AstraZeneca says data is ‘consistent’ with previous analysis after NIH questioned use of outdated results for COVID-19 vaccine

Kate Feldman, New York Daily News
·2 min read

AstraZeneca, the British-Swedish pharmaceutical company headed to market with its COVID-19 vaccine, said Tuesday that its published results went exactly as planned, despite questions from the National Institute of Health.

The National Institute of Allergy and Infectious Diseases, part of the NIH, offered a rare rebuke early Tuesday morning, questioning whether AstraZeneca had used “outdated information” from a clinical trial “which may have provided an incomplete view of the efficacy data.”

A day earlier, the pharmaceutical company crowed that its two-dose vaccine is 79% effective at preventing symptomatic cases of COVID-19, with no reported severe illnesses or hospitalizations among vaccinated volunteers.

“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,” the NIAID said in a statement.

But AstraZeneca pushed back immediately, saying the data they gathered and then released was a “pre-specified interim analysis with a data cut-off” of Feb. 17.

A preliminary assessment of the analysis released Monday showed that the results were “consistent” with interim analysis, the company said. That analysis will be released within 48 hours.

AstraZeneca, which plans to request approval from the Food and Drug Administration next week, has had a messier launch than other vaccines. More than a dozen countries recently suspended their use of the shot over concerns over blood clots, although the European Union’s drug regulator determined last week that there was no link between the vaccine and blood clots.

“This is really what you call an unforced error because the fact is this is very likely a very good vaccine & this kind of thing does, as you say, do nothing but really cast some doubt about the vaccines & maybe contribute to the hesitancy,” Anthony Fauci, President Biden’s chief coronavirus adviser, said on “Good Morning America” Tuesday.

If approved in the U.S., AstraZeneca would become the fourth available vaccine stateside, joining Moderna, Pfizer and Johnson & Johnson.