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Scientists Press Case In opposition to the Covid Lab Leak Concept

In the recent debate on the origins of the coronavirus, a group of scientists this week presented an overview of scientific findings that they believe show that natural spread from animals to humans is a far more likely cause of the pandemic than a laboratory incident.

The scientists refer, among other things, to a recent report showing that markets in Wuhan, China, had sold live animals susceptible to the virus, including civet cats and raccoon dogs, in the two years before the pandemic began. They observed the striking similarity of the appearance of Covid-19 to other viral diseases caused by natural spillovers and pointed to a variety of newly discovered viruses in animals that are closely related to the virus that caused the new pandemic.

The back and forth among scientists takes place as intelligence agencies work with a deadline for the end of summer to give President Biden an assessment of the origin of the pandemic. There is now disagreement among intelligence officials as to which scenario is more likely for a viral origin.

The new paper, which went online on Wednesday but has yet to be published in a scientific journal, was written by a team of 21 virologists. Four of them also worked on a 2020 paper in Nature Medicine that largely ruled out the possibility that laboratory manipulation could turn the virus into a human pathogen.

In the new paper, the scientists provided further evidence that the virus was spilled from an animal host outside of a laboratory. Joel Wertheim, a virologist at the University of California, San Diego and co-author, said a key point in support of natural origin is the “uncanny similarity” between the Covid and SARS pandemics. Both viruses appeared in China in late autumn, he said, with the first known cases emerging near animal markets in cities – Wuhan in the case of Covid and Shenzen in the case of SARS.

In the SARS epidemic, the new paper suggests that scientists will eventually trace its origin back to viruses that infected bats far from Shenzen.

Due to the spread of viruses similar to the new coronavirus in Asia, Dr. Wertheim and his colleagues predict that the origin of SARS-CoV-2 will also be a long way from Wuhan.

Since first surfacing in the final months of 2019, the viral culprit of this pandemic has not yet been found in any animal.

In May, another team of 18 scientists published a letter arguing that the possibility of a laboratory leak must be taken seriously due to insufficient evidence of a natural origin for the coronavirus or a leak from a laboratory. Wuhan, where the pandemic was first documented, is home to the Wuhan Institute of Virology, WIV for short, where researchers have been studying coronaviruses from bats for years.

One of the signatories of the May 2021 letter, Michael Worobey of the University of Arizona, co-authored the new paper, which advocates natural spillover.

He said his views evolved as more information emerged. Among other reasons for Dr. Worobey’s shift was the growing evidence of the Huanan animal market in Wuhan. When the pandemic first appeared in Wuhan, Chinese officials tested hundreds of samples from animals sold in the market and did not find the coronavirus in any of them.

But last month, a team of researchers presented an inventory of 47,381 animals from 38 species that were sold in Wuhan’s markets between May 2017 and November 2019. This included species such as civets and raccoon dogs, which can act as intermediate hosts for coronaviruses.

Dr. Worobey called this study “a groundbreaking paper”.

He also pointed out the timing of the earliest cases of Covid in Wuhan. “The Huanan market is right in the epicenter of the outbreak, with later cases radiating into space from there,” said Dr. Worobey in an email.

“No early cases cluster near the WIV, which has been the focus of most speculation about a possible lab escape,” he said.

However, other scholars say that such arguments are speculative and that the new review is mostly a repetition of what is already known.

“Basically, it really boils down to an argument that because almost all previous pandemics have been natural in origin, it must be,” said David Relman, a Stanford University microbiologist who organized the May Letter to Science.

He noted that he does not reject the natural origin hypothesis as a plausible explanation for the pandemic jump. But dr. Relman believes the new paper is “a selective sample of outcomes to be used to argue one side”.

Dr. In their new paper, Worobey and his colleagues also presented evidence against the notion that so-called gain-of-function research, which intentionally changes the function of a virus, may have played a role in the pandemic. The researchers argue that the coronavirus genome does not have mandatory signatures of manipulation. And the diversity that coronavirus scientists have discovered in Asian bats could serve as an evolutionary source for Covid-19.

But Richard Ebright, a molecular biologist at Rutgers University and a staunch critic of attempts to reduce the likelihood of a laboratory leak, said this was a straw man argument.

Dr. Ebright said it was possible that a WIV laboratory worker caught the coronavirus on a field expedition to examine bats or while processing a virus in the laboratory. The new paper, he argued, did not address such possibilities.

“The review does not advance the discussion,” said Dr. Ebright.

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FDA requires federal investigation into approval

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the US agency and Biogen representatives prior to the drug’s approval on June 7.

“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares of Biogen fell by more than 3% after the announcement.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by US regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. STAT News and other media outlets reported FDA officials used a regulatory shortcut to gain approval in order to get the drug on the market sooner.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

It’s rare for an FDA chief to call for an investigation into the agency’s own decisions. It’s the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

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15 States Attain a Deal With Purdue Pharma Over Opioids

At a press conference Thursday to announce the settlement, the Massachusetts, New York and Minnesota attorneys general pointedly noted that they had asked the Sacklers for years to admit guilt and apologize, but family members refused.

Government lawyers said that instead of spending years looking for more money to meet urgent needs created by the opioid epidemic, they agreed to step back in order to free funds faster.

New York Democrat Rep. Carolyn B. Maloney and California Democrat Mark DeSaulnier introduced a law they call the Sackler Act that would allow states to prosecute company owners in bankruptcy proceedings that the attorneys general are tracking down strongly support own statements. But even if Congress passed such a law, the attorneys general added, the Sacklers and Purdue would almost certainly have closed the case long ago and would have escaped the scope of the bill.

As such, Purdue will cease to exist as such and re-emerge as a new company that would manufacture limited quantities of OxyContin and overdose reversal drugs, according to the overall bankruptcy filing. It would be overseen by an appointed board of directors. The profits would feed payments to funds for distant plaintiffs that would primarily support drug treatment and prevention programs.

Lawyers involved in the negotiations underlined the importance of the public document archive, which can hardly be surpassed in its breadth and depth. Although Purdue has already produced 13 million documents during the litigation, it has now added 20 million more. The size of this one company’s documents rivals that uncovered by the entire tobacco industry, a coveted consequence of the Big Tobacco litigation some 20 years ago.

The Purdue documents will contain statements, emails, and letters that go back two decades. They are expected to reveal detailed details of Purdue’s behind-the-scenes contacts with federal investigators and Food and Drug Administration officials as the company fended off tougher penalties for promoting turbo sales that touted OxyContin as effective and non-addictive. Experts assume that the considerations and mandates of Dr. Richard Sackler, a former President and CEO of Purdue.

In Thursday’s briefing, Maura Healey, the Massachusetts attorney general who was the first to suing Sacklers, said the document pool served as a promise to the families of opioid victims. “It will tell the whole story, all of the conversations, all of the discussions, all of the planning, all of the ways they make money and evade accountability and regulation,” she said.

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No proof a booster shot is required, says Dr. Ashish Jha

Covid booster doses are currently not required, said the dean of the School of Public Health at Brown University on Friday, as highly transmissible new variants test the protection of available vaccines.

“Let me tell you where we are: the data is very clear, if you got your two shots from Moderna or Pfizer or a single shot from J&J you have a very high level of protection against all variants, including Delta” said Dr. Ashish Jha. “I haven’t seen any evidence yet that anyone needs a third shot.”

Jha’s comments come after Pfizer and BioNTech announced Thursday that they are developing a Covid-19 booster shot that will target the Delta variant. Company officials say another vaccination may be needed as immunity to the vaccine appears to decline over time.

In CNBC’s The News with Shepard Smith, Jha emphasized the importance of waiting for the dates when it comes to a booster shot.

“When this evidence comes along, and of course we will want to take that into account, I think I think it is unlikely that we will need third shots for most people,” Jha said.

The Centers for Disease Control and Prevention and the Food and Drug Administration issued a joint statement stating that Americans who are fully vaccinated do not need a booster vaccination.

“Americans who have been fully vaccinated currently do not need a booster vaccination. FDA, CDC, and [the National Institutes of Health] are involved in a science-based, rigorous process to check if or when a refresher might be needed, “said a joint statement released Thursday evening.

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The C.D.C. Points New College Steerage, With Emphasis on Full Reopening

In another shift, the C.D.C. made clear that masks could be optional for vaccinated people, in line with its recommendations for the general public.

Still, the agency said that schools may opt to require universal masking if local cases were rising, for example, or if a school could not determine how many of its students and staff members were vaccinated. And it urged schools to “be supportive of people who are fully vaccinated, but choose to continue to wear a mask.” In general, students and staff members did not need to be masked when outdoors, the agency said.

The C.D.C. also strongly urged schools to promote vaccination, which the guidance called “one of the most critical strategies to help schools safely resume full operations.” Studies suggest that vaccines remain effective against the Delta variant.

The country’s two major teachers’ unions, which have close relationships with the Biden administration, praised the guidance. Randi Weingarten, the president of the American Federation of Teachers, whose members in some cases fought the reopening of schools this past school year, said the recommendations are “grounded in both science and common sense.”

Still, both school and public health officials predicted challenges ahead.

Ms. Weingarten said the mask guidance posed a particular test, since classes with students 12 and older would most likely include a mix of vaccinated and unvaccinated students. Many officials in areas with low vaccination rates have already said they will not require masks in schools — and at least eight states have already banned such requirements.

Updated 

July 9, 2021, 6:08 p.m. ET

Some parents who have advocated school reopening greeted the new guidelines with relief. Meredith Dodson, whose son is entering kindergarten this fall in San Francisco, organized a group of parents who spent the last school year fighting for the city to open its schools. The city finally allowed elementary school students to return in mid-April, but most middle and high school students were not able to do so at all.

“This is a huge step in the right direction,” Ms. Dodson said.

Many schools have already largely or entirely returned to in-person learning. By mid-spring, the vast majority of districts had allowed at least younger students to return to classrooms, although many, especially on the West Coast, only allowed them to attend part-time. Many families — especially Asian American, Black and Hispanic families — chose to keep their children learning remotely.

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Mississippi well being officers plead with aged to keep away from mass indoor gatherings as delta Covid variant rips by state

Medical workers with Delta Health Center wait to vaccinate people at a pop-up Covid-19 vaccination clinic in this rural Delta community on April 27, 2021 in Hollandale, Mississippi.

Spencer Platt | Getty Images

Mississippi state health officials issued new guidance on Friday that calls for state residents over the age of 65 and immunocompromised residents, vaccinated or unvaccinated, to avoid any indoor mass gatherings for the next two weeks amid “significant transmission” of the delta variant over the coming weeks.

The new guidance is in place until July 26 and is not mandatory. The guidance should instead be considered a recommendation.

“We’re not recommending any mandates. What we’re doing is we’re providing personal recommendations for individuals who are at high risk for severe outcomes,” Mississippi State Health Officer Dr. Thomas Dobbs said during a press briefing Friday. “We don’t want anybody to die needlessly.”

Dobbs said he currently “does not anticipate” the guidance being expanded to other age groups in the future.

Officials said they are starting to see significant transmission of the delta variant that is very reminiscent of what was seen in the early days of the pandemic. Mississippi state health epidemiologist Dr. Paul Byers specifically highlighted church groups, school and summer programs, funeral gatherings and workplaces as well as long-term care facilities as areas where officials are already seeing spikes in infections.

“We have directly identified that they are the result of the delta variant, and the transmission … has been pretty significant,” Byers said at the press briefing Friday.

The state is second to last to Alabama out of all states when it comes to the percentage of the population that is fully vaccinated with two doses. About 25% of Mississippians over age 65 are still unvaccinated, and make up the majority of Covid deaths in the state. State health officials also said they are seeing deaths in vaccinated residents as well, “because we are exposing them over and over again,” Dobbs said, though it is a miniscule percentage.

Zoom In IconArrows pointing outwards

Graph shows cases, hospitalizations and deaths among vaccinated vs unvaccinated in Mississippi from June 3 to July 1, 2021.

Mississippi State Health Department

Mississippi is ranked last in the country in its share of adults with at least one Covid shot and the state is also ranked last in the country in the percentage of residents age 12 and older with at least one shot.

“I don’t think that we’re going to have some miraculous increase in our vaccination rate over the next few weeks, so people are going to die needlessly,” Dobbs warned.

State health officials asked vaccinated residents to speak with others about their experience with the vaccine in an effort to raise awareness about the safety and efficacy of the shots.

“Let people, let your family know, let your neighbors know, let your friends know,” Dobbs said. “There’s no more powerful message than trust and faith for people to know how widely utilized the vaccine has been, and understand that people are safe and excited to be protected.”

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What Mother and father Have to Know In regards to the C.D.C.’s Covid Faculty Pointers

But the variant can fuel outbreaks in unvaccinated communities and populations.

“We are vaccinating more people every day, but we are not on our way to interrupting the transmission until the fall,” said Dr. Sean O’Leary, a pediatric infectious disease specialist in Colorado. “Unless we can do that, almost everyone I know in the field is very concerned about an increase in falls.”

Children are far less likely to develop the virus or its variants than adults. Less than 2 percent of children with Covid-19 end up hospitalized, and even fewer – 0.03 percent of cases or less – have died, according to the American Academy of Pediatrics. A small percentage can also develop a rare but potentially serious inflammatory disease.

The emergence of the delta variant is an urgent reason to continue a large number of mitigation measures, especially in primary schools, said Dr. Linas, who has an 11 year old daughter who has not yet been vaccinated.

The agency recommends what is known as a “layered” approach, which suggests that schools combine multiple risk reduction strategies to reduce risk. (This was also known as the “Swiss Cheese Model”.)

In addition to masking, distancing, and vaccination, schools could introduce regular screening tests for the virus. Fully vaccinated students and staff do not need to participate in screening programs or quarantine if they have been in close contact with someone with Covid-19 unless they have symptoms as per guidelines.

The guidelines also highlight the importance of ventilation and encourage schools to bring more fresh air into the home by opening doors and windows or changing HVAC settings. “I’m pleased that ventilation is specifically mentioned as a stand-alone element,” said Joseph Allen, a healthy building expert at Harvard TH Chan School of Public Health. “We’ve been talking about it for 18 months now.”

At this stage of the pandemic, the agency said a number of overarching rules made no sense. Immunization rates vary tremendously across the country, and communities with low immunization coverage can experience significant outbreaks, especially as Delta spreads.

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John Carreyrou predicts Elizabeth Holmes trial final result

The writer of “Bad Blood” has not finished telling the Theranos story.

Three years after his bestseller was published, John Carreyrou is releasing a new podcast to uncover the final chapter of former Theranos CEO Elizabeth Holmes. “Bad Blood: The Final Chapter” follows the upcoming trial against Holmes.

In an interview with CNBC, Carreyrou shared his bold predictions about her criminal fraud trial due to begin in August after several delays due to the coronavirus pandemic and her unexpected pregnancy. Despite the postponements, Carreyrou predicts Holmes will be convicted of wire fraud and said a guilty verdict in her trial will be a “big shot across the bow for Silicon Valley entrepreneurs”.

“The message will be that you can’t really do what you want, you can’t completely ignore rules and regulations. You can’t shake your nose at regulators and authorities,” Carreyrou said.

He warns that a not guilty verdict will set a dangerous precedent among startup CEOs. “Young entrepreneurs will say, ‘Look what Elizabeth Holmes got away with and she didn’t go to jail for it.'” Carreyrou adds, “In this case, it takes a guilty verdict to correct course.”

Holmes and Ramesh “Sunny” Balwani ran the now defunct start-up Theranos together as CEO and President – and at times also as girlfriend and boyfriend.

The two are facing separate criminal jury trials over allegations they lied to patients and doctors while pushing investors for hundreds of millions of dollars. Holmes and Balwani have both pleaded not guilty.

Carreyrou tells CNBC that a large part of Holmes’ defense strategy could be blaming Balwani. He predicts that Holmes will take a stand and tell the jury that Balwani “kept her in his psychological grip, that he was an abusive friend”.

CNBC reached out to Holmes and Balwani attorneys. They did not respond to calls for comment.

Holmes plans to call a psychologist who specializes in relationship trauma as a witness. Carreyrou, who has spent years reporting on Holmes and the events in Theranos, says he is not buying the defense.

“Based on all of the interviews I did for my book and other interviews I did for the podcast, it’s clear that they ran this company and allegedly committed this fraud together as a couple,” he said.

“If they couldn’t agree, she had the last word,” said Carreyrou. “That’s why I find it hard to believe that she was under his psychological grip and had no will of her own.”

Watch the video to learn more from Carreyrou about his trial predictions, new evidence he’s received, and his upcoming podcast.

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F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

The Food and Drug Administration on Friday called for a federal investigation into the process that led to the approval of a new drug for Alzheimer’s disease that has sparked harsh criticism from lawmakers and the medical community.

In a letter to the independent office of the Inspector General of the Department of Health, Acting Commissioner of the FDA, Dr. Janet Woodcock, the scrutiny the agency has been through regarding the approval process for the drug known as Aduhelm. She pointed to interactions between representatives from drug developer Biogen and the agency, saying that some “may have occurred outside of the formal correspondence process”.

“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is critical that the disputed events be verified by an independent body,” wrote Dr. Woodcock. She noted that the review should investigate whether communications between agency staff and Biogen representatives violated FDA rules.

The unusual request to examine the decision-making process of one’s own employees for an individual drug approval is likely to exacerbate the controversy surrounding the approval of Aduhelm. The FDA approved the drug a month ago, overcoming stout objections from its own independent advisors who said there wasn’t enough evidence to know if the drug was effective.

After the decision, three of these experts left an FDA advisory panel.

Dr. Woodcock’s request for an investigation came a day after the FDA narrowed its recommendations on who should receive the drug. After initially being recommended for all Alzheimer’s patients, the agency’s new guidelines should only prescribe it to people with mild cognitive problems.

Biogen did not immediately respond to a request for comment.

STAT, the medical news organization, first reported that Dr. Billy Dunn, the agency’s head of neuroscience, in early May 2019 held an off-the-book meeting with a Biogen manager, Dr. Al Sandrock, exit. While it is not uncommon for pharmaceutical company executives to meet frequently with FDA officials, it is uncommon to provide data that would be part of an FDA application outside of a formal framework.

A few months earlier, Biogen had discontinued two late-stage studies of the drug after early analysis found the drug would not prove effective. However, the Biogen researchers who analyzed the data soon concluded that the decision to stop the studies was premature and that the drug might be effective after all.

The meeting between Dr. Dunn and Dr. Sandrock was a first step in resuming the talks that led to approval last month.

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CDC says totally vaccinated academics and college students needn’t put on masks indoors in up to date steering

Students wearing masks listen to teacher Dorene Scala during third grade summer school at Hooper Avenue School on June 23, 2021, in Los Angeles.

Carolyn Cole | Los Angeles Times | Getty Images

The Centers for Disease Control and Prevention updated its public health guidance for schools Friday, saying fully vaccinated teachers and students don’t need to wear masks inside school buildings.

The CDC’s new guidance comes about two months after federal health officials permitted the use of the Pfizer-BioNTech Covid vaccine for kids ages 12 to 15, allowing middle and high school students to get the shots ahead of the fall school semester.

Teachers and students who are not vaccinated should still continue to wear masks indoors, the U.S. agency said, adding the practice is especially important when inside and in crowded settings, when social distancing cannot be maintained.

The agency also said it still recommends that students remain at least 3 feet apart in classrooms, combined with indoor mask wearing by people who are not fully vaccinated, to reduce the risk of transmission of the virus.

“When it is not possible to maintain a physical distance of at least 3 feet, such as when schools cannot fully re-open while maintaining these distances, it is especially important to layer multiple other prevention strategies, such as indoor masking,” the CDC wrote in its guidance.

The CDC’s recommendation will likely have no impact on students under 12, who are currently ineligible to get a Covid vaccine in the U.S.

The updated guidance comes as several states across the U.S. have largely done away with their mask requirements, social distancing and other pandemic-related restrictions because the Covid vaccines have helped drive down the number of new infections and deaths.

In mid-May, the CDC said fully vaccinated people didn’t need to wear masks in most settings, whether indoors or outdoors. They are still expected to wear masks on public transportation, the agency said, such as on airplanes, buses and trains. The federal government’s mask mandate on public transportation is scheduled to expire on Sept. 13 unless the CDC extends it once again.

The guidance may be controversial as scientists and other health experts say indoor mask mandates many make a return this fall, particularly in low vaccinated states, as the highly transmissible delta variant spreads across the U.S.

Already the dominant variant in the U.S., delta will hit the states with the lowest vaccination rates the hardest — unless those states and businesses reintroduce mask rules, capacity limits and other public health measures that they’ve largely rolled back in recent months, experts say.

This is a developing story. Please check back for updates.