Tag Archives: Rebuke

The FDA and CDC issued an unusual rebuke to the pharmaceutical company hours after it warned of waning immunity from its coronavirus vaccine

But as the Biden administration struggles to boost low vaccination rates in Southern states amid a troublesome level of Covid-19 vaccine hesitancy, decisions about safety precautions in schools will be made, as always, at the local level.
Those decisions have already become a hot political topic as fall approaches, with Republican Texas Gov. Greg Abbott, for example, banning mask mandates in public schools earlier this year, while California health officials announced Friday that they would continue to require students and teachers to wear face coverings indoors even though the CDC’s new guidance said vaccinated teachers and students don’t need to wear masks inside school buildings.
The CDC’s new guidance comes when many parents are still anxious about the risks of Covid-19 variants, as well as the many unknowns about what the long-term effects of Covid infections could be in children.
As school districts brace for the uncertainty of another semester with many unvaccinated children, Pfizer sent a jolt of alarm through the country by announcing Thursday that it is seeing waning immunity from its coronavirus vaccine and it will seek emergency use authorization from the US Food and Drug Administration in August for a booster dose. In an unusual rebuke, the FDA and the CDC released a joint statement hours after the Pfizer missive saying boosters were not needed yet, and Biden administration officials sought to amplify that message Friday.
A very small number of children up to age 18 have died from Covid-19 in the US — 391 out of more than 606,000 deaths, according to CDC data. But there is great uneasiness among parents since only children 12 and older are currently eligible to be vaccinated. There have been notable outbreaks at summer camps this year, including infections among more than 125 campers and adults who attended a summer camp run by a South Texas church. And the risk of new variants remains an intense concern in communities with high numbers of unvaccinated people.
Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, voiced those concerns about the lack of study on the long-term effects of Covid-19 in children during an interview on CNN’s “The Lead” Friday afternoon. He noted that the data about children is often presented in terms of deaths and hospitalizations, numbers he acknowledged are “relatively low” in that population.
“We need clarification on the percentage of children who have debilitating effects from Covid, especially neurological effects in the developing brain,” Hotez told CNN’s Pamela Brown. “We need the pediatric neurological societies to really look into this more in depth. … We tend to use very blunt instruments when talking about either adolescents’ or children’s deaths, and only hospitalizations. There are so many more dimensions to Covid than that.”

New confusion about booster shots

This week’s Pfizer announcement not only sparked new confusion about when booster shots might be needed for adults but also created a potential opportunity for anti-vaccine activists who are looking to undermine public confidence in the shots.
Back in April, Pfizer CEO Albert Bourla suggested that “there will be likely a need for a third dose, somewhere between six and 12 months” after the first round. On Thursday, the company confirmed his prediction in a formal statement, citing a recent statement from Israel’s Ministry of Health that said the efficacy of the Pfizer vaccine declined after six months, along with unreleased data from the company’s ongoing studies.
Pfizer offered an important caveat that was mostly lost in the shock of its announcement, confirming that the vaccine’s protection against “severe disease remained high across the full six months.” The drop in efficacy manifested as a rise in symptomatic illness, the company said, while also pointing to the emergence of dangerous new variants as reason to get a jump on authorization for a booster.
But the hazy reasoning behind Pfizer’s declaration, which was delivered without clear clinical evidence of its underlying assertion, was met with the sharp contradictory statement from the leading US regulatory agencies.
“Americans who have been fully vaccinated do not need a booster shot at this time,” the CDC and FDA said in their rare joint statement. “FDA, CDC, and NIH (the National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”
The message from the government agencies was clear: The decision was not Pfizer’s to make.
“This process takes into account laboratory data, clinical trial data, and cohort data — which can include data from specific pharmaceutical companies, but does not rely on those data exclusively,” they said in the statement.
In an interview with CNN’s Wolf Blitzer on Friday night, Dr. Anthony Fauci, the nation’s leading infectious diseases specialist, disputed the idea that Americans were receiving a “mixed message” and said it is important for them to trust that their government agencies will tell them when and whether they might need a booster shot.
“We respect what the pharmaceutical company is doing, but the American public should take their advice from the CDC and the FDA,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases. “The important bottom line in all of this is that the efficacy (of the vaccine) against severe disease — particularly hospitalization that might lead to death in some individuals — was still really very good.”
White House press secretary Jen Psaki stressed Friday afternoon that the decision about when a booster might be needed is “going to be led by the data and by the science.”
“We wanted to make clear that that is not something that the American people need to plan for at this moment,” Psaki said.
As concerning as Pfizer’s claim might have been to some, the public clash between the pharmaceutical giant and top US government agencies could foreshadow something worse.
Public and private institutions have largely spoken with one voice as the vaccines were developed and distributed, a useful tool for public health leaders working to chip away at hesitance as they pushed forward with this unprecedented mass vaccination campaign.
But signals of a divide between the two could deal a devastating setback to that project, offering fodder to anti-vaccination agitators.
Asked at the briefing whether the administration would push for coordination on these kinds of announcements — as a way of preventing another similar back-and-forth — Psaki appeared to betray some frustration with Pfizer’s actions.
“They are a private-sector company. I can’t speak to the origin or the motivation of their announcement. You’d have to ask them that,” Psaki said. “But the role we can play, from the US government, is to provide accurate information and public health information, which is what we’ve ventured to do last night pretty rapidly in response to the announcement.”

Huge challenge in regional divide over vaccines

As school districts look to the fall semester, Biden’s team is redoubling its efforts to deploy trusted messengers into communities where vaccine uptake is low, but the challenge is monumental given the political polarization in this country and the unfortunate fact that masks and vaccines remain divisive territory.
An analysis by Georgetown University this week underscored the political challenge of changing the mindset of those who remain unvaccinated by showing the huge clusters of unvaccinated people in the Southern United States. An increasing number of studies have demonstrated that vaccine coverage maps bear a striking resemblance to the 2020 election results map — meaning it may be very hard for the Biden administration to shift attitudes toward vaccine acceptance in those regions.
The CDC guidance on schools is likely to become part of that debate, just as it was last year when President Donald Trump was in office.
The CDC stressed Friday that schools should continue using safety precautions, including masking and physical distancing, while encouraging those who are eligible to get vaccinated, such as offering vaccines on site and providing paid sick leave for employees to get vaccinated.
Fully vaccinated teachers and students do not need to wear masks, the guidance said, but the CDC still wants to see unvaccinated children masked indoors and for schools to continue physical distancing if not everyone is vaccinated.
Schools that want to begin phasing out pandemic precautions should do so carefully, the CDC said, by removing them one at a time — if community transmission levels are low — while continuing a robust testing regimen to monitor for increases in spread before removing the next safety measure.
Dr. Megan Ranney, an emergency physician at Rhode Island Hospital and an associate professor at Brown University, noted that she has been a proponent of schools being open even before vaccines were on the scene. But now she is concerned that “the states that have low vaccination rates are also the states that are less likely to put the non-pharmaceutical interventions in place.”
“They’re going to be less likely to say that kids should mask in school,” Ranney said Friday on CNN’s “Inside Politics.” “So they’re going to be setting up their communities, not just for the spread of the virus within the kids, but also within the larger community. Because those kids are then going to spread Covid on to their parents and grandparents and extracurricular school instructors. That’s what worries me even more than whether we can open the schools or not.”

Author: Analysis by Maeve Reston and Gregory Krieg, CNN
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Derek Chauvin Verdict Brings a Rare Rebuke of Police Misconduct

“May it please the court. Ladies and gentlemen of the jury, good morning. The video evidence, I think, will be very helpful and meaningful to you because you can see it for yourself without lawyer talk, lawyer spin, lawyer anything. You can see it for yourself.” “Please. Please. I can’t breathe. Please, man. Please somebody help me. Please. I’m about to die in this thing.” “Oh my God.” “What did he say?” “He said, I’m about to die. Oh my God.” “While watching the George Floyd trial, I noticed the differences and the importance of footage.” “This corner —” “When Stephon was murdered, we only had the officers’ footage. We only had their point of view.” “Hey, show your hands.” “You know, when my son was killed being on the platform, there was several bystanders that filmed. And had it not been for the cameras, we wouldn’t even be here today because they would have probably said it was justified.” “Bro, with your feet on his head, man. You knee on his neck.” “He’s pushing harder.” “Yeah.” “I cannot breathe.” “A little bit more. Right here.” “I don’t watch the footage of my dad’s incident because it’s torture.” “You see the officers giving a trove of blows to his body?” “Yes.” “To his arms, to his torso, to his legs.” “Here it is 30 years later, nothing has changed.” “Now who are you going to believe? The defendants or your own eyes?” “I am watching the George Floyd case with my best friend, Tiffany, at her home.” “Oh my gosh.” “Wow.” “And he’s still on his neck.” “Today was the first time I watched the entire video of George Floyd, and it definitely made me think about my dad begging for his life screaming.” “Check his pulse. Check his pulse.” “His daughter was the same age I was when my dad was beaten.” “My name is Lora Dene King. I’m the middle child of Rodney Glen King.” “The world saw the videotape.” “We thought the video showed excessive force and unnecessary force.” “With that videotape, if they had two eyes and they weren’t blind, you could see that it was excessive force.” “The defense tried to dilute the impact of the tape by dissecting it, frame by frame, in an effort to show that King was a threat to the officers.” “He kind of gave out like a bear-like yell, like a wounded animal. If he had grabbed my officer, it would have been a death grip. If he had grabbed the weapon, he would have had numerous targets.” “He didn’t grab anybody during these events, did he?” “No sir, he did not.” “He couldn’t walk. He had 50 broken bones. His skull was permanently fractured. He had permanent brain damage. My dad was never the same after that. You know, and everybody just considered him to be normal. I think if that happened to anybody, they wouldn’t be normal ever again.” “This doesn’t just affect the person it happened to. It also affects all those people who are out there watching it. They’re all affected forever.” “I was desperate to help.” “I was just kind of emotional, and I went to the African-American that was standing there on the curb. And I was just like, they’re not going to help them.” “Oh my God.” “This man, he witnessed another African-American man getting his life taken. The nine-year-old speaker on the trial.” “Good morning, [inaudible].” “Good morning.” “Which one is you?” “Just so happened to be walking down the street. She will never forget that for the rest of her life.” “You ultimately ended up posting your video to social media, right?” “Correct.” “And it went viral?” “Correct.” “It changed your life, right?” “The girl who filmed George Floyd, the fact that there was nothing she can do to save his life.” “It’s been nights, I stayed up apologizing and apologizing to George Floyd for not doing more.” “That’s something that will haunt her like George Holliday, who captured my dad’s video.” “Without George Holliday, these four officers might not be on trial.” “He just wanted to test this new camera he had. Like, oh let me take — he stood there shaking, terrified. And he still suffers to this day because that was the right thing to do.” “What could he have done to deserve that?” “If I was to see George Floyd’s daughter today, I wish there was something I can say. But it’s not easy. It’s not easy at all. Because I’m sure she’s watched that videotape. And that’s something that carries in your mental every everyday, just like my dad’s video tape.” “For the jury, a difficult decision ahead, knowing that to acquit the four officers could ignite this city.” “Not guilty of —” Chanting: “No justice, no peace. No justice, no peace.” “And damage to the city of Los Angeles running into billions of dollars.” “That’s what I’m saying. The police, they don’t pay a cent for this trial. So my mother and I, we was watching the George Floyd’s trial. And it brought back so many memories of my son Oscar’s case. Oscar’s last picture in his cellphone was of the officer who shot him.” “My name is Wanda Johnson. I’m the mother of Oscar Grant.” “Grant was shot once in the back as he lay face down on the train station’s platform.” “He was unarmed.” “The 27-year-old officer has said he thought he had drawn his Taser gun —” “— but accidentally pulled out his handgun instead.” “And the incident was captured on cellphone video.” “Video speaks for themselves. And the jury will see that and make the correct decision.” “We knew that we would have a very hard time winning in the court systems because the judicial system was not made for everyone in the society.” “As the situation went on, the crowd began to grow and grow.” “Oh my goodness, the same playbook that they used for what happened with Oscar, they used the same thing for George Floyd. Oh, there was a crowd of angry mob people.” “They were behind them. There were people across the street, people yelling.” “We don’t know if they were going to attack us. I thought about the young man testifying in George Floyd’s case.” “You grew angrier and angrier.” “Calling the police on the police.” “911, what’s the address of the emergency?” “How do you have somebody investigate those that they work with? Of course you’re going to find that they’re going to believe the people that they work with quicker than they will believe the citizens who are filing the complaint.” “Would you like to speak with those sergeants?” “Yeah, I’d like to. He was unresponsive. He wasn’t resisting arrest or any of this.” “OK, one second.” “Murderers, bro. Y’all are just murderers, bro.” “You know, when we was going to jury trial for Oscar, they would ask questions like, ‘Do you know anybody who went to jail? Do you know anybody who had an encounter with the police?’ And as soon as the person said that, they would strike them from being a juror, right? Having a jury that consists of different backgrounds, it could help with the decision-making of innocent or guilty.” “The 27-year-old officer —” “— pleaded not guilty to the murder charge.” “His trial had been moved to Los Angeles over concerns of racial tension and intense media scrutiny.” “Everybody, let’s just pray for one minute.” “Father God, we come to you and your son named Jesus Christ. Father, we ask the people that see this —” “Every time I come to my mom’s house, I’m reminded that my son was killed here.” “My name is Sequette Clark. I’m the mother of Stephon Clark.” “22-year-old Stephon Clark was fatally shot while running from police.” “Clark was see evading authorities after allegedly smashing a car window.” “He was shot eight times in his grandmother’s backyard.” “Police apparently thinking he was holding a gun, now say it was a cellphone.” “Out of fear for their own lives, they fired their service weapon.” “And following the incident, officers manually muted their body cameras at times.” “Move over this way.” “As we watched the George Floyd trial, I invited particular members of my family because you can’t address something in the community or the city or the nation until you address it at home with the family.” “When Mr. Floyd was in distress, Mr. Chauvin wouldn’t help him, didn’t help him.” “So that’s just how they left my boy out there. They handcuffed him after he was dead.” “Excessive force.” “Excessive force and lethal force after the fact of death. I felt saddened, heavy, drained. I felt as if I was a slave 400 years ago. Just hearing how he was dead, seeing how he was dead. And then to turn around and hear the defense’s attempt to bring up the fact that we should not focus on the —” “— 9 minutes and 29 seconds —” “— that it took to kill George Floyd. But we should focus on what went on ahead of that. Anything that does not deal directly with the murder of George Floyd is irrelevant in my opinion.” “He’s 6 to 6 and a half feet tall. You did not know that he had taken heroin. Mr. Floyd did use a counterfeit $ 20 bill to purchase a pack of cigarettes. Mr. Floyd put drugs in his mouth.” “Poppa’s already dead. George Floyd is already dead.” “That’s right. That’s right.” “So now you’re resurrecting him just to kill him all over again.” “Basically.” “Defame him in order to justify the wrongdoing of your officers, reminded me exactly of what the district attorney did to Stephon.” “The cellphone examination revealed a domestic violence incident that happened with the mother of his children. Texts and phone calls showing that he was seeking drugs and a photograph of his hand holding 10 Xanax pills.” “What was on his cellphone has zero to do with the actions of the police officers at the time of his homicide. I feel like it’s a bittersweet thing that’s happening watching the George Floyd trial. Because I’m optimistic that this is a piece of justice for the death of my son.” “We might not be here. They’re going to get him. They’re going to get him.” “Was a crime committed? The answer to that question is no. And as a result, we will not charge these officers with any criminal liability related to the shooting death or the use of force of Stephon Clark.” “April 14, 1991: King fights emotional and physical scars. So this is basically a photo album book of my dad’s newspaper articles since he’s been in the news. Years and years and years. You throw someone to the wolves and you expect them to be normal. You know, there’s no such thing as normal after that. And then, can you imagine how many Rodney Kings there is that never got videotaped? There’s plenty of them.” “I would have prayed and hoped that Oscar’s trial would have been televised because America has to really look in the mirror and say, ‘Are all people being treated equally?’” “There was excessive use of force against George Floyd —” “We’re not focused on the videotape, his toxicology, his heart condition. We’re focused on the fact that several people witnessed this man get murdered.” “You can see it with our own eyes. It’s crazy.” “People don’t realize what it does to your family. It’s bigger than just a trial and this officer. We never get to see them again. We never get to smell them again and kiss them again. Our lives are completely affected forever.”

Author John Eligon, Tim Arango, Shaila Dewan and Nicholas Bogel-Burroughs
This post originally appeared on NYT > U.S. News