The Food and Drug Administration released the following statement Friday, Sept. 10, 2021 as COVID-19 makers are racing to submit clinical data seeking regulatory approval for vaccines in children younger than 12.

The Food and Drug Administration advisory panel unanimously voted Friday afternoon to recommend the Johnson & Johnson’s COVID-19 vaccine for an emergency use authorization. For eight hours, the group of independent experts had reviewed the safety and efficacy of the vaccine. READ: FDA finds Johnson & Johnson vaccine effectively prevents COVIDWhile the Johnson & Johnson vaccine is less effective than Pfizer and Moderna’s vaccines, the experts noted that no one who received the Johnson & Johnson vaccine was hospitalized or died from coronavirus. READ: Here’s what makes J&J vaccine different than the othersAdStudies in children are planned with the older group of children expected to begin receiving the vaccine as soon as early March. There are also additional studies planned in immunocompromised people.

LONDON – A woman who received an experimental coronavirus vaccine developed severe neurological symptoms that prompted a pause in testing, a spokesman for drugmaker AstraZeneca said Thursday. The study participant in late-stage testing reported symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, said company spokesman Matthew Kent. The study was previously stopped in July for several days after a participant who got the vaccine developed neurological symptoms; it turned out to be an undiagnosed case of multiple sclerosis that was unrelated to the vaccine. It also is testing the vaccine in thousands of people in Britain, and in smaller studies in Brazil and South Africa. Temporary holds of large medical studies aren’t unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing.