According to an investigation by The BMJ, when GlaxoSmithKline Biologicals halted its RSV vaccine trial over preterm birth risks, Pfizer continued its similar trial while omitting these risks from consent forms. Experts criticized Pfizer’s lack of transparency as an ethical violation compromising informed consent.

Even though Pfizer knew about the GSK trial and safety signal, it continued enrolling thousands of unsuspecting pregnant women without disclosing the preterm birth risk in its consent forms, according to an investigation by The BMJ.

To many healthcare advocates and experts, Pfizer’s omission represents an egregious violation of informed consent and a disregard for the autonomy of pregnant women participating in clinical research.

“Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Dr. Charles Weijer, bioethics professor at Western University in London, Ontario, Canada, told The BMJ.

Children’s Health Defense CEO Mary Holland told The Defender:

“I am horrified that it’s even a question whether Pfizer should have told pregnant women that a previous clinical trial was halted because the RSV vaccine caused preterm birth. Of course it should have told them.

“The standard must be, ‘What would a reasonable pregnant woman want to know about this product?’ And any reasonable pregnant woman would want to know if it causes preterm birth. This cavalier attitude towards the truth and human life is alarming.”

After the safety signals emerged in GSK’s study, the U.S. Food and Drug Administration (FDA) took no action to halt enrollment or to pause or restrict Pfizer’s ongoing maternal RSV vaccine trial.

‘Statistically significant’ shouldn’t form sole basis of Pfizer’s decision

Months after GSK’s revelation of the concerning safety signal, Pfizer also began detecting a numerical imbalance in preterm births in its own trial data but said the data were not statistically significant.

According to The BMJ, Pfizer was tracking preterm births as an “adverse event of special interest” in its trial. But the company did not disclose this on consent forms given to thousands of pregnant trial participants across 18 countries.

“Once the results of the GSK trial on premature births became public, RSV vaccine studies in pregnant women should have been updated to include this possible preterm risk,” said Klaus Überla, Ph.D., chair of Clinical and Molecular Virology at the University Hospital Erlangen, in The BMJ report.

However, regulators took little action to encourage disclosure. The FDA ultimately limited approval of Pfizer’s vaccine to late pregnancy — specifically, for administration between 32-36 weeks only — due to preterm concerns. But the agency did nothing to restrict trial enrollment or require risk disclosure after the GSK findings emerged.

Some defend Pfizer’s lack of disclosure to trial participants by arguing the preterm risk was inconclusive. Dr. Joop van Gerven, an ethics chair in the Netherlands, told The BMJ that informing women “would have caused too much uncertainty.”

However, others challenged this notion. “The renewal of informed consent is a must,” Rose Bernabe, Ph.D., told The BMJ.

Bernabe, a professor of medical research ethics at the University of South-Eastern Norway, referenced guidelines from the Council for International Organizations of Medical Sciences, which state: “Researchers must renew the informed consent … if new information becomes available that could affect the willingness of participants to continue.”

Weijer told The BMJ:

“For Pfizer, the DSMB [Data Safety and Monitoring Board] should have regularly assessed the benefit-harm balance, both on the data in the trial and whether the GSK results affected that balance. They should not base their decision simply on whether a particular result is ‘statistically significant.’ These are difficult decisions, and it is why DSMBs are independent of the company.”

Justine Tanguay, CHD lawyer and director of campaign research for Reform Pharma, told The Defender:

“It’s no surprise that regulatory agencies such as the FDA are prioritizing Big Pharma’s profit over the health interests of its pregnant trial participants when you pull back the curtain and expose the revolving door between government’s top federal employees and key executives for Big Pharma — the industry that FDA is supposed to be regulating.

“In fact, the revolving door has become so commonplace that it is hard to decipher the tangled mess between the private sector and governmental agencies.

“For instance, a former deputy director at the FDA who ran the Office of Vaccines Research and Review and pushed for the licensure of COVID-19 vaccines now works for Moderna as the head of the Infectious Diseases Early Clinical Development and Translational Medicine Program.

“For the sake of public health, such egregious conflict of interests must end.”

‘I think it needs to be addressed’

According to The BMJ investigation, in February 2022, GSK reported that a safety signal had emerged in its maternal RSV vaccine trial, indicating a concerning imbalance in preterm births between the vaccine and placebo groups.

Specifically, GSK observed that 6.81% of births in the vaccine arm were preterm, compared to just 4.95% of births in the placebo arm. Additionally, neonatal deaths were 0.37% in the vaccine group versus 0.17% in the placebo group.

This unexpected safety signal prompted GSK to immediately halt its Phase 3 trial and discontinue the development of its vaccine.

However, Pfizer’s trial of a similar maternal RSV vaccine continued enrolling participants.

Both companies were developing versions of an RSV F protein vaccine that works by targeting the RSV fusion protein to generate antibodies that can neutralize the virus. The F protein is essential for viral entry and its structure is highly consistent across different strains of RSV.

In Pfizer’s Phase 3 data, 5.7% of births in the vaccine arm were preterm compared to just 4.7% in placebo. Ten stillbirths occurred in the vaccine group versus eight in the placebo group. Neonatal deaths in the placebo group (.3%) exceeded those in the vaccine group (.1%). One vaccine recipient died from postpartum hemorrhage and hypovolemic shock.

Pfizer reported the increase in preterm births was most pronounced in trial participants from upper-middle-income countries, notably South Africa, according to the May 18 meeting of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

While Pfizer claimed these numbers were not statistically significant, experts noted this numerical increase in preterm births mirrored the safety signal in the halted GSK trial, raising further questions about the risks of maternal RSV vaccination.

VRBPAC Chairwoman Hana El Sahly, during the May meeting, characterized the signal of increased preterm births during Pfizer’s Phase 2 and 3 trials as “significant” and said it was “probably” reason enough to pause the trial. She said that “failing to design the Pfizer Phase 3 study to deliver that clarity … is a big missed opportunity.”

Four of the 14 VRBPAC members were sufficiently concerned that they voted against finding the drug safe for pregnant women. Notably, one of the dissenting votes came from Dr. Paul Offit, a pediatrician at Children’s Hospital of Philadelphia, who said, “If GSK truly abandons a program on a similar, almost identical vaccine, that is going to hang over [Pfizer’s] program. I think it needs to be addressed.”

Vaccine efficacy inconclusive, limited, with ‘no direct benefit to the mothers’

Peter McCullough, M.D., MPH, in an April 21 Substack post, raised a different point about the viability of the Pfizer vaccine, arguing Pfizer’s study design relied on an outcome that occurred too rarely to reliably measure efficacy.

Basing results on fewer than 2% of babies getting sick left the findings “a statistical blur,” he said — meaning the findings on whether the vaccine provided meaningful protection were inconclusive.

“Pfizer has aggressively advanced RCTs [randomized control trials] into the pregnant population with no assurances on long-term outcomes,” McCullough added, and with “no direct benefit to the mothers.”

In the May VRBPAC meeting, it was further noted that while the incidence of RSV for babies was lower in the vaccine group up to 6 months of age, during the 181- to 360-day period after birth, babies in both groups contracted RSV at similar rates.

After the Centers for Disease Control and Prevention (CDC) recommended the vaccine for pregnant women in September, McCullough told The Defender, “Vaccination of the mother for passive immunization of the infant is an unnecessary and risky strategy that will undoubtedly lead to fetal loss or premature deliveries when deployed on a large scale.”

This controversy comes at a time when the CDC is reporting the largest rise in infant mortality in 20 years, and amidst concerns that doctors are being paid to push vaccines on pregnant women.

Warnings fell on deaf ears

The recent BMJ investigation was not its first warning about the RSV trials. On May 10, following Pfizer’s publication of its Phase 3 trials data, The BMJ warned that Pfizer’s safety signals were similar enough to GSK’s to warrant further analysis.

Überla told The BMJ, “My interpretation of all these data is that there may be a safety signal for preterm births that should be followed up.”

A scientist at the National Institutes of Health who wished to remain anonymous told The BMJ the Pfizer data should be analyzed using more sensitive measures such as average birth weight and subgroup analyses to determine the validity of the safety signal.

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Via https://childrenshealthdefense.org/defender/pregnant-women-pfizer-rsv-vaccine-preterm-birth-risk/

Under “Chair Care,” a program funded by the Centers for Disease Control and Prevention, New Mexico hairstylists are paid and trained as “trusted messengers” to promote COVID-19 and flu vaccines, especially to minority and conservative clients with low vaccination rates.

Public health agencies are funding a New Mexico program to train and pay local hairstylists working in privately owned salons to promote COVID-19 and flu vaccines to their clients.

The “Chair Care” program trains these “trusted messengers” to target New Mexico’s Hispanic, Black, Native American and conservative populations who have been shown to have the lowest vaccine uptake and highest “vaccine hesitancy.”

The Centers for Disease Control and Prevention (CDC) and the New Mexico Department of Public Health (NMDOH) are funding the program, which is run by Presbyterian Community Health and Better Together New Mexico, an NMDOH initiative that connects local organizations to do vaccine outreach throughout the state.

Other partners in the grant program include an unnamed doctor, a salon, a hairstylist and an Albuquerque company, Serna Solutions, which provides behavioral health training.

The program is training hair stylists to spread the agencies’ vetted messaging on vaccines to the public. The “trusted messenger” strategy is based on the assumption that people tend to trust such figures more than they trust public health authorities, according to the project website, which states:

“Research tells us that who a message comes from is just as important — if not more — than what the content of the message is … Chair Care TMs [trusted messengers] play a critical role in sharing the facts about vaccination with their clients because their clients trust them.

“TMs can talk with their clients about vaccinations in a more relaxed, conversational way than traditional authority figures or healthcare providers sometimes can.”

By training the “trusted messengers” to promote their messages, the public health authorities can get their message across to the public, without the public being aware the message is designed and paid for by those health authorities.

Hairstylists who sign up for a six-month commitment participate in two day-long trainings where they receive tools so they can “feel more confident” talking to their clients about taking vaccines.

They will be trained in motivational interviewing, COVID-19 basics, flu basics and long COVID basics.

After the initial training, the hairstylists are required to participate in twice-monthly virtual meetings to receive updated content and program support. At the end of the six-month program, they participate in a half-day debrief.

They also spend 30-45 minutes per week submitting data on their client interactions. The program website doesn’t indicate what types of data they are collecting.

Participants receive a one-time participant stipend, but the amount is also not specified on the website.

Better Together offers grants of up to $300,000 for proposals like Chair Care designed to circulate “vetted vaccine information” or increase access to vaccines for New Mexicans. All projects must include a focus on COVID-19 vaccination.

Better Together did not respond to The Defender’s request for more information about the program at the time of publication.

‘Trusted messengers,’ brought to you by corporate elite and the CDC

Chair Care cites an Ad Council Research Institute report, “The 2022 Trusted Messenger Study,” a follow-up on a similar report published in 2021, as the justification for the program.

The Ad Council is a nonprofit research organization whose directorship is comprised of over 100 representatives from almost every major legacy and social media corporation, Big Pharma, Big Food, Big Tech, professional sports, banking and consulting.

Its mission is to “convene the best storytellers to educate, unite and uplift — by opening hearts, inspiring action and accelerating change.”

The Trusted Messenger Study concluded that Americans don’t trust political leaders and institutions. To “market” messages that will “shift perceptions” and “ignite new behaviors,” leaders have to find the messengers that people trust and get them to deliver the desired message.

A key finding in the study was that local leaders — teachers, community leaders, nonprofits — are important references for people when they are gathering information to make decisions.

Based on these and similar ideas, the CDC since 2021 has doled out hundreds of millions of dollars in grants for the creation of “culturally tailored” pro-vaccine materials and for training “trusted messengers” to promote COVID-19 and flu vaccines to communities of color in every state across the country.

In March 2021, the Biden administration also earmarked $3 billion for the CDC to support local initiatives to “strengthen vaccine confidence.”

The method: motivational interviewing

The Chair Care stylists will be trained to use motivational interviewing to influence their clients.

Better Together defines the method, from the CDC’s website, as “an evidence-based and culturally sensitive approach to helping people manage mixed feelings and move toward healthy behavior change that is consistent with their values and needs.”

According to Psychology Today, it is a counseling method used to help people decide to change their behavior, and it is particularly effective with people who are ambivalent, or even hostile. It can be effective in one or two sessions.

Originally developed for people with substance abuse disorders, the method is now applied broadly in healthcare, psychotherapy, correctional and counseling settings, according to the American Psychological Association.

The clinician — or in this case, the hairstylist — is meant to listen, show empathy and support for the idea that someone can change, and help people think about how they can do so.

The goal is to guide the communication in order to direct people in a way that is “respectful and curious.”

The CDC provides a script for healthcare professionals to implement the methodology to promote COVID-19 vaccine uptake on its website. It also provides training in this method for clinicians working with HIV patients, opioid users and the elderly.

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Via https://childrenshealthdefense.org/defender/chair-care-new-mexico-hairstylists-cdc-covid-flu-vaccines/