Evaluating Safety and Efficacy of Vaxart's Oral Vaccine's Impact on COVID-19 Variants
Part 2 with James F Cummings, MD, as he discusses the need for a stronger response to emerging variants, the importance of protecting high-risk populations, and the potential to reduce vaccine hesitancy through easier administration.
Vaxart has announced the start of a sentinel cohort for its Phase 2b clinical trial, which will evaluate the safety, immunogenicity, and effectiveness of its oral COVID-19 vaccine candidate in comparison to an approved mRNA vaccine. This trial, valued at up to $456 million under Project NextGen, seeks to tackle ongoing challenges related to COVID-19. The study will examine various factors, including effectiveness against symptomatic and asymptomatic COVID-19, immune responses, and the occurrence of adverse events. The primary goal will be to assess the relative efficacy of Vaxart’s vaccine in preventing symptomatic disease, with results expected 12 months after vaccination.
In discussing the broader implications of the trial with James F. Cummings, MD, chief medical officer of Vaxart, he noted the initial successes in COVID-19 vaccine development, highlighting the role of significant investments in improving capabilities and technologies. He stated, “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, along with effective biosurveillance to identify the issues and convert that data into actionable information for solutions. 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. For instance, if a vaccine is administered today, it should still be effective against strains that emerge six months later. This is where mucosal immunity comes into play.”
The first phase of the trial will enroll 400 participants, with 200 receiving Vaxart’s oral vaccine candidate and 200 receiving the approved mRNA vaccine. After a 30-day safety assessment by an independent Data and Safety Monitoring Board (DSMB) and the FDA, the trial will proceed to a second phase, which aims to enroll an additional 10,000 participants to ensure diverse demographic representation, including at least 25% of participants over the age of 65.
Cummings expressed enthusiasm about the next generation of vaccines, noting the logistical advantages of developing a vaccine that does not require complex refrigeration infrastructure. “We aim to create a vaccine for everyone, especially focusing on protecting those at highest risk. In our trial, 25% of participants will be over 65 or at higher risk for severe disease. Historical data from past COVID-19 infections shows that these individuals are at the greatest risk, so we want to assess how well the vaccine prevents symptomatic disease and infections, as well as how effectively it triggers a strong immune response.”
He added that their platform has demonstrated no immune decline in older adults, with similar immune responses observed in both older and younger participants. “This is encouraging because older adults often require higher doses or additional boosters to achieve a robust immune response, but our platform doesn’t show that age-related decline.”
Cummings also addressed the importance of making vaccines accessible and easy to administer. “One significant issue is vaccine hesitancy; many people, including some in my family, are hesitant because they don’t like needles. Our approach could eliminate that concern, as it may be suitable for home use, similar to some vaccines already approved for home administration.” One significant issue is vaccine hesitancy; many people, including some in my family, are hesitant because they don’t like needles. Our approach could eliminate that concern, as it may be suitable for home use, similar to some vaccines already approved for home administration.”
All in all, Vaxart's Phase 2b trial aims to develop an oral COVID-19 vaccine. The study will assess safety and efficacy by comparing its candidate to an approved mRNA vaccine. This effort could improve public health and address vaccine hesitancy in the fight against COVID-19.
Watch part 1 of Cummings interview here: https://www.contagionlive.com/view/vaxart-initiates-phase-2b-study-of-oral-covid-19-vaccine
