British-Swedish pharma company AstraZeneca may have included outdated information from their COVID-19 vaccine trial, the US National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released Tuesday. 

The NIAID, part of the National Institutes of Health, urged AstraZeneca to work with the US  Data Safety and Monitoring Board (DSMB) to review the efficacy data to ensure up-to-date efficacy data can be made public as quickly as possible. 

The AstraZeneca US Phase III trial results published on Monday showed a 79% vaccine efficacy of preventing symptomatic COVID-19, and 100% efficacy at preventing severe disease and hospitalization. 

However, US health officials felt that the information was “outdated” and may have provided an incomplete view of the efficacy data. 

NIAID Director Anthony Fauci also discussed the issue during an appearance Tuesday morning on Good Morning America. 

“Because the fact is, this is likely a very good vaccine,” said Fauci. “It [just] wasn’t completely accurate.” 

Unforced Error

Fauci calls AstraZeneca’s “unforced error” something that will cause some people to doubt the vaccines and contribute to the ongoing vaccine hesitancy. 

“We essentially have to keep trying as hard as we can to get people to understand that there are safeguards in place,” he added, calling the DSMB’s ability to pick up on the discrepancy one example of a safeguard. 

While Fauci oversees the DSMB that assessed the trial results for AstraZeneca and other vaccine makers, he is not directly involved in its assessments. The final decision will be made by the US Food and Drug Administration (FDA), which will conduct their own review following the independent advisory committees. AstraZeneca plans to file with the FDA by mid-April, though their timeline relies on the DSMB clearing its trial results.  

AstraZeneca responded to the NIAID’s claims, saying in a statement that the numbers published on Monday were consistent and said it will “immediately engage with the DSMB to share our primary analysis with the most up to date efficacy data.” The company intends to issue results of the analysis within the next 48 hours.  

‘Stunned’ Health Experts Question AstraZeneca’s Credibility 

The national institute’s statement stunned experts, leaving them to question the pharma company’s credibility.  Dr Eric Topol, a clinical trials expert at Scripps Research in San Diego, called AstraZeneca’s response to the DSMB’s statement “unacceptable”. 

“They know exactly what is going on with respect to the time cutoff for primary analysis, which appears to be at odds with the independent Data and Safety Monitoring Board. It should not take 48 hours to sort out,” Topol tweeted on Tuesday.  

“Let’s see all the data, AstraZeneca,” Topol added, calling out the company. “Let’s be clear. This is not about the vaccine. It is about AstraZeneca, their own worst enemy, with an apparent breach on data dissemination. And where is the University of Oxford on this, their partner?” 

Topol had called the DSMB’s statement, which is supported by the National Institutes of Health, to be “unprecedented” in the history of large scale clinical trials. 

“I am rarely speechless. This turn of events has rendered me speechless. What a debacle,” said Helen Branswell, senior writer at Stat News.  

Branswell quoted the Washington Post, which said that the “AstraZeneca results were the equivalent of “telling your mother you got an A in a course, when you got an A in the first quiz but a C in the overall course.” 

Branswell added that, after this “extraordinary public rebuke of AstraZeneca by the DSMB”, the company team will “face tough, tough questioning.” 

Laurie Garrett, a former senior fellow at the Council on Foreign Relations, tweeted that the Board should “fire the entire AstraZeneca management team. “[The team] has made so many major blunders in launching the company’s COVID-19 vaccine that it will be a textbook study for decades in business schools and Communication departments.” 

The renewed skepticism for the pharma company in the US may counter the European Medicines Agency’s statement last week, which declared that the vaccine was safe, in spite of rare blood clotting events seen in Europe. 

Image Credits: Flickr, National Institutes of Health.