The United States Food and Drug Administration (FDA) is taking a deeper dive into the investigation of AstraZeneca Plc’s COVID-19 vaccine study and will now look at data from previous trials of similar vaccines developed by the same researchers at Oxford University. Despite taking a closer look, they don’t believe there are any safety issues associated with these vaccines. “It just shows that the FDA is being thorough,” explains a source.
AstraZeneca’s trial in the U.S. has been on hold since September 6th, when a participant in Britain fell ill with transverse myelitis, a rare spinal inflammatory disorder. Regulators in the United Kingdom, Brazil, India, and South Africa have already resumed studying the efficacy of the vaccine.
Given the increased FDA investigation, further delays are likely for what was one of the most advanced COVID-19 vaccine studies in the U.S. The additional data requested by the FDA was expected to be delivered in early October and will require time to review.
An effective vaccine is essential for efforts to end the global COVID-19 pandemic that has already killed over one million people. President Donald Trump (who announced that he tested positive for COVID-19 on October 2nd) and his administration have pledged 1.2 billion dollars to support the development of AstraZeneca’s vaccine and to secure 300 million doses for American citizens. Pfizer Inc, Moderna Inc, and Johnson & Johnson are also in the U.S. vaccine race.
The FDA declined to comment, and Oxford University did not respond to requests. In a statement, AstraZeneca said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial.”
Further Reading:
- ‘Very concerned’ about AstraZeneca Vaccine side effects
- Can the FDA be trusted on a COVID Vaccine?
- COVID-19 & Your Health
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.