The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance,… Read More »FDA issues Covid-19 vaccine guidance as White House reportedly relents
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA… Read More »Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend
Officials in Maryland’s Prince George’s County say they “will spare no time or expense” investigating the circumstances surrounding the death of a veteran public health worker who died of COVID-19 after relatives and co-workers believe she contracted the coronavirus on the job. The probe follows… Read More »Maryland County Pledges Investigation of Health Worker’s Coronavirus Death
As a veteran public health worker, Chantee Mack knew the coronavirus could kill. She already faced health challenges and didn’t want to take any chances during the pandemic. So she asked — twice — for permission to work from home. She was deemed essential and… Read More »Essential and in Danger: Coronavirus Sickens, Even Kills Public Health Workers
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The NIAID create the Covid-19 Prevention Trials Network by combining four existing ones, primarily focused on HIV and AIDS, which will continue that work in addition to their new focus on Covid-19.
The company is running a Phase I/II study that started in May in Australia and plans to open a Phase III study of its vaccine candidate, NVX-CoV2373, that will enroll up to 30,000 participants starting in the fall.