FDA authorized the first stand-alone, at-home COVID-19 test, plus it warned more companies over COVID-19 claims and fast-tracked a promising vaccine in the top news articles this week. Here is a quick roundup:
1. FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for its Everlywell COVID-19 Test Home Collection Kit, which is authorized to be used by individuals at home who have been screened using an online questionnaire reviewed by a health care provider.
“This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit,” the agency said in a press release.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
2. FDA issued warning letters to two companies for selling fraudulent COVID-19 products. It warned Noetic Nutraceuticals, which claims its CBD products may help with COVID-19.
“We are getting a lot of questions about whether CBD (Hemp Extract) can help with the Coronavirus (COVID-19),” Noetic said on its web site. “The short answer is YES, it certainly can help. Now, let’s be clear, it is not seen as a cure, but CBD has properties (anti-bacterial, anti-viral, and anti-inflammatory) that can aid with symptoms and help a person stay healthy to fight off illness.”
The agency also warned The Golden Road Kratom, which claims that its kratom products are safe and/or effective for the prevention and treatment of COVID-19. “Kratom contains a special compound known as chloroquine or Cq, that research shows is powerfully combative against the coronavirus,” the company said on its web site.
3. FDA granted "fast track" designation to Moderna’s experimental COVID-19 vaccine, Reuters reported. The pharma maker expects to start a late-stage study of the vaccine in early summer and says there is potential for a marketing application approval in 2021, Reuters said.
Moderna announced positive interim clinical data of the vaccine, mRNA-1273, from its Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID).
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, MD, PhD, chief medical officer at Moderna, in a press release.