FDA Approves Pfizer Vaccine to be given to Pregnant Women to Protect their Babies from RSV, but Connection to Preterm Labor is Seen – Inside Story Everyone is Missing!
Monday, the FDA announced their approval of the first ever vaccine designed to prevent RSV infection in babies for the first 6 months of life by administering the vaccine to pregnant women in the third trimester of pregnancy.
While the vaccine showed promise in decreasing RSV hospitalizations in the first 6 months of a baby’s life, there are serious concerns about the increase in preterm births seen in the study that was used as the evidence to approve the vaccine.
The concerns were raised about the vaccine’s safety due to side effect data and the previous discontinuation of a similar vaccine by another drugmaker. Some panel members expressed worries about a potential increase in premature births, however ultimately, the vaccine was passed through.
Why the Pfizer RSV Vaccine May Be Harmful for Pregnant Women and Their Babies
In the minutes of the FDA committee meeting, the increase in preterm births was discussed during the Pfizer trial, as “[In this slide] we see the preterm births in Pfizer Matisse trial.” In their presentation, they mentioned this not statistically significant, which may be true; but, if real, it would be highly clinical significant, and they simply weren’t powered to detect this difference.
This means the study needed more participants to tell if a real difference was there or not.
Previous Trial of Identical Vaccine was Canceled Due to High Premature Births
In 2022, GlaxoSmithKline (GSK) halted a late-stage clinical trial of its RSV vaccine in pregnant individuals due to a higher risk of premature birth and associated neonatal deaths. The trial showed that vaccinated pregnancies had a 38% higher likelihood of premature birth compared to the placebo group.
Pfizer’s data also indicated potential excess premature births. FDA advisers expressed frustration over the size of the final phase 3 trial, as it was insufficient to determine if the increased rate in the vaccinated group (5.7%) versus the placebo group (4.7%) was statistically significant.
Dr. Marchand explains that “this is even worse than just an unknown possibility, because last year, GSK stopped all trials on their RSV vaccine for exactly this reason – an increase in preterm births, and their vaccine was said by the FDA to be “almost identical to this vaccine.” stated by Dr. Paul Offit of the FDA.
This means the data that proves the connection between these vaccines and preterm birth exists, and the FDA approved the vaccine anyway!
A Brief Look at Pfizers Trial
Pfizer’s clinical trial involving over 7300 pregnant individuals across 18 countries found a higher number of premature births in the vaccinated group compared to the placebo group.
Pfizer’s data showed a 17% higher rate of preterm births (201/3568 vax (5.6%) vs. 169/3558 placebo (4.7%)), and GSK’s showed 238/3496 (6.8%) in the vax arm and 86 out of 1739 (4.9%) in the placebo arm).
Dr. Marchand states that“it’s very important to look at all the data on this class of vaccines, including the published Pfizer trial as well as the data from the ethically terminated GSK trial. That’s when the risk of preterm birth becomes very clear.”
Pfizers RSV Vaccine and the Link to Premature Births
Dr. Marchand states that “there is a very clear link between this vaccine and preterm birth. While it may save lives protecting babies from RSV, it may also cost lives exposing babies to preterm birth.”
Babies born before the standard 37 weeks of gestation are also at significantly higher risk of death and disability, from both RSV and generally, which could counter any benefits of the vaccine.
Previous Disapproval of Pfizers RSV Vaccine
The trial data influenced four out of 14 panelists to vote against the safety of Pfizer’s vaccine. Hana El Sahly, a vaccinologist at Baylor College of Medicine, highlighted the pattern of increased premature births in both the late-stage trial and the smaller phase 2B trial.
So how did the FDA finally approve the vaccine based on the SAME trial?
Is the Pfizer RSV vaccine still worth getting during pregnancy?
Dr. Marchand does not believe the vaccine to be useless, but believes extensive counseling will be necessary regarding risks. He believes that this vaccine should likely be limited to babies known to be born with a high risk of RSV, such as special genetic immunosuppressive disorders.
“It’s especially important that the public is aware of all known side effects of new vaccines, especially in light of the complete mess the medical community has made of the public trust regarding the COVID19 vaccines.” states Dr. Marchand.
ABRYSVO, and the GSK RSV Vaccines composed of viral glycoproteins, and do not contain any live viruses, only glycoproteins found in viruses. They do not use the mRNA technology that is found in many COVID19 vaccines.
About Dr. Greg Marchand MD:
Greg Marchand is the director of the Marchand Institute for Minimally Invasive Surgery, as well as the fellowship program director for the Institute’s SLS (Society of Laparoendoscopic Surgeons) Accredited fellowship in Minimally Invasive Gynecologic Surgery.
Dr. Marchand is an associate professor of medicine at several local medical schools in Arizona, and enjoys teaching students, fellows and residents. Dr. Marchand holds dual certifications from the American Board of Obstetrics and Gynecology in both OBGYN and Minimally Invasive Gynecologic Surgery.
Dr. Marchand is also accredited as a “Master Surgeon in Minimally Invasive Gynecologic Surgery” by the Surgical Review Corporation. Dr. Marchand is extensively published and has completed a two year fellowship in Minimally Invasive Gynecologic Surgery (MIGS).
Dr. Marchand is recognized internationally as a pioneer in developing laparoscopic techniques, as well as an expert minimally invasive surgeon and teaching surgeon. Dr. Marchand was recently honored with a World Record for performing a total laparoscopic hysterectomy through the smallest incision ever.
Dr. Marchand was also one half of the team that was recognized by the Guinness Book of World Records(TM) for removing the largest uterus ever without needing to cut open the patient.
When he is not in the operating room Dr. Marchand enjoys low carb living and chasing around his 10 year old football star son, Sebastian. Dr. Marchand’s Website: www.GregMarchandMD.com
About the Marchand Institute for Minimally Invasive Surgery:
The Marchand Institute for Minimally Invasive Surgery is a research and educational not-for-profit corporation and functional “Think-Tank” for the advancement of women’s health and minimally invasive gynecologic surgery. The institute is located in Mesa, Arizona.
The institute adheres to the highest levels of quality for their research and maintains an extremely diverse environment in the workplace. “Our efforts are split between the publication of high-quality medical research in women’s health and expert level surgical education.”
Institute Website: www.MarchandInstitute.org