Unintended consequences potentially explain vaccine failure from the outset

One of the curious findings from the original randomized trials of mRNA vaccines was an explosive rate of early infection after the first injection as compared with placebo.

In a recent paper from Sfera et al, the description of pathological syncytia or fusion between immune cells is described: “The LNP technology, to put it simply, mimics viral envelopes with externalized phosphatidylserine (ePS), a universal “eat me” signal, that directs immune cells to engulf the particle.

Sfera A, Thomas KG, Sfera DO, Anton JJ, Andronescu CV, et al. (2022) Do Messenger RNA Vaccines Induce Pathological Syncytia?. Int J Pathol Clin Res 8:137. doi.org/10.23937/2469-5807/1510137

However, as ePS is also a potential “fuse me” signal, LNP may inadvertently facilitate the formation of pathological syncytia. Moreover, ePS may activate a disintegrin and metalloprotease 10 and 17 (ADAM10) (ADAM 17), master regulators of syncytia formation, contributing further to the unintended consequence of cell-cell fusion…

As mRNA vaccines are based on pre-fusion epitopes, the fusion pathology may be undeterred, allowing viral infection by syncytia formation to continue unabated. This is significant, as it could account for the reoccurrence of COVID-19 symptoms in fully vaccinated individuals.”

The authors point out that SARS-CoV-2 utilizes more than just the ACE2 receptor to gain entry into the fused cells and by overlooking this possibility, vaccine developers have made a blunder. This is further complicated by the choice of lipid nanoparticles and polyethylene glycol which facilitate entry into organs were syncytia as well as Spike protein will incite inflammation and immune system regulation.

Sfera also considers pregnancy: “Several studies demonstrated that SARS-CoV-2 can activate HERV-W, an ancestral gene that encodes for the physiological placental fusogen syncytin-1 responsible for the merger of trophoblasts during the early pregnancy. This suggests that the reproductive post-vaccine events may be triggered by the furin cleavage site pathology.” Such processes could occur in the gravid uterus and compound the bleeding and clotting risks of ill-advised vaccination is this special population.

In summary Sfera et al point out the following blind spots of well-funded DARPA consultants, BARDA funded academic researchers, and later by Pfizer and Moderna in mRNA vaccine development:

1) pathologic syncytia formation,

2) use of lipid nanoparticles with PEG,

3) failure to consider SARS-CoV-2 could use alternative points of cell entry other than ACE2 (metalloprotease pathway, antibody dependent enhancement, cell penetrating peptides, viroporins).

With billions of people rushed into indiscriminate mRNA vaccination, virologists and immunologists will be picking up the pieces of a failed vaccine campaign that has left so many at risk for more SARS-CoV-2 infections and progressive complications over the months and years to come.