AstraZeneca and Johnson & Johnson announced on Friday that they would resume their Phase 3 clinical trials of Covid-19 vaccine candidates in the United States.
AstraZeneca’s trial was suspended just days after it started in early September, following news of a UK participant who developed a spinal cord injury after receiving the experimental vaccine. Johnson & Johnson’s trial was suspended on October 12 after an unspecified injury to one of its study participants.
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“We are very optimistic that AstraZeneca and Johnson & Johnson will resume testing as soon as possible,” said Paul Mango, deputy director of policy at the US Department of Health and Human Services on Friday.
Drugmakers join Moderna and Pfizer in advanced clinical trials in the United States. These companies have announced their intention to submit emergency use authorization applications in the second half of November, Mango said. Moderna said on Thursday that it completed registration for its 30,000-person trial.
In a statement released Friday, Johnson & Johnson said they had found no evidence the vaccine candidate caused the undisclosed injury. It is not clear whether the volunteer received the experimental vaccine or the placebo.
Dr Matt Hepburn, vaccine manager for Operation Warp Speed, said during the media call that the staged trial should reassure Americans that the highest standards are being met.
“Here’s how to keep a clinical trial running to the highest ethical and quality standards,” Hepburn said of the AstraZeneca trial.
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The Operation Warp Speed briefing follows a meeting Thursday of the Food and Drug Administration’s Vaccine Advisory Committee, which met for the first time to discuss Covid-19 vaccines. At the all-day meeting, independent experts raised concerns about vaccine trials, wondering if they were designed to address safety concerns. Another common question was whether granting emergency use authorization would hamper long-term safety studies.
The planned mango vaccines will be available to “most vulnerable citizens” by the end of 2020, and all seniors will be able to get vaccinated by the end of January.
He added that by April, the nation “will be able to vaccinate any American”.
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