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January 2021
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Ashland City Pharmacy
Ashland City, TN

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Tulsa, OK

News You Can Use
FDA Clears First OTC
At-Home Covid-19 Test

The Food and Drug Administration has approved the first at-home test for COVID-19 that can be purchased over the counter. The Ellume COVID-19 Home Test is a rapid, lateral-flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab for anyone 2 years old and older. 

This “authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA commissioner Dr. Stephen Hahn. “As we continue to authorize additional tests for home use, we are helping expand Americans' access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”

So far, the FDA has approved more than 225 diagnostic tests for COVID-19, including more than 25 that allow for home collection of samples that are then sent to a lab for testing. The Ellume test is the first that can be used entirely at home without a prescription.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer. Ellume’s test works in conjunction with a free smartphone app that offers step-by-step testing instructions, including a how-to video. All analysis is performed using the test’s electronic analyzer, which displays the test result on the user’s smartphone in 15 minutes or less via Bluetooth.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr. Sean Parsons. “Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

Ellume — which is based in Valencia, Calif., and Brisbane, Australia — said the test is priced at $30 and that it expects to ship the first tests in the United States in the first week of January. A spokesperson said the company was in advanced discussions about national retail commercialization. As it prepares to ship the test, Ellume is ramping up its manufacturing efforts, with production on track to create 100,000 tests per day in January. The company noted that this is made possible by the support of a $30 million WP-2 grant from the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative.
In data submitted from a simulated home-setting clinical study of 198 participants, the test showed an overall sensitivity of 95% and specificity of 97% when results were compared with an RT-PCR lab test. In patients with symptoms, sensitivity was 96% and specificity was 100%, while asymptomatic individuals saw a test sensitivity rate of 91% and specificity of 96%. 

By David Salazar Published in Drug Store News (edited)

COVID-19 Vaccine Adding Key 2nd Shot as Nationwide Campaign Ramps Up




The FDA cleared Moderna’s mRNA vaccine, mRNA-1273, for emergency use in people 18 years and older. The authorization allows the company and federal government to immediately distribute the shot nationwide; it comes a week after Pfizer and BioNTech's emergency vaccine nod. 

It also adds a key second option—and more vaccine supplies—amid the United States' nationwide vaccination push. . 

In 2021, dose distribution and availability should ramp up considerably. Pfizer and Moderna each say they’re on track to deliver 100 million doses by the end of the first quarter. Pfizer and the federal government are in talks for more doses, while Moderna just inked a new pact for another 100 million doses to be delivered in the second quarter. 

Bernstein analysts said they expect 200 million Americans will be vaccinated against the novel coronavirus by May 31, and that the people remaining at that point will either have refused the vaccine or found themselves ineligible. The analysts expect hundreds of millions of doses from Pfizer and Moderna to be delivered through their Operation Warp Speed deals, but also expect "some contribution” from the Johnson & Johnson and Novavax programs. Those companies are set to report efficacy data in early 2021. 

As the first-to-market vaccines, Pfizer and Moderna are set to earn billions of dollars in revenue next year. Bernstein analysts have predicted the COVID-19 vaccine market will be worth $38.5 billion in 2021, with Pfizer taking a $14.3 billion slice and Moderna earning $10.3 billion from its shot. J&J, Novavax and AstraZeneca are also in line for multibillion-dollar coronavirus vaccine revenues next year, the analysts wrote.

By Eric Sagonowsky published in Fierce Pharma - edited
COVID-19 Vaccine Codes:
Updated Effective Date for Moderna

On December 18, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older. Review Moderna’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when the vaccines are free.

Related links:


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Tap into NCPA’s library of on-demand learning webinars
Missed an NCPA webinar? No problem – we have an archive full of helpful, timely webinars you and your team can access when it's convenient for you. Recent subjects include Need-to-Knows for Administering COVID-19 Vaccines, HPV and Head and Neck CancersDo You Know the Facts? and Creating Confidence in COVID-19 Vaccines. Note: CE credit is available only for live webinars.
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