Seeking truth and restoration of public trust in COVID immunizations

This morning, September 3, 2025, I had the privilege of participating in a two-hour discussion as a member of the ACIP COVID-19 Workgroup under Dr. Retsev Levi’s leadership.

I look forward to having positive impact using my expertise including in data review, cancer, disease pathogenesis and human subjects protections. The Workgroup members have incredible depth and expertise with scientific leaders in the field and experienced clinicians to cover its charge.

Besides my work in causes and treatments of cancer that I have dedicated my career to, my group has published some papers related to COVID including:

Zhou L, Huntington K, Zhang S, Carlsen L, So EY, Parker C, Sahin I, Safran H, Kamle S, Lee CM, Geun Lee C, A Elias J, S Campbell K, T Naik M, J Atwood W, Youssef E, A Pachter J, Navaraj A, A Seyhan A, Liang O, El-Deiry WS. MEK inhibitors reduce cellular expression of ACE2, pERK, pRb while stimulating NK-mediated cytotoxicity and attenuating inflammatory cytokines relevant to SARS-CoV-2 infection. Oncotarget. 2020 Nov 17;11(46):4201-4223. doi: 10.18632/oncotarget.27799. PMID: 33245731; PMCID: PMC7679035.

Huntington KE, Louie AD, Lee CG, Elias JA, Ross EA, El-Deiry WS. Cytokine ranking via mutual information algorithm correlates cytokine profiles with presenting disease severity in patients infected with SARS-CoV-2. Elife. 2021 Jan 14;10:e64958. doi: 10.7554/eLife.64958. PMID: 33443016; PMCID: PMC7872512.

Zhang S, El-Deiry WS. Transfected SARS-CoV-2 spike DNA for mammalian cell expression inhibits p53 activation of p21(WAF1), TRAIL Death Receptor DR5 and MDM2 proteins in cancer cells and increases cancer cell viability after chemotherapy exposure. Oncotarget. 2024 May 3;15:275-284. doi: 10.18632/oncotarget.28582. PMID: 38709242; PMCID: PMC11073320.

I have also commented publicly back in April, 2020 and since then about the furin cleavage site that was revealed in the Nature Medicine COVID origins paper.

“The proximal origin of SARS-CoV-2 | Nature Medicine; can anyone help me understand where the polybasic furin cleavage peptide came from (aa 682-685 of spike)?”

By October of 2021 I posted “There is “absence of a known virus containing this arginine doublet encoded by the CGGCGG codons” in the middle of the mysteriously appearing furin cleavage site of SARS-CoV2 https://news-medical.net/news/20210217/The-origin-of-SARS-CoV-2-furin-cleavage-site-remains-a-mystery.aspx I’ve asked about where the FCS came from but no clear answer”

In May of 2022 I posted “Someone should write a book and call it “The Furin Cleavage Site”. I wish I had the time and some of the expertise in evolutionary biology. Whoever writes such a book (if it’s well done), I expect it would be a bestseller around the world.”

As a result of my interest in asking questions and contributing my expertise through our research publications I came under a relentless attack that escalated since July of 2024. Science Guardians has been exposing the orchestrated attacks. I recently gave a Podcast interview with Dana Parish on COVID, vaccines, and cancer.

My comments here will reflect some observations I made that do not reflect anything proprietary or confidential but rather a focus on some less appreciated aspects of COVID outcome data gathering or COVID vaccine outcomes.

There are currently 4 FDA-approved COVID vaccines that include COMIRNATY (BioNTech; Pfizer), SPIKEVAX (Moderna), MNEXSPIKE (Moderna), and NUVAXOVID (Novavax). The first 3 are mRNA vaccines while NUVAXOVID is a protein vaccine. MNEXSPIKE was just approved by the FDA on May 30, 2025.

I reviewed the current package inserts for all 4 of the approved vaccines. It jumped out at me that all 4 package inserts made two statements that are relevant to risk among sub-groups of individuals.

The first is that data on administration to pregnant women is insufficient to inform vaccine-associated risks in pregnancy.

The second is that the FDA-approved vaccines have not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.

Notably absent in the package insert was any acknowledgment of any contaminants (or that there may be contaminants) as a result of the vaccine manufacturing process.

It is of interest that myocarditis has been observed not just with COVID mRNA vaccines but also with the protein vaccine. This brings up questions of mechanism including the possibility of cross-reacting spike protein anti-bodies that affect the heart among other mechanisms.

The CDC has been capturing data in COVID-NET as a gold standard database in the United States through a hospitalization surveillance network. The database captures outcomes in hospitalized patients with COVID but there are limitations. It is difficult for example to determine whether a hospitalization is due to COVID or unrelated in an individual who also happens to have COVID.

Interestingly the cases in such a database would not include hospitalizations for seemingly unrelated issues like a broken arm, an IV catheter-related issue, or a psychiatric admission.

Some strategies for increasing certainty that an admission was for COVID might be if Remdesivir or steroids were used although with steroids it can be difficult to differentiate in asthmatics who have positive COVID tests.

For various reasons I have been aware that COVID virus has neurotropism that has been associated with severe COVID infection. As such I started to wonder about exclusion of psychiatric admissions from databases that are trying to capture COVID outcomes.

There are several references on neuropsychiatric associations with COVID including “COVID-19: Psychiatric illness,” “Neuropsychiatric disorders following SARS-CoV-2 infection,” and “Risk of neuropsychiatric and related conditions associated with SARS-CoV-2 infection: a difference-in-differences analysis.” Could such exclusions lead to underreporting of CNS complications.

I found a literature suggesting that spike protein after infection may linger within the CNS leading to neurological symptoms and that the furin cleavage site may increase neuronal infections.

Neurological side effects that have been described with COVID vaccines appear to be rare, include Guillain Barre Syndrome, but on balance it is felt that vaccination outweighs risks for CNS side effects from COVID infection.

For a clear understanding of risks from COVID versus risks from vaccines it is important to have reliable long-term outcomes including all-cause mortality data.

In addition as one considers various at-risk groups within the population for any recommendations it is important to weigh risks versus benefits of COVID immunization considering long-term effects including death.

This is particularly relevant for neonates some of whom are vaccinated at 6 months per some guidelines or pregnant women. With regard to pregnant women, I posted to X in April about this topic.

“I have taken a look at this study of live births in vaccinated pregnant women just published by the American Academy of Pediatrics.

The study concludes “COVID-19 vaccination during early pregnancy is not associated with an increased prevalence of major structural birth defects in infants. These results support the safety of COVID-19 vaccination in early pregnancy.”

I will point out that:

“Pregnancies were eligible for inclusion in the cohort if they (1) ended in a live birth”

“There were 135 248 pregnancies in the study period. After excluding 57 196 (42.3%) pregnancies not meeting eligibility criteria, the final analytical cohort comprised 78 052 pregnancies (53.5% privately insured and 46.5% publicly insured)”

“Pregnancy outcome other than livebirth n=20,341” (excluded and not analyzed)

“our study excluded pregnancies ending early (due to spontaneous or medical abortion, ectopic and trophoblastic implantation, and stillbirth) and thus may be affected by live-birth bias: a form of selection bias that occurs when an exposure affects both diagnosis of the outcome and fetal survival. Birth defects and respiratory tract infections during pregnancy can cause or increase the risk of preterm birth or stillbirth, and exclusion of these pregnancies may lead to an underestimation of identified outcomes. The quantification of this bias is challenging because birth defects are not routinely recorded in pregnancies ending prior to 20 weeks, and capture of birth defects among stillborn infants is often incomplete.”

COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects”

In general, given the absence of carcinogenicity data and some reports of cancers in vaccinated individuals, it is important again to have long-term outcomes specifically focused on cancer prevalence among vaccinated individuals.

It is important to relate outcomes with vaccines as they relate to the number of shots taken, both in the short-term as well as long-term.

I have stated for some time that in the population at large there may be variability towards adverse events that might confer greater risks to certain individuals over others. More research should help define that variability to better tailor risk assessment at the individual level.

I think further focus on different risk groups and known outcomes should help inform risk-benefit decisions and in general I think such decisions should involve discussions between patients and their physicians or other healthcare providers outside of a public health emergency.

I am guided by science in seeking truth. I believe if we ask specific questions, we get answers if they are available. If the answers are not available, I think this should be part of the risk-benefit equation for patients and physicians to weigh.

Full transparency with appropriate data reveals truth and will help restore public trust in addition to rational (common sense) COVID vaccination guidelines.

Wafik S. El-Deiry, MD, PhD, FACP

Providence, Rhode Island