“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” AstraZeneca said in a statement.
Source: Reuters
UK-based drugmaker AstraZeneca says the efficacy numbers published on March 22 were based on a pre-specified interim analysis with a data cut-off of 17 February.
The company said it intends to issue results of the primary analysis within 48 hours.
“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” AstraZeneca said in a statement.
“We are now completing the validation of the statistical analysis,” the statement added.
The British-Swedish behemoth also said it will immediately engage with the independent data safety monitoring board (DSMB) to share the primary analysis with the most up to date efficacy data.
The US National Institute of Allergy and Infectious Diseases (NIAID) said on Tuesday that AstraZeneca may have provided an incomplete view of efficacy data on its COVID-19 vaccine from a large scale U.S. trial.
AstraZeneca said a day earlier that its COVID-19 vaccine developed with Oxford University was 79 percent effective in preventing symptomatic illness in a large trial in Chile, Peru and the United States.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. agency said, referring to the independent Data Safety Monitoring Board (DSMB).
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
