FDA Deepens Safety Investigation of AstraZeneca’s Investigational COVID-19 Vaccine

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AstraZeneca’s Phase III COVID-19 vaccine study in the United States is being further delayed due to the U.S. Food and Drug Administration (FDA) wanting to take a more thorough look at information related to the trial.

In early September, AstraZeneca paused its Phase III global vaccine study after a participant in the Phase III COVID-19 study was hospitalized with suspicion of having developed a serious spinal inflammatory disorder called transverse myelitis. The patient, who was hospitalized from the complications, has been released.

The FDA will seek additional information from Oxford University, AstraZeneca’s collaborative partner on the vaccine. Specifically, according to Reuters, the regulatory agency intends to seek data regarding trials of vaccines for other diseases developed by the same scientists. The FDA hopes to determine whether or not similar adverse events have occurred before. Although AstraZeneca’s Phase III COVID-19 trial resumed testing in the United Kingdom last month, the FDA is unlikely to allow studies to resume in the United States until it is satisfied with its investigation. The agency wants to see if similar issues have arisen before, while at the same time not casting aspersions on the efficacy and safety of those same vaccines, Reuters said.

Citing sources familiar with the matter, Reuters said the FDA is trying to be thorough in its investigation, particularly at a time when vaccines have become highly politicized. In multiple campaign stops, as well as during a debate with Joe Biden earlier this week, President Donald Trump predicted a vaccine could be available to the public by the end of the year. There have been rumors that the U.S Food and Drug Administration could grant an Emergency Use Authorization (EUA) to one of the vaccine candidates being supported by Operation Warp Speed due to political pressure.

The FDA intends to scrutinize raw data from the other vaccine trials for additional side effects, the sources said. The sources explained to Reuters that the current data sets requested by the FDA are not in a format in which the regulatory agency requires.

In a brief statement to Reuters, AstraZeneca said it is continuing to work with the FDA to “facilitate review of the information needed to make a decision regarding resumption of the U.S. trial.”

This incident marks the second time the trial had been paused. Last month, AstraZeneca Chief Executive Officer Pascal Soriot said the study had been paused earlier in the summer when another patient developed neurological issues. That patient was diagnosed with multiple sclerosis and it was determined to not be related to the vaccine.

AstraZeneca’s COVID-19 vaccine candidate AZD1222 is a viral vector-based, weakened version of adenovirus containing the genetic material of the SARS-CoV-2 spike protein. It was co-developed with the Jenner Institute at Oxford University. In July, the company published positive Phase I data from its vaccine candidate that showed the preventative medication generated both neutralizing antibodies and immune T-cells that target SARS-CoV-2.

While some companies developing vaccines against COVID-19 predict having data available by the end of October or early November, AstraZeneca will likely not match that deadline. Part of that will be due to the fact the company has changed clinical trial protocols for the vaccine candidate regarding safety and efficacy, Reuters said. According to the report, independent safety monitors will review safety and efficacy after 75 trial subjects become infected with COVID-19, up from the original initial review plan after about 40 infections. The safety monitors could stop the trial if the vaccine proves either highly effective, and therefore should be considered for public use before the trial concludes, or if serious safety problems appear, Reuters said.

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