Oxford-AstraZeneca to publish results of US vaccine trial
London/Chicago – Oxford-AstraZeneca will publish up-to-date results from its major United States coronavirus (COVID-19) vaccine trial within 48 hours after health officials publicly criticised the drugmaker for using “outdated information” to show how well the immunisation worked.
The rare public rebuke marks the latest setback for the vaccine once hailed as a milestone in the fight against the COVID-19 pandemic that has since been dogged by questions over its effectiveness and possible side effects.
Oxford-AstraZeneca said results it published on Monday in which the vaccine had demonstrated 70 per cent efficacy were based on an interim analysis of data through February 17, and it would now “immediately engage” with the independent panel monitoring the trial to share its full analysis.
The British-based drugmaker on Tuesday said it had reviewed the preliminary assessment of its full, or primary, analysis and found it to be consistent with the interim report.
But the Washington Post reported that the data monitoring panel told federal officials they had been working with the company through March, had seen data that showed the vaccine might be 69 per cent to 74 per cent effective, and had “strongly recommended” AstraZeneca include that information in its public statement.
AstraZeneca shares fell 1.8 per cent in London trading.
The US National Institute of Allergy and Infectious Diseases (NIAID) said on Monday that the independent monitoring panel had expressed concern the company may have included outdated data that gave an incomplete view of the shot’s effectiveness.
NIAID Director Dr Anthony Fauci called the whole issue a really unfortunate unforced error.
“This kind of thing does . . . nothing but really cast some doubt about the vaccines and may contribute to the hesitancy,” he told ABC’s “Good Morning America.”
“The data really are quite good but when they put it into the press release it wasn’t completely accurate,” he said.
In addition to the 79 per cent efficacy in stopping symptomatic illness in the trial conducted in the United States, Chile and Peru, the data reported on Monday also showed the shot was 100 per cent effective against severe or critical forms of the disease and posed no increased risk of blood clots.
Dr Larry Corey, co-leader of the US Coronavirus Vaccine Prevention Network, which helped design AstraZeneca’s US trial, said the monitoring panel’s rebuke was something he had not seen before. The virologist at Fred Hutchinson Cancer Research Centre in Seattle, praised the panel for speaking up, saying it showed the system of checks and balances worked.
One US-based investigator who was not authorized to speak publicly said AstraZeneca was not wrong to publish an analysis it had described as interim and expressed concern over the public controversy. (Reuters)