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Wednesday, September 8, 2021

Biden faces 'pivotal moment' with COVID-19 speech

Joe Biden is facing rising COVID-19 challenges as he prepares to lay out new steps in the pandemic fight on Thursday. 

The president will use a speech on Thursday to try to demonstrate he has a handle on the situation. 

But after the pandemic receded in the United States earlier in the summer, the highly contagious delta variant has fueled a new spike, rising to roughly 150,000 cases and over 1,000 deaths per day.

This spike is different from those of last year, in that vaccines are now widely available, meaning the risk is now overwhelmingly for the unvaccinated. 

While experts say there certainly is more the federal government can do, they also say part of the challenge is that a segment of the American population is simply refusing to get the vaccine, allowing the virus to continue to spread.

Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said it is important to “identify what the problem is here, and that is the anti-vaccine movement.”

“This isn’t like what it was last year,” he added. “This is willful.”

Despite a major push from the Biden administration, the U.S. is now well behind many other developed countries in terms of its vaccination rate. In Canada, 69 percent of the population is fully vaccinated, compared to just 53 percent in the U.S., according to a tracker from The New York Times. Sixty-five percent of the United Kingdom’s population is vaccinated, and 78 percent are vaccinated in Portugal.

Numbers are rising, with 75 percent of the 18 and up population having had at least one shot. But just 64 percent of the adult population in the U.S. is fully vaccinated.

The Biden administration has praised private sector vaccine mandates in recent weeks, and issued some of its own, like for the military, but experts have been calling for more actions around mandates as one of the few ways to break through to Americans who remain unvaccinated. 

White House Press Secretary Jen Psaki said that the six steps Biden will announce Thursday will include “requiring more vaccinations,” as well as boosting testing and “making it safer for kids to go to school.”

Psaki said that while the administration has made progress after fighting the pandemic for months, she acknowledged that “he's going to lay out these six steps tomorrow because we have more work to do.”

The remarks come as the school year kicks off and some people go back to work after summer vacations. 

On the political front, while much of the debate in Washington recently has centered on Afghanistan, COVID-19 plays a much larger role in most Americans’ daily lives and could play a major role in next year’s midterm elections. 

Biden ran for the White House in large part on the argument that he could lead the United States through the pandemic, which he argued that former President Trump had mismanaged. As a result, the stumbles and general fatigue among the population with rising cases and deaths is a political threat.

“This 100 percent impacts him and every Democrat next year,” said one Democratic strategist. 

This strategist also criticized Biden for voicing too much certainty that the nation had turned a corner in the spring and summer.

“With the pandemic, they made the same mistakes they made with Afghanistan. They declared victory in July even though Delta was spreading around the world but they did it for optics,” the strategist said.

The pandemic has certainly taken a significant turn for the worse since Biden declared on July 4th that “we’re closer than ever to declaring our independence from a deadly virus,” while also acknowledging that “we’ve got a lot more work to do.”

But others think the political fears are overblown. 

“My take on this is that it's very similar to [people saying] 'the schools will be closed and Biden is doomed,' which melted under the pesky fact of schools being opened,” said Democratic strategist Eddie Vale. 

“So people are [a] little nervous now understandably,” he added. “But the Biden administration saved us on vaccinations from Trump and there will be a huge bump once it's approved for kids. So it could be one month or three months or six months but a lot more people will be vaccinated, things will be open again and everything will be fine.”

In addition to vaccine requirements, experts say the Biden administration could do more to make rapid testing available, including in schools. 

Adalja, the Johns Hopkins scholar, said there should be “free vending machines that have home tests in them.”

But much of the problem centers on the 25 percent of American adults who still have not gotten their first shot of vaccine. 

“It’s pretty challenging given the political ecosystem that COVID lives within,” said Preeti Malani, an infectious disease expert at the University of Michigan. 

“They're willing to die over this belief,” she said of people refusing to get vaccinated. 

While in uncommon situations even vaccinated people can become infected with COVID-19, the vaccines are still highly effective on what matters most: preventing hospitalization and death. 

There is some evidence that the effectiveness of vaccines wanes over time, prompting the Biden administration to announce a plan to begin booster shots eight months after a person’s second shot, beginning the week of Sept. 20. 

But that announcement drew concern from some experts that the administration was getting ahead of the process where health officials at the Food and Drug Administration review the data. 

The administration stressed that its move is pending sign off from the FDA. 

More broadly, Malani said the main problem is not getting people boosters, but rather reaching people who have not had any shots. 

“We need to get first doses in people who are yet unvaccinated, and that’s what’s going to make all of us safer,” Malani said.  

https://thehill.com/homenews/administration/571394-biden-faces-pivotal-moment-with-covid-19-speech

GSK, Pfizer, J&J race toward $10B+ RSV vaccine market: analyst

 While COVID-19 vaccines set all sorts of industry launch records, another potential megablockbuster vaccine market looms on the horizon. Some of pharma's top players including Pfizer, Johnson & Johnson and GlaxoSmithKline are expected to be involved.

RSV, or respiratory syncytial virus, has long been a top target for vaccine developers. While companies have suffered high-profile trial failures over the years, vaccines are now advancing through late-stage testing and could launch in 2023, SVB Leerink analyst Geoffrey Porges wrote to clients this week. 

As companies race to the FDA finish line, a market worth $10.5 billion could take shape over the next decade, Porges says.

Based on currently available information, the analyst expects vaccine giant GSK to nab $2.9 billion of that total revenue by 2030, while Pfizer collects $2.1 billion, J&J picks up $1.7 billion and Sanofi scores $1.2 billion.

GSK, Pfizer and GlaxoSmithKline are all in late-stage testing for their RSV shots. Sanofi, while it's a leading vaccine player worldwide, is taking another approach with its late-stage RSV program. The company and partner AstraZeneca are working on a prophylactic monoclonal antibody for infants, and they plan to file for approval next year.

Other vaccine and drug developers including Bavarian Nordic and Moderna are in mid-stage testing or earlier in RSV and are expected to capture $2.6 billion of the overall market, Porges wrote.

As for the three leading vaccines from Pfizer, GSK and J&J, Porges expects "more or less equal timing" for their launches and a "low probability of real differentiation between the programs." The analysts' team plans to update their RSV sales model over time as more data become available.

Just last week, Pfizer started a phase 3 trial of its RSV vaccine candidate in adults 60 and older. With the company's COVID-19 vaccine launch experience, the company could be a "significant" competitor in the field, Porges wrote. Pfizer expects results as early as the first quarter of 2022, Porges wrote.

GSK expects a late-stage readout for its trial in the second half of next year. J&J hasn't released its expected phase 3 trial timeline. 

By 2030, Porges expects that 72% of the RSV market will come from adults, while 10% comes from maternal immunization—or vaccinating mothers to protect their babies—and 18% comes from infants.

RSV, the top cause of pneumonia and pneumonia in children under one, is spread through respiratory droplets or contact with a contaminated surface. The virus usually emerges in the fall in the United States and peaks in the winter.

But in recent months amid the COVID-19 pandemic, experts have been noting an uptick in RSV cases. During an unusual summer RSV season, pediatric hospitals reported infections around the Southern United States, the CDC warned in June.

https://www.fiercepharma.com/vaccines/gsk-pfizer-and-johnson-johnson-race-toward-10b-rsv-vaccine-market-analyst

The trial of Elizabeth Holmes: Who’s who in the Theranos case

 Theranos Inc. founder Elizabeth Holmes is facing a criminal trial in federal court in San Jose, Calif., on charges that she defrauded investors and patients by lying about the accuracy of her company’s finger-prick blood-testing technology. She has pleaded not guilty to charges of wire fraud and conspiracy to commit wire fraud.

Here are some of the major players in the trial and the events leading up to it. Most of the people declined to comment or couldn’t be reached.

Washington, D.C., native, she dropped out of Stanford University at 19 years old to start the company that became Theranos, a startup that promised to revolutionize the blood-testing industry.

After operating largely in secret for a decade, Theranos began in 2013 trumpeting its technology, which it said could test for dozens of health conditions with a few drops of blood extracted from a finger prick, eliminating the need for large needles and vials of blood.

Theranos’s valuation grew to more than $9 billion, and Ms. Holmes’s bold talk and black turtlenecks drew comparisons to Apple Inc. co-founder Steve Jobs.

The Wall Street Journal first reported on problems at Theranos in 2015, and the company shut down three years later amid scrutiny from regulators and prosecutors. The U.S. attorney’s office in the Northern District of California alleges that the company’s technology was unreliable and inaccurate and that Ms. Holmes knew that, despite her public claims to the contrary.

Her trial was postponed several times, including this spring when Ms. Holmes revealed she was pregnant. She gave birth to a boy in July in Redwood City, Calif.

The Defense Team

Ms. Holmes’s lead lawyer is Kevin Downey, a partner at Williams & Connolly LLP, a Washington, D.C., firm known for its litigation work. Partners Lance Wade, Amy Saharia and Katherine Trefz are also helping with her defense.

Robert Leach is the lead prosecutor in the U.S. attorney’s office in the Northern District of California representing the government. Mr. Leach was one of the prosecutors in a case involving Hewlett Packard’s acquisition of Autonomy Corp. for $11.1 billion in 2011. A year later, HP took an $8.8 billion write-down related to the deal, saying it was duped into overpaying because of what it said appeared to be willfully inflated financial statements. Autonomy’s former chief financial officer was convicted of conspiracy and wire fraud in 2019 and sentenced to five years in prison.

The COO

Ramesh "Sunny" Balwani, a former Theranos president and chief operating officer, is charged alongside Ms. Holmes. Their cases were later separated, and his trial is scheduled for early 2022. He has pleaded not guilty and denies any wrongdoing.

He is a veteran tech executive whose wealth derived from work at an earlier startup. He used his own money as collateral for a loan to Theranos in 2009 and later invested in the company.

In court documents, Ms. Holmes’s lawyers have indicated they may argue that she was in a decadelong abusive relationship with Mr. Balwani that left her under his control during the period in which the government alleges the two blood-testing executives committed a massive fraud. Ms. Holmes claims the abuse by her former business and romantic partner was psychological, emotional and sexual, according to the documents.

Ms. Holmes could argue that "she lacked the intent to deceive because, as a result of her deference to Mr. Balwani, she believed that various representations were true," according to the documents.

Mr. Balwani "unequivocally denies that he engaged in any abuse at any time," according to one court filing.

U.S. District Judge Edward Davila is overseeing Ms. Holmes’s trial. He was a public defender, private-practice lawyer and a local judge before he was nominated by President Barack Obama in 2011 to the federal bench.

The Board

Theranos’s board included power players in Washington and the legal and business worlds, and some could testify at her trial. Among them is litigator David Boies, who was Theranos’s outside counsel. His firm accepted Theranos stock in return for its services.

"I think everybody with hindsight says if I had known and understood everything that I know now, I would have done things differently," Mr. Boies said in an interview with the Journal in 2020.

The Employees

Several former Theranos employees are expected to testify against Ms. Holmes, including Tyler Shultz, the grandson of the late George Shultz, the former secretary of state who was a company board member. Another former employee expected to testify is Erika Cheung, a lab worker.

Patients

Prosecutors have accused Ms. Holmes of defrauding patients and investors by falsely claiming her invention could accurately perform lab tests with just a few drops of blood. The lineup of potential witnesses includes consumers affected by the allegedly flawed technology, including a handful previously unknown to the public.

Some Theranos patients received inaccurate test results for pregnancy, blood disorders and cancer screenings, according to court filings. They often got no response when they asked Theranos about the results, the court filings say. Ms. Holmes’s lawyers have said all labs have error rates and that a few patient anecdotes absent broader accuracy data don’t prove fraud.

https://www.foxbusiness.com/technology/elizabeth-holmes-theranos-case

Gates Foundation ramps up funding to Exscientia in COVID project

 The Bill & Melinda Gates Foundation must have liked what it saw in an initial collaboration with Exscientia to find new antivirals for COVID-19 and related diseases.

Two months after providing initial funding of $1.5 million to get the ball rolling, the philanthropic organisation has now pledged $35 million in funding to a four-year project at the UK artificial intelligence-driven drug discovery company.

Exscientia is matching the funding, which takes the form of an equity investment in the company, and the Gates Foundation may also provide additional funding to the project.

The search will focus on small-molecule drugs that are less likely to have a variation in efficacy against variants of SARS-CoV-2, which causes COVID-19, and will offer greater patient access – for which read they will be easier and cheaper to produce.

The initial funding focused on a new class of small-molecule inhibitors targeting Mpro , a protease enzyme essential for the replication of the SARS-CoV-2 virus, which will now be accelerated, according to the partners.

Now, the Foundation is funding development of up to five broad-spectrum antivirals for SARS-CoV-2 as well as other coronaviruses like MERS.

Exscientia will lead the initial antiviral projects and apply its platform technology to bring the candidates through to the pre-phase 1 stage.

It will also retain worldwide rights to all developed products with “a commitment to make the antiviral products affordable and accessible to people in developing countries” – in line with the Gates Foundation’s  mission of saving lives in developing countries.

The project will be expanded in time to include therapeutics for influenza and paramyxoviruses, another major group of respiratory infections that includes respiratory syncytial virus (RSV) as well as Nipah virus (NIV) – which is capable of causing severe disease in both humans and animals.

“Small molecule therapeutics could provide a superior approach to guard global health,” said Denise Barrault, director of portfolio management at Exscientia.

“Certain targets are prevalent across families of viruses, meaning that potent therapeutics could be broadly effective across multiple virus families,” she added.

The Gates Foundation is also funding development of drug candidates for tuberculosis at Exscientia to the tune of $4.2 million.

Orally-active drugs could be used to treat less severe, non-hospitalised cases of COVID-19. The only antiviral authorised for use against SARS-CoV-2 – Gilead’s Veklury (remdesivir) – is delivered as an infusion so is used only to treat severely ill patients in hospital.

Other companies are developing oral antivirals for COVID-19, notably Merck & Co and Ridgeback Biotherapeutics’ molnupiravir and Pfizer’s PF-07321332, which have both just moved into phase 3 testing to see if they can prevent SARS-CoV-2 infection.

Last year, Exscientia claimed a first by becoming the first company to take an AI-designed drug into the human testing stage – a candidate for obsessive-compulsive disorder partnered with Sumitomo Dainippon Pharma (DSP).

That was followed by the start of trials for a cancer immunotherapy called EXS21546 that grew out of a collaboration with Evotec, and human testing of a second DSP project – DSP-0038 for psychosis associated with Alzheimer’s – in May.

https://pharmaphorum.com/news/gates-foundation-ramps-up-funding-to-exscientia-in-covid-project/

EU lists rare nerve disorder as possible AstraZeneca vaccine side effect

 The European Union's medicine regulator released documents Wednesday that showed a possible, rare side effect of AstraZeneca's COVID-19 vaccine. 

Safety updates from the European Medicines Agency showed that the rare nerve disorder known as Guillain-BarrĂ© syndrome has been added as a possible side effect of AstraZeneca's COVID-19 vaccine, according to Reuters.

The EMA said that a relationship between Guillain-BarrĂ© syndrome and the company's Vaxzevria caused 833 syndrome cases from the reported 593 million doses administered by July 31. 

The European watchdog further categorized the potential side effect as "very rare," according to the wire service. The label represents the lowest-frequency category for the side effect. 

Guillain-BarrĂ© syndrome is a rare, auto-immune disorder in which the body attacks itself and damages its nerves. 

The AstraZeneca vaccine has not been approved for emergency use in the United States. 

In March, the use of the company's product was put on pause in several European countries after reports that the shot could be associated with rare blood clots in patients who received the jab. 

However, the use of the shot resumed in Europe the same month. 

The U.S. Food and Drug Administration has also warned that Guillain-BarrĂ© syndrome is a very rare, but possible, side effect in Johnson & Johnson vaccines, according to Reuters. 

https://thehill.com/policy/healthcare/public-global-health/571329-eu-lists-rare-nerve-disorder-as-possible-astrazeneca

Novavax begins early-stage trial for combined influenza/COVID-19 vaccine

 Vaccine developer Novavax Inc said on Wednesday it has initiated an early-stage study to test its combined flu and COVID-19 vaccine.

The trial, to be conducted in Australia, will enroll 640 healthy adults between the ages of 50 and 70 years and who have either been previously infected with the coronavirus or given an authorized COVID-19 vaccine at least eight weeks prior to the study.

Participants will receive a combination of the company's COVID-19 vaccine candidate, NVX-CoV2373, and its Influenza shot NanoFlu along with an adjuvant or vaccine booster.

"Combination of these two vaccines...may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen," Gregory Glenn, President of Research and Development at Novavax, said in a statement.

Novavax had said in May it expects seasonal influenza and COVID-19 combination vaccines to likely be critical in combating emerging COVID-19 variants. Its vaccine NanoFlu/NVX-CoV2373 had elicited robust responses to both influenza A and B and protected against the coronavirus in pre-clinical studies.

Novavax expects the trial results in the first half of 2022.

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-begins-early-stage-trial-for-combined-influenza-COVID-19-vaccine-36373139/

United Airlines: employees with religious exemption for vaccine face unpaid leave

 United Airlines employees who get religious exemption from COVID-19 vaccination will be placed on temporary, unpaid personal leave from Oct. 2, the U.S. airline said in a memo to staff.

The company said the employees will be allowed to return to their work location once new testing and safety procedures are in place.

https://www.marketscreener.com/quote/stock/UNITED-AIRLINES-HOLDINGS-45899617/news/United-Airlines-employees-with-religious-exemption-for-vaccine-face-unpaid-leave-36378620/