AstraZeneca, J & J resume US trials of COVID-19 vaccines


Two drug manufacturers announced on Friday to resume US testing of their COVID-19 vaccine candidates.

AstraZeneca’s vaccine candidate trial was halted from early September, while Johnson & Johnson’s vaccine study was halted early last week. A study volunteer from each company developed a serious health issue requiring a review of safety data.

Two coronavirus vaccines are among several candidates in the final phase trial, the final stage before obtaining regulatory approval.

Drug makers said they were known to resume testing in the US on Friday from the Food and Drug Administration

Such temporary stops of drug and vaccine testing are relatively common: in research involving thousands of participants, some are likely to fall ill. Stopping a study allows researchers to test whether the disease is a side effect or a coincidence.

The trial of the AstraZeneca vaccine developed with Oxford University has already resumed in the United Kingdom, Brazil, South Africa and Japan.

“Resuming clinical trials around the world is great news because it allows us to continue our efforts to help defeat this terrible epidemic,” AstraZeneca CEO Pascal Sorot said in a statement.

AstraZeneca’s study included 30,000 people in the US, some with vaccines and others with a dummy shot.

The test was stopped after a British participant developed severe neurological symptoms consistent with a rare spinal inflammation called transverse myelitis. The AstraZeneca trial was also halted earlier in the summer.

Johnson & Johnson said it is preparing to resume recruitment soon for its US vaccine study. In a statement, the company did not disclose the nature of the volunteer’s illness, but a deeper evaluation “found no evidence that the vaccine caused the candidate incident.”

The company said it is in talks with other regulators around the world to resume testing in their countries.

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Linda A. on Twitter Follow Johnson: @LindaJ_onPharma

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The Associated Press Health and Science Department has support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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