Johnson & Johnson to Start Late-Stage Coronavirus Vaccine Trial - COVID-19 Clinical Trial
Breaking News | COVID-19

Johnson & Johnson to Start Late-Stage Coronavirus Vaccine Trial

Johnson & Johnson plans to begin what would be the largest, late-stage trial testing a potential coronavirus vaccine in September, the company confirmed Thursday.The phase three trial would enroll up to 60,000 healthy people ages 18 and older across nearly 180 locations in the U.S. and other countries, according to a J&J spokesman and ClinicalTrials.gov. Participants will be randomly selected to receive a dose of the potential vaccine or a placebo, according to details of the trial, which will determine whether the vaccine is safe and effective. They will be followed by researchers for more than two years.

“Our Phase 3 program is intended to be as robust as possible, could include up to 60,000 participants and will be conducted in places with high incidence rates,” J&J spokesman Jake Sargent said in a statement to CNBC. “We are using epidemiology and modeling data to predict and plan where our studies should take place and expect that to be finalized soon.”


Feds OK COVID-19 Tests Without FDA Approval

The US Department Health and Human Services rescinded guidance that mandated that COVID-19 tests gain approval from the Food and Drug Administration (FDA) before use, under an executive order from President Donald Trump.

“As part of HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19, the department has determined that the Food and Drug Administration (“FDA”) will not require premarket review of laboratory developed tests (“LDT”) absent notice-and-comment rule making,” HHS said in a document posted to its website yesterday.The decision will allow private and commercial laboratories to manufacture and administer tests, including labs controlled by Quest Diagnostics and LabCorp. According to Politico, most COVID-19 tests currently used in the United States are made by device manufacturers and thus subject to FDA review.

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