‘Sad Day for Babies and Mums’: FDA Panel Recommends Pfizer’s RSV Vaccine for Pregnant Women
Advisers to the U.S. Food and Drug Administration on Thursday recommended the agency approve Pfizer’s respiratory syncytial virus, or RSV, vaccine for pregnant women, despite concerns about premature births identified during clinical trials.
Advisers to the U.S. Food and Drug Administration (FDA) on Thursday recommended, by a vote of 10 to 4, that the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant women, despite questions about the vaccine’s safety.
During Thursday’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, committee members and medical experts raised concerns about premature births identified during Pfizer’s clinical trials.
The FDA is expected to issue a final decision on the vaccine in August. If approved, it would become the first RSV vaccine authorized for pregnant women.
The Centers for Disease Control and Prevention (CDC) must “sign off” on Pfizer’s vaccine for pregnant women prior to it becoming available to the public.
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Feel free to reply to any comment by clicking the "Reply" button.I am not antivaxx and most of you know this because I am banned from a lot of your postings. (What are you afraid of?) I will say that I see zero reasons for a pregnant woman to be vaccinated for anything. What doctor wants to vaccinate a pregnant woman?
DenoPenno
Level 9
May 20, 2023
1
I've been banned or blocked for being unvaxxed more than everything combined in my life. Gov/pharma aim was injection about 90% of the world. . Most didn't go for Double vaxxed , and that really harms further world record profits and absolute power for the top Globalist. I really really feel bad for Killionaires, they didn't get to harm everyone's immune systems.
They should all be sacked in the FDA, compromised by the pharma industry.
The only reason covid medicines are available is because they were emergency approved. Normally, they would have to wait for 5 years of trials before being released to the public.
The emergency has been declared over.
It is not 5 years yet so why are these medicines still on the market? Let alone be recommended during pregnancy. Be interesting to see if the CDC approves it.
puff
Level 8
May 20, 2023
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"I missed the most damning slide of all from yesterday's advisory meeting on Pfizer's RSV shot for pregnant women. Hat tip to Michael Nevradakis"
MERYL NASS
Michael Nevradakis found possibly the most important chart from yesterday’s VRBPAC meeting yesterday.
I missed it, because Dr. Munjal was flipping through her slides so fast I could not read them. Now I know why she did that. It was to avoid discussing these data while still claiming she presented them. The FDA speakers did not discuss this either, nor did the members. One member, Dr. Pergam I think, wanted to know more about maternal safety, but was blown off. He had probably seen this slide in the briefing documents, which perhaps few of the others had read. I had not.
As Michael noted in his Defender article:
Data reported by Pfizer to the CDC indicated that 14% of pregnant women who participated in Pfizer’s trial sustained an adverse event, with 4.2% sustaining a “serious” adverse event, 1.7% experiencing a “severe” adverse event and 0.5% suffering a “life-threatening” adverse event.
Similarly, the same data showed that 37.1% of infants whose mothers received the experimental Pfizer vaccine experienced adverse events within one month of birth — with 15.5% classified as “serious,” 4.5% as “severe” and 1% as “life-threatening,” while efficacy waned within months of vaccination.
If I understand this correctly, using Pfizer’s numbers below, to possibly save the lives of 20 babies a year (80% efficacy x 25 baby RSV deaths/year) or 1 in 200,000 babies born—you are going to cause 1 in 200 mothers to have a serious adverse event , 1 in 250 to have a severe adverse event (the difference between serious and severe is unknown) and 1 in 500 to have a life-threatening event.
BDair
Level 8
May 19, 2023
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