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Wednesday, January 12, 2022

Where to buy at-home COVID test kits while they’re in stock

 Just when we thought the COVID-19 pandemic was starting to wind down, the Omicron variant made its debut and the contagious virus is spreading more quickly than ever before.

With the recent outbreak of Omicron, urgent care and testing centers have long lines that sometimes last for hours, making people turn to at-home testing options.

According to the CDC, COVID-19 self-tests — also known as at-home tests or over-the-counter (OTC) tests — are one of many risk-reduction measures, along with vaccinationmasking and physical distancing, that protects you and others from the spread of COVID-19.

The problem? They’re always out of stock. Ahead, get all the info on how to use at-home COVID tests, how accurate they are and where you can buy them online.

How to use at-home COVID tests

Of course, read the complete manufacturer’s instructions for use before starting the test and make sure you talk to a healthcare provider if you have questions about the test or your results. Here are general steps to take a self-test, according to the CDC.

  • Wash your hands with soap and water for at least 20 seconds.
  • Open the box and follow the instructions included with the self-test to collect your own nasal or saliva specimen. (If you don’t collect the specimens as directed, your test results may be incorrect.)
  • Perform the steps in the order that they are listed. Some manufacturers may also provide quick reference guides or instructional videos.
  • Collect either a nasal specimen or saliva specimen, depending on the self-test being used.
  • Next, wait to see what result comes back. Generally, this takes 15 minutes.

Accuracy of at-home COVID tests

Invalid test results are rare but can occur. Chief Infection Control Officer Roy Chemaly, M.D. at the University of Texas MD Cancer Center said that “the tests are only accurate 80% of the time, and sometimes less.”

Sometimes invalid results or an error can show on the test device. Invalid results or an error can occur for many reasons — your specimen may not have been collected correctly, or the test may have malfunctioned.

Due to the current infection rate of the coronavirus being so high, many professionals suggest retesting with a PCR test if you have symptoms and test negative using an at-home antigen test as it could be a false negative.

Where to buy at-home COVID tests

Thanks to at-home COVID tests, many people now have the option to test themselves instead of waiting in hour-long lines at their local urgent care office. The tricky part is now getting your hands on one. In an effort to help you obtain a self-test we rounded up a handful of retailers that still have self-tests in stock.

Note: these tests go in and out of stock by the minute so make sure to check back regularly if none are available at this given time.

QuickVue At-Home COVID-19 Test, $27

QuickVue At-Home COVID-19 Test

This simple at-home test is authorized for non-prescriptive home use with self-collected direct anterior nasal (NS) swab specimens from individuals aged 14 and older, and with adult-collected anterior NS samples from those 2 years or older.

It’s most effective when used within six days of symptoms, or 24 to 48 hours after suspected exposure.

BD Veritor At-Home Covid-19 Test, $35

BD Veritor At-Home Covid-19 Test

This Emergency Use Authorized rapid antigen serial test enables you to collect and test your sample at home and receive digital results on a compatible smartphone in just 15 minutes. The serial test is intended to be used twice over two to three days, with at least 24 hours and no more than 48 hours between tests.

InteliSwab™ COVID-19 Rapid Antigen Test, $20-$24

InteliSwab™ COVID-19 Rapid Antigen Test

This test requires less than one minute of hands-on time. InteliSwab has received FDA Emergency Use Authorization for self-testing. You do not need to ship samples to a lab or get a prescription from your healthcare provider. Get your result in 30 minutes.

BinaxNOW COVID‐19 Antigen Self Test (2 Count), $20-$24

BinaxNOW COVID‐19 Antigen Self Test (2 Count)

Get your test results in 15 minutes or less with a simple nasal swab in the comfort and convenience of your home. BinaxNOW COVID-19 Antigen Self Test is available under FDA Emergency Use Authorization.

Make sure to check these links every so often, as the BinaxNOW tests have been going in and out of stock pretty regularly.

Aduhelm verdict puts the heat on Biogen – and on the FDA

 Yesterday’s proposal to limit Medicare’s obligation to pay for Biogen’s Aduhelm could have been worse, but not by much. The draft guidance is so restrictive that, assuming it is implemented, it could result in Aduhelm recording virtually no revenue in the near term.

But it also comes as an apparent slap on the wrists of the FDA: not much reading between the lines is required to see the agency being told that it should never have approved the controversial Alzheimer’s disease drug to begin with. The guidance’s main thrust is that until Aduhelm shows a meaningful benefit on cognition and function it should not be paid for.

While Aduhelm’s accelerated approval is already conditional on a confirmatory study, it seemed unlikely that the FDA would actually pull the drug should such a trial fail years down the line. But the guidance effectively puts pressure on the agency to stick to the conditions of the accelerated approval, as well as making it extremely hard for Biogen to sell any Aduhelm during its conditionally approved phase.

Aduhelm has hardly been prescribed since its approval in June, and Biogen had claimed that doctors were holding off until implementation of the guidance, a national coverage determination (NCD) spelling out the conditions under which all Medicare contractors would have to provide and pay for the drug.

What does it mean?

Few had expected the worst-case scenario of blanket non-coverage, but coverage with evidence development, which the Centers for Medicare & Medicaid Services (CMS) is now proposing, represents a materially worse outcome than the middle ground many analysts had forecast.

In effect it means that Medicare would only cover patients given Aduhelm in randomised, controlled trials that are approved by the CMS, and in those backed by the NIH. Such trials must be conducted in a hospital-based outpatient setting, and meet other criteria.

This was viewed as sufficiently restrictive for Mizuho to remove nearly all Aduhelm sales from its Biogen model yesterday. In a statement Biogen said the draft NCD would almost completely remove Aduhelm coverage for Medicare beneficiaries, and duplicate efforts like Aduhelm’s 1,696-patient Embark and 6,000-patient Icare-AD-US studies.

These two trials are of immediate relevance as more lenient coverage with evidence development might have encompassed them. But, as they have no control arms, if the NCD is enacted per the draft they will not qualify.

Indeed, on the question of available data so far the CMS is scathing, listing 21 phase 3 randomised controlled clinical trials of projects from bapineuzumab to crenezumab alongside those of Aduhelm, and casting doubt on Aduhelm’s purportedly positive Emerge trial given its premature halting for futility.

“With conflicting results from Emerge and Engage, and a secondary analysis that did not resolve the difference, CMS believes that the available evidence is insufficient to establish that the treatment is reasonable and necessary,” the draft NCD states.

No surrogate biomarker

Further, the CMS appears to slam the FDA’s view that brain amyloid-beta plaque reduction is a biomarker capable of backing accelerated approval. The draft instead calls for evidence of meaningful benefit on cognition and function, and says “no biomarker has achieved surrogate status in Alzheimer’s”.

Randomised Aduhelm data will emerge, eventually: Biogen vows to start screening for Aduhelm’s confirmatory trial in May, with primary completion four years after initiation. At least the 1,300 patients expected to be enrolled here might qualify for coverage under the proposed NCD, as long as the study is approved by the CMS.

It must also be stressed that the guidance applies to all amyloid-beta MAbs, and likely raises the bar for what pivotal trials of Eisai/Biogen’s lecanemab, Lilly’s donanemab and Roche’s gantenerumab must show when they yield data this year. Biogen today opened off 10%, but Lilly and Roche fell a more restrained 3% and 2% respectively.

Biogen’s next key event is tomorrow’s analyst call, at which it will presumably say what it plans to do next. It cannot be underestimated how much Aduhelm now reflects on the tenure of the group’s chief executive, Michel Vounatsos.

Clearly, if halving Aduhelm’s price was intended somehow to please the CMS it has not worked, though it might yet raise Biogen’s standing with patient advocates. Yesterday the Alzheimer’s Association called the draft NCD a “shocking discrimination” that proposed to restrict Aduhelm access to “a privileged few – those with access to research institutions”.

Such views are relevant because there now follows a 30-day public comment period. The bull case is that pressure groups succeed in persuading the CMS to reverse or water down the draft guidance, with analysts citing the example of Car-T therapies, whose draft NCD was coverage with evidence development (specifically trials and a patient registry), but whose final determination was full coverage.

That said, Aduhelm’s draft NCD is so negative that the CMS might already have painted itself into a corner.

https://www.evaluate.com/vantage/articles/news/policy-and-regulation/aduhelm-verdict-puts-heat-biogen-and-fda

Infinity beckons for Illumina

 Illumina closed up 17% yesterday having released strong preliminary fourth quarter revenue of $1.2bn, a 25% increase year-on-year and an easy beat of consensus expectations, which had sat at around 15% growth. The company expects to grow at this rate throughout the coming year, too, the regulatory uncertainty surrounding its decision to close the acquisition of Grail without approval from antitrust authorities notwithstanding. Perhaps more interesting for the long term is the news that the company, a specialist in sequencing short strands of DNA, is working on a new long-read technology. Codenamed Infinity, this runs on existing Illumina instruments and can provide sequences of around 10,000 bases in length. Early access for Infinity is to start in the second half of this year, Illumina said yesterday at the JP Morgan conference. Adding long-read tech to its core short-read offering was the thinking behind Illumina’s attempted $1.2bn takeout of Pacbio, squashed on anticompetitive grounds in 2019. Now it seems to be attempting to build a short- and long-read empire from within, taking on Pacbio in the process. Pacbio’s shares sank 11% yesterday, though this might also have been related to its preliminary fourth-quarter sales figures, which at $36m missed analyst expectations.

https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/infinity-beckons-illumina

Top Immunologist Blasts Global COVID Response Driven By 'False Propaganda'

 Via Swiss Policy Research,

Professor Ehud Qimron, head of the Department of Microbiology and Immunology at Tel Aviv University and one of the leading Israeli immunologists, has written an open letter sharply criticizing the Israeli – and indeed global – management of the coronavirus pandemic.

Original letter in HebrewN12 News (January 6, 2022); translated by Google/SPR. See also: Professor Qimron’s prediction from August 2020: “History will judge the hysteria” (INN).

∗ ∗ ∗

Ministry of Health, it’s time to admit failure

In the end, the truth will always be revealed, and the truth about the coronavirus policy is beginning to be revealed. When the destructive concepts collapse one by one, there is nothing left but to tell the experts who led the management of the pandemic – we told you so.

Two years late, you finally realize that a respiratory virus cannot be defeated and that any such attempt is doomed to fail. You do not admit it, because you have admitted almost no mistake in the last two years, but in retrospect it is clear that you have failed miserably in almost all of your actions, and even the media is already having a hard time covering your shame.

You refused to admit that the infection comes in waves that fade by themselves, despite years of observations and scientific knowledge. You insisted on attributing every decline of a wave solely to your actions, and so through false propaganda “you overcame the plague.” And again you defeated it, and again and again and again.

You refused to admit that mass testing is ineffective, despite your own contingency plans explicitly stating so (“Pandemic Influenza Health System Preparedness Plan, 2007”, p. 26).

You refused to admit that recovery is more protective than a vaccine, despite previous knowledge and observations showing that non-recovered vaccinated people are more likely to be infected than recovered people. You refused to admit that the vaccinated are contagious despite the observations. Based on this, you hoped to achieve herd immunity by vaccination — and you failed in that as well.

You insisted on ignoring the fact that the disease is dozens of times more dangerous for risk groups and older adults, than for young people who are not in risk groups, despite the knowledge that came from China as early as 2020.

You refused to adopt the “Barrington Declaration”, signed by more than 60,000 scientists and medical professionals, or other common sense programs. You chose to ridicule, slander, distort and discredit them. Instead of the right programs and people, you have chosen professionals who lack relevant training for pandemic management (physicists as chief government advisers, veterinarians, security officers, media personnel, and so on).

You have not set up an effective system for reporting side effects from the vaccines and reports on side effects have even been deleted from your Facebook page. Doctors avoid linking side effects to the vaccine, lest you persecute them as you did to some of their colleagues. You have ignored many reports of changes in menstrual intensity and menstrual cycle times. You hid data that allows for objective and proper research (for example, you removed the data on passengers at Ben Gurion Airport). Instead, you chose to publish non-objective articles together with senior Pfizer executives on the effectiveness and safety of vaccines.

Irreversible damage to trust

However, from the heights of your hubris, you have also ignored the fact that in the end the truth will be revealed. And it begins to be revealed. The truth is that you have brought the public’s trust in you to an unprecedented low, and you have eroded your status as a source of authority. The truth is that you have burned hundreds of billions of shekels to no avail – for publishing intimidation, for ineffective tests, for destructive lockdowns and for disrupting the routine of life in the last two years.

You have destroyed the education of our children and their future. You made children feel guilty, scared, smoke, drink, get addicted, drop out, and quarrel, as school principals around the country attest. You have harmed livelihoods, the economy, human rights, mental health and physical health.

You slandered colleagues who did not surrender to you, you turned the people against each other, divided society and polarized the discourse. You branded, without any scientific basis, people who chose not to get vaccinated as enemies of the public and as spreaders of disease. You promote, in an unprecedented way, a draconian policy of discrimination, denial of rights and selection of people, including children, for their medical choice. A selection that lacks any epidemiological justification.

When you compare the destructive policies you are pursuing with the sane policies of some other countries — you can clearly see that the destruction you have caused has only added victims beyond the vulnerable to the virus. The economy you ruined, the unemployed you caused, and the children whose education you destroyed — they are the surplus victims as a result of your own actions only.

There is currently no medical emergency, but you have been cultivating such a condition for two years now because of lust for power, budgets and control. The only emergency now is that you still set policies and hold huge budgets for propaganda and psychological engineering instead of directing them to strengthen the health care system.

This emergency must stop!

Professor Udi Qimron, Faculty of Medicine, Tel Aviv University

https://www.zerohedge.com/covid-19/doomed-fail-top-immunologist-blasts-global-covid-response-driven-false-propaganda

Biden wants U.S. agencies to mandate COVID tests for unvaccinated employees by Feb 15

he Biden administration said on Tuesday that federal agencies should require weekly COVID-19 testing by Feb. 15 for unvaccinated government employees who are working on-site or interacting with the public.

A vaccine mandate imposed by President Joe Biden in September covers about 3.5 million federal workers and required them to be fully vaccinated by Nov. 22 or face potential discipline or even termination.

The administration said on Tuesday that unvaccinated employees – including those seeking religious or medical exemptions – “should be tested weekly for any week during which they work on-site or interact in person with members of the public as part of their job duties. Agencies may require more frequent testing.”

The rules do not apply to federal workers who are working remotely.

As of Dec. 8, the U.S. government said it has achieved 97.2% compliance, with 92.5% of employees having received at least one COVID-19 vaccine dose.

The White House Office and Management and Budget (OMB) last month encouraged federal agencies not to issue discipline beyond education and counseling or a letter of reprimand for most employees who had not complied until January. OMB did not immediately comment on how many U.S. employees have been disciplined for failing to comply with the rules.

Biden’s vaccine mandate does not cover federal employees in the judicial and legislative branches or workers in the U.S. Postal Service (USPS).

USPS is covered by a vaccine or testing mandate for companies with 100 or more employees, but has asked for a delay in meeting those requirements.

The administration said on Tuesday that federal agencies may impose disciplinary measures on workers who refuse to get tested, and may also bar employees from agency workplaces pending resolution of any disciplinary action.

https://y94.com/2022/01/11/biden-wants-u-s-agencies-to-mandate-covid-19-testing-for-unvaccinated-employees-by-feb-15/

China suspends more flights from US amid COVID-19 surge

 China has now suspended 70 flights from the United States since the start of the new year as it seeks to prevent the spread of COVID-19.

Beijing canceled six additional flights from the U.S. on Wednesday in response to the positive COVID-19 tests of passengers who had previously landed in China from the U.S., according to Reuters.

The flights being canceled include two United Airlines flights from San Francisco to Shanghai, which will be suspended as of the week of Jan. 2. 

Four flights on China Southern Airlines will also be suspended from Los Angeles to Guangzhou beginning the week of Jan. 31. This move will also impact return flight travelers, Reuters noted.

Before the pandemic, about 100 flights a week went between the United States and China, and prior to the recent suspensions, about 20 flights between China and the United States were operating every week, according to Reuters. 

China also suspended six flights from France and Canada on Wednesday.

China and the United States have been at odds about how to handle aviation limitations during the pandemic, Reuters noted.

After China imposed a 40 percent capacity limitation on flights from the U.S. on United Airlines, the Department of Transportation retaliated with an almost identical restriction on flights coming into the U.S. from China, reports Reuters.

China has effectively shut its borders to travelers. Only 200 flights a week enter the country from international locations, which is about 2 percent of pre-pandemic levels, according to Reuters. 

This is part of China's strict anti-pandemic policy, which has curbed wider spread of the coronavirus throughout the country but has also disrupted the nation's economy. 

https://thehill.com/policy/international/asia-pacific/589331-china-suspends-more-flights-from-us-amid-covid-19-surge

Walgreens, CVS Cut Paid Sick Leave for Workers in Line With CDC Guidance

 Walgreens Boots Alliance and CVS Health Corp have cut paid sick leave for workers who test positive for COVID-19, aligning their policies to a change in U.S. health guidance, the companies said on Tuesday.

The U.S. Centers for Disease Control and Prevention updated its recommendations that people should isolate for five days after a COVID-19 infection, instead of 10.

A spokesperson for CVS said that the company is providing five days of paid leave for eligible full- and part-time workers, except where state or city paid leave laws provide for more. 

The company also added that paid leave is available only to employees who are vaccinated, approved for a reasonable accommodation, or otherwise covered by local laws.

Walgreens said that it is providing COVID-19 paid leave benefits for five days to workers and after Feb. 23 will continue to provide the same benefit for five days to those who are fully vaccinated and test positive for COVID-19.

Both the companies offered up to two weeks of paid leave earlier.

The company added that unvaccinated workers, who have an approved medical or religious exemption, also will continue to be eligible for the paid leave benefit.

Last week, Walmart said workers in the United States will receive one week of paid leave instead of two, if in need of isolation or have tested positive for COVID-19.

Amazon said that the workers infected with the virus can receive up to 40 hours paid leave given the shorter period of isolation.

https://money.usnews.com/investing/news/articles/2022-01-11/walgreens-cvs-cut-paid-sick-leave-for-workers-in-line-with-cdc-guidance