US health authority questions AstraZeneca’s COVID-19 vaccine research data

(Reuters) – AstraZeneca may have used “outdated information” in the results of a large-scale COVID-19 vaccine trial, a US health agency said Tuesday, raising new doubts about the inclusion, its potential US rollout and its developers, once again, in controversy.

The highly unusual rebuke from federal health officials comes just one day after interim data from the drug maker showed above-average results from the US trial seen as a scientific counterbalance to concerns that have persisted since late last year.

The vaccine developed with partner Oxford University was 79% effective in preventing symptomatic illnesses in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalization, and had no increased risk of blood clots.

The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete picture of the data on the trial. efficacy, ”said the US National Institute of Allergy. and Infectious Diseases (NIAID) said in a statement bit.ly/3scE3ji released in the United States after midnight.

“We urge the company to work with the DSMB to review its efficacy data and ensure that the most accurate, current efficacy data is disclosed as soon as possible,” he said, adding that the DSMB had notified AstraZeneca of its concerns. .

AstraZeneca did not immediately respond to a request from Reuters for comment.

Its shares fell 1% in early morning trading.

NIAID is headed 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 describing the pilot design. The role of the board is to supervise the study and to evaluate clinical data to ensure safe and ethical conduct of the study.

Authorization and guidelines for use of the vaccine in the United States will be established after in-depth review of the data by independent advisory committees, the statement said.

DOUBTS RAISED

While it was hailed as a milestone in the fight against the COVID-19 pandemic when it emerged as a vaccine candidate last year, the AstraZeneca shot has generated a steady stream of questions about its efficacy, dosing regimen and potential 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 a poll on Monday found Europeans remained skeptical about its safety.

Fauci, who also serves as chief medical adviser to US President Joe Biden, said Monday the US trial found no evidence of the rare blood clots.

Before the blood clot became a concern, there were also previous separate late-stage studies conducted by partner Oxford University that raised questions about the dosing regimen and the lack of data on its effectiveness for the elderly.

The latest data, which has yet to be assessed by independent researchers, was based on 141 infections among 32,449 participants.

Analysts had also noted that AstraZeneca has managed to produce strong research data against the backdrop of more contagious variants spreading in the United States and other countries.

Already in widespread use outside of the United States, the AstraZeneca vaccine is seen as critical to preventing the spread of COVID-19 around the world because it is easier and cheaper to transport than competing shots.

It has obtained conditional marketing or emergency marketing authorizations in more than 70 countries. Many countries are very confident to end the pandemic, and several state leaders have taken the initiative to boost confidence in the vaccine, including South Korean President Moon Jae-in who received it on Tuesday.

The shot was also at the center of a growing conflict between Brussels and London over so-called vaccination nationalism after a series of setbacks in supply in Europe.