Post by icemandios on Nov 26, 2023 16:06:05 GMT
Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To Pregnant Women In RSV Vaccine Trial
Tyler Durden's Photo
by Tyler Durden
Saturday, Nov 25, 2023 - 10:10 PM
Authored by Megan Redshaw via The Epoch Times (emphasis ours),
(MargJohnsonVA/Shutterstock)
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.
“The vast majority of parents have not heard of RSV if they have not been exposed to CDC fear-mongering and renaming of otherwise harmless common colds. The incidence or prevalence of RSV is not known precisely because it poses no danger to anyone,” Ms. Latypova said. “In the U.S., RSV is attributed as a cause of death to about 17 infants per year out of 4,000,000+ babies—based on a review of 12 years' worth of death certificates.
According to the Centers for Disease Control and Prevention (CDC), RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Although most people recover in a week or two, it can be serious and is more commonly diagnosed in infants.
Both GSK and Pfizer were developing an RSV vaccine for pregnant women, but GSK halted its phase 3 vaccine trial in February 2022 over a possible increased risk of preterm births and neonatal deaths in vaccinated participants.
Immediately after becoming informed of the safety signal, GSK informed health authorities and updated its consent forms. There was no explanation for the increase in preterm births, but GSK told The BMJ it was still investigating the safety signal and was no longer developing its vaccine.
Pfizer Failed to Inform Pregnant Women of Preterm Birth Risk
The BMJ asked Pfizer whether pregnant women in its clinical trial were informed about the potential risk of preterm birth, but the pharmaceutical giant did not respond. As a result, The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites and reached out to more than 80 trial investigators.
According to the investigation, The BMJ did not receive any responses that indicated Pfizer informed pregnant participants of the risk, and some said Pfizer continued to enroll and vaccinate pregnant women for months after the potential risk of preterm birth from GSK’s clinical trial was publicized.
Charles Weijer, a bioethicist and professor at Western University in London, Canada who specializes in research ethics, told The BMJ that pregnant women should have been informed of the safety signal revealed during GSK’s clinical trial so they could consider whether they wanted to receive the vaccine or if they had already received the vaccine, whether they should seek medical advice or follow up.
“Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Mr. Weijer said.
Rose Bernabe, a professor of research ethics and research integrity at the University of Oslo, told The BMJ, “The renewal of informed consent is a must,” especially because Pfizer claimed to follow guidelines from the Council for International Organizations of Medical Sciences and the international Guideline for Good Clinical Practice, both of which contain similar passages stating that informed consent must be renewed “if new information becomes available that could affect the willingness of participants to continue.”
An anonymous clinical trial investigator for Pfizer told The BMJ that in early 2022, they asked Pfizer about the potential risk of preterm birth because of the similarity between GSK and Pfizer’s vaccines and asked whether Pfizer trial participants could be reassured.
“All I got from Pfizer was that their data hadn’t shown any increase in risk, no answer to my question,” the researcher said.
Ms. Latypova told The Epoch Times she was appalled that “any trials of any products were IRB [Institutional Review Board] approved to proceed in this population.”
Pfizer’s Phase 3 Data Suggest Possible Risk of Preterm Birth
According to The BMJ, a year after GSK’s clinical trial was halted, experts called for an investigation of Pfizer’s phase 3 trial after a numerical imbalance in preterm births emerged from its data. Even then, Pfizer did not disclose in patient consent forms for its phase 3 trial that it was studying preterm birth as an “adverse event of special interest,” according to documents from the United States, Canada, the Netherlands, Finland, and New Zealand obtained by The BMJ.
Some consent forms obtained by The BMJ contain inconsistent statements warning of possible “life-threatening” effects of the vaccine on the baby while also stating that only the expectant mother is at risk of experiencing adverse effects.
The consent forms state, “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.”
“Knowing what we know now, the statement in question is irresponsible and, given the benefit of hindsight, is actually factually incorrect,” Ms. Bernabe told The BMJ. “The statement gives the false sense of security that the fetus or neonate will not be exposed to any risk or inconvenience. 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.”
The Dutch national research ethics body also agreed the statement could “potentially cause confusion” for clinical trial participants after being informed of the issue by The BMJ. The Dutch authority subsequently contacted Pfizer about the confusing language and recommended it be adapted, but it had since emerged that no new participants would be enrolled in the study rendering the matter moot.
“The fact that Pfizer was investigating whether the drug was causing preterm birth but then chose not to disclose it appears to indicate intentionality. This intentionality would provide very serious civil causes of action and may even mean that this action could rise to the level of criminal activity,” Mr. Renz told The Epoch Times.
“At this point, the American public really needs to start asking ourselves how many laws Pfizer can violate before their lobbyists can no longer afford to pay off our politicians to look the other way,” he added.
Not everyone agreed that Pfizer had an obligation to inform pregnant women in their clinical trial of the potential risks.
Beate Kampmann, director of the Centre for Global Health at Charité University Hospital Berlin and a lead author of Pfizer’s phase 3 trial publication who oversaw a clinical trial site in the Gambia, told The BMJ that GSK’s results weren’t relevant to her trial participants “as most participants were already in follow-up.”
Ms. Kampmann said the GSK vaccine was not the same as Pfizer’s, and the trial's Data and Safety Monitoring Board, which reviews and evaluates study data to protect participants’ safety and monitor the study’s progress, “did not raise any concerns.”
FDA Signs Off on Pfizer’s RSV Vaccine, Despite Safety Risk
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in May discussed Pfizer’s clinical trial data and an analysis published by the FDA. The analysis showed no increase in preterm births in high-income countries and a numerical increase in upper-middle-income countries driven by South Africa.
The FDA’s VRBPAC committee cleared the shot even though four of the 14 committee members, including Dr. Paul Offit, said Pfizer’s data was inadequate to support its safety. Dr. Offit, a pediatrician and recognized expert in virology and immunology, was concerned by GSK’s results because its vaccine was “almost identical” to Pfizer’s.
Dr. Offit said GSK presented its data during a two-day meeting on RSV in Lisbon, and what they found was that, like Pfizer, there was a temporal association in low- and middle-income countries, meaning “there was sort of a several-month period where you had that increase in statistical association with premature births, but not at other times.”
He also questioned why there was “clearly an increased risk” of premature birth in the vaccinated participants and a decrease in the placebo group.
“If GSK has truly abandoned a program on a similar or almost identical vaccine, that is going to hang over this program,” Dr. Offit said.
Dr. Offit further pointed out that although it was “death” during the GSK clinical trial that initially “got everyone’s attention,” it was severe premature births that led to those deaths.
Dr. Hana El Sahly, VRBPAC chairwoman, said the signal showing an increased risk of preterm births associated with Pfizer’s RSV vaccine was “significant” in phases two and three of its clinical trial and "in a very similar product that was given, you know, on another study."
"So, having said that, is it reason enough to pause? Probably so," Dr. Sahly said. "I mean, increasing the risk of or having pregnant women have 20% increased risk of premature delivery is not trivial, even if it is late preterm delivery. The fact that we're putting them into preterm delivery while we're sitting here debating the matter intellectually is not trivial."
When the FDA authorized the vaccine, it determined available data was “insufficient to establish or exclude a causal relationship between preterm birth and Pfizer’s ABRYSVO RSV vaccine but limited its use to women who are 32 to 36 weeks pregnant to mitigate the potential risk. The FDA is also requiring Pfizer to perform postmarketing studies to “assess the signal of serious risk of preterm birth.”
The FDA in 2022 also required Pfizer to conduct several post-marketing safety studies assessing potential long-term impacts of myocarditis—a type of heart inflammation associated with Pfizer's COVID-19 vaccine—as part of its approval process. The data was required to be given to the FDA in December 2022, but the FDA quietly granted Pfizer an extension when it missed its deadline.
Tyler Durden's Photo
by Tyler Durden
Saturday, Nov 25, 2023 - 10:10 PM
Authored by Megan Redshaw via The Epoch Times (emphasis ours),
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.
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.
“The vast majority of parents have not heard of RSV if they have not been exposed to CDC fear-mongering and renaming of otherwise harmless common colds. The incidence or prevalence of RSV is not known precisely because it poses no danger to anyone,” Ms. Latypova said. “In the U.S., RSV is attributed as a cause of death to about 17 infants per year out of 4,000,000+ babies—based on a review of 12 years' worth of death certificates.
According to the Centers for Disease Control and Prevention (CDC), RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Although most people recover in a week or two, it can be serious and is more commonly diagnosed in infants.
Both GSK and Pfizer were developing an RSV vaccine for pregnant women, but GSK halted its phase 3 vaccine trial in February 2022 over a possible increased risk of preterm births and neonatal deaths in vaccinated participants.
Immediately after becoming informed of the safety signal, GSK informed health authorities and updated its consent forms. There was no explanation for the increase in preterm births, but GSK told The BMJ it was still investigating the safety signal and was no longer developing its vaccine.
A dispute then emerged over whether Pfizer had the obligation to inform women participating in their RSV clinical trial about the potential risk and whether their consent forms should be updated accordingly.
The BMJ asked Pfizer whether pregnant women in its clinical trial were informed about the potential risk of preterm birth, but the pharmaceutical giant did not respond. As a result, The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites and reached out to more than 80 trial investigators.
According to the investigation, The BMJ did not receive any responses that indicated Pfizer informed pregnant participants of the risk, and some said Pfizer continued to enroll and vaccinate pregnant women for months after the potential risk of preterm birth from GSK’s clinical trial was publicized.
Charles Weijer, a bioethicist and professor at Western University in London, Canada who specializes in research ethics, told The BMJ that pregnant women should have been informed of the safety signal revealed during GSK’s clinical trial so they could consider whether they wanted to receive the vaccine or if they had already received the vaccine, whether they should seek medical advice or follow up.
“Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Mr. Weijer said.
Rose Bernabe, a professor of research ethics and research integrity at the University of Oslo, told The BMJ, “The renewal of informed consent is a must,” especially because Pfizer claimed to follow guidelines from the Council for International Organizations of Medical Sciences and the international Guideline for Good Clinical Practice, both of which contain similar passages stating that informed consent must be renewed “if new information becomes available that could affect the willingness of participants to continue.”
An anonymous clinical trial investigator for Pfizer told The BMJ that in early 2022, they asked Pfizer about the potential risk of preterm birth because of the similarity between GSK and Pfizer’s vaccines and asked whether Pfizer trial participants could be reassured.
“All I got from Pfizer was that their data hadn’t shown any increase in risk, no answer to my question,” the researcher said.
Ms. Latypova told The Epoch Times she was appalled that “any trials of any products were IRB [Institutional Review Board] approved to proceed in this population.”
“Pfizer had an ethical obligation to inform the participants in their clinical trial that GSK terminated their experiment,” Ms. Latypova said. At the same time, she’s not sure why ethical behavior would be expected from Pfizer given their response to thousands of reported deaths and injuries, including miscarriages, in their COVID-19 vaccine trials.
According to The BMJ, a year after GSK’s clinical trial was halted, experts called for an investigation of Pfizer’s phase 3 trial after a numerical imbalance in preterm births emerged from its data. Even then, Pfizer did not disclose in patient consent forms for its phase 3 trial that it was studying preterm birth as an “adverse event of special interest,” according to documents from the United States, Canada, the Netherlands, Finland, and New Zealand obtained by The BMJ.
Some consent forms obtained by The BMJ contain inconsistent statements warning of possible “life-threatening” effects of the vaccine on the baby while also stating that only the expectant mother is at risk of experiencing adverse effects.
The consent forms state, “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.”
“Knowing what we know now, the statement in question is irresponsible and, given the benefit of hindsight, is actually factually incorrect,” Ms. Bernabe told The BMJ. “The statement gives the false sense of security that the fetus or neonate will not be exposed to any risk or inconvenience. 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.”
The Dutch national research ethics body also agreed the statement could “potentially cause confusion” for clinical trial participants after being informed of the issue by The BMJ. The Dutch authority subsequently contacted Pfizer about the confusing language and recommended it be adapted, but it had since emerged that no new participants would be enrolled in the study rendering the matter moot.
“The fact that Pfizer was investigating whether the drug was causing preterm birth but then chose not to disclose it appears to indicate intentionality. This intentionality would provide very serious civil causes of action and may even mean that this action could rise to the level of criminal activity,” Mr. Renz told The Epoch Times.
“At this point, the American public really needs to start asking ourselves how many laws Pfizer can violate before their lobbyists can no longer afford to pay off our politicians to look the other way,” he added.
Not everyone agreed that Pfizer had an obligation to inform pregnant women in their clinical trial of the potential risks.
Beate Kampmann, director of the Centre for Global Health at Charité University Hospital Berlin and a lead author of Pfizer’s phase 3 trial publication who oversaw a clinical trial site in the Gambia, told The BMJ that GSK’s results weren’t relevant to her trial participants “as most participants were already in follow-up.”
Ms. Kampmann said the GSK vaccine was not the same as Pfizer’s, and the trial's Data and Safety Monitoring Board, which reviews and evaluates study data to protect participants’ safety and monitor the study’s progress, “did not raise any concerns.”
She said GSK’s results were location-specific and involved a temporary finding that is still poorly understood. Ms. Kampmann told The BMJ that questions on informed consent and potential side effects in the trial amounted to “getting hung up on issues which are not borne out by the analysis and are distorting the benefits this vaccine can bring.”
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in May discussed Pfizer’s clinical trial data and an analysis published by the FDA. The analysis showed no increase in preterm births in high-income countries and a numerical increase in upper-middle-income countries driven by South Africa.
The FDA’s VRBPAC committee cleared the shot even though four of the 14 committee members, including Dr. Paul Offit, said Pfizer’s data was inadequate to support its safety. Dr. Offit, a pediatrician and recognized expert in virology and immunology, was concerned by GSK’s results because its vaccine was “almost identical” to Pfizer’s.
Dr. Offit said GSK presented its data during a two-day meeting on RSV in Lisbon, and what they found was that, like Pfizer, there was a temporal association in low- and middle-income countries, meaning “there was sort of a several-month period where you had that increase in statistical association with premature births, but not at other times.”
He also questioned why there was “clearly an increased risk” of premature birth in the vaccinated participants and a decrease in the placebo group.
“If GSK has truly abandoned a program on a similar or almost identical vaccine, that is going to hang over this program,” Dr. Offit said.
Dr. Offit further pointed out that although it was “death” during the GSK clinical trial that initially “got everyone’s attention,” it was severe premature births that led to those deaths.
Dr. Hana El Sahly, VRBPAC chairwoman, said the signal showing an increased risk of preterm births associated with Pfizer’s RSV vaccine was “significant” in phases two and three of its clinical trial and "in a very similar product that was given, you know, on another study."
"So, having said that, is it reason enough to pause? Probably so," Dr. Sahly said. "I mean, increasing the risk of or having pregnant women have 20% increased risk of premature delivery is not trivial, even if it is late preterm delivery. The fact that we're putting them into preterm delivery while we're sitting here debating the matter intellectually is not trivial."
When the FDA authorized the vaccine, it determined available data was “insufficient to establish or exclude a causal relationship between preterm birth and Pfizer’s ABRYSVO RSV vaccine but limited its use to women who are 32 to 36 weeks pregnant to mitigate the potential risk. The FDA is also requiring Pfizer to perform postmarketing studies to “assess the signal of serious risk of preterm birth.”
The FDA in 2022 also required Pfizer to conduct several post-marketing safety studies assessing potential long-term impacts of myocarditis—a type of heart inflammation associated with Pfizer's COVID-19 vaccine—as part of its approval process. The data was required to be given to the FDA in December 2022, but the FDA quietly granted Pfizer an extension when it missed its deadline.