Health officials have advocated for a pause in the Biden administration’s COVID-19 booster shot rollout due to insufficient data, people familiar with the matter told The New York Times.
In a meeting with White House officials, including White House pandemic coordinator Jeffery Zients, last week, acting commissioner of the Food and Drug Administration (FDA) Janet Woodcock, along with Rochelle P. Walensky, head of the Centers for Disease Control and Prevention (CDC), said recommendations for booster shots may not be complete by the White House’s timeline.
The agencies told the White House they may only be able to recommend booster shots for some individuals and still have to determine if they will recommend the shots for all of the vaccines.
President Biden announced in August the government was aiming to recommend booster shots for those who got their vaccine more than eight months ago on Sept. 20.
Health officials are still debating booster shots to determine when a person might need them. In addition, poorer countries are urging richer countries to donate vaccine doses before starting booster shots.
A White House spokesperson told the Times last week that the administration is waiting for approval from the FDA and recommendations from the CDC before rolling out booster shots.
“We always said we would follow the science, and this is all part of a process that is now underway,” spokesperson Chris Meagher said.
“When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus," Meagher added.
Individuals who heard about the meeting between Zients and the health officials said it is not clear how Zients responded to the agencies’ comments, according to the Times.
Other countries such as Israel have already begun giving booster shots to their citizens. The European Union has decided against giving booster shots, saying it wants to focus on giving more people their first shots.
So far, the U.S. has only offered additional shots to immunocompromised individuals who didn’t form the high amount of antibodies needed from the first two doses.
Republican South Dakota Gov.Kristi Noem on Tuesday issued an executive order restricting abortion medications, requiring that they be picked up in person at a doctor's office.
In her executive order, Noem dictated that abortion-inducing medications such as mifepristone may be dispensed to a woman by a physician licensed in South Dakota only after an in-person examination. Data on the number of chemical abortions performed and any complications as well as information to indicate if the woman was "coerced or sex trafficked and forced to take the pills" will also be collected, per Noem's order.
Her oder also says that no manufacturers, suppliers or physicians will supply abortion medications via telemedicine or mail service. They also cannot be provided in any school or on state grounds, including colleges and universities, with the South Dakota Republican claiming that the "abortion industry" is targeting young women.
Noem directed the South Dakota Department of Health to "develop an abortion clinic license specific to the pharmaceutical nature of medical abortion in keeping with South Dakota's existing surgical abortion clinic licensing requirements."
Noem noted that the FDA is expected to lift further restrictions on abortion medications beginning Nov. 1 and wrote, "The result is likely to be an increase in chemical abortions and resulting complications."
"South Dakota is a state that values life and prioritizes women's health and safety above politics by basing public policy on science and data rather than political talking points," Noem wrote in her order.
This move comes shortly after Texas passed a ban on abortions past six weeks, before most women even know that they're pregnant. It is considered to be the most restrictive abortion law in the U.S., allowing individuals to sue anyone who “aids or abets” an abortion after six weeks for up to $10,000 and legal fees.
The new law has been highly criticized for its extreme effects, with President Biden calling it "almost un-American."
"I respect people who ... don't support Roe v. Wade. I respect their views. I respect those who believe life begins at the moment of conception and all. I respect that, don’t agree, but I respect that. Not going to impose that on people," Biden said to reporters last week.
French pharmaceutical major Sanofi SA said Wednesday that it has entered into a definitive agreement to acquire U.S.-based biopharmaceutical company Kadmon Holdings Inc.
Sanofi said that holders of Kadmon common stock will receive $9.50 a share in cash, representing a total equity value of about $1.9 billion on a fully diluted basis.
The company said that the acquisition supports its strategy to strengthen growth in its transplant business and to continue to expand its general medicines core assets. As a result, Sanofi said it will immediately add Rezurock--a drug used in the treatment of post-transplant graft-versus-host disease--to its transplant portfolio.
Sanofi said it plans to finance the transaction in cash, and that it expects to close it in the fourth quarter of 2021, pending customary closing conditions.
Dr. Anthony Fauci has been accused by critics of lying after newly released documents appear to contradict his claims that the National Institute of Health did not fund gain-of-function research at China’s Wuhan lab.
Senator Rand Paul led the criticism against Fauci on Tuesday after the documents, obtained by The Intercept, detailed grants given to EcoHealth Alliance — the nonprofit that funneled federal funds to the Wuhan Institute of Virology for bat coronavirus research.
Included in the trove of documents is a previously unpublished grant proposal that EcoHealth Alliance, which is run by Peter Daszak, filed with Fauci’s National Institute of Allergy and Infectious Disease.
Fauci has repeatedly insisted that NIH funding of the Wuhan lab does not constitute as “gain-of-function” research, which modifies the biological agent, and in the case of a virus, could increase its transmissibility or virulence.
“Surprise surprise – Fauci lied again. And I was right about his agency funding novel Coronavirus research at Wuhan,” Sen. Paul tweeted after the documents were made public.
In a follow-up tweet later in the day Tuesday, Rand said he was referring the issue to the Department of Justice.
“I have already asked the DOJ to review Fauci’s testimony for lying to Congress,” Rand wrote. “This report should make it abundantly clear that he needs to be held accountable.”
The grant proposal included in the documents was for a project titled “Understanding the Risk of Bat Coronavirus Emergence,” which involved screening thousands of bat samples, as well as people who worked with live animals, for novel coronaviruses, the outlet said.
The $3.1 million grant was awarded for a five-year period between 2014 and 2019. After the funding was renewed in 2019, it was suspended by the Trump administration in April 2020.
The grant directed $599,000 to the Wuhan Institute of Virology for bat coronavirus research.
Fauci clashed with Paul during a Senate hearing in July after the Kentucky senator quizzed the infectious disease expert about earlier testimony he had given in which he denied NIH-funded gain-of-function research.Included in the trove of documents is a previously unpublished grant proposal that EcoHealth Alliance filed with Fauci’s National Institute of Allergy and Infectious Diseases.J. SCOTT APPLEWHITE/POOL/AFP via Getty Images
The proposal acknowledged the risks of such research, saying: “Fieldwork involves the highest risk of exposure to SARS or other CoVs, while working in caves with high bat density overhead and the potential for fecal dust to be inhaled.”
The documents also include a second grant titled “Understanding Risk of Zoonotic Virus Emergence in Emerging Infectious Disease Hotspots of Southeast Asia,” which was awarded in August last year.
Under the terms and conditions of that grant approval, there is a section noting that prior to “further altering the mutant viruses,” the NIAID needs to be given a “detailed description of the proposed alterations and supporting evidence for the anticipated phenotypics characteristics of each virus.”
Fauci has repeatedly insisted that NIH funding of the Wuhan lab does not constitute “gain-of-function” research.Hector Retamal/AFP via Getty Images
Richard Ebright, a molecular biologist at Rutgers University, said the documents – obtained via a Freedom of Information Act request — made it clear that Fauci had been “untruthful” about gain-of-function research.
“The documents make it clear that assertions by the NIH Director, Francis Collins, and the NIAID Director, Anthony Fauci, that the NIH did not support gain-of-function research or potential pandemic pathogen enhancement at WIV are untruthful,” he tweeted.
“The materials show that the 2014 and 2019 NIH grants to EcoHealth with subcontracts to WIV funded gain-of-function research as defined in federal policies in effect in 2014-2017 and potential pandemic pathogen enhancement as defined in federal policies in effect in 2017-present.”
The proposal was for a project titled “Understanding the Risk of Bat Coronavirus Emergence,” which involved screening thousands of bat samples.FeatureChina via AP Images\\“This had been evident previously from published research papers that credited the 2014 grant and from the publicly available summary of the 2019 grant. But this now can be stated definitively from progress reports of the 2014 grant and the full proposal of the 2017 grant.”
Gary Ruskin, executive director of U.S. Right To Know, told the Intercept that the documents provided a “road map to the high-risk research that could have led to the current pandemic.”
NIH funding of work at the Wuhan lab has come under increasing scrutiny amid the pandemic, with Republican senators like Rand Paul of Kentucky and Tom Cotton of Arkansas accusing Fauci of lying about whether the money was used for gain-of-function research.
According to another report, the NIH funded a total of 65 research projects at the Wuhan institute — more than Fauci had let on.
The report, based on a soon-to-be-released book titled “What Really Happened in Wuhan,” claims that top US officials were unaware that Fauci had lifted an NIH ban on gain-of-function research.
“I was in meeting after meeting with Dr. Fauci and that never came up,” former national security advisor Robert O’Brien told the author. “I don’t know if he alerted anyone. I never heard about it until I was out of office.”
Fauci has repeatedly testified in front of lawmakers that the NIH has not funded gain-of-function research at the Wuhan lab.
He has clashed with Sen. Paul on a number of occasions, including in May when the infectious disease expert was grilled about the origins of COVID-19 and funding of the Wuhan lab on Capitol Hill.
“Sen. Paul, with all due respect, you are entirely, entirely and completely incorrect… the NIH has not ever and does not now fund gain of function research in the Wuhan Institute,” Fauci said.
They butted heads again during a Senate hearing in July when the Kentucky senator quizzed Fauci about his earlier testimony.
“Dr. Fauci, knowing that it is a crime to lie to Congress, do you wish to retract your statement of May 11 where you claimed that the NIH never funded gain-of-function research and move on?” Paul (R-Ky.) asked during testimony before the Senate Health, Education, Labor and Pensions Committee.
Fauci clashed with Paul during a Senate hearing in July after the Kentucky senator quizzed the infectious disease expert about earlier testimony he had given in which he denied NIH-funded gain-of-function research.
Paul, citing two academic papers by the Wuhan institute, accused Fauci of “obfuscating the truth” by not admitting that the lab was involved in gain-of-function research.
“Senator Paul, I have never lied before the Congress, and I do not retract that statement. This paper that you’re referring to was judged by qualified staff, up and down the chain, as not being gain-of-function,” Fauci said.
Fauci with Peter Dazsak, the president of EcoHealth Alliance.EcoHealth Alliance
“Senator Paul, you do not know what you are talking about, quite frankly, and I want to say that officially. You do not know what you are talking about,” Fauci said.
The senator went on to describe the definition of gain-of-function, including how it involves increasing the transmissibility of a virus in animals to humans.
“They took animal viruses that only occur in animals and they increased their transmissibility to humans,” Paul said, referring to scientists at the Wuhan lab.
“How you can say that is not ‘gain-of-function,’ it’s a dance, and you’re dancing around this, because you’re trying to obscure responsibility for 4 million people dying around the globe because of the pandemic.”
Fauci responded: “Senator, because if you look at the viruses that were used in the experiments that were given in the annual reports that were published in the literature, it is molecularly impossible.
“I want everyone to understand that if you look at those viruses, and that’s judged by qualified biologists and evolutionary biologists, those viruses are molecularly impossible” to result in COVID.
“And you are implying that what we did was responsible for the deaths of individuals, I totally resent that, and if anybody was lying here, Senator, it is you.”
Fauci’s boss, NIH director Francis Collins, issued a statement in May denying claims the NIH or NIAID had supported specific “gain-of-function” research.
“NIH and NIAID have for many years supported grants to learn more about viruses lurking in bats and other mammals that have the potential to spill over to humans and cause widespread disease,’ Collins said.
“However, neither NIH nor NIAID have ever approved any grant that would have supported “gain-of-function” research on coronaviruses that would have increased their transmissibility or lethality for humans.”
Local officials who want to extend enhanced unemployment benefits can do so, the White House said on Tuesday, a day after the administration and U.S. Congress allowed a program to lapse which had boosted payments during the COVID-19 pandemic.
Programs providing up to $300 extra a week to millions of people who lost their jobs during the pandemic ended on Monday as the U.S. celebrated Labor Day.
Benefits were also available for people who normally do not qualify for state unemployment money, with checks going to those without jobs for an extended period of time and to "gig workers" who perform on-demand services, including as drivers, delivering groceries or providing childcare. Those people will be cut off entirely.
White House press secretary Jen Psaki said there are other options available for states to extend benefits to people in need.
"The message to these individuals is we're going to continue to have your back," she said.
The funding for extra jobless benefits had been provided as an economic stimulus measure in a series of bills following the COVID-19 pandemic, including the $1.9 trillion American Rescue Plan passed in March by Biden and his fellow Democrats. The administration never pushed for a nationwide extension.
Psaki said the White House would "continue to work with states where you're living to help them implement programs, including the distribution of the American Rescue Plan funding, so that you can get the assistance you need."
Republicans opposed the benefits, saying they would discourage work at a time when a record 10.1 million job openings were available, as of the end of June. Many governors cut off the extra payments in their states.
Still, there was little direct evidence the payments were the primary factor pushing people out of the labor force.
The White House is leaving the choice to the states and said it will work with them to access other funding from the stimulus bill or other sources if they want to expand unemployment benefits.
"Twenty-four states ended these benefits already," she told reporters aboard Air Force One.
"There's 26 states left. All of those states are not in the same economic circumstances. Their unemployment rate ranges from 3% to 7%, or about an average of 5%, and almost all if not all of those states have the funding and the ability to continue to implement additional benefits."
President Joe Biden has made engineering a recovery from the COVID-19 recession a key focus since taking office in January, but the rebound has faced obstacles from rising coronavirus cases to higher prices, lingering unemployment and a lack of available workers and supplies.
Nonfarm payrolls increased by 235,000 jobs last month after surging 1.053 million in July, the Labor Department said on Friday. Economists had expected 728,000 new jobs.
Strykertoday announced theacquisitionofGauss Surgical, a Menlo Park, CA-based medical device company that has developed Triton™, an artificial intelligence-enabled platform for real-time monitoring of blood loss during surgery. Financial details of the acquisition were not disclosed.
– Triton combines the power of A.I. with the simplicity of a mobile device to deliver accurate blood loss during surgery. Triton has demonstrated improvements in maternal and surgical care through earlier recognition of hemorrhage leading to earlier intervention.
About Gauss
Founded in 2011, Gauss’s mission is to digitally augment clinicians with software that radically improves diagnostic accuracy and leads to improved patient safety and clinical outcomes. Gauss’s flagship product, Triton, leverages computer vision to detect surgical and obstetric hemorrhage in real-time and notifies clinicians who can enact timely intervention and treatment. Triton was granted De Novo clearance from the U.S. Food and Drug Administration (FDA) in 2014, as the first-ever computer vision software for surgical use, and several follow-on 510(k) clearances. Available on the iPhone, Triton has been widely adopted by health systems in the United States and is a recipient of the Apple Design Award, which recognizes the best in design, innovation and technology on Apple platforms.
