mRNA COVID-19 Vaccine
- Generic Name
- mRNA COVID-19 Vaccine
McMaster University Launches Phase-2 Trial of Novel Inhaled COVID-19 Vaccine
• Canadian researchers at McMaster University have begun phase-2 clinical trials for AeroVax, an innovative inhaled COVID-19 vaccine that directly targets the lungs and upper airways where infection begins.
• The $8M CIHR-funded study aims to recruit 350 participants across Hamilton, Ottawa, and Halifax, testing a needle-free alternative that preliminary data suggests induces stronger immune responses than traditional injected vaccines.
• This entirely Canadian-developed vaccine could potentially reduce recurrent infections by providing robust protection at the infection site, with plans to advance to phase-3 efficacy trials following successful completion.
Vaxart Advances Oral Vaccine Programs for COVID-19, Norovirus, and Influenza
• Vaxart's Phase 2b COVID-19 oral vaccine trial is set to expand to 10,000 participants, pending FDA review of safety data and BARDA approval.
• A Phase 1 trial for Vaxart's second-generation oral norovirus vaccine constructs is planned for the first half of 2025, with initial data expected by mid-2025.
• Preclinical studies are underway for a new avian influenza vaccine candidate, designed to address the latest clade 2.3.4.4b strains.
• Vaxart's existing funding, including a Project NextGen award, is expected to sustain operations into 2026, supporting key clinical and regulatory milestones.
Simultaneous COVID-19 and Flu Vaccines Show Similar Safety Profile to Sequential Administration
• A randomized clinical trial found that simultaneous administration of mRNA COVID-19 and inactivated influenza vaccines (IIV4) has a similar safety profile to sequential administration.
• The study assessed reactogenicity, serious adverse events (SAEs), and adverse events of special interest (AESIs) over 121 days, finding no significant differences between the two groups.
• Participants aged 5 years and older were included, with assessments of health-related quality of life (HRQOL) conducted pre-vaccination and daily for 7 days post-vaccination.
• The findings support CDC recommendations for simultaneous administration of COVID-19 and influenza vaccines, offering practical benefits for vaccine delivery.
FDA Approves Updated COVID-19 Vaccines Targeting Omicron Subvariants for 2024-2025 Season
• The FDA has approved updated mRNA COVID-19 vaccines from Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty) targeting the Omicron KP.2 subvariant for the 2024-2025 season.
• Novavax's updated protein-based COVID-19 vaccine, targeting the Omicron JN.1 subvariant, has also received emergency use authorization for individuals 12 years and older.
• The updated vaccines are formulated to provide improved protection against currently circulating variants, addressing waning immunity from previous exposure or vaccination.
• Health officials recommend that everyone aged 6 months and older receive a COVID-19 vaccine, particularly those at higher risk of severe illness.
Drug Development Updates
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