UNITED STATES – Health and Human Services Secretary Alex Azar stated to CNBC that the late-stage coronavirus vaccine trial by AstraZeneca remains on hold in the U.S. due to federal investigators questioning its safety for the patients.
One of the participants in the U.K. reported a serious adverse reaction to AstraZeneca’s Covid-19 vaccine, called AZD1222, resulting for the global clinical trials to be put on hold last September 6. Though the U.S. trials are on hold, they decided to proceed in the U.K. on September 12.
Azar stated to CNBC, “Look at the AstraZeneca program, phase three clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical trials. Still on hold here in the United States as the (U.S. Food and Drug Administration) seeks answers to important questions to verify safety information around those vaccines. Plan is by the book, we’re keeping patient safety at the center of everything we do,” In defense of the Trump administration’s quick development of a vaccine.
Michele Meixell, AstraZeneca’s spokeswoman, confirmed that the U.S. trials for the vaccine are still on hold when she issued a statement to CNBC that says, “Regulators in each individual country determine when trials can start and they do this in their own time frame, On the current U.S. trial status specifically, we are continuing to work with the FDA to facilitate review of the information and the agency will decide when the U.S. trial can resume.”
The Trump administration’s Operation Warp Speed aims to manufacture and distribute a coronavirus vaccine in record time. This program is a partnership between federal agencies, which includes the U.S. Centers for Disease Control and Prevention, the Department of Defense, the Health and Human Services and the Food and Drug Administration.
There are at least four Candidates who launched their late-stage trials of the vaccine. This includes Pfizer, Moderna, AstraZeneca (who launched it by the end of August), and Johnson & Johnson.
On the other hand, Americans are still concerned about the safety of the vaccine. They are worried the President Donald Trump might be rushing to release the vaccine to boost his reelection chances, as recorded by CNBC’s research poll. Only 42% of the voters believed that they would immediately receive the vaccine when it becomes available.
The Washington Post reported that the FDA is expected to have a statement released for new and firmer standards for approving an emergency authorization of a Covid-19 vaccine in an effort to strengthen public trust and transparency.
Azar also said to CNBC, “The president’s made it clear, I’ve made it clear, the FDA commissioner has made it clear, and the CEOs of the relevant companies have made it clear — this is going to be by the book based on science, data and the law.”
