The U.S. Department of Health and Human Services (HHS) in mid-February appointed the new members to the Advisory Committee on Immunization Practices (ACIP), which dictates U.S. vaccine policy.
The Defender reports: Commenting on the new appointments, Children’s Health Defense (CHD) President Mary Holland said:
“ACIP has long been a rubber stamp for any and all vaccines Big Pharma wants to push. But the brazenness of the HHS-Big Pharma fusion has never been so much on display.
“The only silver lining in this grotesque display is that more and more people are waking up to the reality that ACIP has nothing to do with health and everything to do with profit.”
The ACIP is described as an independent, nonfederal expert body made up of professionals with clinical, scientific and public health expertise. The committee decides which vaccines should be recommended to the public, who should take them and how often — recommendations the CDC typically rubber stamps.
This external advisory committee includes a chair, an executive secretary, and 15 voting members — 14 medical experts and a lay member representing consumers.
It also includes a non-voting body that offers input composed of eight ex officio members from other federal health departments and liaison representatives from health-related professional organizations like the American Association of Pediatrics.
However, when the committee convened last week to make its spring recommendations, it was missing so many voting members that it lacked a quorum. Vacant committee spaces on the “independent” committee had to be temporarily filled by government employees — ex officio members can be sworn in as temporary voting members.
Over the last year, HHS struggled to fill eight vacancies. An additional four members will be needed when existing members’ four-year terms are up at the end of June.
As seats on the committee sat unfilled, industry news sites like StatNews suggested the committee “appears to be atrophying” and Medriva said there is an “unprecedented lack of expertise in the committee.”
When HHS finally announced the new members to fill the vacancies, it was also reported the new members would be filling spots at last week’s meeting. However, they had not yet taken their positions at the time the meeting occurred on Feb. 28-29.
A CDC spokesperson confirmed to The Defender that nine members have been appointed to the committee, including Dr. Helen Keipp Talbot, an infectious diseases researcher at Vanderbilt University who previously served on the committee from 2018 through 2022 and will rejoin the committee to serve as chair.
Members typically are not eligible for reappointment, but in Talbot’s case, the HHS provided a waiver to that existing policy.
In addition to Talbot, four members will begin their tenure immediately upon submission of paperwork. These include Dr. Denise Jamieson, dean of the University of Iowa Carver College of Medicine; Dr. Yvonne Maldonado, a professor of pediatrics at Stanford University; Dr. Robert Schechter, a medical officer with the California Department of Public Health; and Dr. Albert Shaw, an infectious diseases professor at the Yale School of Medicine.
The other appointees will begin on July 1. They include Dr. Edwin Asturias, a pediatric infectious diseases specialist at the Colorado School of Public Health; Noel Brewer, Ph.D., a professor of health behavior at the University of North Carolina; Dr. Helen Chu, an infectious diseases specialist at the University of Washington; and Dr. George Kuchel, a professor of geriatric medicine at the University of Connecticut.
All nine appointees will serve four-year terms.
“Stringent measures and rigorous screening” are reportedly used to avoid the committee members having “real or apparent” conflicts of interest.
However, all of the new appointees except for the public member have received grant funding or consulting fees from major pharmaceutical companies, including vaccine makers like Pfizer, Moderna and Merck, or have worked for HHS or on recent HHS grants developing or testing vaccines or investigating how to improve vaccine uptake.
Many of them have been key public advocates for the COVID-19, respiratory syncytial virus (RSV) and human papillomavirus (HPV) vaccines, crafting and promoting the CDC’s message in the media and in the clinic.
Several have sat, sometimes together, on other vaccine advisory committees for the World Health Organization (WHO), the state of California, and The Lancet, among others.
What constitutes a conflict of interest?
The committee’s policies and procedures document, updated in 2022, defines a “conflict of interest” for committee members.
According to the ACIP policies, while members are actively on the committee, neither they nor their immediate families can be employed by or hold stock in a vaccine manufacturer. They cannot receive royalties from a vaccine that is being evaluated by the committee. They cannot act as advisers, consultants or a paid litigation expert to a vaccine manufacturer, or otherwise receive money from a vaccine maker — with exceptions — while they serve on the committee.
The committee’s definition of a conflict of interest doesn’t prohibit members from benefiting financially from HHS grants while on the committee.
It also doesn’t apply to their activities before or after their time on the committee, which is when most potential members have taken money from industry or engaged in vaccine promotion that raises questions about their impartiality.
This narrowly defined conflict of interest differs markedly from how HHS defines conflict of interest in its ethics training for HHS employees. In that training, HHS warns employers that criminal law prohibits them “from participating personally or substantially in an official capacity that would have a direct and predictable defect on your financial interests,” according to a source at the CDC who asked not to be named.
HHS also notes in its training that “appearances matter” and a conflict of interest arises if a reasonable person with knowledge of relevant facts would question someone’s impartiality.
Impartiality is not a requirement for membership on the CDC advisory committee. Members are required only to declare their financial conflicts at each meeting and to recuse themselves where appropriate.
Members may be granted waivers if the committee’s need for their services outweighs the conflict of interest, according to the CDC.
Below are the new appointees, with a summary of their research and their links to Pharma or public health agencies and research that could raise questions about their impartiality.
Jamieson promoted COVID vaccines for pregnant women
Dr. Denise Jamieson spent most of her career working for the CDC before becoming a faculty member at Emory University and then a dean at the University of Iowa.
Jamieson is a spokesperson for the American College of Obstetricians and Gynecologists and a member of its Practice Advisory on COVID-19 Vaccines and Pregnancy.
She publicly promoted the COVID-19 vaccine as “safe and effective” for pregnant women as early as Spring 2021 — even though in January 2021, regulatory agencies were aware from Pfizer’s own data that the vaccines pose serious risks for pregnant women.
The American College of Obstetricians and Gynecologists recommended pregnant women get vaccinated despite a lack of clinical trials showing safety and even before the CDC began advising pregnant women to take the vaccine.
The association was among the many women’s health organizations that had urged Pfizer and Moderna to speed up vaccine tests in pregnant women, The New York Times reported.
Last year, Freedom of Information Act requests revealed the CDC bankrolled the association to the tune of $11 million to promote COVID-19 vaccination as “safe and effective” for pregnant women.
As part of her public outreach promoting the COVID-19 vaccines, Jamieson said in public interviews that fertility concerns about the vaccines were “myths” with “no biological plausibility.
Jamieson also said there was no evidence that the vaccines caused menstrual irregularities, despite early reports that vaccines were causing menstrual irregularities. She also began advocating vaccination for adolescent girls even before the vaccines were approved for adolescents.
Maldonado studied COVID vaccines in children for Pfizer
Stanford’s Dr. Yvonne Maldonado took tens of thousands of dollars in consulting fees and nearly $4 million in research funding from Pfizer since 2016, according to OpenPaymentsData.CMS.gov, the government website that tracks pharmaceutical industry funding to medical professionals.
She also received consulting fees for Trumenba, a meningococcal vaccine for meningitis B.
Among the projects she has headed up are studies of nasal swab techniques that led to home testing and the development of an antibody test to detect the virus, which received U.S. Food and Drug Administration (FDA) approval.
Maldonado was a strong public advocate for testing the vaccines in children. She promoted testing the vaccines on kids in outlets like NBC News as early as October 2020, despite acknowledging children were at very low risk for serious illness.
She led clinical trials for the Pfizer-BioNTech COVID-19 vaccine in children at Stanford, promoted them as 90% effective for children and was an early advocate for including the vaccines on the childhood immunization schedule.
In this video from November 2021, Maldonado celebrates the short amount of time it took to make the vaccines and promotes them for children:
Maldonado also advocated to expand the use of Paxlovid for children.
The Bill & Melinda Gates Foundation recently funded the Maldonado Group to do a 2.5-year study on the oral poliovirus vaccine in Veracruz, Mexico.
Experts have widely criticized the Gates Foundation for over a decade for its self-interested work promoting polio vaccines in the developing world at the expense of other, more important public health measures.
Shaw, a strong COVID vaccine advocates
Albert Shaw, M.D., Ph.D., studies the immunology of aging at the Yale School of Medicine. He recently was the principal investigator on a major observational study of adults hospitalized with COVID-19, funded by the National Institute of Allergy and Infectious Diseases.
Shaw also publicly advocated for COVID-19 vaccination, particularly for the elderly and for pregnant mothers. He appears frequently on local news sounding the alarm on the dangers of COVID-19, even for strains like XBB 1.5, promoting the vaccines as “safe and effective” and encouraging people to get vaccinated and boosted.
OpenPaymentsData reports that Shaw was paid $2,590.00 in consulting fees by Boehringer Ingelheim Pharmaceuticals Inc. in 2022 and $1,425.71 from GSK (formerly GlaxoSmithKline) in 2019.
Schechter, a ‘public advocate’ on multiple HHS committees
Dr. Robert Schechter appears to hold the position of the public member, meant to represent consumers on the committee. Schechter also serves as the public member of the National Vaccine Advisory Committee, another HHS vaccine advisory committee.
However, he was a medical officer with the California Department of Public Health for decades working primarily on the California Vaccines for Children Program.
He has functioned as a spokesperson, informing the public about vaccines in California, frequently quoted in local media. He also is a member of the American Association of Pediatrics.
Schechter also served on the California Department of Public Health Western States Scientific Safety Review Workgroup, along with other existing and incoming members of the CDC advisory committee Maldonado and former chair Dr. Grace Lee. That group set COVID-19 vaccine and booster recommendations.
Asturias, a global vaccine researcher with consulting fees from 5 Pharma companies
Dr. Edwin Asturias is a professor of pediatrics with a focus on Latin America. He has served on several different vaccine advisory boards globally, including in Guatemala and for the WHO.
Asturias is a member of the Strep A Vaccine Global Consortium whose mission is to make sure Strep A vaccines are available and administered. He also receives grant funding from Pfizer and is a paid consultant for Curevac, Inovio and Moderna.
Much of his research focuses on the epidemiology of disease, largely in rural Guatemala. However, over the last several years Asturias has published several articles on “vaccine hesitancy” among rural Latin American people and how to overcome it.
He has worked on several studies of community perceptions of vaccines in his native Guatemala, including studies of attitudes among trusted leaders and parents who are key to building vaccine confidence.
According to OpenPaymentsData, Asturias received approximately $4,000 in consulting fees and over $1 million in research funding from Merck in 2022.
Since 2016, Asturias has received over $60,000 in consulting fees and travel costs from Merck, Pfizer, GSK, Sanofi Pasteur and Astellas Pharma, and almost $3 million in research funding from Pfizer, over $750,000 in research funding from GSK and a small amount of funding from Takeda Vaccines.
That is in addition to tens of thousands of dollars in payments from those same companies in 2014.
Brewer, a Merck consultant who developed the ‘Announcement Approach’ to HPV vaccination
Asturias will be joined on the committee by another Merck consultant and “vaccine hesitancy” expert, Noel Brewer, Ph.D.
Brewer is a behavioral psychologist at the University of North Carolina’s Gillings School of Public Health, a paid consultant for Merck and the recipient of commercial research grants from Merck, Pfizer and GSK.
Over the past several years, Brewer received millions of dollars in funding from HHS for research on how to increase teen uptake of the HPV vaccine, documents obtained by CHD via a Freedom of Information Act request revealed.
Merck, for which Brewer consults, makes Gardasil, the only HPV vaccine commercially available in the U.S.
Brewer is best known for developing and testing the “Announcement Approach” to vaccinating the vaccine-hesitant. The approach involves having providers skip the step of discussing with families in “open-ended conversation” whether or not they want their child vaccinated for HPV and instead “presume” the family wants the vaccine and announce the child will receive it as if it were a routine part of the office visit.
Brewer and others’ previous research shows this method reduces the time a provider needs to spend talking with their patients and increases vaccine uptake.
HHS also has dedicated millions of dollars in funding to other researchers to test ways to expand Brewer’s approach.
In what was perhaps a Freudian slip, Brewer announced his new appointment on X, formerly Twitter, saying the committee would be setting the “vaccine police”:
Dr. Peter Hotez responded with his congratulations. The two worked together on the Lancet Commission of Vaccine Refusal, Acceptance and Demand in the USA, which was “formed to address the persistent and important threat to public health in the USA posed by suboptimal uptake of some vaccines.”
Chu has ties to Pharma, Gates ventures and is an advocate for the RSV vaccine
Dr. Helen Chu is an infectious disease specialist and co-author of the JAMA study that concluded the COVID-19 bivalent boosters were effective in children and adolescents ages 5-17.
Chu has consulted for pharmaceutical companies AbbVie, Vindico, Ellume, Medscape, Merck, Clinical Care Options, Catalyst Medical Education, Vir, Pfizer, Prime Education and the Gates Foundation.
She also served on advisory boards for Vir, Merck and AbbVie and conducted continuing medical education teaching with Medscape, Vindico, Catalyst CME and Clinical Care Options.
Gates Ventures has published her research and she also obtained support from Cepheid, a PCR testing company.
As an RSV researcher, Chu early on, on X (formerly Twitter), raised the alarm about a “triple-demic” dangerous for children and the elderly.
Later, she promoted the RSV vaccine, particularly for pregnant women. She is a co-author of a systematic review in The Lancet, out this month, finding that infants, particularly pre-term babies, have a higher risk for RSV-related severe acute lower respiratory infection.
Chu and her co-authors conclude: “Preventive products for RSV can have a substantial public health impact by preventing RSV-associated … severe outcomes from infection in preterm infants,“ a finding that implies vaccination during pregnancy or of infants would be appropriate, as these are the measures currently available or being considered.
GSK halted its Phase 3 clinical trial of RSV in pregnant women in 2022 after the company identified a safety signal for preterm birth. Pfizer was criticized for not informing women of the risk, the BMJ reported. Pfizer’s version of the RSV vaccine received FDA approval after Chu presented her research to the FDA’s vaccine advisory committee in May.
After the FDA approved it, the CDC advisory committee that Chu will sit on recommended it.
In less than a year since its approval, CDC data and the Vaccine Adverse Event Reporting System (VAERS) already show reports of 34 deaths, 302 serious adverse events and according to news reports this week, a safety signal for Guillain-Barré syndrome, The Defender reported.
As an example of her Pharma-funded educational work, in March, Chu presented a Pfizer-funded webinar to educate providers on “the burden of RSV in older adults” and the “importance of RSV awareness.”
Kuchel strongly advocates the RSV vaccine for pregnant women and the elderly
Dr. George Kuchel, professor of geriatric medicine is a strong advocate for the RSV vaccine in pregnant women and older people. He promoted the vaccine as potentially “transformational” for older people — just like the COVID-19 and flu vaccines, he said.
In 2023, Kuchel told the media there was no evidence the vaccine posed a risk to pregnant women, despite the safety signals in GSK’s trials.
Kuchel is currently working on a five-year, $9 million grant from the National Institute of Allergy and Infectious Diseases to study flu vaccines in older adults.
According to OpenPaymentsData, he has taken consulting fees — approximately $13,000 from Janssen Global Service in 2019 and approximately $1,300 from Novo Nordisk in 2020.
Former member Talbot replaces Lee as chair
The final new appointee, former committee member Dr. Helen Keipp Talbot, will rejoin the committee as chair. Her research focuses on adult vaccination, influenza vaccination, human coronaviruses and vaccine trials for respiratory illnesses such as RSV.
According to Talbot’s curriculum vitae — last updated in 2018 before she joined the committee — her most recent research funding comes from both the federal government (CDC, National Institutes of Health) and Sanofi Pasteur, primarily for the study of pandemic preparedness in 2015 and influenza vaccination.
Sanofi and MedImmune have been recurrent funders since 2009, along with AstraZeneca, Gilead, Protein Sciences, VaxInnate and Wyeth (since acquired by Pfizer).
According to the OpenPaymentsData, Talbot received roughly $1.4 million in research payments and associated research funding since 2014 (417 total payments) from these companies, along with 29 general payments totaling $17,000, The Defender reported.
Talbot sat on the committee through the pandemic that voted to recommend the COVID-19 vaccines and boosters for adults and children.
Talbot will replace former chair, Dr. Grace Lee, who was associate chief medical officer for practice innovation at Stanford Medicine Children’s Health and a pediatrics professor at Stanford School of Medicine since 2017.
While committee appointments are typically four years long, Lee served only two, and the chair position currently sits vacant. Her office did not respond to The Defender’s inquiry as to why she resigned from the committee.
While she was on the committee, her husband, Joshua Salomon, Ph.D., health policy professor at Stanford was heading up a major, multi-million dollar five-year CDC-funded project to model local and national policies for responding to infectious diseases. That work is also funded by the Gates Foundation.
(Article by Sean Adl-Tabatabai republished from ThePeoplesVoice.tv)