A unit of the National Institutes of Health has cast a shadow on findings released by AstraZeneca that pointed to promising results from a U.S. trial of its two-dose Covid-19 drug.
AstraZeneca’s response indicated that it would issue results from its own analysis in two days.
In what pharma industry observers viewed as a stunning move, the Data and Safety Monitoring Board notified AstraZeneca and federal research entities that it was concerned about AZ’s information on initial data from the trial.
The data indicated that the two-shot drug effectively halted hospital stays and deaths from Covid-19 and compared favorably with the one-dose Johnson & Johnson vaccine.
The board expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the drug’s effectiveness.
“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,” a release stated.
AstraZeneca issued the following statement.
“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.
The statement continued, “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.”
Authorization and guidelines for using the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after a review of the data by independent advisory committees, the release stated.
The National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services.
The vaccine, which has been authorized in dozens of nations, has a rocky history in human trials.
An early trial was paused and later resumed when one person developed a rare condition.
An apparent mix-up led to half doses being administered in one trial outside the U.S. The trial indicated a second dose spaced 12 weeks out showed a high level of effectiveness.
The trials in the United States did not include a wider spacing of doses, although AstraZeneca included the earlier finding in a press release announcing the latest trial’s results.
The U.S. government has invested $1 billion in research and agreed to purchase hundreds of millions of doses of the AZ vaccine, which comes with advantages that include low costs and storage in a refrigerator rather than a deep freeze.
AstraZeneca employs about 1,500 in Delaware.
