AstraZeneca said on Wednesday that the results of a primary analysis of US test data show that its vaccine is 76 percent effective against Covid-19 days after questioning whether its previously reported efficacy rate may have been based in “outdated information”.
On Monday, the company announced a 79 percent effectiveness rate after an interim analysis of the Phase 3 trial.
In an unusual move, a federal health institute said concerns were raised that AstraZeneca may have included “outdated information” that provided an incomplete view.
The company said the initial results were based on data with a cutoff point on February 17 and promised to release more up-to-date information quickly. The company said on Wednesday that the latest primary analysis confirms that the vaccine is safe and effective.
In announcing the 76 percent effectiveness rate on Wednesday, AstraZeneca said again that the vaccine developed with the University of Oxford is 100 percent effective in preventing serious and fatal cases.
AstraZeneca said in Wednesday’s statement that the 76 percent rate comes from the results of the primary analysis from the U.S. Phase 3 study and is consistent with the “pre-specified interim analysis” that was announced on Monday.
AstraZeneca said it will now ask the Food and Drug Administration for emergency use authorization and will release its data for analysis by the scientific community in the peer-reviewed literature.
More than 50 countries worldwide have approved the AstraZeneca vaccine.
The National Institute of Allergy and Infectious Diseases said on Tuesday that the Data and Security Monitoring Council “expressed concern that AstraZeneca may have included outdated information from that study, which may have provided an incomplete view of the efficacy data.”
The number of symptomatic cases in the trial changed between the two statements.
There were 190 symptomatic cases, representing 49 additional cases from the interim analysis, the company said on Wednesday.
There are 14 other possible or probable cases, so the number may fluctuate, he said.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the situation unfortunate and an “unforced mistake”.
“The fact is, this is most likely a very good vaccine,” said Fauci on ABC’s “Good Morning America” program on Tuesday.
“It was not necessary,” he said. “If you look at them, the data is really very good. But when they put it in the press release, it was not entirely accurate.”
Although the overall prevention rate for symptomatic Covid-19 was assessed by AstraZeneca to be 76%, the company reported that, for those 65 and older, the rate was 85%.
The AstraZeneca Phase 3 trial had 32,449 participants. There were no cases of serious illness and hospitalization among those who received the vaccine, AstraZeneca said. He said there were eight serious cases among the group that received the placebo.
Mene Pangalos, the company’s executive vice president for biopharmaceutical research and development, said the results of the primary analysis are also consistent with the intermediate analysis.
“We look forward to presenting our regulatory submission for Emergency Use Authorization in the U.S. and preparing for the launch of millions of doses across America,” said Pangalos in the company statement.
The FDA will eventually decide whether or not to grant emergency use authorization, and health officials say that this will only be done after an independent and thorough review.
If authorized for use, it would be the green light room in the USA
A vaccine developed by Pfizer and BioNTech was the first to receive authorization from the FDA, which occurred in December. Since then, Moderna and Johnson & Johnson vaccines have received emergency use authorization.
More than 85 million people in the United States have received at least one dose of the Covid-19 vaccine, and of these, more than 46 million have been fully vaccinated, according to the Centers for Disease Control and Prevention.
There have been more than 30 million cases of Covid-19 in the United States, according to a count of NBC News reports. More than 547,000 people died.
