My last thread was a rundown of the history of the FDA

Now let’s talk about how drugs & vaccines get approved

DO NOT LISTEN 2 POTUS, dude at the gas station or your cousin on FB.

Fauci is right..earliest we will see a vaccine is spring 2022 (about 18m)

Here’s why

Before a drug gets to your PCP or the store shelf it undergoes a clinical trial process

There’s 4 phases 2 the clinical trial process (gonna try to keep this brief)

First a drug company applies 4 a patent on the drug they want to study.

The patent lasts 20y
Usually takes 10-15y to go through the entire trial process & get FDA approval

As of 2017 it costs over $3 billion to develop a drug or vaccine

The process begins with animal trials. If that data is favorable, the human trials process begins

Phase I: Healthy Patients
AKA first in human trials

Patients selected here are healthy and don’t have the condition/disease under study. Usually small, less than 200 patients, can last a few weeks to several months.

Once the data is collected & reviewed, the drug moves on

Phase II: D. A. M. E.
Dosing
Absorption
Metabolism
Excretion

This phase is EXACTLY what it says. We’re looking at how well the body absorbs the drug, how it metabolizes (processes) the drug, how much is excreted and what dose levels will work

Usually patients in Phase II studies are still healthy patients. However depending ON the drug (cancer, HIV) patients with the disease might be enrolled

These studies usually have a lot of doctor visits and can last at least 12-24 months

Phase III: Safety & Efficacy
This phase is PIVOTAL because its the LAST step before the drug company can apply 2 get FDA approval

This phase is about figuring which doses (found in Phase II) are safe & effective

Patients in this phase HAVE the disease under study

Phase III trials have thousands of patients spread across sites around the country. Study can last 2-3y, or longer if needed.

If drug fails at this stage billions $ lost, time lost & 4 some small companies they can go bankrupt

Safety data collected here goes in pkg insert

If drug/vaccine makes it through Phase III, the company applies for FDA approval

Drug/vaccine gets FDA approval

Then we go to Phase IV

Phase IV: Post marketing studies
FDA often request drug companies do these to monitor effectiveness & safety data

This data is collected from the drug company, MDs and consumers on regular basis

Safety data is STILL being collected on Aspirin which has been on mkt since 1890s

You’ve probably keep hearing about fast track status

One good thing coming out of 1980s AIDS epidemic was the FDA creating “fast track” status for certain drugs

So drugs that have promising data used to treat HIV, certain cancers, Ebola & now Coronavirus can apply 4 fast track status

A process that normally takes 10-15y from concept 2 approval is now shortened to 18-24m under FDA fast track

So like I said, even with clinical trials starting now, the EARLIEST we will get a #coronavirus vaccine is 2022

ONE MORE THING; you’ve probably heard reports about a Corona vaccine in China or SKorea

Even if that vaccine is effective & gets approved OUTSIDE the US, FDA regulations REQUIRE the vaccine undergo US clinical trials to PROVE safety & efficacy BEFORE getting FDA approval 4 use