AstraZeneca Will Release More Vaccine Data As Health Officials Detail Worries
After members of a U.S. safety board questioned AstraZeneca's new covid vaccine trial data, Dr. Anthony Fauci said the drug maker needs to "straighten" out its issues. Worries deepen that trust in the vaccine has taken a hit.
Axios:
AstraZeneca Commits To More Vaccine Data After Concerns From NIH
AstraZeneca acknowledged on Tuesday morning that a press release about its U.S. coronavirus vaccine trial was based on data through Feb. 17, and promised to release more complete results that are "consistent with" the interim data within the next 48 hours. The National Institute of Allergy and Infectious Diseases (NIAID) released an unusual statement early Tuesday expressing concerns that AstraZeneca's release may have used "outdated information" that "may have provided an incomplete view of the efficacy data." (3/23)
The Wall Street Journal:
U.S. Health Officials Raise Concerns Over AstraZeneca Vaccine Data
AstraZeneca said it would update and reissue later this week efficacy data from human trials of its Covid-19 vaccine after U.S. officials took the rare move of publicly questioning their accuracy—the latest misstep by the British drug giant as it struggles to get its shot into American arms. ... The day before, AstraZeneca released interim data from a large-scale U.S. trial that it said found its Covid-19 vaccine to be 79% effective in preventing symptomatic disease. (Strasburg, Burton and Walker, 3/23)
Politico:
Fauci: AstraZeneca Needs To 'Straighten Out' Vaccine Data
The DSMB “wrote a rather harsh note” to AstraZeneca with NIAID Director — and Biden medical adviser — Anthony Fauci copied in, he told POLITICO. “The issue that the DSMB had is straightforward and very simple: The DSMB had data that they know the company had. When they saw the press release, they said, ‘wait a minute — the data in the press release do not reflect the most recent data that we know you have,'" he said. Fauci also discussed the issue during an appearance Tuesday morning on "Good Morning America." The data board felt the data released by AstraZeneca "might, in fact, be misleading a bit, and wanted them to straighten it out," he said. (Owermohle, 3/23)
Also —
Stat:
Mishaps, Miscommunications Overshadow AstraZeneca’s Covid Vaccine
Yet again, AstraZeneca is in a crisis of its own making. The latest in the drug manufacturer’s long string of mishaps and miscommunications came Tuesday, when top federal health officials accused the company of highlighting in a press release overly positive data about the efficacy of its coronavirus vaccine. It came after widely publicized snafus like administering incorrect doses during clinical trials and keeping U.S. regulators in the dark after pausing a trial entirely due to safety concerns. (Joseph and Facher, 3/23)
Stat:
Swashbuckling CEO Flies AstraZeneca Into Turbulence
It took eight years, a failed hostile takeover, and a sweeping scientific turnaround for AstraZeneca CEO Pascal Soriot to become one of the drug industry’s leading lights. Now, after 11 bumbling months of Covid-19 vaccine development, the French-born executive finds himself at the center of a multinational credibility crisis, moving from scandal to scandal as his rivals bask in global acclaim. (Herper and Garde, 3/23)
The Wall Street Journal:
AstraZeneca Covid-19 Vaccine Dispute Shines Spotlight On Data Monitoring Boards
The dispute over AstraZeneca’s Covid-19 vaccine trial has exposed the crucial role played by independent expert panels in behind-the-scenes oversight of clinical pharmaceutical trials. The panels, called data and safety monitoring boards, are typically composed of medical experts and scientists such as biostaticians, clinicians and epidemiologists. They are tasked with safeguarding the safety of study volunteers and the scientific integrity of the studies, said Joseph Ross, professor of medicine and of public health at Yale University School of Medicine. (Walker, 3/23)
