Neighbor Tuesday: Vaccine update round-up
Placebo-controlled trials, Dr. Phil, and vaccine safety monitoring
Phew, there’s *gestures wildly* so much happening in the public health space right now - especially with vaccines. I’m sure you’ve heard of some of it in the news by now - and, maybe asking “what are placebo-controlled trials?” “Wait, do we have vaccine safety monitoring systems and are they working?”, and “And, what the heck does double-blind mean?” It’s noisy out there, neighbors. Let me see if I can help.
What are placebo-controlled trials, and do we need them?
This past week, RFK Jr. said he would require all new vaccines to go through a placebo-controlled trial before approval. You might have heard these also called “double-blind, placebo-controlled trials”. It’s almost become a trope now, but let me tell you what these trials are - and, more importantly, why we don’t need them in vaccine trials. Let me show you why.
A double-blind, placebo-controlled trial is where you enroll a group of people, randomize them into two groups (placebo vs new treatment/vaccine/etc) and follow-up with them over time to see if your endpoint of interest differs between the two groups. For example, let’s say we are trying to test a new drug for diabetes. In a double-blind, placebo-controlled trial, you would enroll a group of 100 people (for example), of which 50 received the new drug and 50 received a placebo (or a sugar pill). “Double-blind” means that the people enrolled and the study team enrolling the people (and following them up) do not know who is enrolled in the drug or placebo group. This is a gold standard of science - but, not all the time. Let’s say we already know through lots of previous studies that not treating diabetes leads to really bad outcomes for people, and we have a treatment for diabetes that works really well. Therefore, is it ethical to treat some with a newer drug and don’t treat others at all? The answer is no. (And, sounds a lot like the Tuskegee Syphilis study I wrote about in my book.)
Here’s another example with vaccines:
Let’s say we want to do a placebo-controlled trial for a vaccine for measles. We enroll 100 people - 50 get the vaccine and 50 get a placebo. Then ALL 100 would have to be exposed to measles and followed up to see who was protected or not. BUT, we know that measles is a debilitating disease with bad outcomes. So, it would be unethical to expose everyone to measles for the purpose of science. That’s why we do Phase testing for vaccines (more on that later). It’s more of an ethical way to evaluate vaccines.
Another example is seatbelts. We know seatbelts work to protect people from bad outcomes if they have a wreck. A placebo-controlled trial would mean that we need to (unnecessarily) test that out by randomizing people to 2 groups: No seatbelts and seatbelts - and, then HAVE EVERYONE GET IN A WRECK TO SEE WHAT HAPPENS. It’s just not ethical. It’s also unnecessary. Here’s a few other examples from a science-friend of mine:
So, how is testing done?
When it comes to vaccines, we already have a study design in place for testing - plus 40+years of rigorous research, testing after testing after testing in Phase trials, and monitoring for any adverse events. The testing that is currently being done for vaccines are the phase clinical trials.
In Phase 1, you enroll a really small group of people, give them a vaccine, and then monitor for anything and everything in terms of safety. Once it passes that stage, you move on to Phase 2 with more people and more monitoring. Then onto Phase III and IV. Each Phase is done with extreme rigor and scientific integrity. So, once you get a vaccine to market for widespread use, like with COVID vaccines, lots of people have received that vaccine, and really great scientists continue monitoring to make sure they are safe. (And, I know some of the scientists running these trials. I guarantee they are some of the best and most neighborly people on the planet. They want deeply for these vaccines to work well for those who will get them, including their own families and children. I guess I’m trying to say that it’s absurd to think there’s some kind of coercion happening to make vaccines unsafe or look past any safety concerns. That’s the opposite of what’s happening).
Back to seatbelts, it makes no sense to do a placebo-controlled trial to “test” them and make sure seatbelts are safe. It’s unethical, irresponsible, and just bad science because we now have years of data showing they work.
We have the same evidence with vaccines. I’m not saying we don’t test vaccines for safety and rigor. I’m saying we don’t start from the beginning - we build on decades of vaccine research - and test them the right and ethical way in Phases.
As another science-friend said, “For…vaccines, we don’t start from scratch - we build on decades of safety data. This isn’t cutting corners; it’s responsible science that preserves both rigor and ethics.”
Can you help me understand what VAERS is?
What this means to me is that we continue what we’ve been doing. We test rigorously through trials, and we monitor closely and diligently for safety issues. There are many ways to do this - but the main one is the Vaccine Adverse Event Reporting System (VAERS). I want to highlight this one for you because you will likely hear about this in the coming weeks if you haven’t already. Recently, RFK Jr. went on Dr. Phil and sowed doubt in our current vaccine safety monitoring systems (namely, VAERS) along with sowing doubt in vaccines themselves. The verbiage was smooth and sounded convincing. But, it was pseudo-science wrapped in candy wrappers.
So, what is VAERS?
VAERS is an online system where anyone can go and report adverse reactions after they have had a vaccine. The goal of VAERS is to look for any patterns in the reporting to see if safety issues are occurring for people. It is a safety signal for vaccines and designed to quickly identify issues that might arise. However, it is now being revamped to comply with President Trump’s Executive Orders (although it’s unclear what that means here). Here’s a screenshot of the VAERS website.
What does that mean? We don’t know yet. But, I want you all to be aware of what was said on Dr. Phil and what is being said about vaccines, vaccine testing, vaccine safety, etc right now. And, be aware of what is said in the coming months. I anticipate a ton of changes and continued sowing of doubt in arguments that might seem convincing. So, use wisdom, wisdom, wisdom. Be cautious of “studies” that might be coming out - for example, I’ve already written about the study sanctioned by RFK Jr. about finding the “cause” of autism in three months. There’s no way that’s possible - so, be cautious of those types of claims that come out in the coming months.
Of course, I’ll be here to help walk you through it. Onward we go, neighbors!
-Emily