United States health officials question AstraZeneca trial results

Share

During the trial, an unblinded statistical analysis group that is walled off from the company acts as an intermediary to handle data requests and many other interactions with the monitoring board.

President Moon Jae-in is receiving his first dose of the AstraZeneca vaccine at a public health center in Jongno District, central Seoul, on Tuesday.

AstraZeneca also said the study's independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week. The KDCA said that around 288,000, or 76 percent, of over 376,000 people eligible for this batch of vaccines agreed to receive the AstraZeneca vaccination. "We simply can not get enough of it", he said. The group notified the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority, and AstraZeneca of concerns they had with the data release.

US health officials have raised concerns that AstraZeneca may have included "outdated information" from its coronavirus vaccine trial that could have provided an "incomplete view" of the efficacy data.

The federal government has also bought two million doses of the vaccine from the Serum Institute of India, which is manufacturing billions of shots.

Companies sponsoring drug or vaccine trials typically wait for the monitoring board to run analyses and conclude that the study has yielded an answer before they announce trial results. Furthermore, it claimed to have run the numbers from its intended primary analysis and that these results were "consistent" with the results released yesterday.

"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible", said the group headed by Anthony Fauci, the top USA infectious disease official.

According to a news release from Kingston, Frontenac, Lennox and Addington Public Health (KFL&A Public Health), the COVID-19 shot was administered at the Amherstview Drugs Pharmacy.

AstraZeneca reports powerful COVID-19 protection in new vaccine trial
The U.S. study comprised more than 30,000 volunteers, of whom two-thirds were given the vaccine while the rest got dummy shots. It was initially considered a global leader in the race to field a vaccine against COVID-19.

In Norway, a top official warned on Monday it might not be able to resume its use of the AstraZeneca vaccine because so many people were rejecting it.

Several countries suspended its use earlier this month, citing concerns that it could cause strokes, which in some cases could be fatal.

The WHO has been raising concerns on equitable distribution of vaccines across the world.

This is just the latest public communications issue the company has faced over the last three months.

Vaccines from Pfizer/BioNTech and Moderna that use messenger RNA (mRNA) technology to produce an immune response both had efficacy rates of about 95% in their pivotal clinical trials, far above the 50% benchmark set by global regulators.

Dr. Larry Corey, co-leader of the U.S. Coronavirus Vaccine Prevention Network, which helped design AstraZeneca's U.S. trial, said the monitoring panel's rebuke was something he had not seen before. That will give it more opportunities to mutate, and so increase the risk of a new variant emerging that could make the vaccine less effective.

As Fauci also pointed out, the data squabble means little when it comes to the AZ vaccine's approval process at the FDA.

Share