Debunking the “COVID Vaccine-Free” Claim in Regenerative Medicine: What the Science and Regulations Actually Say

1. There is No Evidence That COVID-Vaccinated Donors Produce Inferior Amniotic Tissue

Multiple peer-reviewed studies have examined the impact of COVID-19 mRNA vaccines on the placenta and fetal membranes. The consistent conclusion? There is no histopathological evidence of damage to the placenta, amniotic fluid, or related structures due to COVID-19 vaccination.

A key study published in Obstetrics & Gynecology evaluated placentas from vaccinated individuals and found no adverse changes compared to unvaccinated controls, including no inflammation, infarction, or reduced cellularity [1]. Another multicenter cohort study in JAMA confirmed that maternal vaccination during pregnancy did not alter birth outcomes, placental structure, or tissue viability [2].

From a regulatory standpoint, neither the FDA nor the American Association of Tissue Banks (AATB) considers COVID-19 vaccination status an exclusionary criterion for donor eligibility. If the vaccine had any meaningful effect on the viability or safety of tissue, it would be reflected in donor screening protocols. It isn’t.

Bottom line: The suggestion that vaccinated donors produce biologically inferior tissue is not supported by science and is not recognized by any regulatory or accreditation body.

2. “COVID Vaccine-Free” Claims Require Proof of Donor History and Collection Timeline

If a company is marketing a product as “COVID vaccine-free,” they must be able to show:

• Documented donor medical history confirming the individual was not vaccinated, and/or
• Verifiable proof that the tissue was collected prior to widespread vaccination, i.e., before early 2021.

Anything collected before 2021 is now 4+ years old, which raises critical questions about how the product has been stored and preserved since collection. Unless it's been cryopreserved or culture-expanded, that tissue would likely fall outside the standard expiration window, even under the best storage conditions. Extending the shelf life of biologic products beyond one year typically requires cryopreservation using chemical additives like DMSO, which has been associated with cytotoxicity and potential mutagenicity in human cells [3]. These agents, along with the freeze-thaw cycle and culture and expansion (more on that below), may alter the integrity of native proteins and extracellular vesicles [4,5], raising concerns about product safety and therapeutic consistency in long-stored formulations.

3. The Culture-Expansion Question: Is That What You’re Really Getting?

To preserve and market tissue collected more than 4 years ago, companies may turn to cell culture and expansion, a process that grows cells in vitro to extend usability. But this changes the product entirely.

Culture-expanded tissues:

• Fall under FDA Section 351, which classifies them as biologic drugs [6]
• Require an Investigational New Drug (IND) application, a Biologics License Application (BLA), and adherence to full drug regulations [7]
• Are no longer minimally manipulated, and therefore are not comparable to fresh, acellular, amniotic fluid-based products

Expanded cells are also subject to changes in gene expression, cellular aging, and phenotypic drift, all of which can alter their clinical behavior [8,9]. For a deeper dive into what culture and expansion really means, and why it matters, check out our full blog on the topic here.

So, if a company is offering “COVID vaccine-free” tissue, and that tissue is actually more than 4 years old, they either:

• Need to be operating under full FDA drug regulation (Section 351), or
• Are making a claim that is unverifiable and possibly noncompliant

Either way, it’s worth questioning.

4. Marketing Without Evidence is Misinformation

Clinicians are right to ask for transparency—but claims that appeal to emotion or misinformation rather than data don’t serve the provider or the patient.

At Nova Vita Labs, we rely on:

• FDA-compliant protocols under 21 CFR Part 1271
• AATB-aligned donor screening standards
• Amniotic fluid collected from healthy, consenting donors in late-term Cesarean births
• No culture expansion, no biologic drugs—just acellular, native biologic material screened for sterility and safety

If a competitor is suggesting their product is “safer” or “purer” due to donor vaccination status, the logical next step is simple: Ask them for the paperwork and scientific proof. Without verified timelines and vaccine records, the claim doesn’t hold up. From a compliance standpoint, marketing unverified donor characteristics to imply clinical superiority could also raise ethical or legal concerns.

Conclusion: Let Science and Regulations Guide the Conversation

The safety and efficacy of regenerative products should be grounded in validated science—not speculative claims or vaccine misinformation.

There is no clinical or regulatory basis for preferring COVID-unvaccinated donor tissue. Suggesting otherwise may seem like a clever marketing tactic, but it collapses under scrutiny. If a company is making that claim, it’s worth asking: Where’s the proof—and what kind of product are they really offering?

References:

1. Shanes, E. D., Otero, S., Mithal, L. B., et al. (2021). SARS-CoV-2 Vaccination in Pregnancy: Measures of Immunity and Placental Histopathology. Obstetrics & Gynecology, 138(3), 405–407. https://doi.org/10.1097/AOG.0000000000004477
2. Goldshtein, I., Nevo, D., Steinberg, D. M., et al. (2022). Association of BNT162b2 COVID-19 Vaccination During Pregnancy With Neonatal and Early Infant Outcomes. JAMA Pediatrics, 176(5), 470–477. https://doi.org/10.1001/jamapediatrics.2022.0001
3. Santos NC, et al. (2003). Biophysical and biochemical damage induced by DMSO in human erythrocytes. Chemical Research in Toxicology, 16(2): 278–285. DOI: 10.1021/tx025631f
4. Lener T, et al. (2015). Applying extracellular vesicles based therapeutics in clinical trials – an ISEV position paper. J Extracell Vesicles, 4: 30087. DOI: 10.3402/jev.v4.30087
5. Witwer KW, et al. (2019). Storage of extracellular vesicles: a position paper of the International Society for Extracellular Vesicles. J Extracell Vesicles, 8(1): 1575678. DOI: 10.1080/20013078.2019.1575678
6. U.S. Food and Drug Administration. 21 CFR Part 1271. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
7. Galipeau, J., & Caplan, A. I. (2016). The mesenchymal stromal cells dilemma—Does a negative phase III trial of random donor MSCs mean that autologous cells are better? Cytotherapy, 18(1), 5–7.
8. Wagner, W., Horn, P., Bork, S., et al. (2008). Replicative senescence of mesenchymal stem cells: a continuous and organized process. PLoS ONE, 3(5), e2213.
9. Tarte, K., Gaillard, J., Lataillade, J. J., et al. (2010). Clinical-grade production of human mesenchymal stromal cells: occurrence of aneuploidy without transformation. Blood, 115(8), 1549–1553.

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