San Francisco-based biotech company Vaxart Inc. has announced that its lead COVID-19 oral vaccine candidate has been chosen to participate in the US Federal government’s Operation Warp Speed program. Under the initiative, the vaccine will be tested in a non-human primate (NHP) challenge study.
Vaxart’s vaccine joins six other COVID-19 vaccine candidates, deemed to be “the most promising” by the program, including ones from Johnson & Johnson, Moderna and AstraZeneca (the latter is in partnership with the University of Oxford). The vaccines are currently undergoing testing in large-scale, randomized, early-stage clinical trials to evaluate their safety and efficacy.
Operation Warp Speed is committed to funding the development and manufacturing of a coronavirus vaccine before the demonstration of vaccine efficacy and safety. According to the program’s mandate, while this carries financial risk, there is no product risk.
Vaxart’s candidate vaccine is in oral tablet form rather than an injection, and is stable at room temperature, making its administration, storage and transport relatively safe and easy.
“We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated. SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa – nose, mouth or eyes – strongly suggesting that mucosal immunity could serve as the first line of defense,” said Andrei Floroiu, Chief Executive Officer of Vaxart Inc. in a press release from the company.
Operation Warp Speed is a public-private partnership involving top US health agencies including the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) among others.
The program’s goal is to deliver millions of doses of a safe and effective vaccine for COVID-19 by January 2021 “as part of a broader strategy to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics (collectively known as countermeasures),” according to the HHS.
The need for a vaccine against the SARS-CoV-2 coronavirus that causes COVID-19 remains pressing as the global case count has now reached 10.2 million, with over half a million deaths.
In response to the growing number of outbreaks of the novel coronavirus around the world that began early this year, Vaxart initiated a program in January to develop a COVID-19 vaccine based on its VAAST (Vector-Adjuvant-Antigen Standardized Technology) oral vaccines platform, which uses adenovirus type 5 (Ad5) as a delivery system.
Vaxart generated oral vaccine candidates based on the published genome of the virus and demonstrated that it could elicit both mucosal and systemic immune responses in preclinical models. The mucosal immune response is of particular significance as the coronavirus is primarily an infection of the respiratory tract.
Results from the first round of preclinical testing, released by Vaxart at the end of January, showed animals that received one of the vaccines had statistically significant levels of anti-SARS-CoV-2 antibodies in their serum two weeks after the first vaccination, compared to untreated controls.
In May , the biotech company announced it had finally selected its lead COVID-19 vaccine candidate, partnering with KindredBio and Emergent BioSolutions to prepare for large-scale cGMP manufacturing, alongside clinical testing. Emergent has received $628 million dollars from Operation Warp Speed for the bulk manufacturing of COVID-19 vaccines.
Under Operation Warp Speed, the US government hopes to identify the most promising vaccine candidate while still undergoing development and testing. The federal program will provide support to expedite it through clinical and regulatory process in order to have it available for the public as soon as possible.
Since the announcement, Vaxart has seen the price of its shares sky-rocket on the US stock market. However, there is a tight race between the top vaccine contenders, as governments, health officials and the general public eagerly await a safe and effective vaccine for COVID-19.