23 September 2020
The Food and Drug Administration plans to toughen the requirements for a coronavirus vaccine emergency authorization, which would make it more difficult for one to be ready by the election, the Washington Post reported Tuesday.
Why it matters: Public skepticism of an eventual vaccine keeps increasing as President Trump keeps making promises that are at odds with members of his own administration.
- This skepticism is bad. A rushed, unproven vaccine would be even worse.
Driving the news: The new FDA guidance would be much more rigorous than what was used to provide emergency authorization to hydroxychloroquine or convalescent plasma. Both authorizations were controversial.
- The agency is expected to ask vaccine manufacturers to monitor late-stage clinical trial participants for a median of at least two months, beginning after the participants receive their second shot.
- It will also be looking for at least five severe coronavirus cases in each trial's placebo group, along with cases in older people, to further indicate that the vaccine works.
Between the lines: The new standards, combined with other elements of the authorization process, would make it very unlikely than any vaccine will be ready for administration before Nov. 3.
The other side: Some critics say that an emergency authorization — versus a full approval — shouldn't be used at all for a vaccine.
- "Things are so revved up right now that there is quite a possibility that the American public won't accept a vaccine because of all the things that are going on," Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the Post.
What they're saying: "The FDA has previously noted that the agency intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA," the agency said in a statement.
Transcripts show George Floyd told police "I can't breathe" over 20 times
Section2Newly released transcripts of bodycam footage from the Minneapolis Police Department show that George Floyd told officers he could not breathe more than 20 times in the moments leading up to his death.
Why it matters: Floyd's killing sparked a national wave of Black Lives Matter protests and an ongoing reckoning over systemic racism in the United States. The transcripts "offer one the most thorough and dramatic accounts" before Floyd's death, The New York Times writes.
The state of play: The transcripts were released as former officer Thomas Lane seeks to have the charges that he aided in Floyd's death thrown out in court, per the Times. He is one of four officers who have been charged.
- The filings also include a 60-page transcript of an interview with Lane. He said he "felt maybe that something was going on" when asked if he believed that Floyd was having a medical emergency at the time.
What the transcripts say:
- Floyd told the officers he was claustrophobic as they tried to get him into the squad car.
- The transcripts also show Floyd saying, "Momma, I love you. Tell my kids I love them. I'm dead."
- Former officer Derek Chauvin, who had his knee on Floyd's neck for over eight minutes, told Floyd, "Then stop talking, stop yelling, it takes a heck of a lot of oxygen to talk."
Read the transcripts via DocumentCloud.