Vaxart COVID-19 Oral Vaccine Description
Vaxart announced the initiation of a development program to develop an oral H1 influenza vaccine targeting the novel coronavirus SARS-CoV-2.
Vaxart oral recombinant vaccines are formulated as tablets that are enterically coated for efficient delivery to the small bowel. The enteric coating protects the active ingredient from the acidic environment in the stomach.
By targeting the small bowel, the vaccines engage the finely-tuned immune system of the gut to generate broad systemic and mucosal immune responses for robust, persistent immunity.
Vaxart is currently developing a liquid formulation for young children and adults who are unable to ingest tablets. Vaxart vaccines do not contain whole killed or attenuated viruses. No eggs are used in the production process.
On May 20, 2020, Sean Tucker, Ph.D., chief scientific officer of Vaxart, announced “In a phase 2 efficacy study, we have demonstrated that our oral H1 flu tablet vaccine protected against influenza infection after just 1-dose. Based on these results, we believe our vaccines are ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes COVID-19.”
“The results of our recently published influenza challenge study demonstrated that our oral tablet vaccine primarily protects through mucosal immunity, a potential key factor when targeting mucosal pathogens, such as this new coronavirus,” said Sean Tucker, Ph.D. chief scientific officer of Vaxart.
This was a Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
"For COVID-19, a key challenge will be to manufacture sufficient vaccine and efficiently vaccinate the millions at risk, and ultimately the entire population. Our vaccines are administered orally using a room temperature-stable tablet, an enormous logistical advantage over injectable vaccines in large vaccination campaigns."
Vaxart is a clinical-stage biotechnology company primarily focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. This development effort is based on the oral vaccine platform, VAAST.
Vaxart completed Phase 1 trials for an H1N1 influenza A strain and for an influenza B strain, demonstrating safety and immune responses that correlate with protection from influenza. For more information, please visit www.vaxart.com.
Vaxart COVID-19 Oral Vaccine Indication
This Oral vaccine candidate oral H1 flu tablet is indicated to prevent the new SARS-CoV-2 coronavirus, which causes COVID-19 disease in humans.
In preclinical testing, all animals that received one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls.
Vaxart plans to select one or more vaccine candidates for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.
Vaxart COVID-19 Oral Vaccine Dosage
An oral H1 flu tablet vaccine administered using a room temperature-stable tablet could be of logistical and critical benefit during major public health vaccination campaigns.
Vaxart COVID-19 Oral Vaccine News
July 14, 2020 - Some experts say a vaccine puffed in the nose would be better at protecting people from infection.
June 26, 2020 - Vaxart, Inc. announced that its oral COVID-19 vaccine has been selected to participate in a non-human primate challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccines for Americans by January 2021.
May 20, 2020 - Sean Tucker, Ph.D., chief scientific officer of Vaxart said: “In a phase 2 efficacy study that was recently published in the Lancet Infectious Diseases, we have demonstrated that our oral H1 flu tablet vaccine protected against influenza infection after just one dose. Based on these results, we believe our vaccines are ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes COVID-19.”
May 20, 2020 - Kindred Biosciences, Inc. announced it has entered into an agreement with Vaxart, Inc. for the manufacture of Vaxart’s oral vaccine candidate for COVID-19. KindredBio will produce the candidate vaccine bulk drug substance under Good Manufacturing Practices, and provide it to Vaxart to be formulated into a vaccine tablet to be taken by mouth instead of by needle injection. KindredBio will manufacture the vaccine for clinical trials beginning in the second half of 2020.
May 14, 2020 - Coronavirus vaccine taken by tablet instead of injection is about to go into human trials.
May 12, 2020 - Vaxart, Inc. provided a corporate update. “In January we pivoted to COVID-19, and we are now on track to start the first Phase 1 study in the second half of this year with our oral tablet vaccine,” said Wouter Latour, MD, chief executive officer of Vaxart. “We are developing a state-of-the-art gene-based vaccine utilizing our proprietary vector platform, and the lead candidate vaccines performed well in preclinical testing, generating very high levels of antibodies.”
April 21, 2020 - Vaxart announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose.
March 18, 2020 - Vaxart announced that it has entered into an agreement with Emergent BioSolutions Inc., whereby Emergent will deploy its molecule-to-market contract development and manufacturing services to help develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease-19 (COVID-19).
January 31, 2020 - Vaxart, Inc. announced today that it has initiated a program to develop a coronavirus vaccine candidate based on its proprietary oral vaccine platform, VAAST.
September 1, 2015 - Study: High-titer neutralizing antibodies to influenza after oral tablet immunization: a phase 1, randomized, placebo-controlled trial.
2014 - Vaxart, Inc., announced clinical results demonstrating that its H1N1 tablet vaccine generates protective immunity comparable to currently licensed influenza vaccines, as measured by hemagglutinin inhibition assay (HAI), the established correlate of protection. Vaxart’s founder and chief scientific officer, Sean Tucker, Ph.D., discussed the data in a presentation today at the 15th Annual World Vaccine Congress in Brussels.