HHS Lifts Freeze on Vaxart's COVID-19 Study as Vaccine Developers Face Regulatory Challenges
The Department of Health and Human Services (HHS) has lifted its stop order on Vaxart's COVID-19 vaccine trial, allowing the biotech company to resume patient screening and enrollment. This development comes as other vaccine developers in the space continue to grapple with regulatory hurdles and scrutiny.
Vaxart's Study Resumes with Government Oversight
Vaxart announced in an SEC filing on Monday that HHS had unfrozen its COVID-19 vaccine trial, which had been paused since February. The company can now proceed with its multi-billion-dollar contract, signed under the Biden administration, for the development of an oral COVID-19 vaccine.
The lifted stop order permits Vaxart to:
- Resume incurring costs related to the project
- Participate in meetings and communicate with collaborators, including government entities
- Reactivate field sites and assess potential participants for the 10,000-patient portion of the study
However, HHS has stipulated that Vaxart must engage in further discussions with the Biomedical Advanced Research and Development Authority (BARDA) regarding "costs, timelines, and regulatory pathway agreement." The biotech has already held a virtual meeting with BARDA to discuss dosing plans for the study.
Challenges Persist for Other Vaccine Developers
While Vaxart's study has been given the green light to proceed, other COVID-19 vaccine developers continue to face obstacles:
GeoVax's Project NextGen Halted
GeoVax, another company developing a COVID-19 vaccine with government support, received an HHS stop work order earlier this month. The company's multi-antigen injection, GEO-CM04S1, is part of Project NextGen, a $5-billion initiative under the Biden administration focused on next-generation vaccines and therapies.
GEO-CM04S1, currently in Phase IIb development, has shown promise as both a primary and booster shot, even in patients who previously demonstrated substandard responses to approved vaccines.
Novavax Faces FDA Delays
Novavax, meanwhile, is dealing with delays in the FDA approval process for its COVID-19 vaccine. The agency missed its April 1 decision deadline and has requested a postmarketing commitment from the company to generate additional clinical data. Despite these setbacks, Novavax maintains that its investigational vaccine is "approvable."
Broader Vaccine Market Faces Scrutiny
Beyond COVID-19-specific challenges, the broader vaccine market is encountering increased skepticism from health authorities. HHS Secretary Robert F. Kennedy recently suggested that vaccine complications may be more common than currently understood, citing inadequacies in the existing surveillance system.
Kennedy is proposing changes to the Vaccines Adverse Event Reporting System to better identify the potential "contribution" of vaccines to various health outcomes, though specific details of these proposed changes remain unclear.
As the pharmaceutical industry continues to navigate these regulatory and public perception challenges, the resumption of Vaxart's study represents a positive development in the ongoing effort to combat COVID-19 and improve vaccine technologies.
References
- HHS Unfreezes Vaxart’s COVID-19 Study, Resumes Funding as Headwinds Batter Vaccines Space
While Vaxart can proceed with its study, fellow COVID-19 vaccine developers GeoVax and Novavax continue to be hamstrung by various regulatory roadblocks.
Explore Further
What are the specific efficacy and safety endpoints being assessed in Vaxart's resumed COVID-19 vaccine trial?
How does Vaxart's oral COVID-19 vaccine compare in clinical development stage and potential market differentiation to other vaccines such as GEO-CM04S1 and Novavax?
What are the anticipated regulatory hurdles Vaxart might still face with the BARDA and other agencies regarding its COVID-19 vaccine?
What impact might the proposed changes to the Vaccines Adverse Event Reporting System have on the regulatory landscape for Vaxart and other vaccine developers?
What is the competitive landscape of COVID-19 vaccines under development in terms of innovation, particularly within the framework of Project NextGen?