The US health agency is questioning COVID-19 vaccine test data at AstraZeneca

SINGAPORE (Reuters) – AstraZeneca may have leaked outdated information about its latest COVID-19 vaccine test, giving an “incomplete” picture of its effectiveness, a major U.S. health agency said Tuesday. cast doubt on a possible U.S. outbreak and plunder its developers, once again, into controversy.

The outrageous public appeal from federal health officials comes just one day after interim data from the drug dealer revealed better-than-expected results from a U.S. test. That was seen as a scientific counter to concerns that have gripped the effectiveness and potential side effects.

The vaccine, developed by Oxford University, was 79% effective in preventing symptomatic illness in the large trial that also occurred in Chile and Peru, according to the data. It was also 100% effective against severe or acute forms of the disease and hospitalization, and there was no increased risk for blood clots.

The Data Protection Review Board (DSMB), an independent committee overseeing the lawsuit, has expressed concern that AstraZeneca may be leaking outdated information from that trial. , which may have provided an incomplete view of the efficacy data, “the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement bit.ly/3scE3ji released after midnight in the United States.

“We urge the company to work with the DSMB to review the efficiency data and ensure that the most up-to-date efficiency data is made public as soon as possible,” he said. e, adding that the DSMB had contacted AstraZeneca about their concerns.

AstraZeneca did not immediately respond to Reuters’ request for comment.

Its shares were down 1.2% in mid-morning trading.

The report raises new questions about the effectiveness of the vaccine as it is administered in dozens of countries around the world and clouds the timeline for emergency use approval in the United States.

“It simply came to our notice then. The negative reports about this vaccine will not stop, although I think it is well and safe, but it is clearly not as effective as the two mRNA vaccines, ”said Peter Kremsner, of University Hospital. in Tuebingen, Germany.

Competitive vaccines from Pfizer and Moderna that use so-called mRNA technology have shown efficiency levels of around 95% each, well above the 50% criterion set by global regulators.

The DSMB is organized by NIAID, and its role is to provide review research and evaluate clinical data to ensure that the study is safe and ethical. NIAID is led by US infectious disease expert Anthony Fauci and is part of the National Institutes of Health.

“Outside of DSMB’s concerns are highly unusual for multinational pharma companies and suggest a high level of disruption between the DSMB and the sponsor,” Citi analysts said in a note.

PHOTO FILE: A vial of the AstraZeneca coronavirus (COVID-19) vaccine is seen, as vaccines begin after a brief discontinuation of use for concern for possible association with blood clots, in Turin, Italy, March 19, 2021. REUTERS / Massimo pinca

DOUBTS RAISED

Called a milestone in the fight against COVID-19 pandemic disease when it first emerged as a vaccine competitor, the AstraZeneca bullet has been facing questions since the end of last year when the drug dealer and Oxford University published data with different efficacy readings due to measurement error.

A later study suggested that the difference was due to the dosing time rather than the dose given.

Confidence in the vaccine took another blow this month when more than a dozen countries, mostly in Europe, stopped the bullet for a while after reports linked it to a pouring disorder rare blood in a very small number of people.

The EU drugs regulator said last week it was safe but a poll on Monday showed Europeans remained skeptical about its safety.

Fauci, who is also the chief medical adviser to U.S. President Joe Biden, said Monday that the U.S. lawsuit found no indication of the rare blood clots and the NIAID statement did not raise questions about the U.S.’s findings. blood test.

The most recent data, not yet reviewed by independent researchers, were based on 141 diseases among 32,449 participants.

Analysts had noted AstraZeneca’s performance in extracting robust test data against a background of more infectious changes spreading in the United States and other countries.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the latest data request should perhaps relate to efficacy readings from recent diseases that may be introducing new changes and thus lower levels of protection.

“Maybe the other vaccines are showing so effective that we don’t know so much.” It doesn’t bother me especially if they haven’t found a hidden safety issue, which doesn’t seem to be . “

The AstraZeneca vaccine is seen as an important factor in tackling the global spread of COVID-19 as it is easier and cheaper to carry than competitive strains.

Unconditional marketing or emergency use has been allowed in more than 70 countries. Many countries rely heavily on it to end the pandemic, and several state leaders have built the picture to build confidence in the vaccine including the President of Korea Right, Moon Jae-in, who got it Tuesday.

Reporting by Miyoung Kim in Singapore; Additional commentary by Shubham Kalia in Bengaluru, Ludwig Burger in Frankfurt and Kate Kelland in London; Edited by Edwina Gibbs and Josephine Mason

.Source