anti-infective therapeutics using 43,414 unique triplets of clinical trial, drug, and disease between January 1, 2000, and January 7, 2020, yielding 2,544 vaccine programs and 6,829 nonvaccine programs targeting infectious diseases. The overall estimated PoS for an industry-sponsored vaccine program is 39.6%, and 16.3% for an industry-sponsored anti-infective therapeutic.

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We plot the number of development programs known to start in each month from January 2000 through December 2019 in Figure 3...As can be seen in Figure 3A...We see a precipitous fall in the number of infectious disease treatment development programs initiated between late 2018 and mid-2019, which is likely related to declining investment in the research and development (R&D) of novel antibiotics, precipitated by the closure of antibiotics biotechnology firms and the withdrawal of pharmaceutical companies from the antibiotics business (Hu, 2018; Langreth, 2019)...Between January 2000 and June 2011, the number of non-industry-sponsored vaccine development programs initiated is on par with the number of non-industry-sponsored, nonvaccine anti-infective drug development programs initiated (see Figure 3B). However, the number of nonvaccine drug development programs initiated begins to outpace the number of vaccine development programs after January 2012, and such programs experience a rapid boom between mid-2015 and mid-2018 before declining rapidly between October 2018 and January 2019.

3A

3B

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From Table 1, we can see that the overall PoS for industry-sponsored vaccine development programs is 39.6%...In contrast, non-industry-sponsored vaccine development programs have an overall PoS of only 6.8%...

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Probabilities of Success - Vaccine Development Programs

Respiratory Infections PoS: 40.5% (Industry-Sponsored) 11.5% (Non-Industry Sponsored)

[DoodleBob]

This is a follow-up study to the baseline study of the estimation of clinical trial success rates and related parameters. In that study, vaccine clinical trials succeeded only 33% of the time from 2000-2015 and for Vaccines (Infectious Disease) it took a median of about nine years to get through Phases 1-4 of all clinical trials, to obtain approval.

The data are clear: only 41% and 12% of all industry- and non-industry-sponsored vaccines, respectively, made it through all phases of clinical trials to obtain approval, and it takes about nine years at the median to obtain approval.

By contrast, the shots currently available had NO clinical trials of anything longer than a few months.

As I've said repeatedly, if people want to take the COVID19 shots because of commodities or age etc., then that's a personal choice and I'll never give you grief.

But for people who look at this data and have hesitancy, they shouldn't be treated like pariahs.

[DoodleBob]

FYI