By Maryanne Demasi at Brownstone dot org.
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.
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.
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...