Injecting RSV antibodies is not vaccination

… but it’s still risky

You can skip this eight and a half minute video and read the transcript below.

The ACIP committee recently recommended the injection of a product into babies containing RSV antibodies. The product by Merck is called Enflonsia, and the active ingredient is called Clesrovimab. And they added the procedure to the recommended childhood immunization schedule for the first week of life to compete with a different monoclonal product by Beyfortus, even though these are not vaccines. A vaccine is supposed to induce the body to make antibodies, but that’s not what this is. Here, they are directly injecting antibodies, thinking that the injected antibodies will provide protection safely. It’s NOT completely safe, and two of the ACIP doctors, Levi and Pebsworth, know it’s not safe.

First, doing this will not prevent the baby from getting infected by the virus associated with RSV symptoms. The ACIP committee knows that. The idea is that the injected serum antibodies will be able to block and neutralize the RSV virus AFTER the infection happens and before tissue damage reaches dangerous levels. This idea has merit in some infants but certainly not all of them. Most babies will never experience severe RSV symptoms, and of those that do, most of them that are in developed countries like the United States will recover with early supportive care including IV hydration, suctioning of excess mucus, and oxygen supplementation. Underdeveloped countries lack the ability to provide early supportive care, so the introduction of antibodies in these areas might be appropriate in cases where the infant does not have detectable anti RSV antibodies transferred from the mother and the baby is not healthy. I have stated numerous times that antibodies should be reserved for lifesaving treatments of severe symptoms. That idea will work for RSV symptoms in adults, but not RSV in infants. By the time severe symptoms show up in the lungs of infants, the late introduction of antibodies would be able to stop further viral replication, but not address the inflammation, which can be dangerous in infants.

Even though injecting antibodies makes sense in some cases, it does not come without risk. Consider that when you inject these antibodies without the RSV antigens present, the antibodies have nothing to attach to. This can be counterproductive, as the immune system can build antibodies against the injected antibodies, resulting in negative efficacy. This is called ADA, or antidrug antibodies. In fact, in the published clinical trial, approximately 36.7% of treated infants developed antidrug antibodies (ADAs) over time. This is not safe because infants with ADAs may be more likely to develop infusion-related reactions (fever, rash, swelling, wheezing), especially upon re-exposure. This was not fully investigated.

They want you to believe these antibodies are pure and safe. But where do they get these antibodies? They get them from Chinese hamster ovary cells. That’s right, hamster ovaries. Here’s how that works. First, they study the blood from people that recovered from RSV to identify the natural serum antibodies. Next, they isolate the DNA instructions that code for the antibody proteins. They insert that DNA into circular plasmids and force those plasmids into Chinese Hamster Ovary cells with different laboratory techniques. Once the plasmids are inside the cells, the DNA enters the nuclei of the hamster cells, gets converted to mRNA, the mRNA exits the nucleus, joins up with a ribosome, translates that message into the antibody protein that gets released into the surrounding culture medium outside the cell. The antibodies are then collected and purified, but not all the DNA gets removed. This is known and permitted. Sound familiar? Residual DNA can integrate into human DNA, disrupt genes, and result in cancer, something they admittedly never tested for, verified in section 13 of the Enflonsia package insert.

Additionally, there is no guarantee that the antibodies produced using this process will be exactly the right shape. Shape is everything when it comes to antibody function, and the ACIP committee knows that too. The possibility of misfolding of mass manufactured antibodies does happen, and these could find their way into some monoclonal batches despite sophisticated methods to prevent it. Additionally, post-production degradation (during storage, shipping, etc.) can lead to aggregation or partial unfolding. This is a perfect setup for antibody dependent enhancement that can worsen the symptoms in the baby when it does get exposed to the RSV virus.

The bottom line is, RSV antibodies should be reserved for babies that do not have detectable natural RSV antibodies that were transferred from the mother and were born preterm, or have other heart/lung diseases. Even if no RSV antibodies are detectable, less than 0.05% of healthy full-term infants will experience life threatening RSV symptoms. Therefore, since most healthy infants experience either mild symptoms or none at all, we should not be injecting healthy babies. This is reasonable, scientifically grounded, and fits the first do no harm philosophy.

What the ACIP committee has done is unacceptable. Introducing a lab-engineered antibody into millions of healthy infants is a major biological blunder. Long-term effects of repeated attempted prevention of RSV symptoms in infants are not fully understood. Passive antibody transfer, which is what this is, may interfere with the infant’s own immune development and memory formation. It may also delay or suppress natural immunity from mild RSV infection which is typically self-limiting in healthy infants. It’s not easy being a parent. Your job is to stay informed, and my job is to inform you. You have a choice, at least for now, so please make the right choice.

Thanks for reading, and thanks for staying smart.