One month after Vaxart announced the selection of its lead vaccine candidate for COVID-19, the Bay Area-based company said it has been selected to participate in the U.S. government’s Operation Warp Speed program. X. The problem, however, is that Vaxart was not among the pharmaceutical companies selected by the U.S. government through Operation Warp Speed to receive substantial funds to support their research and production efforts. There are occasionally "classic pump and dump scheme[s]" when a smaller company puts out an exaggerated claim, as alleged in the Vaxart lawsuits, Parasidis told ABC News. “We are cooperating with the U.S. attorney’s office regarding these requests and have provided documents and information in response,” Vaxart said in the securities filing. ", In a statement to ABC News, a spokesperson for Vaxart denied the allegations, writing, "The Vaxart non-human primate challenge study was organized and funded by Operation Warp Speed, as stated in the June 26, 2020 company press release. The HHS declined to comment on Vaxart's vaccine. and is cooperating with this informal inquiry.”. Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available 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). Operation Warp Speed (OWS) is a public–private partnership initiated by the U.S. government to facilitate and accelerate the development, manufacturing, and distribution of … The New York Times reported the next month that Vaxart appeared to have overstated its involvement in Operation Warp Speed. According to the Department of Health and Human Services (HHS), which sponsors the program, Operation Warp Speed aims to "deliver 300 million doses of a … Vaxart, a small California biotechnology working on a COVID-19 vaccine, is now being investigated by the government and sued by investors for allegedly exaggerating its role in the Trump administration's Operation Warp Speed, a multibillion dollar program to accelerate COVID-19 vaccine and treatment research. The Vaxart logo displayed on a smartphone. Operation Warp Speed has granted billions of dollars to more than a half-dozen pharmaceutical companies based on the promise of their vaccine technology. Watch live coverage as President Trump gives an update on Operation Warp Speed and his administration's coronavirus response. A number of shareholder lawsuits have also been brought against Vaxart, its executives and its board, accusing the company of misleading investors by overstating its role in Operation Warp Speed. Perhaps the biggest news is that Vaxart's drug has been selected by Operation Warp Speed for funding. Rather, its involvement with the program was limited, with its vaccine candidate selected for sponsorship in their preliminary test studies on animals. The company is not currently receiving federal funding as part of Operation Warp Speed. On Oct. 14, Vaxart revealed in a Securities and Exchange Commission filing that it is being investigated by federal prosecutors and the SEC over the disclosure of its involvement in Operation Warp Speed. But the company, which had just 15 employees this summer, is not among the drug makers that have received substantial funding for their research and production efforts through Operation Warp Speed. The biotech's experimental vaccine candidate is unique because it is an oral tablet, as opposed to administered by an injection, like many of the others in development. The biotech firm said it was under scrutiny about claims it made on its involvement in Operation Warp Speed, the federal program to develop Covid-19 cures. . Operation Warp Speed has granted billions of dollars to more than a half-dozen pharmaceutical companies based on the promise of their vaccine technology. 24/7 coverage of breaking news and live events. The statements made in that press release are accurate and any allegation to the contrary is baseless.". Vaxart is one of dozens of companies pursuing coronavirus vaccines. ABC News' George Stephanopoulos on Tuesday spoke with Dr. Moncef Slaoui, Operation Warp Speed's chief science adviser, and asked him for an … "In August 2020, the Enforcement Division of the Commission requested that the Company provide, on a voluntary basis, a variety of documents that broadly pertain to same subject matters of the documents provided to the U.S. Attorney’s Office, and related matters," the company wrote in its SEC filing. Turn on desktop notifications for breaking stories about interest? In a statement to CNN Business Saturday, … Operation Warp Speed’s opaque choices of COVID-19 vaccines draw Senate scrutiny. Despite the ongoing controversy, Vaxart shares soared again this week after the company announced a major milestone in its COVID-19 vaccine research. Shares of the US vaccine developer jumped 63% before the opening bell. In October 2020, Vaxart was under investigation by the SEC and federal prosecutors after the company may have exaggerated its role in and investment from Operation Warp Speed. By Jon Cohen Jul. Vaxart Inc. VXRT, -1.52% said Friday its oral COVID-19 vaccine has been selected to take part in a non-human primate challenge study funded by the U.S. government's 'Operation Warp Speed… The company announced in June that it had been selected to participate in Operation Warp Speed, the U.S. government’s flagship effort to develop cures and treatments for Covid-19. Vaxart, a California biotech firm that is attempting to develop a Covid-19 vaccine, has come under scrutiny from federal prosecutors and the Securities and Exchange Commission. It added that it had “voluntarily provided documents requested by the S.E.C. The announcement sent its stock price skyrocketing to $17 from less than $3 a share prior to the news release. This week, the company said that it had begun its Phase 1 trial and that initial tests on hamsters had yielded promising results. Vaxart's COVID-19 Vaccine Candidate Tapped for Operation Warp Speed Primate Study. U.S. Investigates Vaxart’s Claims Related to Covid-19 Vaccine. Vaxart Inc said on Friday it would test its potential COVID-19 vaccine on monkeys in a study organized by the Trump Administration's vaccine-acceleration program called "Operation Warp Speed". Such lawsuits are not uncommon, according to Ohio State University professor of law and public health Efthimios Parasidis. Published: Jun 26, 2020 By Alex Keown. Operation Warp Speed is the federal government … By Sara Murray, CNN. MORE: Faster development of COVID-19 vaccine could raise global incomes by $9 trillion, IMF says, MORE: COVID-19 vaccine: Lessons from 2001's anthrax attacks. "We are cooperating with the U.S. Attorney’s Office regarding these requests and have provided documents and information in response," it wrote. Vaxart announced its inclusion in Operation Warp speed a day after disclosing plans to ramp up manufacturing of its COVID-19 vaccine to one billion or more doses a … Vaxart said it had received a subpoena from the Justice Department concerning its role in Operation Warp Speed and the stock sales in July, the company disclosed in a securities filing this week. JUST WATCHED This week, Vaxart said it had administered its first oral dose to a volunteer. . Vaxart’s COVID-19 Vaccine Selected for the U.S. Government’s Operation Warp Speed Its vaccine candidate was one among those being tested in an animal trial sponsored by the federal initiative. The company said it had begun its first-phase trial on 48 volunteers aged 18 to 54 years old after initial tests on hamsters yielded promising results. . In 2019, several hedge funds invested in Vaxart, with the largest investment coming from Armistice Capital which acquired 25.2 million shares. “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. Officials at the Department of Health and Human Services, which is coordinating Operation Warp Speed, distanced the department from the company, saying it was involved only in preliminary studies but had not yet won government support. A woman in medical garb holds a syringe and vial. The company was served with a grand jury subpoena in July from the U.S. District Court for the Northern District of California. In August, the S.E.C.’s enforcement division requested documents from the company about the same matter, Vaxart said in the filing, which was reported earlier by Fierce Pharma, a trade publication. Vaxart stock rocketed Friday after the federal government selected its coronavirus vaccine for the Operation Warp Speed program. But Vaxart’s involvement in Operation Warp Speed was limited. its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021,” as well as that Vaxart is “. Science’s COVID-19 reporting is supported by the Pulitzer Center.. Vaxart's vaccine, an oral tablet, was only involved in preliminary studies on primates sponsored by Warp Speed. CNN's Jake Tapper interviews the head of Operation Warp Speed Moncef Slaoui about the pending FDA approval of the Pfizer coronavirus vaccine. ABC News chief medical correspondent Dr. Jen Ashton talks about the trials being paused at this stage and concerns of the time it's taking. On June 26, 2020, Vaxart announced that “. At times, "startup companies get so excited at the prospect of making money that they sometimes shoot out press releases without a proper review. 2, 2020 , 7:10 PM. But in June of this year, Vaxart claimed it was "one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated." Investment. SARS … The company announced in June that it had been selected to participate in Operation Warp Speed, the U.S. government’s flagship effort to develop cures and treatments for Covid-19. Operation Warp Speed has granted billions of dollars to more than a half-dozen pharmaceutical companies based on the promise of their vaccine technology. Nonetheless, the company in June issued a news release that stated: “Vaxart’s Covid-19 Vaccine Selected for the U.S. Government’s Operation Warp Speed.” That sent shares of the company soaring, and within days, a hedge fund, Armistice Capital, had sold shares worth more than $200 million. Vaxart said the study would be organized by "Operation Warp Speed", a joint program by the U.S. Department of Health and Human Services (HHS) and the Department of … "The Company has voluntarily provided documents requested by the SEC and is cooperating with this informal inquiry.". SOUTH SAN FRANCISCO, Calif., June 26, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc., a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, today announced that its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program … Florida newspaper issues retraction of its endorsement of political candidate, Permanent resident facing deportation hoping for Biden's help: 'Need a miracle', Trump admin offered $700M to 9/11 victims to save Sudan deal, Jury: Black bikers' race was a factor, but city won't pay. Vaxart said the study would be organized by "Operation Warp Speed", a joint program by the U.S. Department of Health and Human Services (HHS) and the Department of Defense that aims to speed up the development of coronavirus vaccines, treatments and diagnostics. Vaxart, a small California biotechnology working on a COVID-19 vaccine, is now being investigated by the government and sued by investors for allegedly exaggerating its role in the Trump administration's Operation Warp Speed, a multibillion dollar program to accelerate COVID … That sent Vaxart’s stock price soaring, allowing a hedge fund that controlled the company to reap an instant $200 million profit by selling shares. But in June of this year, Vaxart claimed it was "one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated.". . Vaxart's small size and lack of experience in bringing vaccines to market also raises questions about the company's ability to meet the goals of Operation Warp Speed. ", It is important to note that the company's actions may not always be intentionally devious, added Parasidis. In addition, the SEC filing outlines several similar lawsuits filed in California and one in Delaware since August alleging violations of federal securities laws by Vaxart and a number of its officers and directors. Updated 2146 GMT (0546 HKT) May 1, 2020 . Trump administration's 'Operation Warp Speed' identifies 14 vaccines to focus on By Chandelis Duster and Jim Acosta , CNN Updated 10:44 AM ET, Mon May 4, 2020 Trump grants 'Operation Warp Speed' a blank check to develop vaccine, source says. The California company Vaxart disclosed receiving a subpoena from federal prosecutors. Within days, a hedge fund that partly controlled the company, Armistice Capital LLC, sold shares, reaping a $200 million profit on alleged insider trades. The value of Vaxart stock has fallen more than 50 percent since mid-July, when it hit new highs on the heels of its Operation Warp Speed announcement. "The market realizes the claims are exaggerated, the stock falls and then these lawsuits happen. 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