AstraZeneca issued updated phase III trial data for its COVID vaccine on Wednesday after facing questions on its accuracy of its preliminary US study.
The company now says its vaccine is 76% effective in protecting against symptomatic cases of virus. A release issued on Monday reported a symptomatic efficacy rate of 79%, but the next day, the National Institute of Allergy and Infectious Diseases said it had been informed the company may have included information from its US results that provided an “incomplete view of the efficacy data.”
The updated report still says that the vaccine is 100% effective against severe disease and hospitalisation. A number of US health officials have criticised the company for what seemed like cherry-picking of data in an effort to improve the results’ appearance.
At the time, AstraZeneca said the figures were based on a “pre-specified interim analysis” and promised it would share an updated analysis in the coming days.
Dr Anthony Fauci, White House chief medical advisor and director at the NIAID, was more supportive of the company, calling the situation “unfortunate” and said it was likely AstraZeneca would issue a modified statement.
“This is really what you call an unforced error because the fact is this is very likely a very good vaccine,” Fauci told ABC’s Robin Roberts on “Good Morning America” on Tuesday. “This kind of thing does … really cast some doubt about the vaccines and maybe contribute to the hesitancy. It was not necessary.”
The BBC’s medical editor, Fergus Walsh, was told the results may have been rushed out of a desire to address the safety concerns surrounding possible blood clots. These had resulted in AstraZeneca vaccines being withdrawn from circulation in some European countries.
The updated results include 190 symptomatic cases out of over 32 000 participants — about 50 more symptomatic cases than the data set released on Monday.
The findings suggest the vaccine is more effective in patients aged 65 and older, with a newly reported efficacy rate of 85% for that population, up from 80% stated earlier.
AstraZeneca reiterated that there were no safety concerns with the vaccine and that it was well tolerated.
Source: NBC News