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Monday, February 1, 2021

Gilead Ups Ownership In Arcus to 19.5%

 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that Gilead Sciences is increasing its ownership in Arcus to 19.5%, from approximately 13%, by purchasing 5,650,000 additional shares of Arcus’s common stock at a per share purchase price of $39.00.

"Gilead’s additional investment in Arcus demonstrates the strength of our relationship, a recognition of the depth of our pipeline and our shared commitment to bringing innovative, transformative therapies to cancer patients as quickly as possible," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The proceeds from this financing will support and enable the acceleration of our development plans for our four clinical-stage molecules, including AB680, our small molecule CD73 inhibitor, for which we recently presented encouraging data in first-line metastatic pancreatic cancer. We appreciate Gilead’s continued confidence in Arcus and our ability to execute. We look forward to providing a multitude of data readouts across our entire portfolio of clinical molecules, including the ARC-7 study interim analysis for domvanalimab expected in the second quarter, throughout what we expect will be a transformational year for the company."

The Arcus-Gilead partnership, which closed in July 2020, includes an Option, License and Collaboration Agreement, a Common Stock Purchase Agreement, and an Investor Rights Agreement. Collectively, this transaction established a 10-year partnership to co-develop and co-commercialize next-generation cancer immunotherapies, provided for an initial equity investment and upfront payment to Arcus totaling $375 million, and gave Gilead the right, but not the obligation, to make additional equity investments in Arcus by purchasing additional shares of Arcus’s common stock. Arcus and Gilead entered into an amended and restated Common Stock Purchase Agreement to provide for this purchase of 5,650,000 additional shares of Arcus’s common stock. No other agreements or terms were amended. Following this investment, Arcus expects its cash and investments to fund its operations through at least 2023.

Pfizer, BioNTech Preclinical Data from Investigational COVID Vax Program in Nature

  Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that preclinical data in non-human primate and mouse models from Pfizer and BioNTech’s mRNA-based vaccine candidates, BNT162b1 and BNT162b2, for the prevention of COVID-19 were published in the journal Nature. Some of these data were initially made available to the public on September 9, 2020 via the online preprint server, bioRxiv. For additional details, please read the previously issued press release.

The preclinical data found immunization of rhesus macaques with either the BNT162b1 or BNT162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. Additionally, the vaccine candidates protected macaques from SARS-CoV-2 challenge, with BNT162b2 protecting the lower respiratory tract from the presence of viral RNA and with no evidence of disease enhancement. In mice, one intramuscular dose of either vaccine candidate elicited a dose-dependent antibody response with high virus-entry inhibition titers and strong TH1 CD4+ and IFNg + CD8+ T-cell responses.

These preclinical results contributed to the decision by Pfizer and BioNTech to commence the pivotal Phase 3 safety and efficacy portion of the clinical study to evaluate potential prevention of COVID-19 disease by BNT162b2.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.

AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

  • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.
  • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.
  • Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).
  • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
  • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
  • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
  • Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
  • Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
  • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
  • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.
  • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report.
  • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization.
  • Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.

Novartis (NOVN:SW) (NVS) PT Raised to CHF89 at HSBC

https://www.streetinsider.com/Analyst+Comments/Novartis+%28NOVN%3ASW%29+%28NVS%29+PT+Raised+to+CHF89+at+HSBC/17892398.html

Novavax (NVAX) Now A Premier COVID Vaccine Company: Jefferies

 

Jefferies analyst Kelechi Chikere reiterated a Buy rating and $200.00 price target on Novavax (NASDAQ: NVAX).  Thinks FDA EUA possible.

https://www.streetinsider.com/Analyst+Comments/Novavax+%28NVAX%29+Is+Now+A+Premier+COVID+Vaccine+Company%2C+Jefferies+Thinks+FDA+EUA+Possible/17884735.html

Sunday, January 31, 2021

Amazon algorithms promote vaccine misinformation: study

 As vaccine misinformation has prompted some to say they will refuse to be inoculated against the coronavirus, the world's largest online retailer remains a hotbed for anti-vaccination conspiracy theories, according to a new study by University of Washington researchers.

Amazon's search algorithm boosts  promoting false claims about vaccines over those that debunk health misinformation, the researchers found—and as customers engage with products espousing bogus science, Amazon's recommendation algorithms point them to additional health misinformation.

Amazon is a "marketplace of multifaceted health misinformation," wrote co-authors Prerna Juneja, a Ph.D. student at UW's Information School, and professor of social computing Tanu Mitra in the new paper, which will be presented at a conference on human-computer interaction in May.

The top eight search results Thursday afternoon for the phrase "vaccine" in Amazon's online bookstore, for instance, were vaccine denialist tomes—including books like "Anyone Who Tells You Vaccines Are Safe and Effective is Lying," by the British conspiracy theorist Vernon Coleman, and "The Vaccine-Friendly Plan," a book purporting to show a nonexistent causal relationship between vaccination and autism co-authored by Oregon physician Paul Thomas.

The Oregon Medical Board last year suspended Thomas' license for misleading parents about vaccine safety and failing to adequately vaccinate patients, including a child who later contracted tetanus and was hospitalized for 57 days.

"This book confirmed everything I have suspected about vaccines," one verified purchaser commented earlier this week below Coleman's book, which is sold by Amazon.com. "Read this book!"

In the context of the ongoing mass COVID-19 vaccination campaign, "battling against anti-vax misinformation has never been more important," Juneja said in an interview Thursday. "This is the most urgent time."

Amazon provides "customers with access to a variety of viewpoints. We're committed to providing a positive customer experience and have policies that outline what products may be sold in our stores," a company spokesperson said in a statement. "Our shopping and discovery tools are not designed to generate results oriented to a specific point of view and we are always listening to customer feedback." Amazon recently added a banner linking to the federal government's fact page on COVID-19 vaccines above results for searches with the keyword "vaccine."

Other academics have examined how the result-ranking algorithms of search providers like Google and social networks like Facebook and Twitter contribute to the spread of misinformation, but the UW researchers believe their study is one of the first to apply similar methodologies to the realm of e-commerce.

Overall, more than 10% of Amazon products returned for search terms like "vaccine," "immunization" and "autism" are misinformative, according to the UW study, which examined books, audiobooks and e-books, as well as products including dietary supplements and even apparel—like shirts with the slogans "Anti-Vax Mom" and "NO Medical Tyranny."

Amazon has previously faced scrutiny over the sale on its platform of pseudoscientific dietary supplements and media promoting vaccine conspiracy theories. After a 2019 CNN report described the extent of anti-vax falsehoods on Amazon.com, a sharply worded letter from Rep. Adam Schiff, D-Calif., prompted Amazon to yank some products from its platform, including the fake-science film "Vaxxed" and two books that claimed to contain cures for autism.

During last summer's bump in coronavirus cases, NPR documented that people searching Amazon for "coronavirus supplement"—a medically inaccurate term, as no dietary supplements have been proven to cure COVID-19—might see results for elderberry capsules, an echinacea-and-garlic tincture and a colloidal silver liquid. None of those products is an effective remedy against the coronavirus.

But unlike the market for , which is dominated by third-party vendors using Amazon's Marketplace platform, Amazon itself is selling many of the top-ranked vaccine denialist books, a review of the first five pages of search results for "vaccine" shows. Plenty of those are available for free to Kindle Unlimited subscribers, which gives members access to more than 1 million e-books for the flat price of $9.99 a month. Some of the results are "sponsored," meaning the seller paid Amazon to list them higher in the search rankings.

Platforms like Amazon have a responsibility to adjust their algorithms to not favor misinformation, Juneja said, because "people trust the results that search engines show to them."

Previous research from the University of Washington and Microsoft, for instance, indicates that people rarely look at low-ranked search results.

Some platforms have taken action to reduce the spread of health misinformation through their sites.

Facebook and Twitter announced last month that they would begin removing  misinformation, a measure taken as public health officials began ramping up mass vaccination campaigns to control the spread of COVID-19. Both have previously taken steps to delete posts with false coronavirus information.

Previously, Google and YouTube have said they would deprioritize health misinformation in their search algorithms and pull ads from anti-vaccination conspiracy theories.

Amazon recently curbed sales of products promoting neo-Nazi views and the QAnon conspiracy theories after the Jan. 6 riot at the U.S. Capitol. Many members of the mob were adherents of those beliefs, authorities said. In a first for a company that has long defended its right to sell books many would find questionable, Amazon earlier this week prohibited the sale of "inappropriate or offensive" books, including those containing hate speech and content "glorifying terrorism."

https://techxplore.com/news/2021-01-amazon-algorithms-vaccine-misinformation.html

Additional Covid-19 vaccines bring choices, complications to rollout

 It’s always good for consumers to have options, right? And indeed, the United States should soon have three Covid-19 vaccines being injected into people’s arms, with more potentially on the way in the coming months, accelerating the race to vaccinate hundreds of millions of people as quickly as possible.

But all vaccines are not equal, and increasingly, health authorities and providers will be dealing with shots with varying attributes: different storage requirements, efficacy, dosing regimens, and manufacturing platforms. That, plus the possibility of a pickier public who may want a certain shot over another, could complicate an already-messy rollout. But the different features also open the door to greater access beyond just more supply — a more convenient one-shot vaccine will likely soon be available.

The main point, experts stress, is how remarkable it is the U.S. has multiple Covid-19 vaccines just a year into the pandemic. All the immunizations that regulators authorize will have been shown to be safe and effective, so you should get whichever one you have the opportunity to get, they say.

“In the event that you have the choice to get vaccinated, I’d encourage you to take the vaccine that you’re given,” John Brooks, the chief medical officer of the Centers for Disease Control and Prevention’s Covid-19 response, said at a briefing Friday.

Johnson & Johnson, which on Friday reported its vaccine was 66% effective in preventing moderate to severe disease and 85% effective in preventing severe Covid-19 in clinical trials, plans to file for emergency use authorization with the Food and Drug Administration in early February. Presuming regulators move quickly, health authorities will have the advantage of a third shot to distribute with millions more in supply.

Unlike the two-dose mRNA vaccines already authorized from Moderna and Pfizer-BioNTech, the J&J vaccine requires only one dose. It is also cheap, and can be kept in normal refrigerators, making it easier to store and transport than the mRNA vaccines, which have to be kept at subzero temperatures, sometimes in special freezers that smaller clinics might not have.

“That’s going to be huge for rural populations,” Alan Morgan, the CEO of the National Rural Health Association, said about J&J’s shot.

Similarly, it could now be easier for vaccine campaigns to go out into communities instead of requiring people to come to hospitals to get vaccinated, which could reach people who don’t have access to health care or who are mistrustful of health institutions but may listen to community leaders. Polling data, for example, have shown that people of color, who have faced historic and ongoing mistreatment by medical providers, are less likely to get Covid-19 vaccines as quickly as other people. Plus, early vaccine distribution data show disproportionately low numbers of Black and Latino adults have received shots.

“It’s easier to bring the vaccine to hard-to-reach areas,” Mitchel Rothholz, chief of staff of the American Pharmacists Association, said about J&J’s vaccine.

Some people, however, may want to pick their vaccine as if it were a piece of produce they could squeeze to find the choicest option. Clinical trial results or reports about side effects could steer what people want.

It’s difficult to compare clinical trials of different products against each other. The pandemic has also changed: J&J’s trial occurred as at least one variant that appears to have some impact on vaccine efficacy was circulating, while the Moderna and Pfizer-BioNTech trials were completed before variants of concern started transmitting widely. Without clinical data to evaluate each vaccine against the newer strains, it’s difficult to determine if the existing Covid-19 vaccines could be less effective against variants of the virus.

Still, some people might remember the headlines of Moderna’s and Pfizer’s product offering greater than 90% effectiveness against Covid-19 and question J&J’s announcement of 66% effectiveness.

Public health officials were quick to tout J&J’s data as a strong result, particularly given that regulators initially said a vaccine would only have to be 50% effective to be authorized. A vaccine that’s 66% effective is an incredibly powerful tool in fighting respiratory viruses, they stressed. “We would be celebrating a seasonal influenza vaccine with 60% efficacy,” Jay Butler, the deputy director for infectious diseases at the CDC, told reporters.

In the U.S. arm of the clinical trial, J&J’s vaccine was 72% effective, which, in the absence of the mRNA data, “one would have said this was an absolutely spectacular result,” Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, said at a separate White House briefing. What’s more, the immunization was 85% effective at preventing severe disease and, in the trial, all hospitalizations and deaths occurred among people who got the placebo. None of the vaccinated people diagnosed with Covid-19 got sick enough to need hospital care.

“If it comes to getting my family members vaccinated, and all that’s available is J&J or Novavax, I’d tell them to take it,” said Robert Hancock, president of the Texas College of Emergency Physicians.

Novavax is another vaccine maker that, on Thursday reported that its vaccine was 90% effective in one trial in the United Kingdom, but 49% effective in another trial in South Africa, likely because of the B.1.351 variant circulating in that country, which appears to evade some aspects of the immune response. The company has not said when it might apply to the FDA for authorization.

The differing efficacy levels among vaccines could also complicate the logistical advantages J&J’s shot provides. If states started allocating J&J’s shot only to rural areas, “there may be concerns that that’s inequitable,” said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. “People in rural areas might feel like they’re getting short shrift.”

Julie Swann, the head of the department of industrial and systems engineering at North Carolina State University, who advised the CDC during the H1N1 pandemic, agreed. She said providers should start surveying their communities to see whether people have a preference for which vaccines they receive. “It would be a real mistake to distribute J&J solely based on infrastructure,” she said.

Eventually, as more vaccines get authorized, health officials could recommend that certain people, based on age or other risk factors for more severe Covid-19, are prioritized for certain shots. Perhaps the mRNA vaccines could be reserved for people who are most vulnerable to the coronavirus, suggested Swann, while the J&J vaccine could be deployed to more general populations.

For now, federal health officials haven’t issued guidelines for who should get which vaccines.

Another question looms for the vaccine drive: the variants. It appears that B.1.351 has some impact on at least some of the vaccines, though experts note that immunizations don’t work like light switches that are either on or off. Rather, people vaccinated may be less defended from getting infected against B.1.351 than other forms of the coronavirus, but the vaccines could still protect them from getting severe Covid-19.

For now, health authorities and companies say the emergence of B.1.351 and other variants serves as a signal they need to be ready to adapt vaccine designs if and when a form of the virus emerges that could significantly “escape” the immune protection conferred by vaccines. Some vaccine makers have started studying booster shots engineered specifically against B.1.351, and federal health authorities said Friday they are reviewing contingency plans to tweak the vaccines if needed.

“We will continue to see the evolution of mutants,” Fauci said. “We, as a government, the companies, all of us that are in this together will have to be nimble to be able to adjust readily to make versions of the vaccine … specifically directed towards whichever mutation is actually prevalent at any given time.”

The variants add pressure to the vaccine campaigns in other ways. B.1.351 and other variants that have been confirmed in the United States appear to be more infectious than earlier forms of the virus, which means a higher proportion of the population will need to be vaccinated to drag down the U.S. epidemic. If more people get vaccinated and cases decrease, that lowers the chance of even more nefarious variants popping up.

“The sooner we can get people immunized, the better chance we have that this will not keep happening with more and more variants emerging because there’s such a large population of viruses,” Francis Collins, the director of the National Institutes of Health, told reporters Friday.

https://www.statnews.com/2021/01/29/additional-covid19-vaccines-bring-choices-and-complications-to-rollout/

China's CanSino says gets green light to continue Phase III trials

 China’s CanSino Biologics Inc said on Monday an independent committee found the drugmaker’s COVID-19 vaccine met its pre-specified primary safety and efficacy targets under an interim analysis of Phase 3 trial data.

No adverse events related to the vaccine had occurred and the findings of the Independent Data Monitoring Committee (IDMC) meant the company could go ahead with advancing its Phase 3 clinical trial for the candidate, known as Ad5-nCoV or Convidecia, CanSinoBio said.

“The company remains blinded to whether the participants involved in the trial received vaccine or placebo,” it said.

CanSinoBio began the late-stage trial for its one-dose vaccine in Russia in September in partnership with NPO Petrovax Pharm LLC and already has a supply deal with Mexico.

https://www.reuters.com/article/us-health-coronavirus-vaccine-cansinobio/chinas-cansino-says-gets-green-light-to-continue-phase-iii-trials-idUSKBN2A111W