The HHS/NIH "Generation Gold Standard" shifts the vaccine paradigm

… but we can do better.

A few days ago, on May 1, 2025, the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announced the development of the next-generation, universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated, whole-virus platform.

The idea is that by injecting the whole virus, but making it replication defective, we can get broader serum antibody protection. This idea is not new. The injectable polio virus vaccine, for example, is supposedly made replication defective by using formaldehyde. Decades ago, a few batches were injected into people that were not fully deactivated by the formaldehyde, and as a result, 40,000 cases of mild polio, 200 cases of paralysis, and 10 deaths occurred in what is now called the Cutter Incident. There are other vaccines used in the United States that inject whole viruses, supposedly deactivated by formaldehyde. These include Fluzone, Ixiaro, and TICOVAC. There have been failures in those vaccines as well, indicating that some doses may not have been rendered completely replication defective by the formaldehyde.

There is only one vaccine currently used in the United States that uses the afore mentioned beta-propiolactone to inactivate the virus, and that is the rabies vaccine called RabAvert made by Bavarian Nordic. Curiously, there is no way to know if there were deactivation failures in this vaccine because they always administer rabies antibodies with the vaccine. This would obviously mask any failures that occur. The point I’m making is that you have no idea how many particles there are in that vaccine syringe, nor how potent they are before they shove it into you, and it will always be like that.

What the NIH wants to do is inject you with, or perhaps inhale a product called BPL-1357 that contains four whole, supposedly replication defective viruses at once. They are targeting the avian influenza virus strains H1N9, H3N8, H5N1, and H7N3. Since inactivation of these viruses by beta-propiolactone leaves all the proteins on the virus’s shell mostly intact, the idea is that a broader serum antibody response will be built since we’re not injecting just one protein or the message to make just one protein.

It is true that a broader immune response will happen but think this through. It takes a couple of weeks to ramp up that antibody response. So, the deactivated viruses that get in you either by injection or inhalation, are not just going to float around in your bloodstream waiting for robust antibodies to be built by your B-cells. They are going to attach to cellular receptors just like they would in a normal infection. This is going to create an inflammatory immune response that will result in undesirable vascular and neurological adverse effects.

The NIH scientists boast that not only will there be a robust B-cell antibody response, but also a robust T-cell response that can be cross-reactive and prevent future infections across diverse viral families. But wait! Many of us already have that t-cell cross-reactivity, and it can be measured! This is where the paradigm shift must occur. If you want to talk about “universal” protection, people should be tested for antigen specific mucosal IgA and t-cell cross-reactivity FIRST. Yeah, it’s expensive to do that, but worth it. The shift should be toward individualized immunology, not toward a universal vaccine. This way people who are already immune will not be subjected to an unnecessary potentially dangerous vaccine procedure, and people who are not immune will have an informed choice.

Thanks for reading, and thanks for staying smart.