FDA Approves COVID Vaccine & Home Test
FDA Approves Moderna COVID Vaccine
FDA Okays Australia's Home Diagnostic Test For COVID
The FDA has given emergency approval to Moderna's COVID vaccine, making it the second COVID vaccine, along with Pfizer's, available in the US. The vaccine is 95% effective and is available to adults, while trials are expanded for teenagers. Meanwhile, the Australian diagnostic test company Ellume has scored a big win. The FDA has approved its over the counter, at home, COVID-19 test. This is the first COVID-19 test approved for use at home.
Ellume Home COVID Test
The system uses a nasal swab to collect data, analyze and send results to the person's smartphone. The results come within twenty minutes. The US Food and Drug Administration itself is calling this innovation from Australia a "major milestone in diagnostic testing".
New At-Home COVID Technology
The results from the home test kit are very thorough. The sensitivity rate, which tells you if you have COVID-19, is 95% accurate. The specificity rate, which tells if you are COVID-19 negative, is 97% effective. The test kits include an electronic analysis and a companion app, It has been deemed effective by the FDA for anyone over the age of two.
Ramping Up Operations
The Australian company is now ramping up manufacturing operations to 100,000 kits per day by January 2021. The cost of the test kit is $30.00. The company says it will deliver 20 million test kits to the US within the first half of 2021. This is yet another technological milestone in the fight against COVID. And it gives Americans more options for testing to determine if they have the disease.
COVID's Toll
In the US alone, 310,700 Americans have died from COVID and 17,2 million have been infected by the disease. Globally, there are more than 75 million COVID cases and 1.66 million deaths. And, in California, the availability of ICU beds is now 0%.
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