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Thursday, November 18, 2021

Hospitalizations rising among fully vaccinated in U.S.: Fauci

 As cases of Covid-19 rise throughout the U.S., health officials warn that an increasing number of fully vaccinated people are being hospitalized or going to the emergency room. The concern about waning immunity against severe Covid infection comes as the Food and Drug Administration is expected to authorize a Pfizer-BioNTech vaccine booster shot for all adults 18 and older.

“What we’re starting to see now is an uptick in hospitalizations among people who’ve been vaccinated but not boosted,” Dr. Anthony Fauci, the director of the National Institute for Allergy and Infectious Disease, said Tuesday in an interview. “It’s a significant proportion, but not the majority by any means.”

On Wednesday, Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, reported a decline in vaccine effectiveness among the elderly and residents of long-term care facilities, many of whom were the first to be eligible to be vaccinated last winter.

“Although the highest risk are those people who are unvaccinated, we are seeing an increase in emergency department visits among adults 65 and older, which are now again higher than they are for younger age groups,” Walensky said Wednesday at a White House Covid briefing. 

Walensky also pointed to new data on long-term care facilities from the agency's National Healthcare Safety Network comparing rates of Covid disease between people who are vaccinated with two doses and those who have received extra doses.

“The rate of disease is markedly lower for those who received their booster shot, demonstrating our boosters are working,” she said.

Fauci and Walensky stressed that the majority of hospitalizations and deaths are still among unvaccinated people in the U.S.

"Studies show that those who are unvaccinated continue to be more likely to be infected, more likely to be in the hospital and more likely to have severe complications from Covid-19," Walensky said at the briefing.

The current seven-day rate of hospital admissions is about 5,300 per day, according to the CDC, and about 1,000 people in the U.S. are dying from Covid every day.

Still, it’s not clear how many breakthrough hospitalizations there are. Although the CDC has been tracking the rate of hospitalizations among fully vaccinated people, its website shows data only through Aug. 28. According to the latest data from the CDC, an unvaccinated person is at 11 times greater risk of dying from Covid than a vaccinated person.

The CDC didn’t respond to a request for new numbers.  

At least 31 million people have received extra doses of a Pfizer, Moderna or Johnson & Johnson vaccine, according to the CDC. 

Fauci pointed to data from Israel that show a major improvement in protection against severe disease and hospitalizations in those who have had boosters compared to those who haven’t. In a study published last month, Israeli researchers found a twentyfold reduction in severe disease among those over 60 who got booster shots. 

Another study last month from Israeli researchers and faculty members of Harvard Medical School found that booster doses were 92 percent effective at preventing severe disease when compared to having received a standard two-dose regimen at least five months previously. 

As vaccination rates increase in the U.S., it’s expected that more vaccinated people would be hospitalized with Covid, simply because the vaccines aren’t 100 percent protective against severe illness, Fauci said.

“That’s where we get back to the importance of getting a boost,” Fauci  said. “It will dramatically diminish the likelihood that if you do get infected with a breakthrough infection that you’ll wind up in the hospital.” 

The U.S. is only starting to see “inklings” of waning protection against severe disease, Fauci said — but Israel has been about six weeks ahead in Covid’s development throughout the pandemic, one reason federal health officials have relied on its data. 

“If you look strictly at the data from Israel, it’s very clear that the differences in immunity waning is much more profound in the elderly, but it goes across the board,” Fauci said, noting that, in particular, people over 40 who have had boosters showed marked improvement in protection against severe disease.

Given the lack of national data on breakthrough illnesses among younger adults, it’s unclear how many cases of severe disease there have been and whether boosters would provide a benefit.

“I wouldn’t be surprised that sooner or later, you’re going to see the data indicate that it’s also going to be very important for [younger] people, when they have boosters available, to get the booster shot,” Fauci said. 

Dr. Bob Wachter, the chair of the University of California, San Francisco, department of medicine, would like to expand boosters to all adults over 18. 

“It was reasonable to start boosting with people at the highest risk of a bad outcome or the highest risk of exposure,” Wachter said. “However, we’ve sort of gone through that stage, and there’s enough vaccine around.” 

One of the biggest questions surrounding booster doses was a potential risk of inflammation of the heart muscle, or myocarditis, which has been associated with the mRNA vaccines, especially in young males. Israeli health officials report that no significant signals of myocarditis have emerged yet, Fauci said.

Along with the push for boosters, giving first doses to the unvaccinated is critically important, experts say.

Dr. Paul Sax, a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said getting people their first doses and others booster doses can absolutely happen at the same time. 

“They’re separate processes and seem to be not in conflict with each other,” Sax said. “We can definitely do both, because I think most of the people who are vaccinated would agree to a booster dose if it meant they’d be better protected."

Sax is also strongly in favor of widening booster doses to include all adults over 18. 

“It’s inevitable and in my opinion the right move,” he said. “It does appear that two doses just isn’t sufficient.”

https://www.nbcnews.com/health/health-news/hospitalizations-rising-fully-vaccinated-us-fauci-says-rcna5907

COVID Rapid Test Prices 'Ridiculous'

 Experts are advocating for rapid COVID-19 tests as an added layer of safety for holiday gatherings -- but they're also railing against the high costs of these tests in the U.S., and pleading for prices to come down.

On Amazon, a two-pack of rapid tests ranges from $23.99 for the Quidel QuickVue to $34.99 for the On/Go test (a.k.a. Access Bio's CareStart test). Prices for rapid tests start at $23.99 on the websites for CVS, Walgreens, and Rite Aid.

If just 10 people planning to gather for Thanksgiving wanted to test that morning, it would cost about $120 -- potentially the most expensive item on the holiday table.

"Paying $25 for a box of two tests is ridiculous," Carlos del Rio, MD, of Emory University in Atlanta, told MedPage Today. "Frankly, it's a travesty that in the middle of a pandemic we have such poor access to rapid testing."

"They should cost $5 for two tests," he added.

Eric Feigl-Ding, ScD, of the Federation of American Scientists, called rapid testing a "wealthy, urban privilege. Most of rural America can't afford it."

In a previous story, Tinglong Dai, PhD, of Johns Hopkins Carey Business School in Baltimore, said current prices are vastly higher than what public health experts had initially expected.

"Originally we thought these tests could cost $5 each," Dai said.

U.S. prices are in stark contrast to many European countries, where rapid tests are free or very inexpensive, according to reports. European regulators have also authorized more than 100 rapid tests, compared with about 10 now authorized in the U.S.

The few tests allowed on the U.S. market is one reason that these tests have been in short supply, which has played a role in driving up prices, the previous story found. Another driver was unexpected rising demand as cases increased in the U.S. due to the Delta variant, and as employers sought out tests for employees returning to offices.

The federal government has since launched several initiatives to bring more rapid tests onto the U.S. market, including a $2 billion investment to supply the tests to places such as long-term care facilities, homeless shelters, and jails, and a $1 billion investment in incentives to manufacturers.

The FDA also announced that it would implement new policies to bolster access to at-home testing and help ensure accuracy and reliability of the tests.

But experts aren't convinced that those moves are enough. Operation Warp Speed, for instance, invested $18 billion to make COVID-19 vaccines a reality.

Michael Mina, MD, PhD, of the Harvard T. H. Chan School of Public Health in Boston, tweeted that the "government should subsidize cost fully" for the tests, noting that they're "NOT a luxury. NOT personal medicine," but that they are "critical public health tools."

del Rio agreed that the tests should be subsidized by the federal government.

Rapid tests aren't without their problems. One FDA-authorized rapid test, the Ellume COVID-19 Home Test, was recalled for its potential to yield false-positive results.

And, historically, rapid tests aren't as sensitive as gold-standard PCR tests, though proponents have argued that their reliability increases among those who are truly infectious -- which could help curb viral spread.

"Companies can charge whatever they want, whatever the market will bear," del Rio said. "It's really a travesty these aren't being subsidized appropriately."

https://www.medpagetoday.com/special-reports/exclusives/95748

LA schools offering gift cards, 'Hamilton' tickets for student vaccinations

 The Los Angeles Board of Education announced that they will spend about $5 million on prizes, including gift cards to Amazon and Target as well as tickets to the play "Hamilton," as incentives to encourage student vaccinations. 

The board hopes the incentive program will boost the county's roughly 72 percent vaccine compliance rate for students by Sunday, the Los Angeles Unified School District's (LAUSD) self-imposed deadline to get students 12 and older vaccinated, the Los Angeles Times reported. 

The program mainly consists of raffle prizes, which have included gift cards to grocery stores; tickets to Disneyland, Six Flags Magic Mountain and Universal Studios Hollywood; and entertainment packages for graduation night, according to the Times. Some schools have also brought in food trucks and given out t-shirts to students who comply with the vaccine mandate. 

The board had to waive a rule at a financial incentives meeting Tuesday that mandates "a limit of $40 for personal gifts to students and parents/guardians," given that rewards on average would be between $100 and $350, the Times noted. The $5 million is covered by taxpayer funding, and any additional prizes will come from donors.

The board defended the spending in a report, writing that the money serves "a legitimate public and educational purpose," according to the Times. 

The district announced in September that all students would be required to be fully vaccinated by Jan. 10, the start of the second semester, or they would not be allowed on campus.  

City officials also announced that weekly coronavirus testing for students and school staff members will end at the beginning of the December break, an effort that has resulted in 500,000 tests a week and a total cost of about $350 million, according to the Times.

https://thehill.com/policy/healthcare/582117-la-schools-offering-gift-cards-hamilton-tickets-for-student-vaccinations

Critically ill flown to other states due to lack of Boston ICU beds

 A number of critically ill patients onboard Boston MedFlight helicopters have had to be flown to neighboring states in recent days due to a lack of ICU beds in the city. 

Boston MedFlight CEO Maura Hughes told CBS Boston that the situation has occurred "half a dozen times in the last 10 days" and that patients were taken to hospitals in Rhode Island, Connecticut and New Hampshire.

"It's not a great solution, particularly for the patient's family, when you tell them 'Yes, we have a bed. But it's in Connecticut," Hughes told the local news outlet. 

The CEO also noted that although some of the patients Boston MedFlight helicopters are carrying are ill with the coronavirus, a good number of them are in critical condition because they put off getting care for medical issues during the pandemic. 

The difficulty in finding ICU beds in the area has resulted in helicopter crews caring for some patients for much longer amounts of time than usual while they search for hospitals with open beds, according to CBS Boston.  

"A lot of times it's not the medical care that's complicated, it's the logistics" Hughes noted.

Boston MedFlight is a nonprofit organization that provides transportation and medical care regardless of whether the patient can pay, CBS Boston noted. 

As of Wednesday, Massachusetts had 2,650 new confirmed coronavirus cases, bringing the total number to 823,800, according to the Massachusetts Department of Public Health

https://thehill.com/homenews/coronavirus-report/582137-critically-ill-flown-to-other-states-due-to-lack-of-boston-icu

Masks most effective public health measure in fighting COVID-19?

 

  • A massive analysis of 72 studies across the world was published on Thursday.
  • Researchers found personal protective and social measures reduced incidences of COVID-19.
  • Masking wearing, hand washing and social distancing all had measured impacts in preventing cases of COVID-19, transmission and death.

An analysis of studies across the world revealed that wearing a mask, hand washing and social distancing are some of the most effective ways to prevent catching COVID-19 and spreading the disease.

The BMJ, a global health care publisher, released a massive review Thursday that analyzed 72 studies from around the world to evaluate how non-pharmaceutical health measures reduced cases of COVID-19. Researchers found measures like hand washing, mask wearing and physical distancing significantly reduced incidences of COVID-19. 

Researchers supported vaccines and agreed they have proven to be safe and effective and can save lives. However, most vaccines do not give people 100 percent protection and it’s not known how vaccines will prevent future spread of COVID-19, given the growing trend of variants like delta.

There’s also herd immunity to consider as the threshold for achieving it varies greatly by the country and its population response to vaccines, types of vaccines available, and which population groups are prioritized to get a vaccine, among other factors. 

But public health prevention strategies have also been shown to be beneficial in fighting respiratory infections. Researchers found that wearing a mask could reduce COVID-19 incidence by 53 percent. 

One experiment across 200 countries showed 45.7 percent fewer COVID-19 related deaths in countries where mask wearing was mandatory, according to the study. In the U.S., one study reported a 29 percent reduction in COVID-19 transmission in states where mask wearing was required. 

Social distancing has also proven to be effective, with researchers finding that an analysis of five different studies indicated a 25 percent reduction in incidence of COVID-19. 

Hand washing was found to be another crucial preventative measure, with researchers finding that there was an estimated 53 percent reduction in COVID-19 incidence. Though researchers said this was substantial, their final analysis found it to be not statistically significant.

Researchers also found that lockdowns and closures of businesses and schools have largely been effective in containing COVID-19, but depended on early implementation when rates of COVID-19 were still low. 

“When implementing public health measures, it is important to consider specific health and sociocultural needs of the communities and to weigh the potential negative effects of the public health measures against the positive effects for general populations,” researchers wrote. 

According to the Centers for Disease Control and Prevention (CDC), as of Nov. 17,  there have been more than 47 million total cases of COVID-19 in the U.S. and more than 700,000 deaths. Despite the alarming numbers, and research supporting mask wearing, many states around the country have adopted policies against mask mandates, like in Florida, where Republican Gov. Ron DeSantis (R)  signed an executive order banning counties or municipalities from implementing such requirements.

According to AARP, only six states currently require most people to wear masks indoors in public places, whether or not they have been vaccinated against COVID-19, while 11 states never imposed any mask mandate at any point during the pandemic. 

https://thehill.com/changing-america/well-being/prevention-cures/582132-huge-new-study-finds-masks-most-effective-public

Surge of US COVID-19 cases this winter predicted

 

  • A new surge in coronavirus cases in Europe is causing concern in the United States.
  • The average new daily coronavirus cases in the U.S. is over 85,000, a more than 14 percent increase from a week ago.
  • But some experts are optimistic, citing the expanding accessibility to vaccines and the possibility of new treatments such as antiviral medications.

A new surge in coronavirus cases in Europe is causing concern in the United States, with some doctors and researchers predicting an equally troubling spike in the U.S.

“I’ve been predicting a pretty bad winter wave again, and it looks like it’s starting to happen,” Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine, told The Guardian. “There’s just too many unvaccinated and too many partially vaccinated [people].” 

According to the latest data from the Centers for Disease Control and Prevention (CDC), the average of new daily coronavirus cases in the U.S. is over 85,000, a more than 14 percent increase from a week ago. 

The Institute for Health Metrics and Evaluation (IHME) projected 863,000 total deaths from the coronavirus pandemic by March 2022. However, the CDC reports 762,994 people have already died in the U.S. from COVID-19. The IHME’s worst-case scenario projection predicts more than 1 million coronavirus deaths by March 2022.

Only 58.9 percent of the U.S. population are fully vaccinated against COVID-19.

However, some experts are optimistic, citing the protection from vaccinations, vaccines becoming available to children, as well as the possibility of new treatments such as antiviral medications.

“I do expect to see cases increasing – we’ve started to see this in the last week or so,” David Dowdy, an associate professor of epidemiology at Johns Hopkins University, told The Guardian. “I don’t think what we’re seeing in Europe means we’re in for a huge surge of serious illness and death as we [saw] here in the US” in winter 2020.

“People can still get Covid, there can still be breakthrough infections,”  added Rupali Limaye, an associate scientist at Johns Hopkins University. “But the great news is if you have been vaccinated you are very much less likely to be hospitalized or have severe infection.”

https://thehill.com/changing-america/well-being/prevention-cures/582146-experts-predict-an-alarming-surge-of-us-covid-19

Arcus’s near dream scenario

 Given that in today’s biotech market deals that fall short of a full-blown takeover sometimes disappoint, Gilead today opting in to several Arcus pipeline assets might be seen as falling short of a dream scenario. In reality, however, this is a better outcome than level-headed Arcus investors had a right to expect.

Most had focused on the anti-Tigit MAb domvanalimab, and the glaring fact that no meaningful data had been disclosed for it, with Arcus instead issuing a mealy-mouthed statement that seemed to kick the opt-in can down the road. But in fact Gilead has opted not only to license in domvanalimab but three other key assets too, giving Arcus a $750m windfall.

Domvanalimab was a particular focus because the Tigit mechanism has generated a huge amount of interest, courtesy largely of Roche’s tiragolumab. And under Gilead’s 2020 tie-up with Arcus domvanalimab was singled out as the most lucrative programme, capable of triggering a $275m opt-in payment plus up to $500m in regulatory milestones.

However, keenly awaited data disclosure, thought to be key to determining whether Gilead opted in, did not materialise. In June Arcus merely said the Arc-7 study had met “internal thresholds”, and then 10 days ago – still revealing no data – it stated cryptically that Gilead had “initiated its opt-in review process for our anti-Tigit programme”.

Surprise!

Thus today’s news that Gilead was picking up not only Tigit but also etrumadenant and quemliclustat should come as a pleasant surprise, and the multiple projects involved increased the opt-in fee to $725m. Arcus traded up 15% this morning.

Etrumadenant is an adenosine A2a/A2b receptor antagonist, while quemliclustat is a small-molecule CD73 inhibitor. The opt-in also includes a second Arcus anti-Tigit MAb, AB308, while the original tie-up had given Gilead rights to zimberelimab, the anti-PD-1 MAb with which domvanalimab is being combined in the Arc-7 trial.

Domvanalimab is Fc-silenced, an approach Arcus had argued was a key differentiating factor, though there was little scientific data to back such a claim. Most other Tigits have functioning Fc regions, though a notable exception here is Compugen’s COM902.

However, Arcus’s recent advancement into the clinic of AB308, an Fc-active project, was seen by some as suggesting a lack of faith in domvanalimab, and consequently as a sign that the Arc-7 data were too weak to persuade Gilead to sign on the dotted line. Gilead actually opting in to both assets takes all such speculation off the table.

On triggering the opt-in today small changes were made to the 2020 tie-up, slightly reducing ex-US royalties payable by Gilead and cancelling a $100m option continuation payment Arcus had been due to receive next year. Gilead retains rights to opt in to additional Arcus’s clinical projects at $150m a pop.

Arcus bulls will note that the opt-in does not rule out an eventual takeover, though this surely now becomes a distant catalyst. And, with the entire clinical pipeline now in Gilead’s hands, along with a 19.7% equity stake, the chances of any other company making an approach must be close to zero.

Beholden to Gilead: selected Arcus pipeline assets
ProjectMechanismSelected trialGilead involvement
ZimberelimabAnti-PD-1 MAbArc-7, ph2 1st-line NSCLC, domvanalimab combo +/- etrumadenantLicensed under 2020 deal
DomvanalimabAnti-Tigit MAb (Fc-silent)Arc-10, ph3 1st-line PD-L1 ≥50% NSCLC, zimberelimab comboLicensed under 2021 opt-in
EtrumadenantSmall-mol A2a/A2b receptor antagonistArc-6, ph2 in prostate cancer, various combosLicensed under 2021 opt-in
Quemliclustat (AB680)Small-mol CD73 inhibitorArc-8, ph2 1st-line pancreatic ductal adenocarcinoma, zimberelimab + chemo comboLicensed under 2021 opt-in
AB308Anti-Tigit MAb (Fc-active)Arc-12, ph1 zimberelimab combo in various cancersLicensed under 2021 opt-in
UnnamedAnti-CD39 MAbPreclinical (Wuxi tie-up, competes with Surface's SRF617 & Astrazeneca/Innate Pharma's IPH5201)None
AB521HIF-2α inhibitorPreclinical (competes with Merck & Co's Welireg & Arrowhead’s ARO-HIF2)None
Source: company presentations & Evaluate Pharma.

https://www.evaluate.com/vantage/articles/news/deals/arcuss-near-dream-scenario