- AstraZeneca and the University of Oxford are facing criticism for the results of the COVID-19 vaccine trial after they acknowledged a mistake in vaccine dosing.
- In the study, some patients received two full doses of the vaccine, while others had a half dose in the first shot and a full dose in the second.
- AstraZeneca CEO Dr. Mene Pangalos described the “error” as “serendipity”: The vaccine was 90% effective in the group against the initial half-dose, compared to 62% in the full-dose group.
- Some health experts have expressed concern about the mistake. “Astrazeneca / Oxford is rated poorly for transparency and rigor,” said a biostatist at the University of Florida.
- Pangalos told The Wall Street Journal on Wednesday that the mistake was “insignificant.”
- Visit the Business Insider website for more news.
AstraZeneca and the University of Oxford on Wednesday acknowledged a dosing error in their COVID-19 vaccine trial – and some health experts say it has eroded their self-confidence in the shot.
The COVID-19 vaccine was on average 70% effective, according to the large-scale study results announced on Monday. The vaccine was 62% effective in those who had two full doses, but rose to 90% in those who had half the dose at the first shot.
On Monday, AstraZeneca acknowledged that half the dose was initially a “mistake,” Reuters first reported. The plan was for patients in the UK study to receive two full doses of the vaccine one month apart, but some received half the dose for their first shot.
“We went back and checked … and learned that the vaccine dose was halved,” Dr. Mene Pangalos, head of AstraZeneca, who is responsible for the company’s research and development, told Reuters.
Half a dose seemed to increase the effectiveness of the vaccine, and Pangalos described the defect as “serendipity.”
“Essentially, that’s how we stumble into doing half the full dose (group),” Pangalos said. – Yes, it was a mistake.
More than 20,000 volunteers in the UK, Brazil and South Africa took part in the studies.
In a press release on Monday, AstraZeneca said less than 2,800 patients received the smaller dosing regimen, compared to nearly 8,900 patients who received two full doses.
Some experts raised concerns about the error.
On Tuesday, Moncef Slaoui, head of the U.S. vaccination program against Operation Warp Speed, told reporters that participants receiving the half-strength starting dose were under the age of 55, according to The New York Times.
If half the dose has not been tested in elderly patients, this raises questions about the effectiveness of AstraZeneca, as elderly people are usually at the highest risk of serious infection.
In addition, the results of the effectiveness of clinical trials in the UK and Brazil, which, according to The Times, were designed differently, were collected.
John LaMattina, former president of Pfizer’s global research and development unit, is a beep “it was hard to believe” that the Food and Drug Administration would issue an emergency license for a vaccine whose most effective dose had been given to 2,300 people.
—John LaMattina (@John_LaMattina) November 24, 2020
John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, told The Times: “The press release raised more questions than it answered.”
Natalie Dean, a biostatisticist at the University of Florida who designs vaccine studies, posted on Twitter: “Astrazeneca / Oxford gets poor quality transparency and rigor when it comes to the results of vaccine trials they report.”
He asked how AstraZeneca had tracked the investigations.
“I really don’t know what to do with the results,” Dean wrote in a follow-up tweet. “I’m glad it’s not the first vaccine they’re reading because it’s terribly confusing for experts and non-experts alike.”
—Natalie E. Dean, PhD (@nataliexdean) November 24, 2020
Read more: Wall Street analysts explain how an unexpected break in AstraZeneca’s coronavirus vaccine trial could slow down the pandemic stop
AstraZeneca did not respond immediately to Business Insider’s comments, but a spokesman told The Times that the negotiations were “conducted to the highest standards”.
Pangalos also told The Wall Street Journal on Wednesday that the mistake was “insignificant.”
“Either way, cut the data – even if we only believe in full-dose, full-dose data … We still have efficacy that reaches the approval threshold for a vaccine that is more than 60% effective – ot “he said.
This is not the first hurdle AstraZeneca and Oxford University have faced. Their vaccine trials were paused after an “unexplained disease” in one of the UK’s experimental participants in September. But they were soon given the green light to start again.
This month, pharmaceutical manufacturers Pfizer and Moderna announced that late-stage test results suggest that their vaccines are about 95% effective in preventing COVID-19.
Although AstraZeneca has been shown to be less effective, the manufacturers say it is significantly cheaper and easier to distribute than the other two.