Health Impact News – by Brian Shilhavy
The pharmaceutical trade publication, Fierce Pharma, is a publication targeting investors in pharmaceutical products, such as vaccines.
This week (April 2020) they published an article titled:
Don’t count on a COVID-19 vaccine for at least five years, says AI-based forecast
Investors want to be assured that a new product does not get rushed to market too quickly, bypassing safety regulations, for obvious reasons.
They have learned their lessons from previous products that gained FDA approval but later turned out to harm people, like the Merck VIOXX scandal in years passed, where up to 60,000 people are suspected of dying due to dangerous side effects of the drug, before it was pulled from the market.
This is a pharmaceutical investment firm’s worst nightmare.
A company called Clarivate has developed an analytical tool called Cortellis Analytics which apparently uses artificial intelligence to predict how long it will take to bring a certain drug to market.
Using a tool it developed called Cortellis Analytics, Clarivate estimated that Moderna has just a 5% probability of success with its COVID-19 vaccine mRNA-1273, and that the time window for approval would be 5.2 years.
The low probability of success reflects the fact that mRNA is a new, unproven approach to vaccines, said Sarah Hardison, Ph.D., head of product, regulatory and pharmacovigilance at Clarivate, in an email.
What could change these predictions is whether or not companies developing the vaccine would be granted “emergency-use approval from the FDA to get mRNA-1273 on the market quickly.”
When asked if Moderna might get an emergency-use approval from the FDA to get mRNA-1273 on the market quickly, Zaks said he couldn’t make any promises. “The decision on emergency use is going to be an evolving one…as the data matures to make that determination,” he said. “So it’s very hard to predict today.”
Clarivate’s Cortellis tool uses machine learning to forecast development timelines and the probability of success for drug candidates that have entered clinical trials. The firm said in a recent online post that as of April 8 there are 185 companies and research institutes working on 156 COVID-19 medicines and vaccines, 11% of which are in clinical development.
The other vaccine candidate that Clarivate evaluated was Inovio’s DNA vaccine INO-4800, which the company moved into clinical testing last week. Clarivate forecasts a probability of success of 15% for INO-4800 and an approval timeline of 5.5 years.
As Fierce Pharma reports, Clarivate is not the only medical analytics company raising questions about the fast-approval process for a COVID-19 vaccine.
Clarivate isn’t the only firm raising questions about the growing optimism that a solution to COVID-19 will rescue everyone from their quarantines soon.
Analysts at SVB Leerink spoke to a vaccine development-specialist earlier this month and warned in a report to investors that “safety is often more important than efficacy to regulators, and long-term safety must be established before” a vaccine will be approved.
So while politicians and drug companies are out in the public these days conditioning the public to accept a fast COVID-19 vaccine to be available to the public in a short time, investors are obviously a bit more skeptical, and more concerned with safety over an entirely new class of vaccines that seeks to alter people’s DNA.
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