CureVac, a biopharmaceutical company, recently announced it began a Phase I dose-escalation clinical trial for its mRNA-based rabies vaccine and stated that mRNA can “simplify” vaccine manufacturing.
The breakthrough of vaccines ended epidemics and prevented outbreaks – a powerful technology that is gaining breakthrough status with mRNA leading the charge. Big pharma companies like Pfizer have signed hundred-million dollar deals into mRNA-based vaccine research.
Manufacturers like BioNTech, Pfizer’s partner in mRNA vaccine research, said that mRNA vaccine manufacturing can be more cost-effective as the vaccines do not require the same amount of quality control as typical virus-based vaccines.
Vaccines with mRNA technology are also able to rapidly adjust to changing viruses allowing for greater protection, according to BioNTech.
Moderna, another vaccine manufacturer, recently opened an mRNA specific vaccine manufacturing site to develop its mRNA-based pipeline.
mRNA vaccine manufacturing isn’t limited to these companies, AstraZeneca, eTheRNA, and Sanofi have all invested into the potential ‘game-changer’ technology.
In-PharmaTechnologist (IPT) spoke with Dan Menichella (DM), CEO of CureVac, about its prophylactic rabies vaccine (CV7202) and where mRNA exists in the vaccine manufacturing sector.
IPT: What role does mRNA technology play in today’s vaccine industry?
DM: mRNA vaccines are a promising alternative to conventional vaccine approaches because of their high potency, potential for rapid development and production, and low cost to manufacture.
You can see the excitement around the mRNA technology by the recent investments and partnering in the space.
An important advantage of this vaccine technology is its potential to rapidly adapt a vaccine candidate to match circulating strains – it allows an efficient and fast transfer to large-scale production. In addition, mRNA offers a unique potential for the development of multivalent vaccines targeting a high number of antigens.
IPT: How does manufacturing differ for the creation of vaccines using mRNA as opposed to traditional methods?
DM: mRNA vaccines have the potential to significantly simplify vaccine manufacturing and product release.
mRNA-based vaccines, for different disease targets, can be manufactured in a single multiproduct facility using standardized production methods. This allows a faster, cheaper, more potent and more flexible (one for all) manufacture as compared to traditional vaccines.
We believe mRNA technology has the potential to be disruptive and replace a significant part of traditional vaccine manufacturing since it can be easier and faster, resulting in reduced costs in the long -term.
IPT: In the future can mRNA vaccine technology be applied to different uses outside the prophylactic use?
DM: The lipid nanoparticle (LNP) formulation we are using for our rabies vaccine is also applicable to other local administrations of mRNA requiring a local immune activation, like therapeutic cancer vaccines or intratumoral mRNA treatments. Our preclinical results in these settings appear very promising.
IPT: How did CureVac design this trial?
DM: With our mRNA-based vaccine, we are testing either a one-shot dose for the travelers market and a two-shot dose for post exposure. In a pre-clinical study, a single intramuscular vaccination of non-human primates with this mRNA vaccine induced antibody titers well above the World Health Organization’s (WHO) [guidance of] titer of 0.5 IU/ml, which remained stable during an observation period of up to nine months. The human clinical trial design will provide important insights as to how these preclinical data translate into humans, which will guide the further development of our platform.
