According to an article published by JAMA Network‚ researchers for a maternal vaccine against respiratory syncytial virus (RSV) in infants stopped clinical trials because of an increased risk of preterm births. “A vaccine given during pregnancy that prevents RSV in infants was about 66% effective at protecting against RSV-associated respiratory illness‚ and about 69% effective at protecting against severe disease‚ according to a study in the New England Journal of Medicine‚” Chief Nerd wrote‚ citing JAMA Network. “However‚ the researchers stopped the trial early because of an increased risk of preterm births. Despite the potential risks of maternal RSV vaccination‚ ‘it is essential to weigh this small risk against the proven benefits‚’ the authors of a linked editorial wrote‚ adding that most of the preterm births occurred between 34 and 37 weeks‚” Chief Nerd added. “A vaccine given during pregnancy that prevents RSV in infants was about 66% effective at protecting against RSV-associated respiratory illness‚ and about 69% effective at protecting against severe disease‚ according to a study in the New England Journal of Medicine. However‚… pic.twitter.com/LWaGaCZDY4 — Chief Nerd (@TheChiefNerd) April 14‚ 2024 The Defender noted the halted study was GlaxoSmithKline’s maternal respiratory syncytial virus (RSV) vaccine. “GSK stopped developing a vaccine for pregnant women to protect newborns against syncytial virus (RSV) after identifying an increased risk of preterm births. Pfizer won approval of its nearly identical vaccine after the company said the increased rate of preterm births in its trials was statistically insignificant‚” the outlet wrote. “The results of this trial‚ in which enrollment was stopped early because of safety concerns‚ suggest that the risks of any and severe medically assessed RSV-associated lower respiratory tract disease among infants were lower with the candidate maternal RSV vaccine than with placebo but that the risk of preterm birth was higher with the candidate vaccine‚” an article published in The New England Journal of Medicine stated. “151 more preterm births and 10 more neonatal deaths in the vaccine group‚” Chief Nerd noted. 151 more preterm births and 10 more neonatal deaths in the vaccine group Study Link: https://t.co/8EAafbAkeK pic.twitter.com/qvMQHv5sOa — Chief Nerd (@TheChiefNerd) April 14‚ 2024 The Defender reports: GSK on Thursday provided more details on the clinical trials for its maternal respiratory syncytial virus (RSV) vaccine. The company halted the trials and stopped developing the vaccine in February 2022‚ after identifying an increased risk of preterm birth among vaccinated mothers. The details‚ published in a peer-reviewed article in the New England Journal of Medicine (NEJM)‚ came after GSK previously reported the increased risk and subsequent termination of the trials to regulators‚ GSK’s investors and in the press. According to the NEJM article‚ GSK was unable to identify a mechanism by which the vaccine caused the preterm births. However‚ the company also couldn’t identify any causes other than the vaccine being investigated. Although GSK ended its trials due to the preterm birth safety signal‚ the U.S. Food and Drug Administration (FDA) in 2023 approved Pfizer’s RSV vaccine for pregnant women‚ — even though Pfizer also reported elevated rates of preterm birth among vaccinated women during clinical trials for the vaccine‚ Abrysvo. Pfizer said the rates of preterm birth during the Abrysvo trials were not statistically significant. However‚ the FDA limited approval of the vaccine for women in weeks 32-36 of their pregnancy. The authors of an editorial that accompanied the NEJM article noted that although Pfizer’s FDA-approved maternal RSV vaccine is bivalent and GSK’s RSVPreF3-Mat is monovalent‚ “the vaccines are otherwise similar.” “Excess maternal deaths with @pfizer ABRYSVO [Respiratory Syncytial Virus Vaccine]. Should signal market recall/withdrawal. To be safe‚ women should decline this new injection‚” Dr. Peter McCullough said. Excess maternal deaths with @pfizer ABRYSVO [Respiratory Syncytial Virus Vaccine]. Should signal market recall/withdrawal. To be safe‚ women should decline this new injection. @ChildrensHD @ICANdecide @TexasLindsay_ @TXforVaxChoice @jathorpmfm https://t.co/caT4Vh9q2g https://t.co/kE09M77IXa pic.twitter.com/hLFlGTfqY4 — Peter A. McCullough‚ MD‚ MPH® (@P_McCulloughMD) April 15‚ 2024 Per JAMA Network: The maternal vaccine evaluated in the study is similar to Abrysvo‚ which the US Food and Drug Administration (FDA) approved last year to protect against RSV in infants. The FDA-approved vaccine is currently being monitored for vaccine-associated risks including preterm births. Despite the potential risks of maternal RSV vaccination‚ “it is essential to weigh this small risk against the proven benefits‚” the authors of a linked editorial wrote‚ adding that most of the preterm births occurred between 34 and 37 weeks. So safety concerns put a stop to RSV study for pregnant women but those same safety concerns did not put a stop to the RSV shot being released‚ recommended by CDC‚ and pushed by every OBGYN https://t.co/GXUTWwTeqJ — Daniel Horowitz (@RMConservative) April 15‚ 2024 “Pfizer failed to inform pregnant women participating in its clinical trial for the respiratory syncytial virus (RSV) vaccine that the clinical trial of a similar vaccine by GlaxoSmithKline (GSK) was halted after a safety signal revealed a potential risk of preterm births leading to neonatal deaths‚” The Epoch Times reported last November. Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To Pregnant Women In RSV Vaccine Trial https://t.co/d95GKqHttG — zerohedge (@zerohedge) November 26‚ 2023 From The Epoch Times: Even though Pfizer knew about the potential safety signal and was studying preterm births as an “adverse event of special interest‚” it continued to enroll women in its clinical trial and did not fully inform participants of the risks the vaccine may pose to their babies—and in some cases‚ provided misleading and contradictory statements‚ according to an investigation by The BMJ. “The BMJ article demonstrates Pfizer’s continued disregard for the law and patient choice‚” attorney Thomas Renz told The Epoch Times in an email. “The entire point of informed consent is to ensure a patient can make a decision based on all available information. Rather than embracing the Nuremberg Code and American laws and regulations‚ Pfizer seems to view informed consent as a barrier to sales—something that causes vaccine hesitancy or drug hesitancy.” “There should have never been a clinical trial in pregnant women studying any injections aimed at RSV in pregnant women‚” Sasha Latypova told The Epoch Times in an email. “Pregnancy and potential to become pregnant is historically the most protected class of human subjects from clinical research because the risks and potential to cause inadvertent harm are too devastating to justify scientific interest in made-up subjects like RSV.” Ms. Latypova is a retired pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development and co-founder of several organizations that work with pharmaceutical companies to design‚ execute‚ collect data‚ and submit clinical trial data to the U.S. Food and Drug Administration (FDA). According to Ms. Latypova‚ what was once considered a harmless cold has since been rebranded as RSV.

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