Vaccine Administration: The Growing Role of Prefilled Syringes
Prescribers and patients alike appreciate safe and easy vaccine administration. Today, of the 900 or so vaccine-development programs that are reported to be in development in Informa’s PharmaProjects database with known route of administration, one quarter are being evaluated in non-injectable formats, including oral, inhaled, and nasal routes, notes Cornell Stamoran, PhD, vice-president of corporate strategy and government affairs for Catalent, and about one third of these non-injectable programs are already in the clinical phases.
“There are also examples of promising R&D activities involving microneedle patches (which deliver the vaccine subcutaneously via a reservoir or coating on the needles), and, potentially, certain vaccines could be dried and stabilized in the microneedles to overcome issues related to logistics and ultracold storage conditions,” notes Vincenza Pironti, PhD, senior staff scientist, research and development, pharma services for Thermo Fisher Scientific. However, Pironti continues, “the regulatory landscape is still unclear about the acceptance criteria of these newer forms, as methods for release are still unclear, but these new modalities can represent potential solutions in the future.”
“Initial theoretical work and early R&D efforts suggest that the transdermal route may work, but more study and clinical trials are required to establish the safety and efficacy profiles and demonstrate benefits of this alternative approach, and then move toward the manufacturing considerations to allow these novel products to reach the market,” adds Stamoran.
In June 2022, Catalent announced it is carrying out a feasibility study with Israeli biopharmaceutical company MigVax, to investigate the possibility of delivering the COVID-19 vaccine to the oral mucosae (for absorption through the mouth and intestines) using Catalent’s proprietary Zydis Bio orally disintegrating tablet (ODT) technology, which creates a freeze-dried tablet that disperses in the mouth without water (1).
MigVax’s lead oral vaccine program for COVID-19, MigVax-101, which would be transported using the Zydis Bio ODT in unrefrigerated vehicles and stored in standard warehouses, “has shown positive results in preclinical tests,” said the companies at the time of the announcement. MigVax is also working with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop oral tablet vaccines that are broadly protective against both SARS-CoV-2 variants and other coronaviruses, such as severe acute respiratory syndrome and Middle East respiratory syndrome.
Early work is also underway to pursue intranasal vaccines for COVID-19. Today, several dozen companies are at work, exploring not just aerosolized sprays but also nasally administered drops, powder, and gels (2).