Drug Development Expert Sounds Alarm Over Rushed-to-Market COVID-19 Vaccines
These are the takeaways
Hedley’s credentials to accompany the video
This is a bit more on the video titled Drug Development Expert Sounds Alarm Over Rushed-to-Market COVID-19 Vaccines I shared yesterday.
Before delving into the takeaways, a little background on me, so you know I’m qualified to speak on the topic. Below is the expert witness report I did for PJH Law, December 2021:
EXPERT REPORT Prepared By Hedley Rees Managing Consultant at PharmaFlow Limited.
It covers my background, various speaking engagement across US/EU, and journals that have published my work. Then it drills down into the issues of warp speed development.
This is a video interview from 2011, where I describe the contents of my first book:
The PharmaFlow website is here.
The takeaways from the video
With that out the way, these are the main takeaways from the interview.
Report GAO-07-49: NEW DRUG DEVELOPMENT: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts was issued November 2006, Full report here.
Chart on page 8, provided by Phrma, shows it takes 10 - 12 years from beginning of preclinical development to regulatory approval.
It also shows that for every 250 molecular compounds launched into development, only 5 enter the clinic. Of that 5, only one is approved.
That’s proof of a broken system, isn’t it?
Gene therapies are a lot more difficult to develop than the drugs of 2006, as they are biologics (living things) and their effect when in the body is largely untried and untested.
Safety testing must be carried out on the manufactured product, not that made in the laboratory. It starts with small scale manufacture of 10-15 Kg API and testing that for safety. Every scale-up requires testing again, as molecular structure could change.
Chemistry, manufacturing & controls (supply chain data) is crucial, as it determines the safety of what enters a patient’s body.
Pre-approval inspections of companies producing drug substance and drug product ensure Current Good Manufacturing Practice has been followed. Inspections are typically two experienced FDA inspectors for 4 days.
Frozen vaccines shipped direct to vaccination centres are likely to have contravened CGMP, as people thawing and controlling the breakdown from 5 doses to a single dose will not have been trained, nor have access to standard operating procedures; also, there should have been quality control on the single vial produced by the vaccination centre prior to administration.
The degree of outsourcing of physical activities is a major problem for supply chain control.
IMHO, there should have been a new development programme for each new variant. Regulatory approval is given for a medical ‘indication’, and the indication is determined by the cause, symptoms and nature of the disease.
When a drug is approved for an indication, the label claim awarded is specific to the indication and the data that were submitted by the manufacturer at the time. There was only ever one (emergency) approval.
Check the video for more…
I’ve missed stuff, of course. Feel free to check to video to find out what.