James F Cummings
Image credits: Vaxart
Vaxart, Inc announced that an independent Data Safety Monitoring Board (DSMB) has reviewed the initial 30-day safety data from a sentinel cohort of 400 participants in its Phase 2b COVID-19 vaccine trial. The DSMB has recommended that the trial proceed without modifications, signaling a positive safety profile for the investigational vaccine.1
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study designed to evaluate the relative efficacy, safety, and immunogenicity of Vaxart’s oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults previously vaccinated against the virus.1
In an online interview, James F Cummings, MD, Vaxart’s chief medical officer, elaborated on the significance of the DSMB’s safety review for Vaxart’s oral COVID-19 vaccine and what it indicates about the vaccine’s potential as an alternative to injectable options. He said, “To date, Vaxart’s vaccine platform has maintained a clean safety profile in studies comprising more than 800 participants across our pipeline of vaccines. While Vaxart remains blinded, we are encouraged that, after careful review, the DSMB has authorized this study to continue, without modification, into the 10,000 person cohort, the next step in this study upon favorable review from FDA and following BARDA approval.”
Cummings continued, outlining key milestones and data points to watch for as the trial moves into the next phase, “This 10,000 person cohort should take about 6 months to fully enroll. There is then a 12 month follow-up period for safety, immunogenicity, and efficacy. We will remain blinded until the last study volunteer completes their 12-month follow-up visit, then complete our analysis of these key features (safety, efficacy, and immunogenicity).”
He further discussed the importance of backing from the FDA and BARDA in determining whether Vaxart’s oral vaccine could become a viable option in the COVID-19 vaccine landscape, “Vaxart performs all of its clinical trials in compliance with regulatory requirements. The FDA review is a required step of our clinical trial and serves to ensure that the trial is conducted in accordance with FDA regulations, important as a necessary step toward licensure. We are grateful for the support and partnership with BARDA in moving this vaccine effort forward as part of Project NextGen, which will allow us to determine whether our investigational vaccine, which elicits both a systemic and mucosal response, could be an alternative to current injectable vaccines that target a serum response.”
What You Need To Know
The DSMB recommended that Vaxart’s Phase 2b COVID-19 vaccine trial proceed without modifications based on the initial safety data.
The trial will expand to 10,000 participants, with a 12-month follow-up period to assess safety, immunogenicity, and efficacy.
Vaxart’s oral vaccine is supported by BARDA and NIAID as part of Project NextGen, with funding of up to $460.7 million.
In October 2024, Cummings first spoke with Contagion when Vaxart had just initiated its Phase 2b trial.2 He highlighted the vaccine’s potential to generate systemic and mucosal immune responses, which could provide stronger protection, especially against emerging variants. He also noted the logistical advantages of an oral vaccine, stating, “It’s a pretty neat idea, and that we have a pill-based form that’s thermally stable. This is something that has stability at room temperature and doesn’t require a needle, syringe, or any medical professional to administer. From start to finish, it’s a very economical way of fielding a vaccine for global health.”3
He also discussed the need for more durable vaccines that can provide lasting protection against mutating strains: “One key aspect of the response to COVID-19 has been the initial vaccine efforts, which were impressive given we started from scratch. This was made possible by significant investments from the government and various institutions in improving capabilities and technologies. However, while it was a strong start, it wasn’t the best approach moving forward. We know the virus mutates several times a year, so we need a more durable and broader response.”4
In conclusion, Vaxart’s Phase 2b trial is progressing after receiving a positive safety review from the DSMB. The trial will expand to 10,000 participants to further assess the vaccine’s safety, efficacy, and immune response. The oral vaccine, with its potential to target both systemic and mucosal immunity, offers a practical alternative to injectable vaccines. Supported by the FDA and BARDA under Project NextGen, Vaxart is exploring whether this vaccine can provide lasting protection against COVID-19, especially as the virus continues to evolve.
