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Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To
Pregnant Women In RSV Vaccine Trial

Authored by Megan Redshaw via The Epoch Times

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.
(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.

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.
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 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.
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.”

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.”
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.