RSV "Vaccine" for Babies

What is RSV?

Respiratory syncytial virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious. Infants and older adults are more likely to develop severe RSV and need hospitalization.

Yearly Stats

2.1 million outpatient visits in children under 5,

58,000-80,000 hospitalizations in children under 5, and 100-300 deaths in children under 5 (0.5 to 1.7%)

About the RSV "Vax"

Technically, Beyfortus (nirsevimab-alip) is NOT A VACCINE. It is a monoclonal antibody - a laboratory made protein that mimics the immune system’s ability to fight off harmful pathogens such as viruses. Monoclonal antibodies are derived from outside of the human (in this case, it is derived from a Chinese hamster’s ovary). 

Basically, instead of the  body making its own antibodies to fight against RSV via exposure, Beyfortus provides the antibodies so they’re already present in the case of exposure. 

Trials and Studies

The safety and efficacy of Nirsevimab were supported by three clinical trials (Trials 03, 04 and 05). These trials showed 70-75% efficacy (1). 

In study PMID 32726528 from Nov 2016-Nov 2017 a total of 969 infants received nirsevimab and 484 received the placebo. The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (2.6% [25 infants] vs 9.5% [46 infants], and the incidence of hospitalization for RSV-associated lower respiratory tract infection was 78.4% (0.8% [8 infants] vs 4.1% [20 infants] lower with nirsevimab than with the placebo. 

In study PMID: 35235726 a total of 994 infants were assigned nirsevimab and 496 placebo. Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirv group and 25 infants (5%) in the placebo, corresponding to an efficacy of 74.5%. Hospitalization occurred in 6 infants (0.6%) in the nirv group, and in 8 infants (1.6%) in the placebo.

1 fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

Possible Misleading Data

The Beyfortus (nirsevimab-alip) study was intended to run over multiple seasons, but because of COVID-19 it was put on hold. 

According to Dr. Christian Tillen Felter on behalf of Sanofi and Dr. Tanya Vilifana on behalf of AstraZeneca, “The phase 3 MELODY study in 2019 was severely impacted by the COVID-19 pandemic. We know that RSV circulation did disappear at that time…because the study was intended to run over several seasons, it was put on hold at that point. We went into discussion with the FDA about the data that we had and decided to move forward with our initial FDA filing based on the primary cohort.”

Study enrollment then resumed in 2021, and the final findings were presented on October 20, 2022 at the ACIP Meeting. The problem, though, is that in March 2020-May 2021 there was an “estimated relative reduction of 99.6% in RSV test positivity.” This is part of the time-period that was used to finalize the study that Nirsevimab was working, meaning there may not have been adequate levels of RSV to actively determine efficacy. 

Why Some May Choose To Get It

Parents may choose Beyfortus if they have a premature or high risk infant born close to, or during, the RSV season. They may also choose if their child, especially one with compromised immunity, is going to be in daycare during RSV season.

Why Some May Decline

A breastfed baby who is not in a daycare setting during RSV season is very low risk, and many parents do not feel that the antibody injection is necessary - especially with a 0.5-1.7% fatality rate.

Some parents may not feel that an efficacy of 70-75% is worth it, especially given the possible gaps in data. And others may not be comfortable with the newness of the vaccine, method of study, etc.

Ingredients & Options to Consider

As far an ingredients go, they actually aren’t the worst in comparison (no aluminum, mercury, formaldehyde). Polysorbate 80 is used, which is a possible carcinogen in large amounts (0.1-0.2 mg is used). 

There have been studies showing Polysorbate 80 when taken dietarily may be associated with gut microbiome disruption and gut inflammation (1) - there is no mention, however, of PoIysorbate 80 as an injection. However, there’s no harm on doubling up on probiotics if you want to take extra precautions. There’s also no harm in detoxing with bentonite clay and/or epsom salt. 

1 https://pubmed.ncbi.nlm.nih.gov/25731162/

Trials & Infant Fatalities

There’s info out there about Beyfortus causing 12 infant deaths during clinical trials. Four were from cardiac arrest, two from SIDS, and the others from preexisting comorbidities, and one from a car accident.

This is a difficult path to navigate, because the “experts” say there’s no indication that the vaccine caused the deaths. This very well may be true. But often times it’s difficult to trace vaccine injuries back to the actual vaccine, since many happen months after the injection takes place. It’s also important to note that 12 deaths out of the number of babies trialed comes out to about 0.3%. Some may see this number and feel it’s not as scary of a number and feel comfortable moving forward with the injection. Others may see that there were such a limited number of babies trialed to begin with and not feel comfortable moving forward. Both feelings are valid. 

Nevertheless, regardless of cause, any infant fatality is heartbreaking and my thoughts and prayers go out to those parents. 

Detoxing with Bentonite Clay

After receiving the injection you can do what's called "mudding" the injection site and the tops and bottoms of feet. All you need is Bentonite Clay and Medi-Mineral Serum. Mix a few TBSP of the clay with a few tsp of the serum to make a paste. Apply on the injection site and tops and bottoms of feet. Leave for 20-30 minutes (you can wrap with plastic wrap or a thin cloth to make cleanup easier).

Do this 1x/day for 3 days after receiving the injection. 

*best to not use a metal bowl or spoon as metal can react with the clay and change its properties. 

Bentonite Clay: helps remove impurities from the body

Medi-Mineral Serum: hydrates skin, rich in minerals strengthen the skin and immune system, antioxidant properties, detoxification promotion

Detoxing with Epsom Salt

Soak in a bath with 1/2-1 c of Epsom salt for 10 minutes. This will boost sulfur levels in the body to increase the detoxification process. Do this the same day as the injection (after the injection has been administered. Be mindful of how long you keep baby in as too much epsom salt can cause fatigue, dehydration, skin irritation, and diarrhea. We typically aim for no more than 10 minutes.