BREAKING: ACIP launches sweeping Covid-19 vaccine review under Retsef Levi

Billions of Covid vaccine doses were rolled out on assurances they were safe and effective. Now, ACIP’s new Covid immunisation working group is asking the questions regulators never did.

MIT professor Retsef Levi has been an outspoken voice on the CDC’s vaccine advisory committee (ACIP) since its dramatic overhaul in June.

He has pressed agency officials on uncomfortable questions, challenging the narrow surveillance windows used to track harms and insisting that delayed effects could not simply be ruled out.

He also raised concerns about the safety of RSV monoclonal antibodies after clinical trials showed a clear imbalance in infant deaths.

click icon for full story

Now, Levi is no longer just a dissenter.

He has been appointed chair of the CDC’s new Covid-19 vaccine working group, and with today’s release of its Terms of Reference, the scale of his task has come into sharp focus.

Under the guidance of Levi and his colleagues, the ACIP working group now has a mandate unlike anything the committee has ever undertaken.

For the first time, federal advisers will investigate the unresolved issues that have dogged the vaccines since their rushed rollout in late 2020.

From DNA contamination in the manufacturing process to the persistence of spike protein and mRNA in the body, from immune class switching following repeated boosting to safety in pregnancy, cardiovascular risks, and long-term disability, the list of questions is as sweeping as it is sensitive. (full list below)

The Terms of Reference stretch far beyond the narrow remit that characterised ACIP’s early deliberations, when myocarditis was acknowledged as the only confirmed harm and most safety reviews stopped at 42 days.

Levi and his team are now tasked with probing long-term outcomes, mapping vaccine policies around the world, and assessing, to what extent, years of official reassurances about safety and efficacy hold up against emerging data.

It is a striking reversal for the CDC and the FDA.

For years, these agencies dismissed critics who raised concerns about DNA contamination, biodistribution, immune imprinting, or reproductive safety as “alarmists” and spreaders of “misinformation.”

Now, the CDC’s own advisory body has committed to revisiting each of those questions in detail, and to identifying the gaps in evidence that should have been addressed before mass vaccination ever began.

The stakes could not be higher.

Covid-19 vaccines remain one of the most divisive issues in medicine, and the CDC’s credibility has been battered by accusations of selective data presentation.

Only this week, experts accused the agency of obscuring seizure risks from RSV monoclonal antibodies by slicing the data into subgroups that hid a statistically significant signal.

click icon for full story

Against that backdrop, the creation of a Covid-19 working group will be more than bureaucratic housekeeping—it is a test of whether ACIP can restore the public’s trust by confronting uncomfortable truths.

How this will play out is uncertain. The group, in its official capacity, must weigh the benefits and harms of Covid-19 vaccines, potentially exposing flaws in past policy against the danger of repeating them.

For Kennedy, Levi, and the newly reconstituted ACIP, the challenge is not only to parse the science but to show that vaccine oversight in America is no longer a rubber stamp.

Following the publication of the Terms of Reference, I sat down with Levi to hear his view on what this new chapter means for vaccine policy, scientific integrity, and public trust.

This interview has been edited for brevity. The views expressed are Prof Levi’s opinions, not those of ACIP.

DEMASI: Congratulations on being elected chair of this working group. Can you reveal who else will be on it? Can you name names?

LEVI: I’m not able to name names yet, because we haven’t fully formed the work group. But two of my ACIP colleagues are included, Dr Robert Malone and Dr James Pagano. We plan to engage a range of experts in different areas, leading scientists in academia and clinicians with field experience. I’m confident that together with colleagues at the CDC and FDA we’ll build a robust team.

DEMASI: I looked at the terms of reference – there's an extraordinary range of issues, from DNA contamination to pregnancy safety to immune imprinting. What do you see as the most pressing issues?

LEVI: Yes, this is a comprehensive and ambitious agenda we’ll be working on in the coming months and years. The work group will set priorities, and in consultation with the CDC, we will focus on key issues fundamental to understanding the efficacy and safety of the Covid-19 vaccines.

This is new technology, so it raises new questions. For example, unlike traditional vaccines, when a Covid vaccine is administered, we don’t know the actual dose. The vaccine introduces into the body’s cells the mRNA code that is wrapped in nano lipids, and as a result the cells are instructed to produce the spike protein. However, everyone could produce a different amount of spike protein. The initial safety paradigm was that the vaccine contents would only stay in the arm and be cleared after a short duration. Now we know that’s not true – so we need to understand the biodistribution and persistence of the mRNA, the spike protein, and the lipid nanoparticles, and what their respective risks are.

DEMASI: Hearing you say all this feels surreal. Billions of doses have been administered, and we were assured the testing was “rigorous.” Yet now you’re saying there are huge unknowns — about dosage, how long it lingers in the body, even its safety. Were we lied to by public health authorities?

LEVI: I want to be forward-facing. I think that the new ACIP was appointed with a goal of asking more questions and bringing all the available information and knowledge needed to understand the efficacy and the safety of these Covid-19 vaccines. Many of our questions are not fully answered and require further investigation. I believe that only transparent and comprehensive pursuit of the answers will allow us to rebuild trust, and ensure that whatever we recommend is based on the best scientific evidence, and honesty about what we know and what we do not know.

DEMASI: But again, shouldn’t this have been done before we started injecting people?

LEVI: I hear you. I believe that the new ACIP members were appointed to assess and change the way ACIP makes recommendations. We will leave no stone unturned and look at all possible data from the FDA to the CDC, from the published and unpublished literature, and from the experience of clinicians who care for patients as well as from patients themselves. We need to be fully transparent about what we know, and what we don't, and unfortunately that was not always practised consistently in the past. My intention is to be part of changing that.

DEMASI: You were quite vocal at the June meeting about the issues with surveillance of adverse events when looking at vaccine harms – especially long-term harms. What needs to change to improve this?

LEVI: That's a great question. The current post-marketing pharmacovigilance systems aim to track specific adverse events that fit into well-known diagnoses like myocarditis or heart attacks and focus on occurrence soon after vaccination. For example, they will assess occurrence of adverse events within a week or a month post-vaccination. However, these systems are not designed to identify adverse events that don’t fit one diagnosis, involve non-specific symptoms, or take longer to emerge. “Long Covid vaccine sequelae” is a good example. So we cannot merely rely on CDC data or existing surveillance systems. We must look further – at the wider scientific literature, published or not – and understand things like the product’s pharmacokinetics and other related biological mechanisms. We also have to look at the clinical experience in the field. As I already said, these are not traditional vaccines where you control the dose and distribution within the body. With mRNA vaccines you don’t.

DEMASI: So, would you consider these “gene therapies” or not?

LEVI: I think that this is something very valid to argue because the Covid vaccine delivers genetic material to cells so they make the spike protein. Also, as you know, there is an issue with DNA contamination – high levels of plasmid DNA found in the vaccines – which is not supposed to be there, and the question is, what is that doing to the body? There is evidence that some people may still be producing spike protein more than 700 days after the last vaccination. That's a very concerning finding.

DEMASI: So are you saying that if someone is still making spike protein 700 days after being vaccinated, then some of the contaminating plasmid DNA – which is not supposed to be there - may have integrated into their genome and they are now a spike factory?

LEVI: Well, I think that’s definitely one of the plausible mechanisms that could explain this finding. Yes. There might be others, and this is an example of a major gap in our current knowledge that requires further research, promptly.

DEMASI: There’s so much zealotry surrounding vaccines, I don’t know why it is so hard to imagine that they may cause long-term harms…

LEVI: For some reason, there is a misconception that harms of vaccines primarily show up shortly after vaccination, and long-term harms are assumed to be unlikely and essentially ignored. But remember that the goal of vaccination is to drive a long-term impact on the immune system, so why don’t we acknowledge that it may also cause long-term harm? We also have to look at what repeated exposure does – especially with vaccines that are given every season, like Covid-19. We know already that they create some unique changes in the composition of antibodies – there is what is known as class switching – antibodies switching into IgG4 – which is typically considered to have a role in downregulating the immune response. It is also associated with a lot of autoimmune conditions. Now, do we know for sure what the impact is? No, but this is another important set of questions we have to answer, and that we’ll be examining.

DEMASI: That’s fascinating. You mentioned the DNA contamination issue. What data will you be seeking to investigate this issue?

click icon for full story

LEVI: The DNA contamination issue is interesting because we cannot just look at the published literature. It has been documented by several labs across the world, including an FDA lab as you’ve shown, but it’s difficult to get this stuff published in high-impact academic journals, which is unfortunate. So we will be digging further for answers, potentially consulting with various experts who do this work. I just want to emphasise I don't view ACIP as an entity that does the research itself. We are here to gather the research and knowledge that has accumulated so far, summarise and understand the implications, the gaps, and formulate recommendations.

DEMASI: One of those gaps in the terms of reference is Covid vaccines in pregnancy. Thoughts?

LEVI: Yes, vaccinating pregnant women is particularly concerning. We tell them not to eat sushi, right? We place many restrictions during this time because pregnancy is a delicate biological process, and any interruption or exposure could have grave implications for the foetus, baby, and mother. Yet with Covid vaccines we gave broad recommendations in pregnancy, with no clinical trials. The original pivotal trials excluded pregnant women, and the only trial ever conducted was very small, underpowered, focused on vaccination in later stages of pregnancy and stopped early. Having researched this topic myself, I can say the literature is mostly retrospective observational studies – methodologically weak for assessing safety. I believe the process we followed failed the principle of ‘first do no harm.’ We need a different approach: be honest about what we know and don’t, and do what it takes to close these gaps, including potentially randomised clinical trials.

DEMASI: The terms of reference make a note that you will compare US policy with policies in other countries… why is that important?

LEVI: In many ways, US vaccination policy is among the most aggressive in the world, including with Covid vaccines until recently. Mapping those differences and understanding the rationale of other countries, and comparing the pros and cons, is part of our job. For example, in the US we give the hepatitis B vaccine on the first day of life. That’s not the case in Sweden, Denmark and other countries. When we even discuss not doing that here, some people scream “it’s a crime”… But Sweden and Denmark have reasonable policies and we could potentially learn from them.

DEMASI: Much of this inquiry will come too late for people who've already been vaccine-injured. What do you say to that? What is in it for them?

LEVI: I'm glad you're asking this, because I want to make sure we don't leave them behind. We have a moral obligation to do whatever we can to document the injuries and care for injured people – not just Covid vaccine injuries, but vaccine injuries more broadly. Not only have we not done this in the US, but often vaccine-injured people have been outrageously gaslighted and accused of being anti-vaxxers…

DEMASI: Right, they took the vaccine and they’re still called anti-vaxxers…

LEVI: That’s flawed and morally wrong. We want to acknowledge and validate them. I hope that a big part of our work will be to understand the vaccine. As part of doing that we're going to engage the physicians who care for these patients, to build an understanding of how these injuries occur, what the typical patterns and mechanisms are, and where the current diagnostic and therapeutic gaps lie. Many vaccine-injured patients go from doctor to doctor, are gaslit, and rarely or wrongly diagnosed. From this process, I hope we will be able to formulate recommendations regarding policies the CDC and other agencies could adopt to create a system that acknowledges injuries, diagnoses them, and invests in the research needed to develop treatments.

DEMASI: At the last meeting, the CDC only admitted to myocarditis as the only real signal. Do you expect that your investigations will uncover more safety signals?

LEVI: When you read through the literature, the statement that the only harm the Covid-19 vaccines cause is myocarditis—seems to me very detached from reality. We need a far more nuanced approach that does not just look narrowly at short-term specific diagnoses but instead looks more broadly at what we know about potential harms. This is the only way we can rebuild and sustain trust in vaccines.

DEMASI: You are on social media occasionally, so surely, you’ve seen people screaming that we already have enough data to recommend no one gets another mRNA shot. Ever. What’s your reaction?

LEVI: I understand the impatience and realise we might receive different criticisms. However, I strongly believe that unless we run a very rigorous and evidence-based process it will be hard to secure broad trust in ACIP recommendations – and this is critical.

DEMASI: Yesterday, the American Academy of Pediatrics came out with their own vaccine schedule, diverging from the CDC’s schedule… What do you think about that?

LEVI: As my colleague Dr Cody Meisner said at the last ACIP meeting, it’s childish behaviour. They declared their position before ACIP even met – they boycotted the meeting. That tells you where their priorities lie. They have the right to say whatever they want, but I have at least two major problems with their recent recommendations on the Covid-19 vaccines. First, the public has mostly rejected them – in fact, most medical professionals are not taking them either. So it's a little ironic coming from a Medical Association representing doctors. Second, they receive funding from Pfizer, Moderna and other vaccine manufacturers. If anyone on ACIP had those financial entanglements, they would be excluded from discussion and policy recommendations, but this doesn’t stop the AAP from posting, publishing and promoting vaccine recommendations on those same products.

DEMASI: I agree, it’s unethical.

LEVI: It creates a major credibility issue for them, but that’s their problem, not mine. I'm focused on ACIP and the working group as part of ACIP, and we are going to work collaboratively, particularly with the CDC experts, to bring the American public the best information and be transparent about what we know and don't know regarding the risks and benefits of different vaccine products, and hopefully allow them to make informed decisions about their health and specifically about vaccination.

DEMASI: Good luck with it all. Talk soon.

LEVI: Thanks, Maryanne.

---

TERMS OF REFERENCE:

---