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 books 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 dietary supplements, 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 vaccine 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

Morgan Stanley's 'Three Rules For The New D.C.'

 By Michael Zezas, Head of U.S. Public Policy Research at Morgan Stanley

New presidential administration, same investor hand-wringing: what might come out of DC to push financial markets? If you’re struggling to pull some signal from the noise that is lawmakers hedging statements and debating mundanities like ‘budget reconciliation’, you’re not alone. So here are three shortcuts for making sense of the policy debates in DC that will affect markets in 2021.

• The rule of two Joes: What’s the difference between an aspirational and enacted policy? In our view it is the difference between those espoused by President Joe Biden and those of Senator Joe Manchin, who along with other senators (i.e., Tester, Sinema, Kelly, Warner) represents the Democratic party’s more centrist cohort. With Democrats in control of the White House and Congress, they can pass a lot of legislation…assuming all 50 Democratic senators can agree on its content. The most progressive and most moderate member must agree, as losing either’s support will tank legislation. We think that the legislative power accrues towards the electorally vulnerable center, then, consistent with historical analogues.

• Deficits break deadlocks: Even proposals which appear to have party consensus, like infrastructure and healthcare spending, face a challenge…there’s agreement to spend the money, but not how to finance it. Progressives and moderates appear far apart on their tolerance for tax increases. But we don’t expect that this will prevent policy enactment. Deficits will bridge the gap. Expanding the deficit does not appear to be a political liability, as surveys show that voters may permit such action in exchange for popular policies. This dovetails with the new economic orthodoxy of the party, where progressives’ flirtation with MMT and moderates’ Keynesianism for the moment agree that the US can push deficits further before inflation becomes a challenge. Said differently, we don’t think that Democrats will let tax and deficit disagreements get in the way of their spending agenda.

• Boundaries from budget reconciliation: There are plenty of reasons to not expect Democrats to be able to get enough Senate Republican votes for any of their major initiatives to avoid a filibuster. This actually helps to clarify the policy path for investors, as it means viable legislation is only that which can be passed by a simple majority through a workaround called ‘budget reconciliation’. At the risk of oversimplifying, it helps to think about this process as one where legislators can change the numbers on the federal income statement, but not add or subtract any line items. Because of its painstaking process, reconciliation typically can only be executed once per fiscal year. With those boundaries, investors should expect two major pieces of legislation in 2021 with a focus on reconcilable items: stimulus first and then either infrastructure or healthcare after the October start of the next fiscal year.

In our view, one clear takeaway from these rules is that 2021 will be another year of US fiscal expansion: Applying those rules to the plans of the new administration and its allies in Congress, we think you end up with a policy path that is net supportive to US growth in 2021. Fiscal stimulus can likely get done earlier in the year, though the final number after intra-party negotiation (‘the rule of two Joes’) is likely closer to US$1 trillion than the US$1.9 trillion proposal. An infrastructure or healthcare plan can likely follow, but not until later in the year (‘boundaries from budget reconciliation’) and likely with more moderate tax hikes than progressives espouse (‘the rule of two Joes’) that don’t fully cover the spending (‘deficits break deadlocks’).

Importantly, this policy course reinforces the US growth path and outlook for a multi-year bull market, though it does not preclude a near-term correction: As our economists have pointed out, the economy is increasingly on solid footing, with substantial excess household savings ready to be deployed once vaccines enable the normalization of economic behavior later this year. Further fiscal support only underscores that the US economy is accelerating into a new, sustained growth cycle, which should support a multi-year bull market.

Yet this outlook is not without risk to markets, particularly in the short term. As our equity strategy colleagues have pointed out, there are pockets of the market where excessive optimism is priced in, warranting investor caution. US policy issues are one potential catalyst to watch. In the coming weeks, investors could easily conflate banal headlines about legislative negotiation with the more legitimate risk that Democrats are at an impasse on stimulus. Unless such headlines also reference a shift in view among moderate Democrats that improvement in the COVID-19 outlook has mitigated the need for further action, we would fade such confusion and view any related market weakness as an opportunity.

[ZH: translation - despite the record drop in US hospitalizations and plunge in covid cases, expect the fearmongering to only get worse in order to allow the Dems the green light to pass trillions more in stimulus.]

https://www.zerohedge.com/markets/morgan-stanley-reveals-three-rules-new-dc

Olsterholm: Biden administration needs to focus on first vax doses

 Michael Osterholm, a top epidemiologist who advised President Joe Biden’s transition team on the coronavirus pandemic, said Sunday that the U.S. needs to “call an audible” with its vaccination program, prioritizing a rush to give a single dose to as many people as possible ahead of a likely surge of cases attributed to more contagious mutations of the virus.

Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told “Meet the Press” that he expects to see a new surge of infections “in the next six to 14 weeks,” thanks to the spread of new variants like the one first discovered in the United Kingdom. Looking at an increase in hospitalizations in the U.K. during the spread of this new variant, he predicted another surge in the U.S. will usher in “something like we have not seen yet in this country.”

“We still want to get two doses in everyone, but I think right now, in advance of this surge, we need to get as many one-doses in as many people over 65 as we possibly can, to reduce serious illness and death that is going to occur over the weeks ahead,” Osterholm said.

Right now, the two coronavirus vaccines approved for emergency use require two doses spaced out over a few weeks, but studies do show the vaccines provide significant protection after just one dose. A vaccine candidate from Johnson & Johnson, which could be authorized in the coming weeks, requires just one dose.

https://www.nbcnews.com/politics/meet-the-press/top-epidemiologist-says-biden-administration-needs-focus-first-vaccine-doses-n1256293

Hundreds arrested at anti-lockdown protests in Brussels, Budapest and Vienna

 Police have dispersed or detained hundreds of protesters against Covid-19 lockdowns in Hungary, Austria and Belgium as continuing quarantine regimes across Europe chafed against the economic and social toll of nearly a year of restrictions on business, travel and community life.

Police in Brussels said on Sunday they had arrested scores of people in an attempt to prevent two banned demonstrations against measures to curb the spread of the coronavirus. “We are above 200 arrested at the moment,” mainly around the rail stations in the Belgian capital, a police spokesman said around midday.

Police evacuated one square in front of the main railway station, where some of the protesters were football supporters from Belgian clubs. Dozens of people, responding to calls on social media, also began gathering at the Atomium landmark in Brussels.

“We remind you that there is no authorisation to come and demonstrate this Sunday,” Brussels police said in a tweet. “Those people who still intend to demonstrate in Brussels today will be approached, dissuaded from staying and if necessary [detained],” it said.

Belgium has registered one of the highest death rates in the world during the coronavirus pandemic, but restrictions closing bars and restaurants since October along with a night-time curfew have brought infection and hospital cases down in the past two months.

The country last week banned nonessential trips in and out of the country until 1 March.

Belgium’s neighbour the Netherlands was rocked by anti-curfew riots last week. But protesters took a different tack on Sunday in Apeldoorn under the rallying call of “drinking coffee together”.

Around 400 people dispersed peacefully in the central Dutch city after gathering for an authorised demonstration at a community centre.

In Amsterdam, a heavy police presence thwarted a mainly peaceful but unauthorised demonstration.

Around 5,000 people defied a ban to march in Vienna in protest against a curfew and lockdown aimed at curbing the spread of new Covid-19 variants.

The march was organised by the far-right FPOe party, and many participants ignored government regulations on mask wearing and the need to keep minimum distances from each other.

Neo-Nazi militants and thugs were reportedly among the crowd, which refused to disband and blocked traffic as it began to march towards the national parliament. Police intervened and detained some protesters.

Police also dispersed protesters at a Sunday demonstration in Budapest where workers in the country’s struggling hospitality sector demanded civil disobedience and a rethinking of lockdown restrictions.

Organisers of the demonstration at a central square in Hungary’s capital called for restaurateurs to break pandemic rules by opening their businesses to customers on Monday, in defiance of strict pandemic measures limiting restaurants and cafes to takeout service.

“Every tool that we have used until now has been depleted so, beginning now, every business should open in the spirit of civil disobedience,” protest organiser Aron Ecsenyi said.

The demonstration came alongside increasing calls for government action from Hungary’s hospitality sector as the country’s lockdown, which began on 11 November, approaches the three-month mark. Hungary’s government has insisted that only mass vaccination of the population can bring an end to the lockdown.

Pandemic restrictions were extended on Thursday until 1 March, and many business owners complain that they have received little to none of the government’s promised financial assistance while other businesses such as shopping malls and retail stores have been permitted to remain open.

Polish police said they raided discos in the cities of Wrocław and Rybnik that had opened in breach of coronavirus restrictions on Saturday, using stun grenades and teargas to clear the dancefloor.

Almost 150 officers were deployed at the Face 2 Face club in Rybnik, local police said on Sunday. Two officers were injured, and police arrested three men and checked the ID papers of 213 others.

Similar operations requiring less force were held in the south-western city of Wrocław, police said.

As is the case elsewhere, restrictions on dance and sport clubs, hotels, restaurants and ski areas have run into opposition in Poland, and some venues have decided to open despite the risk of heavy fines.

Poland has recorded more than 37,000 Covid-19 deaths from more than 1.5 million cases among a population of 38 million people.

https://www.theguardian.com/world/2021/jan/31/hundreds-arrested-at-anti-lockdown-protests-in-brussels-budapest-and-vienna

Noninvasive Saliva Tests for COVID Effective as Nose, Throat Swabs

 You now have a more comfortable, easier-to-perform option for COVID-19 testing besides the “stick in the nose” and throat swab methods.

Saliva-based testing has shown accuracy in detecting positive coronavirus infection 83 percent of the time, while nose-throat swab tests have shown 85 percent accuracy, according to a review of dataTrusted Source from 16 studies including 5,900 participants published in JAMA Internal Medicine.

The study authors also report that saliva-based testing has shown 99 percent accuracy at identifying negative cases for COVID-19, with a far less invasive and discomforting process.

Furthermore, the researchers suggest that the ease of use and good diagnostic performance of the saliva-based test may make it an attractive alternative that could bolster test rates.

Dr. Seema Kumar, a medical director at Mytonomy, said at-home testing decreases the risk of COVID-19 exposure, increases access to testing, and reduces the burden on laboratories.

She said these are all critical benefits during the ongoing and ever-evolving pandemic.

“These tests are best used for those with mild symptoms or a known or suspected exposure to someone with a COVID-19 infection,” Kumar told Healthline.

“Saliva testing is very sensitive. It can detect the virus as well as one copy per microliter of saliva,” added Dr. Spencer Kroll, FNLA, an internal medicine specialist in New Jersey.

“It is reassuring that many saliva test kits show high concordance with nasal swab polymerase chain reaction (PCR) testing for SARS-CoV-2 detection,” he told Healthline.

However, Kroll said that the approximate mismatch of saliva testing versus nose-and-throat swab testing leaves room for missed cases that could have otherwise been detected with a nasal swab PCR test.

“Therefore, negative saliva results do not absolutely preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions,” he said.

“Negative results must be combined with clinical judgment, patient history, and epidemiological data,” Kroll said.

Kumar agrees.

“Test results are interpreted in context of symptoms, possible or known exposures, and prevalence of disease within the community,” she said.

Importantly, “sometimes a repeat test is needed,” Kumar said.

“The home testing offers convenience, but it is always best to review your results and questions with your healthcare provider,” Kumar said.

https://www.healthline.com/health-news/noninvasive-saliva-tests-for-covid-19-as-effective-as-nose-throat-swabs#What-experts-think

FEMA asks DoD for up to 10,000 troops to back US vax push

 The Federal Emergency Management Agency (FEMA) has asked the Pentagon to ready as many as 10,000 troops to support 100 COVID-19 vaccination sites nationwide, with the goal of administering 450,000 vaccinations a day. 

The federal government envisions 50 "mega" vaccination sites capable of administering 6,000 shots per day, in addition to 50 "large" vaccination sites providing 3,000 shots per day, according to defense officials. 

The first of the FEMA-powered vaccination sites are expected to be operating by mid-February, a senior White House official told CBS News, and will scale up as vaccine production intensifies in the coming months. 

FEMA's "Prepare to Deploy Order" to the Department of Defense (DOD) is expected to be approved, but has not yet been greenlighted. California, Virginia, Michigan, Delaware and New Mexico are among the states that have requested federally run vaccine centers. 

The FEMA-run sites will be entirely new in most cases, according to a senior White House official, but the federal agency will work with governors to provide personnel and support to existing state-run vaccination centers where they're needed. The agency will offer funding, logistics, staffing and mobile vaccination clinics, but governors are free turn down DOD deployments to their state. 

California Governor Gavin Newsom's office, which has been struggling with high infection rates for months, is relying on FEMA for help in establishing "high-volume vaccination sites" in several locations. The California National Guard announced it will be assisting at two facilities to start: Cal Expo-Sacramento and the Long Beach Convention Center. 

Michigan has requested up to 16 federally supported sites statewide, according to its Emergency Management and Homeland Security Division. "It is clear that additional vaccine will not be immediately available to support these sites, however planning will begin to ensure that sites are available when there is sufficient vaccine to support them," a spokesperson told CBS News.

Deputy Secretary of Defense David Norquist and the Pentagon's COVID coordinator, Max Rose, visited a FEMA site in Arizona Friday for a firsthand assessment of what military support is needed.

"This is not a militarization of the vaccination operation or federalization of vaccines," a senior White House official told CBS News. "This is the United States government providing whatever assistance is needed in parts of the community, in support of the governor."

President Biden announced Monday that the administration had its sights set on more ambitious vaccination targets, and hoped the U.S. could ramp up capacity to administer 1.5 million shots daily. The administration is increasing the weekly supply of COVID-19 vaccines to states and territories by 16% next week and the White House has boosted its vaccine forecast to give governors a three-week heads-up on forthcoming allocations of the shots, helping them better plan distribution of the vaccine. The Biden administration argues that the government faces distribution challenges that go beyond the availability of doses. 

"The issue is not just vaccine supply," White House Press Secretary Jen Psaki told reporters Thursday.  

"By the summer, we will have enough supply for the public. But that doesn't ensure that everybody will have had a vaccine," Psaki said. "We need to ensure we have the materials to distribute the vaccine, the vaccinators and qualified individuals to literally put the shots in the arms of Americans, and the places to do it."  

But states have expressed different concerns about the race to vaccinate their residents. CBS News reached out to all 50 states and Washington, D.C. to ask them about the biggest obstacle to distributing the vaccine in their state. Over half responded, and all of them, regardless of the state's political leaning, pointed to vaccine supply. 

"Our greatest concern is getting increased vaccine allotment to support it," a spokesperson from Delaware's Emergency Management Agency told CBS News.  

Officials from a handful of states – including Georgia, Idaho, Indiana, Montana, North Carolina, North Dakota, Oklahoma, Utah and Vermont – say they'll need more information about the rate of manufacturing and distribution of the vaccine before they'll know how much extra federal assistance they'll need.  

Oklahoma Deputy Health Commissioner Keith Reed said his state would be interested in FEMA-supported vaccination sites — if they offer additional shots. "We are certainly interested in this option if indeed it includes more vaccine allocation," Reed told CBS News. "If it is simply a redirection of our existing vaccine supply, we would have to carefully consider our ability to direct the activities to ensure it met with our citizen's needs." 

A spokesperson from North Carolina Governor Roy Cooper's office noted that, "while additional support is welcome, North Carolina has currently administered 95% of the first doses received by the state, and additional supply remains a critical need."

"Our largest concern is just having more doses. Our state partners are able to administer nearly all doses each week," Joe Dougherty, director of public affairs for Utah's department of public safety, wrote in an email to CBS News, adding, "We just want to have proper expectations about what is coming and when." 

"Indiana currently has 215 vaccination sites available and has built capacity for mass vaccination clinics," a spokesperson from Indiana's Department of Health said. "We simply need more vaccine." 

"We have more demand for vaccinations than we have vaccine," Mike Nowatzki, communications director for North Dakota Governor Doug Burgum, told CBS News. "We have the infrastructure and would like to administer more doses each week." 

"The main thing Idaho needs is more vaccine," said Zachary Clark, spokesperson for the Idaho Department of Health. "Currently demand for vaccine in Idaho far outpaces supply."

Governors on both sides of the aisle have pushed the federal government for more shots, casting doubts on plans to concentrate resources around opening up more vaccination sites. 

"You're saying you're going to put federal resources in this and create your own [vaccination] sites," Florida Governor DeSantis said in a Fox News appearance Thursday night. "It is really not necessary," the Republican governor added. "I think a lot of Democratic governors agree with me. Just get more supply of the vaccine because we were promised initially that we were going to get more up to this point. I can get it into seniors' arms if we just get more in the shipments." 

"The distribution points or healthcare workers right now are not our constraint," New Jersey Governor Phil Murphy – a Democrat – said on MSNBC Thursday. "The constraining factor right now is supply of doses."  

The doses are on the way, the White House COVID-19 Response Team promises.  

"We have an anticipated 600 million doses that we will have by over the summer, enough to vaccinate all people over age 16," Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention, told "CBS This Morning" Friday. 

Governors already have federal personnel in place to help with the vaccination effort. The Defense Department says nearly 20,000 members of the National Guard have been called to assist at 260 vaccination sites in 26 states and territories across the country – and many of them were deployed while still under orders of the Trump administration. 

Pentagon press secretary John Kirby told reporters Thursday that FEMA's request for military assets would be "reviewed urgently but carefully." 

"We are obviously going to source this request," Kirby said.

By Wednesday, FEMA had obligated more than $1.2 billion to states, territories and tribes to cover COVID-19 vaccination expenses at 100% federal cost share and more than $57.5 billion to fund the pandemic response, according to a spokesperson.  

The agency has already deployed 200 of its own personnel to help out at state vaccination centers in nine states: Illinois, Kentucky, Maryland, Nevada, New Jersey, Pennsylvania, Texas, Virginia, West Virginia and the U.S. Virgin Islands. The U.S. Coast Guard has deployed 18 reservists and is identifying 1,000 more for future missions, according to FEMA.

https://www.cbsnews.com/news/fema-pentagon-ready-10000-troops-covid-vaccination-sites/

Biotech Investors: Mark Your Calendar For February PDUFA Dates

 Coming off a stellar year, when a record 53 new molecular entities were approved, 2021 has a lot to live up to. NMEs are a measure of innovation among biopharma companies, as they refer to drugs containing an active ingredient that has never been approved previously.

Although the calendar for drug approval decisions, known as PDUFA dates, for January was fairly light, most verdicts issued in the month were positive. Among the drugs approved in the month were Merck & Co., Inc.'s MRK 1.1% heart failure drug, an expanded indication for Pfizer Inc.'s PFE 0.13% lymphoma drug and Aurinia Pharmaceuticals Inc's AUPH 2.17% kidney inflammation drug.

Here are the key FDA decisions due for February:

Adamas Seeks Label Expansion For Its Parkinson's Drug

Company: Adamas Pharmaceuticals Inc ADMS 10.06%
Type of Application: sNDA
Candidate: Gocovri
Indication: "Off episodes" in Parkinson's disease patients receiving levodopa-based therapy
Date: Feb. 1 (estimated date provided by the company)

The FDA accepted the application for label expansion on June 4.

Gocovri, extended-release capsules, has already been approved for dyskinesia in Parkinson's disease patients treated with levodopa-based therapy, with or without other dopaminergic medications.

In 2020, Gocovri sales came in at $71.2 million, up 30% year-over-year.

Clinical evidence supporting Gocovri's effect on off episodes was demonstrated in two large pivotal Phase 3 trials and is currently included in the GOCOVRI prescribing information.

Mallinckrodt Awaits Nod For Skin Tissue Therapy To Treat Burns

Company: Mallinckrodt PLC MNKKQ 2.07%
Type of Application: BLA
Candidate: StrataGraft
Indication: deep partial-thickness thermal burns
Date: Feb. 2

StrataGraft, an investigational regenerative skin tissue therapy, is in development for the treatment of adult patients with deep partial-thickness thermal burns.

On Aug. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. 2.

Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns, according to Mallinckrodt. Autograft, the current standard of care, involves surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care.

StrataGraft skin tissue is engineered to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.

‘Go Or No-Go' For Regeneron's Adjuvant Therapy To Treat Inherited High Cholesterol Condition?

Company: Regeneron Pharmaceuticals Inc REGN 0.48%
Type of Application: BLA
Candidate: evinacumab
Indication: homozygous familial hypercholesterolemia, or HoFH
Date: Feb. 11

HoFH is an ultra-rare, inherited form of high cholesterol, affecting approximately 1,300 patients in the U.S. With the vast majority of these patients unable to reach target LDL-C levels with currently available therapies, the need for an effective therapy has become acute.

Evinacumab is an investigational fully-human monoclonal antibody that binds to and blocks the function of ANGPTL3.

Can TG Therapeutics Lymphoma Drug Cross The FDA Hurdle?

Company: TG Therapeutics Inc common stock TGTX 0.46%
Type of Application: NDA
Candidate: umbralisib
Indication: marginal zone lymphoma
Date: Feb. 15

Umbralisib, TG Therapeutics' investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, is being evaluated as a treatment for patients with previously treated marginal zone lymphoma, who have received at least one prior anti-CD20 based regimen. It also is being evaluated for use in patients with follicular lymphoma who have received at least two prior systemic therapies.

G1's Trilaciclib Awaits Regulatory Clearance For Treating Chemotherapy-Induced Toxicities

Company: G1 Therapeutics Inc GTHX 6.96%
Type of Application: NDA
Candidate: trilaciclib
Indication: small cell lung cancer
Date: Feb. 15

Trilaciclib is an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. G1 submitted the regulatory application in June based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with small cell lung cancer.

The application was accepted by the FDA for priority review In August, with a PDUFA goal date of Feb. 15.

In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression — damage to bone marrow stem cells. Myelosuppression often leads to anemia, neutropenia or thrombocytopenia.

Sarepta Seeks Nod For Third Exon-Skipping DMD Drug

Company: Sarepta Therapeutics Inc SRPT 0.81%
Type of Application: NDA
Candidate: casimersen
Indication: Duchenne muscular dystrophy
Date: Feb. 25

Casimersen, a phosphorodiamidate morpholino oligomer, is engineered to treat patients with Duchenne muscular dystrophy who have genetic mutations that are amenable to skipping exon 45 of the dystrophin gene.

The company submitted the NDA in June 2020, with the FDA accepting the application in late August, granting priority review.

If approved, casimersen would be the third exon-skipping medicine in its PMO RNA-based platform, offering treatment to the 8% of Duchenne patients who are amenable to exon-45 skipping.

The company has received conditional approval of Amondys 45 as the brand name for casimersen.

Second Approval For Regeneron's Checkpoint Inhibitor Libtayo In The Offing?

Company: Sanofi SA SNY 0.76% and Regeneron 
Type of Application: sBLA
Candidate: Libtayo
Indication: lung cancer
Date: Feb. 28

Libtayo, jointly-developed by Sanofi and Regeneron, is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. It has already been approved for treating cutaneous squamous cell carcinoma, a type of skin cancer, that has spread or cannot be cured by surgery or radiation.

The companies are now seeking approval for the drug as a treatment option for first-line locally advanced or metastatic non-small cell lung cancer with 50% or more PD-L1 expression.

CoreMedix Seeks Approval For Catheter-Related Blood Stream Infection Treatment

Company: CorMedix Inc. CRMD 1.03%
Type of Application: NDA
Candidate: defencath
Indication: catheter-related blood stream infections
Date: Feb. 28

Defencath is to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related blood stream infections. The company said if approved, defencath will potentially be the first antibacterial and antifungal catheter lock solution in the U.S. to prevent catheter-related infections in hemodialysis patients.

Following FDA acceptance of the regulatory application for priority review, the PDUFA goal date was fixed at Feb. 28.

Can Athenex' Oral Chemotherapy Medication Pass FDA Muster?

Company: Athenex Inc ATNX 0.93%
Type of Application: NDA
Candidate: Oral Paclitaxel
Indication: breast cancer
Date: Feb. 28

The regulatory application for Oral Paclitaxel, comprising oral paclitaxel and encequidar, was accepted by the FDA for priority review in early September, as a treatment option for metastatic breast cancer.

Currently intravenous Paclitaxel is considered foundational chemotherapy in multiple tumor types.

https://www.benzinga.com/general/biotech/21/01/19387602/attention-biotech-investors-mark-your-calendar-for-february-pdufa-dates