Post by icemandios on Mar 23, 2021 17:03:21 GMT
UPDATED: Middle-of-the-night NIH statement raises concerns on AstraZeneca's US vaccine trial readout
Zachary Brennan
Senior Editor
The NIH took the very unusual step to release a statement at midnight, raising fresh questions about data from AstraZeneca’s US-based Covid-19 vaccine trial.
The statement says that late Monday, the Data and Safety Monitoring Board (DSMB) overseeing the trial notified the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and AstraZeneca “that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
NIH added, “We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
AstraZeneca said in a statement on Tuesday, “The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February. We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis. We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
Eric Topol, director of the Scripps Research Translational Institute, criticized the AstraZeneca statement on Twitter.
The identities of those on the DSMB are not publicly disclosed, although it’s the same group of experts that oversaw previous Covid-19 vaccine trials run by Moderna and Johnson & Johnson, and NIAID director Tony Fauci serves as the designated senior representative of the US government for the oversight group. But he does not participate in the DSMB process of developing recommendations regarding a clinical trial.
Fauci told Good Morning America on Tuesday that the DSMB sent a “harsh note” on how the data were outdated in the AstraZeneca press release and “might be misleading,” which led NIAID to put out the statement to bring the company and DSMB back together to discuss the data. “This is what you really call an unforced error because the fact is this is very likely a very good vaccine but this does nothing but cast some doubt about the vaccines and maybe contribute to the hesitancy. It was not necessary. The data really are quite good but when they put it into the press release it wasn’t completely accurate.”
AstraZeneca said Monday morning that an interim analysis of the trial of more than 32,000 participants showed the vaccine had 79% efficacy at preventing symptomatic Covid-19. The company also said on a call with the press that it saw 5 cases of severe disease among participants who received placebo in the trial and 0 among those who got vaccine, leading to 100% efficacy finding for severe disease. But that detail was not included in the press release.
Mene Pangalos, EVP at AstraZeneca, also confirmed that “there are more cases that have happened since the interim” analysis, so “the number will be higher.” He also explained that two trial participants received the vaccine for every one participant that received placebo, “so it’s highly significant and again we continue to have zero cases on the vaccine arm as we look at the cases.”
The company had said it expects to submit the findings to the FDA in the first half of April for an emergency use authorization — and would release 30 million doses if the authorization comes. Another 20 million would be delivered within a month.
The AstraZeneca vaccine has been under a cloud of uncertainty from the beginning, with the FDA halting the US trial from September to late October due to a safety concern, and then European countries halting its use as they investigated blood clots before restarting the use of the shots. The company has been roundly criticized for its handling of the data before, and this new incident promises to raise fresh doubts that could drag back the rollout around the world.
Michael Carome, director of Public Citizen’s Health Research Group, added in a statement, “This remarkable NIAID statement once again highlights the dangers of disseminating critical scientific information by company press release. There is no better way to undermine public confidence in a vaccine than for the manufacturer to make comments overstating the product’s effectiveness or safety and to then have to backtrack.”
Zachary Brennan
Senior Editor
The NIH took the very unusual step to release a statement at midnight, raising fresh questions about data from AstraZeneca’s US-based Covid-19 vaccine trial.
The statement says that late Monday, the Data and Safety Monitoring Board (DSMB) overseeing the trial notified the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and AstraZeneca “that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
NIH added, “We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
AstraZeneca said in a statement on Tuesday, “The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February. We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis. We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
Eric Topol, director of the Scripps Research Translational Institute, criticized the AstraZeneca statement on Twitter.
This @astrazeneca statement in response to the @nih press release is unacceptable. They know exactly what is going on w/r to the time cutoff for 1° analysis, which appears to be at odds with the independent Data and Safety Monitoring Board. It should not take 48 hrs to sort out
Fauci told Good Morning America on Tuesday that the DSMB sent a “harsh note” on how the data were outdated in the AstraZeneca press release and “might be misleading,” which led NIAID to put out the statement to bring the company and DSMB back together to discuss the data. “This is what you really call an unforced error because the fact is this is very likely a very good vaccine but this does nothing but cast some doubt about the vaccines and maybe contribute to the hesitancy. It was not necessary. The data really are quite good but when they put it into the press release it wasn’t completely accurate.”
AstraZeneca said Monday morning that an interim analysis of the trial of more than 32,000 participants showed the vaccine had 79% efficacy at preventing symptomatic Covid-19. The company also said on a call with the press that it saw 5 cases of severe disease among participants who received placebo in the trial and 0 among those who got vaccine, leading to 100% efficacy finding for severe disease. But that detail was not included in the press release.
Mene Pangalos, EVP at AstraZeneca, also confirmed that “there are more cases that have happened since the interim” analysis, so “the number will be higher.” He also explained that two trial participants received the vaccine for every one participant that received placebo, “so it’s highly significant and again we continue to have zero cases on the vaccine arm as we look at the cases.”
The company had said it expects to submit the findings to the FDA in the first half of April for an emergency use authorization — and would release 30 million doses if the authorization comes. Another 20 million would be delivered within a month.
The AstraZeneca vaccine has been under a cloud of uncertainty from the beginning, with the FDA halting the US trial from September to late October due to a safety concern, and then European countries halting its use as they investigated blood clots before restarting the use of the shots. The company has been roundly criticized for its handling of the data before, and this new incident promises to raise fresh doubts that could drag back the rollout around the world.
Michael Carome, director of Public Citizen’s Health Research Group, added in a statement, “This remarkable NIAID statement once again highlights the dangers of disseminating critical scientific information by company press release. There is no better way to undermine public confidence in a vaccine than for the manufacturer to make comments overstating the product’s effectiveness or safety and to then have to backtrack.”