Vaccine advisory committees and transparent practices

Why changes to ACIP are concerning.

The US secretary for health, who recently stated “don’t take medical advice from me” has disbanded the ENTIRE Advisory Committee for Immunization Practices (ACIP). The primary reason for this is that he claimed the members had “too many conflicts of interest.” He has subsequently and rapidly appointed an entirely new committee. All of these actions are unprecedented and in this article I want to unpack what he has done, the implications of this and what this could mean in terms of vaccine trust and access.

What is ACIP and its remit?

ACIP make recommendations to the CDC who then set the U.S.A. adult and childhood immunization schedules based upon their advice. In the UK, the Joint Committee for Vaccines and Immunisation (JCVI) play a similar role. Positions on the boards are held by technically qualified people trained in a clinical medical field and/or possessing in-depth knowledge of vaccines and immunization e.g. epidemiology, immunology, infectious disease. Appointees are enrolled on 4 year terms which are staggered with seats becoming vacant as members rotate off the committee. New members are selected by the ACIP steering committee and then the health secretary gives final sign off. The chair of ACIP is selected by the Health secretary and drawn from the experienced ACIP members with at least 2 years service. This entire process ensures a level of expertise (even into how the committee runs) is held at all times as there will typically be a mix of more and less experienced members on the panel enabling new members to be supported as they transition into the committee role. Obviously an all new panel means no such mentoring is likely to be able to occur.

Are ACIP members screened for conflicts of interest?

All new recruits go through extensive vetting for their expertise, skills and any conflicts of interest. ACIP are a non-partisan organisation operating independently of party politics. There is a clear code of conduct and all members must “be committed to continued development and improvement in this important area of public health.” All meetings can be viewed publicly via webcast and the minutes are accessible. So, in other words, this committee is robustly set up with a transparent design. As such, RFK Jr’s statement regarding conflicts of interest does not seem particularly plausible.

There may be another reason underlying the disbanding the entire panel revealed in a lengthy op-ed JFK Jr wrote in the Wall Street journal. He stated “the current Trump administration would not have been able to appoint a majority of new members until 2028.” Even so, selecting new members would not be something normally that would be purely at the whim of the health secretary.

Who is in the new ACIP?

RFKJr quickly announced, just a few days after disbanding ACIP, that he had appointed an entirely new committee of 8 members (previous committees had more members to account for expertise, conflicts of interest on any given vaccines and timing conflicts). It is not clear how the new panel was appointed. Nor is it clear how or even if standardised vetting for conflicts of interest was done. To my knowledge, there has never been such a situation, whereby an entire ACIP was unilaterally disbanded. This raises serious questions about whether the new recruits have undergone the same level of scrutiny as in all previous committees.

RFKJr had stated a rationale for the change was that “A clean sweep is needed to re-establish public confidence in vaccine science”. However, the speed and lack of transparency over due process for selection rather contradicts this statement and potentially further undermines vaccine trust. The new panellists are Joseph R Hibbel, Martin Kulldorff, Retsef Levi, Robert W Malone, Cody Meissner, James Pagano, Vicky Pebsworth and Michael A Ross. Several of these new members are known to be close allies of Kennedy with histories of anti-vaccine activity raising questions of their views adhering to the “continued development and improvement in this important area of public health.”

Robert W Malone is one of the most high-profile new members of ACIP. He has claimed to have helped with the invention of mRNA vaccines. However, this claim is somewhat overstated: he was indeed involved as a graduate student in very early experiments on the development of mRNA technology but his role in the overall development that took many years was actually limited. He has since made a reputation for himself, especially during the peak of the Covid-19 pandemic, critiquing the mRNA vaccines. At the least, his track record is not consistent with an unbiased approach to assessing vaccines.

Martin Kulldorff also became very well known during the peak of the Covid19 pandemic as one of the co-authors of the Great Barrington Declaration. In effect this declaration wanted to avoid mass closures by enabling herd immunity to be built up via natural infection with the exception of the most vulnerable people. It should be noted that many otherwise healthy people became very sick or even died from Covid19 before the vaccines were available. Recent reports have shown that Kulldorff served as a paid expert witness for plaintiffs accusing Merck of concealing the risks of Gardasil (the vaccine targeting human papillomavirus (HPV) - the case was subsequently lost by the plaintiffs. Public filings show he was remunerated at approximately $400/h and he made at least $33,000 from the case. He has also received a $4,000 retainer in a similar case in North Carolina. Under ACIP’s rules, committee members cannot serve as a "paid litigation consultant or expert witness in litigation involving a vaccine manufacturer" during their tenure.

Retsef Levi has made numerous public statements against mRNA vaccines including SINCE his appointment was announced. Previous statements have called for the mRNA vaccines to be disbanded immediately. As such, it is difficult to reconcile his profile with someone who should be unbiased when making decisions about vaccines in the USA. Vicky Pebsworth has also been involved in making statements questioning HPV vaccine safety that conflicted results in a paper she coauthored.

Another recruit , Dr. Michael Ross was said by Kennedy to be a clinical professor of obstetrics and gynecology at George Washington University and Virginia Commonwealth University- however, reports have since shown he has not worked in either institute for 8 and 4 years respectively. Obviously, the fact he doesn’t appear to have a current active University affiliation doesn’t necessarily mean he will not have expertise however it doesn’t exactly reassure that a consistent, due process has been followed in selection.

Overall, there is a lot of concern about several new appointees in terms of their biases, conflicts of interest and the vetting processes. This matters a lot for vaccine trust.

Trust in vaccines is being eroded.

There were concerns by many when Kennedy was appointed to the role as health secretary over his extensive history of anti-vaccine action including a paid role chairing the Children’s Health Defense “non-profit” which has a track record in vaccine disinformation amongst other things. Since coming into his post he has led on several actions that undermine vaccine trust.

Kennedy announced plans to launch a study into exploring possible links with MMR and autism spectrum disorder (ASD) despite the putative link being thoroughly and extensively debunked. He has contradicted a recent and extensive recent report by CDC into ASD that used multiple data sources showing that increased prevalence of ASD is due to better screening, diagnosis and access to services. Instead, he has repeatedly asserted that ASD is preventable and due to environmental factors even though the evidence overwhelmingly points to genetics being the major driver.

Kennedy has made repeated claims that none of the childhood vaccines recommended in the USA (except the COVID-19 vaccine) - have undergone "inert placebo" testing intimating that vaccines are not fully tested. This is misleading as in fact, childhood vaccinations, were all initially tested against a placebo. Furthermore, all new vaccines already go through randomized placebo trials. Only vaccines that are tweaked for new targets as the virus changes like flu would not go through full placebo testing as the changes are so minor. It is considered unethical to withhold a vaccine known to be safe from a particular group.

Vaccines have been with used for decades and have saved millions of lives and casting doubt on how they were tested risks eroding vaccine trust.

Access to vaccines is being hindered.

Ready access to vaccines is a cornerstone for enhancing vaccine uptake however multiple actions in the USA are now impeding vaccine accessibility.

Since coming into office Kennedy delayed the ACIP meeting delaying decisions over autumn vaccines. Even after recommendations were made by ACIP, Kennedy over-ruled their Covid-19 vaccine recommendations. Healthy children and pregnant women are no longer automatically eligible for the Covid-19 vaccine. To access these vaccines they must consult with their health care provider. Unfortunately, even the blessing of a healthcare provider doesn’t guarantee access. It not clear that insurance companies will cover the costs of vaccines that are not mandatory. Recent reports describe access being denied in pharmacies despite having a medical recommendation.

The health department now wants all new vaccines to undergo safety testing in placebo-controlled trials prior to being licensed. Any brand new vaccine is alreday tested in such a way BUT it seems that, contrary to usual practice this new framework will also be applied for the approval processes for Covid-19 vaccines. Companies such as Novavax and Moderna have already been facing regulatory delays due in large part to the delayed ACIP meeting and are now tasked with new testing requirements. The goalposts just keen being shifted and consequences include the withdrawal planned roll out of a combined flu and Covid-19 vaccine.

Vaccines are not the only thing being impacted. Funding has been cut for numerous research projects resulting in the withdrawal of research projects into Covid-19 - thereby impeding future progress into developing drugs and therapies. Research programmes deigned to tackle unequal vaccine uptake have also had their funding axed. The cuts won’t stop there as incredibly steep cuts to science funding (of over 50% for some of the funders) are also planned if the new budget is approved.

Collectively, there are multiple actions that are coming together to erode confidence, trust and access to vaccines. Vaccines are one of the biggest health successes on our planet saving millions of lives.

I worry that too few people will hear the full facts about RFK actions on the vaccine advisory committee and that not only will access to vaccines be reduced but that the public will be sold a biased account that will further seed unease and mistrust in vaccines. Even if future administrations reverse some of these actions it may take decades to regain the trust that may be lost.

I realise this is very gloomy so on a more practical and positive note - there is ample, reliable information out there about vaccines from multiple sources including the Vaccine Knowledge project , and the British Society for Immunology. Independent SAGE have produced two reports on childhood and mRNA vaccines. The vaccine confidence project continues to do outstanding work on understanding and tackling vaccine confidence and hesitancy including how to talk to vaccine sceptics!

So do seek out those resources and do protest these actions to your local administration. This is already happening and you can join in. At least 300 employees at the NIH signed a letter- the Bethesda Declaration- to the Director Dr. Jay Bhattacharya, voicing concerns about, amongst other things, the deep budget and staffing cuts the NIH has faced. Organisations including the AAAS are holding meetings to share tools to help you share your story with policymakers. The about u-turn in the reinstatement of at least 400 employees to the CDC also shows there is hope in action.

Thankyou for reading!