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Sunday, November 29, 2020
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A crazy 24 hours in the pharma space

Covid-19   Diagnostics   Management & Treatment   Vaccines

Today’s Read: 3.5 minutes

It’s been a crazy 24 hours in the pharma space. Amazon launches a pharmacy, FDA approves an at-home Covid-19 test, and a Covid-19 vaccine is heading to the FDA for EUA. Could there be an end in sight, even if it’s months away?

MORNING BRIEF

First at-home Covid-19 test approved

On Tuesday, the Food and Drug Administration (FDA) granted emergency authorization to Lucira Health for the first at-home rapid coronavirus test that delivers results in 30 minutes. 

The single-use test kit allows users  to collect a nasal sample  themselves, then swirl it in a vial of laboratory solution, and run analysis on it in a portable device that is small enough to fit into a person’s palm. Results are displayed as lights labeled positive or negative. 

While this approval is thought to help expand testing options beyond healthcare facilities and testing sites, the Lucira Covid-19 All-in-One Test Kit will require a prescription, which may limit its initial use. Get more information about the test here.

Pfizer-BioNTech is ready to ask for emergency authorization for their vaccine

Phase 3 trial of the Pfizer-BioNTech Covid-19 is complete. The company announced this morning that an updated analysis of the clinical trial data found the vaccine to be 95% effective. The findings from the Phase 3 trials, as reported by NPR, are:

  • 43,000 volunteers received either a placebo or the experimental vaccine in two shots spaced 21 days apart. 
  • 170 cases of Covid-19 among the participants: 162 in the placebo group compared to eight in the treatment group. 
  • 10 cases of severe Covid-19 were seen in the trial: nine in the placebo group and one in the vaccine group.
  • The most common and significant side effect seen was fatigue, at a frequency of 3.8% after a second dose of the vaccine.
  • No serious safety concerns were observed.

In addition, Pfizer said that it has the two-month follow-up data on at least half of the Phase 3 trial participants that the FDA requires before considering applications for emergency use authorization. The application should be filed within days. And then, we wait.

One more thing you can get with your Amazon Prime account

On Tuesday, the retail behemoth announced its latest venture into the healthcare space, Amazon Pharmacy. It will allow U.S. customers to order prescription medications for home delivery, with Amazon Prime members receiving free delivery.

As CNBC reports, Amazon Pharmacy builds upon the company’s acquisition of PillPack in 2018, specifically PillPack’s infracture—pharmacy software, fulfillment centers, and relationships with health plans. The move creates more competition with Walmart, as well as other traditional chain pharmacies like CVS and Walgreens.

Services start this week in 45 states, with service to be rolled out to Hawaii, Illinois, Kentucky, Louisiana, and Minnesota over time. Prescribers can send prescriptions directly to Amazon Pharmacy, or patients can request to transfer their prescriptions. Also, Amazon will not deliver Schedule II controlled medications, including most opioids.

Finally, PillPack isn’t going away. It will continue to serve customers who tend to be sicker and older and need medicines on a 30-day schedule.

ONE BIG NUMBER

9,000,000

The amount of routine vaccine doses U.S. children could be missing this year, according to new data from Blue Cross Blue Shield. Vaccinations for measles and whooping cough saw a 26% decrease from 2019 levels. What could be the cause? The pandemic, of course! It was cited as the reason for missed vaccinations by 40% of parents.

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