Vaccine protocols and COVID

Basic protocols never change based on a particular set of circumstances. In the cases of vaccines, those protocols are not only determined by local (that is, national) regulatory boards but also by an international board overseen by the WHO. Covid is no different. Nothing has changed.

This article will give a brief overview of the vaccine trial process, what they look like in the case of COVID, and what we can expect in the near future.

From trial to approval

Once a medication is ready for human trials, the first step is to define your cohort, that is, the group you are going to test the medication on. This is a statistical process in order to get large sample results from a smaller sample which in effect gives better results.

This is called a “container” where certain age groups may be left out or gender may be adjusted (e.g. no need to test a birth control pill on men).

The container is large enough and defined enough to eliminate sample bias. The subjects are defined in the same way.

There are essentially 3 phases to every study with each phase increasing the numbers of subjects. The studies are NOT conducted by a regulatory agency OR the drug manufacturer, although both of them track the studies.

Studies are done by CRO (Contract Research Organizations), and always by several different groups, although all may be contracted by the same CRO. In case a trial has a difference in results by different testers, there is some serious explaining to do. More than one study has been terminated or started over with new cohort definitions.

When phase 3 studies are completed, the data is verified and tested by yet another independent group, and then the drug is submitted to the FDA for approval. YET another independent group of physician specialists in the area who reviews the data votes yes or nay and submits their recommendations to the FDA.

The drug then receives market approval based on the cohort. The FDA also has the option to grant compassionate approval or early access (based on the data and review committee) to folks outside the initial container. (You will see on TV Commercials: for patients 12 to 65, for example. That doesn’t mean only folks 12 to 65 can take the drug only that the studies contained people in that age range. Individual physicians can still prescribe for other ages as an “off label use”.)

Once the drug is taken to the market, a whole new series of studies kick in. I’ll spare you that detail.

A word about phase 3 trials

The proctor of the study receives an update on every patient enrolled on a set schedule (that time may vary). EVERY adverse event, whether it seems to be related to the trial or not, is reported immediately. This may range from a sudden ingrown toenail to death.

The proctor then has options: note it or act on it. If they don’t know exactly what to do, the study is halted until they do know.

I have NEVER seen a trial EVER that at some point has NOT been halted. The Covid study is no exception. The only difference is the press is interested in this one.

What does this have to do with COVID and warp speed?

As opposed to a normal study, this study has gone to the top of the waiting list. The study protocol (including the containers) was considered and approved before any other on the waiting trial. This saved anywhere from 1 year to 3 years.

The waiting list is long–lots of new meds out there. When the completed studies are turned over for approval, again the waiting period is waived and IMMEDIATE action will be taken.

In 1992, the U.S. passed the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from companies to expedite the drug-approval process. Even that has been waived. The approval committees are evaluating data as it comes. Mostly putting the red tape along the way is being eliminated but nothing else is.

How are the COVID vaccine trials different?

There are only two main differences between the COVID vaccine and the others. First, it is entirely possible that at least two of the vaccines have fallen into the Abbreviated New Drug Application (ANDA) for approval requiring NO clinical trials or, at most, additional efficacy data. This means we could have had them months ago as all they were was a variation of existing vaccines. No testing of this year’s flu jab has happened, for example. Of course the public wouldn’t have stood for that as the anti-vaxxers have been very active and the politicians even more so.

Russia and China are examples of ANDA they have and have had a vaccine for a while. You aren’t hearing much about “problems” that are of substance.

The other difference is the FDA ADDED a step. President Trump and others, including the industry, were not happy about that, but of course we were unable to explain it in light of all the new social media qualified immunologists. They clamped on a 2 month waiting period after the Phase 3 trials were completed before the approval process can start. They are going to explain that on the 22nd. Who knows, maybe it’s something that should have been done all along.

Yes, most age groups have been considered (portionally on users). NO, at risk groups have not been purposely excluded for any reason other than defining a consistent cohort. That’s not to say they haven’t been evaluated for suitability for vaccines. This one isn’t that special.

What lies ahead?

Now you are hearing about mutated or changing Strains of Covid so there is “no WAY” a vaccine will work (again from social media immunologists). I would not worry about that a lot.

The COVID 19 vaccine is very similar to that of your annual flu shot not only in how it’s made, but in how it works. It will never be like a measles or smallpox vaccine. Nor will this “thing” ever go away like smallpox. Herd immunity will never happen (if it did, the common cold would be rare).

These types of vaccines are not inoculations. While they may not ever totally prevent you from getting the disease, they can and do prevent the viral load from growing to the point of making you seriously ill.

As far as new strains are concerned, it’s important to note that the influenza vaccines–also known as flu shots or flu jabs–are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year as the influenza virus rapidly changes. It will be much the same with Covid. There is an occasional miss (i. e. Swine flu) but that is rare.