AstraZeneca is likely to release outdated data on its latest Covid-19 vaccine trial, which gives a “incomplete” picture of its effectiveness, the US health agency said on Tuesday, casting suspicion of a possible U.S. explosion and throwing its engineers out. , again, controversy.
The surprise of a public reprimand from state health officials comes a day after temporary information from the drug manufacturer showed better results than expected from a U.S. case. That has been seen as the scientific contradiction of the concern that has shot this in its effectiveness and the possible side effects.
The vaccine is developed by Oxford University, which was said to be 79% effective in preventing symptomatic illness in a large trial in Chile and Peru, according to data. It was also 100% effective compared to severe or serious forms of illness and hospitalization, and there was no risk of blood clots.
The Data Safety Monitoring Board (DSMB), an independent committee responsible for the trial, “has expressed concern that AstraZeneca may include outdated details of the case, which may have provided incomplete information on operational information,” the US National Institute of Allergy and Infectious Diseases ( NIAID) in a statement https://bit.ly/3scE3ji released after midnight in the United States.
He said that he urges the company to work with DSMB to review performance information and ensure that timely, up-to-date information is made available to the public as soon as possible, he also added saying that the DSMB had informed AstraZeneca of its concerns.
AstraZeneca did not immediately respond to Reuters’s request for comment.
Its stock fell 1.2% in the morning trading.
This statement raises new questions about the effectiveness of the drug as it is used in many countries around the world and sets a timeline for its approval for emergency use in the United States.
Peter Kremsner, of University Hospital in Tuebingen, Germany said that this is a rare practice. Negative reports about this vaccine do not stop, although my testing is that it is well tolerated and safe, but it is clearly less effective than two mRNA vaccines.
Controversial vaccines from Pfizer and Moderna using so-called mRNA technology have produced almost 95% performance levels each, far more than the 50% benchmark set by global regulators.
The DSMB is organized by NIAID, and its role is to provide monitoring and evaluation of clinical data to ensure safe and accurate research practice. NIAID is led by a U.S. infectious disease specialist. Anthony Fauci is also part of the National Institutes of Health.
“DSMB’s issuance of concerns is very uncommon in international companies and suggests a very high level of conflict between DSMB and the sponsor,” said Citi analysts.
DOUBT WAS RAISED
Praised as a landmark in the fight against the Covid-19 epidemic when it first emerged as a vaccine-resistant, the AstraZeneca rifle has been in the spotlight since late last year when drug makers and Oxford University published data with different active readings due to measurement error.
Recent analyzes have suggested that the measurement time rather than the given dose range represented the difference.
Confidence in this vaccine has continued to grow sharply this month as more than a dozen countries, mainly in Europe, temporarily halted the outbreak after reports linked it to a rare blood-curdling disease in very few people.
The European Union’s drug regulator said last week it was safe but an investigation on Monday revealed that Europeans remained skeptical about its safety.
Fauci, who is also the chief medical adviser to U.S. President Joe Biden, said on Monday the U.S. case had found no evidence of abnormal blood and a statement from NIAID did not raise questions about the findings of the case.
The latest data, which has yet to be reviewed by independent investigators, was based on 141 cases among 32,449 participants.
Analysts had seen AstraZeneca’s success in producing robust experimental data in the aftermath of a variety of infectious diseases spreading across the United States and other countries.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the application of up-to-date data may be related to the effective study of recent infections that may include new variants and thus lower levels of protection.