THE NEUTRAL ZONE
The Food and Drug Administration would be willing to fast-track a COVID-19 vaccine before clinical trials, but not for political reasons, FDA head Stephen Hahn told the Financial Times. The FDA could release an emergency use of the vaccine, which is not the same as full approval, for groups if the health benefits outweigh the risk.
Russia approved a vaccine in early August without routine clinical trials, leading to criticism, but a Russian official said Monday that Hahn’s comments, along with Britain’s move to allow its medial regulator to essentially do the same thing, proves that Russia was right to grant early approval.
Hahn promised transparency and said the data would determine whether the vaccine would be approved before trials. Meanwhile, the U.S. has mass-produced hundreds of thousands of doses of three promising vaccines and will send them off if they are approved. Dr. Deborah Birx, the White House coronavirus task force coordinator, said she was hopeful for a vaccine but urged people to continue to wear a mask and follow social distancing, as she believes those guidelines can also stop the virus.
9 lessons for the next pandemic – Axios – 8/31/2020
Here are nine things the U.S. should do in the next pandemic — some big, some small, some lessons from what went wrong this time, some lessons from what‘s gone right.
What Happens If China Gets the Covid-19 Vaccine First? – Politico – 8/31/2020
An expert on global health and national security who has consulted for the WHO and the Centers for Disease Control and Prevention, isn’t the only one pondering what could go wrong in the next few months, as great powers race to be first to get their hands on the Covid-19 vaccine.
The US just topped 6 million coronavirus cases in about 7 months. What happens next is up to you, Birx says – CNN – 8/31/2020
Birx urged Americans to take personal responsibility, especially if they want to help keep economies open. “Right now, we gain freedom through wearing our masks and socially distancing,” she said.
FDA willing to fast-track coronavirus vaccine, agency chief says – Fox News – 8/31/2020
“Our emergency use authorization is not the same as a full approval,” Hahn said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”