Journal of Excipients and Food Chemicals

This Journal is © IPEC-Americas
December 2020 J. Excipients and Food Chem. 11 (4) 2020 76
*Corresponding address: 5204 Coventry Court, Colleyville, TX 76034,
Tel: 817 501 2984, E-mail: [email protected]
Excipients and mRNA Vaccines.
Shireesh P. Apte*
Editorial Board, Journal of Excipients and Food Chemicals
KEY WORDS: Immuno polarization, immuno modulation, excipient, vaccinology, SARS-CoV-2, mRNA vaccine, lipid nano particles,
lipid excipients
The rapid development of the Moderna and Pfizer/
BionTech mRNA vaccines to combat the pandemic
spread of the SARS-CoV-2 virus has ushered in a new
era of vaccinology. The plug-and-play mRNA vaccine
paradigm has arrived. The accelerated development
of this technology will have a synergistic impact on
the lipidic excipient industry. Excipient molecules
will have considerable importance, considering their
critical role in protecting the labile mRNA sequence
from degradation, facilitating the cellular ingress and
the endosome egress of the mRNA cargo.
The lipidic excipients that constitute the mRNA
carrying lipid-nanoparticles (LNP) can themselves
modulate specific immune responses depending on
their chemical properties, structure and charge. For
example, cationic lipids induce TH-1 cytokines such
as IFN-γ and IL-2. Moderna’s LNP is composed of
a proprietary ionizable lipid, and three commercially
available lipids; cholesterol, DSPC, and DMGPEG2000.
By a fortuitous circumstance, the choice of
FDA approved lipidic excipients is quite voluminous
so that a variety of LNPs’ can be constructed that
can meet diverse immuno-modulation, immunopolarization
and mRNA stabilization requirements.
Both the Moderna and the Pfizer/BionTech vaccines
elicited TH-1 responses in clinical trials.
Among the many advantages of RNA vaccines are:
the ability to be completely synthetically manufactured;
in a short time (the time from sequence selection to
Phase I dosing was ~ two months for the SARS-CoV2
vaccine), the use of the same platform (equipment,
design) with minimal adaptation to process and/or
formulation to manufacture vaccines against multiple
viruses or strains or receptor binding domains (RBD).
Furthermore, mRNA vaccines obviate the risk of preexisting
immunity, that is often seen with viral vectorbased
vaccines such as the adenovirus type-5 (Ad5)
vectored vaccine from CanSino Biologics Inc. or the
Sputnik-V® Ad5 and Ad26 vectored vaccine. Almost
70% and 80% of the US and the African populations
respectively are estimated to have preexisting
neutralizing antibodies against Ad5. Astra-Zeneca
therefore has chosen an adenoviral vector that infects
chimpanzees instead of humans, for its non-replicating
viral vector based ChAdOx1 nCoV-19 vaccine in an
“…..Morn came and went—and came, and brought no day,
And men forgot their passions in the dread of this their desolation……”
Darkness, Byron
This Journal is © IPEC-Americas December 2020 J. Excipients and Food Chem. 11 (4) 2020 77
attempt to intracellularly deliver a larger fraction of
the injected dose. For the same reason, Johnson and
Johnson selected the serotype 26 vectored vaccine
expressing the full-length spike glycoprotein.
Concurrent with the opportunity to elicit a desired
antibody and CD4+ TH response, exogenous mRNA
manufactured intracellular proteins can also elicit a
CD8+ T response through the major histocompatibility
class I (MHC-I) pathway. Activation of cell mediated
immunity may be more important than humoral
immunity since it can be the only means for combating
emerging pathogens that may not induce neutralizing
antibodies. For example, one of the reasons an HIV
vaccine does not yet exist is because the virus rarely
induces neutralizing antibodies. Moreover, the mRNA
itself can be codon optimized or nucleotide modified.
This can be used to adjust the magnitude of the immune
response and/or increase the intracellular expression of
the immunogenic protein. The mRNA coded antigen
protein glycosylates using the cell’s own glycosylation
machinery, hence immune generated antibodies using
the mRNA platform should theoretically have a greater
affinity for the viral RBD.
Since one mRNA sequence is specific to one unique
RBD, multiple mRNA sequences are required to protect
against multiple viruses (or pathogens) or multiple
strains or mutations of one virus (or pathogen). This
assures that cross-reactivity or ‘trained immunity’ to
different strains of the same virus or different viruses
(as is possible with conventional weakened, killed or
vectored vaccines) is eliminated due to the homogenous
‘clean’ structure and nature of the mRNA and provides
a continuous stream of revenue in tandem with not
only new virus threats; but also against different RBD,
or virus strains or mutations. Since, by all accounts, the
mRNA vaccine only provides short-term immunity,
further revenue stream enhancement is possible
because the dosing frequency, vis-a-vis conventional
vaccines, is significantly increased. Multiple (several
times a year) shots of the same vaccine may need
to be administered to one individual throughout his
or her lifetime. Although the possibility of bundling
several mRNA sequences into one vaccine exists, the
increased probability of multiple emerging zoonotic
threats, as well as mutation and immune response type
eliciting specific mRNA vaccines, will continue to drive
market expansion. If it is subsequently discovered
that the response of different population groups to
mRNA vaccines tweaked to elicit specific polarized
immune responses is immune-gene-regulation specific
(combinations of mRNA vaccines and checkpoint
inhibitors), the market penetration of mRNA vaccines
along with the potential to save lives will increase
exponentially. A caveat that must be mentioned, is
that long-term clinical data on mRNA vaccines is nonexistent,
therefore, their potential to cause long-term
deleterious effects is unknown.
As the pharmaceutical industry pipeline of traditional
blockbuster drugs continues to dry up, there is an
opportunity for previous areas that traditionally
provided limited revenue, to not only take a more
prominent role, but to become more profitable, than
they have been in the past. In fact, the mRNA technology
promises to convert the hitherto unprofitable or lowprofit,
moribund field of vaccinology, into a more
vibrant revenue-stream. Comparable in magnitude to
the discovery of penicillin and its enormous potential
to save lives, the rise of the plug-and-play mRNA
vaccine paradigm will necessarily accelerate the growth
in the lipidic excipient industry as well. These valueadded
lipid molecules will now be selected based
on their intrinsic ability to protect the labile mRNA
sequence from degradation, to increase intracellular
and endosome-to-cytosol delivery and to selectively
modulate and polarize the immune system, making
them essential to the success of mRNA therapeutics,
and driving yet another nail in the coffin of the
definition of excipients as ‘inactive ingredients’.
Lipid excipients can be judiciously chosen, or new
molecules manufactured, that will determine how
much (if any) and what aspects of the LNP formulated
mRNA be self-adjuvanting. Lipid excipients may
facilitate the formulation of mRNA vaccines that are
more efficacious, dose sparing, less thermolabile, have
desirable immuno-modulating and immuno-polarizing
characteristics and more amenable to technology
transfer across the globe. Pre-defined lipid excipient
ratio LNPs can be categorized, in which mRNA with a
This Journal is © IPEC-Americas December 2020 J. Excipients and Food Chem. 11 (4) 2020 78
specified range of properties can be formulated using
predefined protocols. Such a cookie-cutter formulation
approach can keep pace with new mRNA sequence
introduction so that new vaccines can be quickly mass
produced and dosed to tame emerging pandemics
before they cause global disruptions. As a species, we
may yet be able to stay ahead of Byron’s dystopian
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