Two drug manufacturers announced on Friday the resumption of US testing of their candidates for COVID-19.
Testing of the AstraZeneca vaccine candidate has been suspended since early September, while the Johnson & Johnson vaccine study was halted early last week. Each company had a research volunteer who developed a serious health problem that required a review of safety data.
The two coronavirus vaccines are among several candidates for testing in the final stage, the last step before asking for regulatory approval.
Drugmakers say they received a green light Friday from the Food and Drug Administration to restart tests in the United States
Such temporary suspensions of drug and vaccine tests are relatively common: In studies involving thousands of participants, some are likely to become ill. Pausing the study allows researchers to investigate whether the disease is a side effect or a coincidence.
Testing of the AstraZeneca vaccine, developed with Oxford University, has already resumed in the United Kingdom, Brazil, South Africa and Japan.
“The relaunch of clinical trials around the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,”
The AstraZeneca study included 30,000 people in the United States, some receiving a vaccine and others a dummy photo.
Testing was stopped after a British participant developed severe neurological symptoms corresponding to a rare inflammation of the spinal cord called transverse myelitis. Testing of the AstraZeneca was also stopped earlier in the summer.
Johnson & Johnson said it was preparing to resume recruitment soon for its U.S. vaccine study. In a statement, the company did not disclose the nature of the volunteer’s illness, but said the in-depth assessment “found no evidence that the vaccine applicant had caused the event.”
The company added that it is in talks with other regulators around the world to resume testing in their countries.
Follow Linda A. Johnson on Twitter: @LindaJ_onPharma
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