The Trump administration announced Monday that it has opened an investigation into whether a California biotechnology company manipulated information about its emergency drug, a controversial immunotherapy that uses a herpes vaccine to reduce the effects of meningitis and pneumonia in transplant patients.
The Department of Health and Human Services said in a press release that it was probing whether Vaxart improperly aired untrue claims of success for Covid-19 in the press or other publicly accessible venues.
“Information released by Vaxart has made its claims appear to be more than scientifically accurate,” said Robert Califf, the secretary of health and human services.
Vaxart had said Covid-19, which is used to prevent meningitis, prevented life-threatening pneumococcal complications of infections in patients receiving transplants. In fact, clinical trials showed that although the vaccine successfully reduced the rate of pneumococcal infection and pneumonia, it didn’t protect patients for as long as those who received other vaccinations, according to a statement issued by HHS and Health and Human Services Secretary Alex Azar.
The question of whether Vaxart manipulated information about Covid-19 is not a new one. A 2017 investigation by STAT News found that Vaxart made similar false and misleading claims about the vaccine in 2016. The company filed a lawsuit alleging that STAT News was responsible for publishing false reports about the vaccine.
The complaint stated that STAT reported false information about the results of clinical trials and appeared to be driving a “drastic increase in investor buying” of Vaxart’s stock after it reported that Covid-19 provided “statistically significant protection” for patients, STAT reported.
Vaxart’s stock rose 9,857 percent after the story was published, STAT reported. In a statement at the time, the company said “this is not something that we publicly disclose and thus it is highly likely that our sales could be affected.”
The dispute sparked concerns that companies are using the public’s faith in science and medicine to sell their products.
Vaxart has denied that it manipulated its medical data. The company previously disputed STAT’s assertion that Covid-19 prevented pneumonia in transplant patients, saying, in a statement, that “it provides protection from three distinct stages of pneumococcal meningitis.”
But at the time, some doctors said that was not the case, according to STAT News.
The company said it has sued STAT because it was forced to respond to the article before it was published. However, a spokeswoman for STAT News told STAT News in a statement: “The STAT News article published on Nov. 22, 2016 was based on more than 60 hours of extensive interviews with experts both in the field and outside the industry. The writer was the recipient of materials from Vaxart showing that Covid-19 may have provided protections from three distinct stages of meningitis. The article was researched and published with the full and proper consideration of a fair and thorough journalistic standard.”
Covid-19 is one of several vaccine candidates Vaxart is developing, including vaccines for hepatitis A and hepatitis B. The company’s share price, which stood at $4.22 early on Friday, has fluctuated since the company announced on Oct. 2 that it was testing Covid-19 in a mid-stage trial. Its shares declined 3.79 percent on Monday and tumbled 9.05 percent on Tuesday to $2.32.