@JoshWalkos - Champagne Joshi

There are currently two RSV vaccines that are FDA approved, Arexvy which is GlaxoSmithKline's and Abrysvo, Pfizer's. Both are approved in adults 60 years of age and older and Abrysvo is the only one approved in pregnant women between 32 and 36 weeks of pregnancy.

@JoshWalkos - Champagne Joshi

Pfizer’s product is the only one approved for use in pregnant women, a significant advantage over rival GSK. This bears out in the recent sales numbers announced by the company: “On a Tuesday conference call, as the drugmaker reported fourth-quarter Abrysvo sales of $515 million, Pfizer execs shared muted enthusiasm for the recent progress the company has made with its rollout.” So as you can see Pfizer has picked up the slack from the plummeting demand for its COVID injections and managed to be first to the maternal market, a huge competitive advantage. https://www.fiercepharma.com/pharma/pfizer-reports-abrysvo-sales-515m-q4-more-evidence-strong-launch-rsv-vaccine

After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown? Pfizer’s Abrysvo generated worldwide sales of $515 million in Q4, with the company laying out plans for how it can increase market share. fiercepharma.com

@JoshWalkos - Champagne Joshi

Pfizer's market advantage was gained with controversy though. Glaxosmithkiline was in the midst of their phase III trial for maternal use and all of sudden of February 28th, 2022 GSK voluntarily halted the trial due to what they termed an unexplained increased risk of preterm birth and neonatal death. https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-halts-trial-respiratory-virus-vaccine-pregnant-women-2022-02-28/

@JoshWalkos - Champagne Joshi

Both GSK and Pfizer’s products are recombinant RSV F protein vaccines and had plans to inoculate pregnant women in order to theoretically protect their soon to be born babies against RSV. Keep in mind that these so called vaccines for RSV are not designed to prevent infection, only to prevent “severe infection”. So the baby or elderly adult who gets the shot still can catch the virus and experience symptoms.

@JoshWalkos - Champagne Joshi

Here are the numbers that prompted GSK to halt the trial. The GSK trial showed In the vaccine arm, 6.81% of births were preterm (95% confidence interval 5.99% to 7.69%) compared with 4.95% (3.97% to 6.07%) in the placebo arm. For neonatal deaths, the percentage was 0.37% (0.20% to 0.64%) in the vaccine versus 0.17% (0.04% to 0.50%) in the placebo arm. GSK FDA Sponsor Briefing Document: https://www.fda.gov/media/165621/download#page=42

@JoshWalkos - Champagne Joshi

As mentioned Pfizer's maternal version of the vaccine, called Abrysvo, was recently approved for maternal use and elder use in the US and the European Union, but is not yet authorized in the UK. Here is their commercial for the maternal version. Oddly this was the only version I could find on YT. They probably pulled it because it’s creepy af.

@JoshWalkos - Champagne Joshi

The FDA approved it with conditions though, only allowing women who are 32-36 weeks pregnant ti receive it. Saying: “Available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo… To avoid the potential risk of preterm birth with use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age.” In Pfizer’s Phase III trial there was an imbalance in preterm births with: 5.7% (4.9% to 6.5%) in the vaccine versus 4.7% (4.1% to 5.5%) in the placebo arm. They called this “not statistically significant”. Package Insert: https://www.fda.gov/media/168889/download

@JoshWalkos - Champagne Joshi

The GSK and Pfizer products are almost identical products and this caused some ethicists and researchers concerns about whether Pfizer should have informed all women participating in its trial about the potential risk or updated its consent forms. The BMJ conducted an investigation on this and spoke to Charles Weijer, bioethics professor at Western University in London, Canada who said that informing pregnant women in Pfizer’s trial about GSK’s results would have allowed women who had not yet received the jab to consider whether they still wanted to get it and women who had already received it to seek additional medical advice and follow-up. “Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Weijer said. https://www.bmj.com/content/383/bmj.p2620

Concerns over informed consent for pregnant women in Pfizer’s RSV vaccine trial Some experts have criticised Pfizer for not informing pregnant women in its trial of maternal respiratory syncytial virus vaccine that trials of a similar vaccine were halted over a potential risk of preterm birth. Others think that notification would have been premature and caused unnecessary anxiety. Hristio Boytchev reports A debate has broken out over whether Pfizer should have told pregnant women participating in its trial of maternal respiratory syncytial virus (RSV) vaccination that a trial of a similar vaccine was halted over a safety signal around preterm birth, The BMJ can report. Both GSK and Pfizer were developing recombinant RSV F protein vaccines to inoculate pregnant women and protect their babies against RSV, a major cause of infant death globally. GSK halted its phase 3 vaccine trial on 28 February 2022 after a safety signal emerged: a possible increased risk of preterm births and neonatal deaths. In the vaccine arm, 6.81% of births were preterm (95% confidence interval 5.99% to 7.69%) compared with 4.95% (3.97% to 6.07%) in the placebo arm. For neonatal deaths, the percentage was 0.37% (0.20% to 0.64%) in the vaccine versus 0.17% (0.04% to 0.50%) in the placebo arm.12 No clear explanation has been found for the increase in preterm births, and experts think that it might be unrelated to the vaccine. GSK told The BMJ that the imbalance was observed primarily in low and middle income countries and not consistently after a peak in late 2021,3 and that it was still investigating the cause of the preterm births but was no longer developing its vaccine. Pfizer was studying preterm births as an adverse event of special interest in its own phase 3 trial, and a numerical (not statistically significant) imbalance in preterm births has recently emerged in phase 3 data: 5.7% … bmj.com

@JoshWalkos - Champagne Joshi

The BMJ said that “Some Pfizer trial consent forms seen, contain contradictory statements, both warning of possible "life-threatening" effects of the vaccine on the baby while simultaneously carrying a passage that said only the expectant mother is at risk from adverse effects. (Here is screenshot of a portion of the consent form Pfizer had women sign)

@JoshWalkos - Champagne Joshi

The BMJ also spoke to Rose Bernabe, professor of research ethics and research integrity at the University of Oslo who said "Considering the gravity of the risk that this irresponsible statement veils, this misleading statement should be a ground for questioning the validity of the consent process." Then why is Pfizer portraying the false sense of security that the fetus or neonate will not be exposed to any risk? Even none other than Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia and VRBPAC committee member said in a meeting that Pfizer’s and GSK’s vaccines were “almost identical” and so was concerned by GSK’s results. FDA VRBPAC Meeting Transcript: https://www.fda.gov/media/169361/download

@JoshWalkos - Champagne Joshi

Pfizer did not disclose in the patient consent forms for its phase III trials that it was studying preterm birth as an “adverse event of special interest”. The consent forms stated: “The risks associated with the study vaccine (RSVpreF or placebo) may be experienced by you, but not your baby, since your baby will not receive the study vaccine or placebo directly.” Here is a screenshot from the consent form I found. Full Consent Form: https://centerforvaccinology.ca/wp-content/uploads/2021/07/PF2001-C3671008_9002-0610_CA_ICF-24Month_24Mar21-.pdf?#page=11

Page Not Found - Canadian Center For Vaccinology centerforvaccinology.ca

@JoshWalkos - Champagne Joshi

The Consent Form also states: “While you are participating, the study team will tell you right away if new information is learned during the course of the study that could change your mind about continuing in this study.” Except they didn’t tell them about the neonatal death and preterm birth signals. Other than that they pinky swear they will tell you. This appears to be a clear violation of Informed Consent. If you are a woman and pregnant wouldn’t you like to know that the trial you are in may increase the risk of your baby being born prematurely or even dying? Even if the risk is relatively low?

@JoshWalkos - Champagne Joshi

“I understand the nature of the study and I understand the potential risks” Considering what we’ve just learned, the question I have to any lawyers out there is, do participants have a case that this violates informed consent or any laws? The other question this begs is that if Pfizer plays fast and loose with its ethics surrounding the most vulnerable among us, what other ethical boundaries are they ok with crossing? I know, I know, that's a rhetorical question because it's clear that they have yet to find any boundaries. Keep your eyes on VAERS in regard to these new "Vaccine" Products. There have already been 128 instances that pregnant women were mistakenly administered the Adult 60+ vaccine and 25 cases where kids under 2 years old received the 60+ vaccine. The CDC issues an emergency notice on this in January. https://emergency.cdc.gov/newsletters/coca/2024/012224.html

Emergency Preparedness and Response Information for the public and health professionals on how to stay safe during public health emergencies. cdc.gov

@JoshWalkos - Champagne Joshi

Since you’ve made it this far you should probably just give me follow and check out my other stuff while you’re at 👇🏻