Food and Drug Administration (FDA) experts recommended a booster shot of the Moderna Covid-19 vaccine for high-risk groups and people older than 65. Next week, Moderna’s application to provide booster doses of its Covid-19 vaccine will move to a panel of independent experts at the Centers for Disease Control and Prevention (CDC).
Joe Biden is reportedly considering former FDA commissioner Robert Califf to once again lead the agency. The FDA has been without a permanent leader since Biden took office, and is currently being led by an acting commissioner who has been criticized for the mishandling of the opioid crisis as drug chief. Califf, who served in the Obama administration, has been criticized for his ties to the pharmaceutical industry.
Biden urged the 66 million unvaccinated Americans to get a vaccine. Although vaccination rates have increased in recent days, he said the US must continue to vaccinate the unvaccinated. He said vaccine mandates “work, they work”, and mounting evidence shows they can increase vaccination rates by up to 20% for some employers.
The House committee investigating the 6 January insurrection is making first moves to hold Steve Bannon in criminal contempt for defying its subpoena. Bannon, apparently on Trump’s instruction, refused to comply with his subpoena.
The attorney general, Merrick Garland, will make his first appearance before the House judiciary committee next week. The testimony is likely to touch on everything from a severe near-total abortion ban in Texas to voting rights and gun violence.
– Maanvi Singh, Lauren Gambino, Jessica Glenza and Joanna Walters
US lawmakers announced two major new proposals seeking to rein in the power of big tech, days after the revelations from a former Facebook employee spotlighted the company’s sweeping impact.
The first bill, proposed by a group of senators headed by Democrat Amy Klobuchar and Republican Chuck Grassley would bar big tech platforms from favoring their own products and services.
The second bill, put forward by House Democrats, would remove some protections afforded tech companies by Section 230, a portion of the Communications Decency Act that exempts them from liability for what is posted on their platforms.
The proposals are part of a slew of bills from this Congress aimed at reining in tech firms, including industry leaders Facebook and Apple. Thus far, none have become law although one, a broader measure to increase resources for antitrust enforcers, has passed the Senate.
Klobuchar and Grassley’s bill would specifically prohibit platforms from requiring companies operating on their sites to purchase the platform’s goods or services and ban them from biasing search results to favor the platform. It is a companion bill to a measure which has passed the House judiciary committee and must pass both houses of Congress to become law.
Dozens of climate activists arrested at Interior Department
Fifty-five climate activists, including Indigenous leaders, were arrested during a protest at the Interior Department, according to the organizers of People vs. Fossil Fuels. Both activists and security personnel were injured.
Activists said that tasers and batons were used against them. The protestors were demanding that Joe Biden halt approvals for fossil fuel projects and declare a national climate emergency. At the Interior Department, the Indigenous Environmental Network – which was leading the protest today – said Indigenous leaders were there to occupy the Bureau of Indian Affair, which is part of the department. They voiced opposition to Line 3, a tar-sands oil pipeline project that opponents say violates protected tribal land.
Hearing reports they are using tasers on Indigenous peoples outside the Bureau of Indian Affairs as Indigenous leaders occupy the building inside. Over fifty natives and allies in the building now #expectus#stopline3pic.twitter.com/twRaka3X9L
Biden reportedly considering former FDA commissioner Robert Califf to once again lead agency
Joe Biden is honing in on Robert Califf, the former Food and Drug Administration (FDA) Commissioner under Barack Obama, as he considers nominees to lead the agency.
The FDA has been without a permanent leader since Biden took office, and is currently being led by an acting commissioner, Janet Woodcock, who has been criticized for her handling of the opioid crisis during her tenure as drug chief.
Califf served as FDA commissioner for about a year, during Obama’s second term. The Washington Post first reported that he is a top contender for the role once again. Although he was confirmed in 2016 with broad support, some senators including Bernie Sanders of Vermont have raised concerns over his ties to the healthcare industry.
“The country desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical device industries has grown dangerously cozier,” said Michael Carome, of the advocacy group Public Citizen. “Califf would not be that leader.”
OPINION: Merck wants Americans to pay $712 for a Covid drug that taxpayers helped develop
Guardian US columnist David Sirota writes:
Last week, we learned that Merck is planning to charge Americans 40 times its cost for a Covid drug whose development was subsidized by the American government. The situation spotlights two sets of facts that have gone largely unmentioned in the legislative debate over whether to let Medicare negotiate for lower drug prices.
Fact one: Americans are facing not merely expensive drugs but prices that are examples of outright profiteering.
Fact two: in many cases, the medicines we are being gouged on are those that we the public already paid for.
These facts show us that pharma-bankrolled Democrats trying to kill drug pricing measures aren’t just bought and paid for in this particular skirmish – they are foot soldiers in the pharmaceutical industry’s larger multi-decade campaign to seal off and rig America’s alleged “free market”.
First, there’s the price point of drugs. It’s not merely that Americans are paying the world’s highest prices for pharmaceuticals, it’s that in many cases, we are paying prices that aren’t even close to what consumers in other countries pay.
A new Public Citizen analysis shows that the 20 top-selling medicines generated almost twice as much pharmaceutical industry revenue in the United States as in every other country combined. Sure, compared with others, Americans may buy a lot of prescription drugs, but this study reflects something much bigger at play: pharma-sculpted public policies that allow drug price levels to go beyond profits and into profiteering.
That term “profiteering” is important here because drugmakers aren’t losing lots of money in other countries where they sell medicines at lower prices.
Covid vaccines for children aged five to 11 are inching closer to authorization in the US, with possible availability as soon as early November, and experts are already looking to the next hurdle: actually getting the shots in those young arms.
Only one-third of parents plan to vaccinate their children as soon as the vaccines are ready, the non-partisan Kaiser Family Foundation has found. Another third of those surveyed want to wait and see how the rollout goes.
“What’s going to be actually more challenging, beyond having the infrastructure to be able to administer the Covid-19 vaccines, is ensuring that parents feel comfortable vaccinating their children,” Syra Madad, an infectious disease epidemiologist and senior director of the System-wide Special Pathogens Program at NYC Health + Hospitals, told the Guardian.
About half of children 12 and older have been vaccinated in the months since the vaccines were given the green light for those ages.
Vaccinating people of all ages is a crucial part of ending the pandemic, said Dr Saad Omer, an infectious disease epidemiologist and director of the Yale Institute for Global Health.
“We will not be able to get out of this pandemic without vaccinating children – both for their own sake and for the sake of having overall protection,” he added.
An FDA advisory panel recommended booster doses for some Americans on Thursday. Photograph: Joseph Prezioso/AFP/Getty Images
Let’s break down the FDA advisory panel’s recommendation about who should get booster shots and why:
First, “It’s important to remember that the vaccines still provide strong protection against serious outcomes” such as hospitalization and death from Covid-19, said FDA vaccine chief Dr Peter Marks.
The panel recommended the booster doses for people who are older than 65, work or live in high-risk settings, or have health problems that might make them susceptible to severe Covid-19.
That recommendation was made in part on the Israeli experience, where Pfizer booster doses were given to people older than 60.
The recommendation was for this group of people to receive the booster dose at least six months after they received both doses of the original vaccine series (typically, two doses spaced 28 days apart).
Moderna booster shots will be half the dose of the original vaccine series – 50-micrograms v 100-micrograms. The goal is to make booster doses with less reactogenicity – or side effects.
This is not the last hurdle for Moderna boosters. The FDA will issue a formal decision on whether to approve booster shots based on experts’ recommendations. They don’t always take experts’ advice, but most of the time they do. As well, a complimentary panel of experts who advise the CDC will consider the evidence on Moderna booster shots next week.
US leaders stress booster shots are not the first line of defense in the pandemic. They can help maintain protection for vulnerable people who are already vaccinated, but work must continue to vaccinate 66 million more Americans.
There will be more booster news in the coming days:
On Friday, the same independent panel of experts who advise the FDA will consider whether it is safe and effective for Americans to have a booster dose of the Johnson & Johnson vaccine. That decision will then also go to a complimentary CDC panel for consideration.
Expert advisors to the FDA and CDC will then consider vaccines for children aged 5-12 years old later this month, an advisory panel sure to be watched closely by parents all over the country.
Mark Warner, a Democratic senator of Virginia, as well as the state’s gubernatorial candidate Terry Mcauliffe, have urged the White House and Democratic leaders in Congress to pass the $1tn infrastructure bill and notch a win while negotiations drag on over the size and scope of Biden’s larger social spending package. The Virginia Democrats believe it could boost the party’s efforts in the state ahead of elections next month.
“I think the president ought to tell the House that we ought to deliver the infrastructure bill,” Warner told CNN.
But House progressives have said they would tank the infrastructure bill if it not passed in tandem with the bigger package.
Psaki was asked twice about these comments but would not engage. She reiterated that the White House is committed to passing both bills and would do so when they had the votes to move the bills.
Ending the briefing on a humorous note, she confirmed that the president is following the Texas governor’s race but that he has made no calls to the actor Matthew McConaughey to urge him to run.
McConaughey is reportedly considering challenging the state’s Republican governor, Greg Abbott, with whom Biden and the White House have repeatedly tangled. It’s far from clear if McConaughey is serious about running for office and if he did, what party he would join to do so.
Psaki demurred when asked if she believes Congress would pass his social spending plan by Pelosi’s 31 October deadline and before he leaves for the Glasgow summit at the beginning of next month. She said she would not comment on the timeline, but reiterated that the “time is unending and we feel that it is time to move forward.”
She said president Biden and senior level officials have been engaged and in constant communication with lawmakers over the bill, including key centrist holdouts, senators Sinema and Manchin. She would not provide details on their outreach.
Related to the White House’s decision to hand over documents related to the January 6 attack on the US capitol, a reporter asked Psaki whether the administration was potentially opening a “pandora’s box” for future presidents who may have political motivations for making public information traditionally kept private about their predecessor.
“I can assure you ... that this president has no intention to lead an insurrection on our nation’s Capitol,” Psaki replied. She said they don’t see it as a breach of decorum given the extraordinary nature of the attack on US democracy.
In response to a question about the White House chief of staff Ron Klain’s “retweets,” a source of constant chatter and criticism, Psaki said his social media habits are “not a top priority”.
She was asked again about comments by US climate envoy John Kerry to the Associated Press, in which he said failure to pass the social spending package would be “devastating” and akin to “President Trump pulling out of the Paris agreement.”
Psaki said that the global climate summit beginning on 1 November in Glasgow was an important international summit, but insisted the US could maintain its leadership role even if negotiations were still ongoing over the sweep of Biden’s agenda.
“None of our objective – or the president’s climate agenda – begins or ends on November 1st and 2nd or the week after,” she said.
The White House has not yet provided a date for when borders would open to travelers from Europe. Pskai said the timeline remains “early November” and refused to give a specific date.
White House press secretary Jen Psaki began Thursday’s briefing by touting new jobs figures, crediting the president’s administration with creating 5 million jobs in the 8 months since Biden took office.
“Growth is up, wages are up and our unemployment is down below 5%,” Pskai said. “We know there’s more work to do.”
She also highlighted an announcement made earlier on Thursday, ahead of Biden’s meeting with Kenya’s leader, president Uhuru Kenyatta, that the US will donate 17 million doses of Johnson & Johnson’s coronavirus vaccine to the African Union.
Asked if Biden can be a credible messenger at COP26 without passage of his Build Back Better plan, which is the centerpiece of his climate agenda, Psaki said “absolutely.”
She said the rest of the world was watching closely, but understood that the Congress was working through the legislative process.
On senate majority leader Chuck Schumer’s decision to bring voting rights legislation up for a vote on Monday, when it is expected to succumb to a Republican filibuster, Psaki vowed to keep pressing. “It’s not an option not to do it,” Psaki said.
Though Biden has said it is a priority, she did not mention filibuster reform, which many activists believe is the only way an evenly-divided senate will advance voting rights legislation. The bill, a compromise plan cobbled together by senator Joe Manchin, is Democrats main response to a sweep of bills in Republican-controlled state legislature to make voting harder.
Next week, Moderna’s application to provide booster doses of its Covid-19 vaccine will move to a panel of independent experts at the Centers for Disease Control and Prevention (CDC).
In general, the FDA advisory panel reviews safety and efficacy, while the CDC panel makes practice recommendations.
On Friday, we will see a similar debate from the FDA’s expert advisory panel about whether to provide a booster shot for Johnson & Johnson.
The FDA and CDC recently recommended people older than 65 and people aged 18-65 working in high-risk jobs should receive a Pfizer booster dose at least six months after their initial two-dose series of vaccines.
Prior to the boost dose debate, experts at both agencies recommended people with compromised immune systems receive a third dose of both the Pfizer and Moderna.
An independent panel of experts who advise the FDA has recommended seniors and certain workers receive a “booster” dose of Moderna’s Covid-19 vaccine. Photograph: Mike Segar/Reuters
An independent group of Food and Drug Administration (FDA) has recommended a booster shot of the Moderna Covid-19 vaccine for high-risk groups and people older than 65, the AP reports.
Former President Trump will be forced to testify in a lawsuit in New York, alleging his Trump Tower security guards assaulted people protesting his 2016 campaign-trail comments about Mexican immigrants.
One of the attorneys questioning Trump, Benjamin N Dictor, said he would question the former president Monday, the Washington Post reported.
I will be conducting the examination of Donald Trump under oath, at Trump Tower,” Dictor said in a written statement. “We look forward to presenting the video record of his testimony to the jury at his trial.”
Federal prosecutors have filed charges against a powerful Los Angeles councilman, Mark Ridley-Thomas, and a former University of Southern California (USC) dean, alleging a major bribery scheme in which Ridley-Thomas promised to steer contracts to USC if the school awarded his son a scholarship and teaching job.
Los Angeles City Councilman Mark Ridley-Thomas charged with conspiracy, bribery and fraud offenses allegedly committed while a member of the Los Angeles County Board of Supervisors. Full announcement on grand jury indictment coming soon. @FBILosAngeles
The 20-count indictment, the latest in a series of major corruption scandals engulfing the LA city council, alleges that in 2017 and 2018, Ridley-Thomas, who was then serving on the LA board of supervisors, offered to award public funds to USC’s School of Social Work. In exchange, Marilyn Louise Flynn, then the dean of the social work school, pledged to give the politician’s son a full-tuition scholarship and a paid professorship job, the US attorney’s office said.
Ridley-Thomas is a prominent lawmaker in the city who has helped craft a new controversial law restricting where unhoused people can sleep outside. Flynn’s attorney said she had not committed any crime, and Ridley-Thomas’s lawyer did not respond to inquiries, according to the LA Times.
One LA former council member is currently in prison after he pleaded guilty to lying about gifts he had received, and another former councilman is facing trial in a racketeering and bribery case.
On Wednesday, in an unrelated case, the California attorney general also filed tax fraud charges against the executive director of SEIU California, the state’s largest labor union, and her husband, alleging that the couple filed false tax returns and owe the state $140,000. The director resigned from her position after the charges were announced.
