US Health Department questions data on AstraZeneca COVID-19 vaccine study

(Reuters) – AstraZeneca could have used “outdated information” in the results of a large-scale study with the COVID-19 vaccine, a US health agency said on Tuesday, casting new doubt on the shooting, its potential launch in the US and has plunged its developers into controversy once again.

The extremely unusual reprimand of federal health officials comes just a day after the doctor’s interim data showed better results than expected from the US study, which had been seen as a scientific counterpoint to concerns about the shooting at the end. last year.

The vaccine developed with the Oxford University partner was 79% effective in preventing symptomatic disease in the large study that also took place in Chile and Peru, according to the data. It has also been 100% effective against severe or critical forms of the disease and hospitalization and does not present an increased risk of blood clots.

The Data Security Monitoring Committee (DSMB), an independent committee overseeing the process, “expressed concern that AstraZeneca could have included outdated information from that study, which could have provided an incomplete picture of the data on efficacy ”, US National Allergy Institute. 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 DSMB to review efficacy data and ensure that the most accurate, up-to-date efficacy data is made public as soon as possible,” he said, adding that DSMB informed AstraZeneca of its concerns. . .

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

Its shares fell 1% in early morning transactions.

NIAID is led by American infectious disease expert Anthony Fauci and is part of the National Institutes of Health. The DSMB is organized by NIAID, according to a document that presents the design of the process. The role of the board is to ensure the supervision of the study and to evaluate the clinical data to ensure the ethical and safe conduct of the study.

The authorization and guidelines for the use of the vaccine in the United States will be established after a thorough review of the data by independent advisory committees, the statement added.

HIGH QUESTIONS

Although hailed as a milestone in the fight against the COVID-19 pandemic when it emerged last year as a vaccine candidate, the AstraZeneca shot saw a steady stream of high questions about its effectiveness, dosing regimen and possible side effects.

More than a dozen European countries stopped using the vaccine earlier this month after reports linked it to a rare blood clotting disorder in a very small number of people.

Germany and France resumed vaccinations after the EU drug regulator said it was safe last week, but an opinion poll on Monday showed that Europeans remained skeptical about its safety.

Fauci, who is also chief medical adviser to US President Joe Biden, said on Monday that the US trial had found no indication of rare blood clots.

Prior to the concern about blood clots, there were also separate late separate studies, led by the Oxford University partner, which raised questions about its dosing regimen and the lack of data on its effectiveness for the elderly.

The latest data, which have not yet been reviewed by independent researchers, were based on 141 infections in 32,449 participants.

Analysts also noted AstraZeneca’s achievement of producing strong test data amid more infectious variants widespread in the United States and other countries.

The AstraZeneca vaccine, which is already widely used outside the United States, is seen as crucial in addressing the spread of COVID-19 worldwide because it is easier and cheaper to transport than rival photographs.

Conditional marketing authorization or emergency use has been granted in more than 70 countries. Many countries are relying heavily on it to end the pandemic, and several state leaders have set fire to boost confidence in the vaccine, including South Korean President Moon Jae-in, who received it on Tuesday.

The shooting was also at the center of a growing conflict between Brussels and London over so-called vaccine nationalism, following a series of supply failures in Europe.