A nurse makes syringes with the preparation of Astrazeneca in Axel Stelzner’s family doctor’s practice.
Hendrik Schmidt | Image alliance via Getty Images
LONDON – A US health agency announced Tuesday that AstraZeneca may have included outdated information in its Covid-19 vaccine trial results, which may cast doubts on published efficacy rates.
It comes just a day after the results of a large U.S. study showed the vaccine was safe and highly effective, and questions whether AstraZeneca can apply for U.S. approval for the vaccine as planned next month.
The Data Safety Monitoring Board “was concerned that AstraZeneca may have included out of date information from this study that may provide an incomplete view of the efficacy data,” the US National Institute of Allergy and Infectious Diseases said in a statement.
“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible.”
NIAID said it was notified of the concerns late Monday along with AstraZeneca and the Biomedical Advanced Research and Development Authority. Under the direction of the White House Chief Medical Officer, Dr. Anthony Fauci, the NIAID is part of the National Institutes of Health.
On Monday, US study results showed that the coronavirus vaccine developed by AstraZeneca and Oxford University is 79% effective in preventing symptomatic illness and 100% effective against serious illness and hospitalization.
The results were welcomed as “surprisingly positive” and “good news for the global community”. It was believed that the trial data could help build public confidence after a number of countries temporarily stopped using the vaccine for safety reasons.
AstraZeneca did not immediately respond to a CNBC request for comment.
AstraZeneca’s shares were down nearly 1% in London on Tuesday.
“It is not unknown that a DSMB disagrees with investigators about the interpretation of the test results,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine on Tuesday.
“It’s usually done privately so I think this is unprecedented,” he added. “I don’t particularly worry if they haven’t found a security issue that has been hidden, which it doesn’t seem to be.”
AstraZeneca said it plans to prepare the primary analysis, which will be submitted to the U.S. Food and Drug Administration for emergency approval before mid-April.
Data from the late-stage human study was based on more than 32,000 volunteers at 88 trial centers in the United States, Peru, and Chile.
The introduction of the vaccine against Oxford-AstraZeneca had stopped in several countries after blood clots were reported in some people who had been vaccinated. Health experts sharply criticized the precautionary measure and cited a lack of data, while analysts expressed concern about the impact on vaccine uptake as the virus continued to spread.
Germany, France, Italy and Spain have resumed the shot after the European Medicines Agency found the shot was safe and effective during its initial investigation into possible side effects. The benefits of giving the vaccine still outweigh the risks.
AstraZeneca said Monday that the independent DSMB had not found an increased risk of blood clots.
Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, told CNBC’s “Squawk Box” Monday that it was “very gratifying to see that the Data Safety Monitoring Board, even with a magnifying glass, is not an imbalance between the vaccinated group and the vaccinated group the placebo group. “
“That gives us a lot of confidence,” he added.
Late last year, AstraZeneca was criticized by US health professionals for the results and methods of their Phase 3 vaccine studies.
Analysts at the US health and biotech investment bank SVB Leerink said at the time that the vaccine “would never be approved in the US”.
AstraZeneca backed out of criticism, saying the studies “were conducted to the highest standards” and that more data would follow.