AZ also’red signal’…

AstraZeneca Corona 19 Vaccine. [AFP=연합뉴스]

The National Institute of Allergy and Infectious Diseases (NIAID) affiliated with the National Institutes of Health (NIH) raised concerns that “old information” may have been included on the results of a US clinical trial of the AstraZeneca Corona 19 vaccine on the 23rd (local time). It is just one day after AstraZeneca announced that the prevention effect was 79% as a result of a large-scale clinical trial conducted in the United States. However, as questions about the appropriateness of the clinical trial data were raised, the US approval of the AstraZeneca vaccine again turned on a’red flag’.

In a statement that day, NIAID said, “The Independent Data and Safety Monitoring Committee (DSMB) has notified that AstraZeneca has expressed concern about the initial data of the clinical trial released by the company. “The committee was concerned that AstraZeneca may have included’outdated information’ in this clinical trial, and this may have provided incomplete data on efficacy.”

“We urge AstraZeneca to work with DSMB to review the data and release the most up-to-date and accurate efficacy data as soon as possible.” It also said that the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) will determine the approval of vaccine use in the United States after a thorough review of data by an independent advisory committee. According to NIAID, the monitoring committee forwarded the comments to the manufacturer AstraZenekawa and the US Department of Health and Welfare Department of Biological Drug Advanced Research and Development (BARDA).

“I’ve never seen anything like this,” said Dr. Eric Topol, a clinical trial expert at the Scripps Institute, told the New York Times (NYT), “It’s very unusual for a generally consensus monitoring committee and vaccine maker to have such an open conflict.” It’s really very troublesome,” he said.

AstraZeneca Corona 19 Vaccine. [AFP=연합뉴스]

AstraZeneca announced on the 22nd that it plans to apply for emergency use approval next month to the FDA and CDC based on the clinical results in the United States. However, Reuters said, “The DSMB’s request for the AstraZeneca vaccine has raised doubts about the plan.”

There are also concerns that the NIAID’s allegations may raise another controversy over the AstraZeneca vaccine.

Previously, after the AstraZeneca vaccination, blood clots appeared in succession, and more than 20 countries temporarily suspended the AstraZeneca vaccination. However, European countries have resumed vaccination after the European Medicines Agency (EMA) concluded that “AstraZeneca vaccine is not considered to be associated with an increased risk of thrombosis.” In addition, the US Food and Drug Administration (FDA) requested additional clinical data, claiming that there was a problem such as missing key information about the clinical results of AstraZeneca.

Professor Paul Griffin told Bloomberg, “When I think that the AstraZeneca vaccine has subsided one concern, another concern arises.”

On the 22nd, AstraZeneca announced that the average prevention effect of coronavirus was 79% by conducting a clinical trial involving 32,000 people in the United States. In the elderly over the age of 65, 80% of the preventive effects were higher than the overall average, and “We have not found that there is an increase in the risk of blood clots.”

Reuters reported that AstraZeneca has not yet expressed its position on the allegations.

Reporter Lim Sun-young [email protected]