First FDA COVID-19 update of 2021

By Jenni Spinner contact

- Last updated on GMT

(Sopone Nawoot/iStock via Getty Images Plus)
(Sopone Nawoot/iStock via Getty Images Plus)

Related tags: Fda, COVID-19, Coronavirus, Vaccine, Testing, Regulation

As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.

While photos of smiling US health workers receiving COVID-19 vaccines continue to spread across social media, the US Food and Drug Administration (FDA) continues in its work to review potential treatments, consider approval of additional vaccines, and offer advice to life-science professionals working hard on additional solutions to battle the virus.

Vaccine actions

To date, the FDA has issued emergency use authorizations to two COVID-19 vaccines. On December 11, the agency granted an EUA for the Pfizer/BioNTech vaccine; a week later on December 18, Moderna’s vaccine landed an EUA.

The agency will continue to review additional vaccines in the works as appropriate. However, FDA officials will keep a close eye on the vaccines and their use even after approvals are granted.

Whenever FDA approves or authorizes a vaccine, our work doesn’t stop there​,” FDA commissioner Stephen Hahn remarked in a video statement. “We’re on the job constantly, and we’ll be helping to set up programs and surveillance to actually detect ongoing safety events​.”

Informational sheets explaining the vaccines, side effects and other issues are available in several languages, including Arabic, Burmese, Cherokee, Chinese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. Additional translations will be shared as they become available.

Illicit COVID-19 products

While the FDA has not to date authorized any consumer products designated for the prevention, detection or treatment of COVID-19, unscrupulous manufacturers have not taken a holiday from attempting to make and sell such unapproved products. In response, the agency has continued issuing warnings to companies advising them to stop their shenanigans.

Via the Center for Food Safety and Applied Nutrition (CFSAN), the government warned Sparrow Health and Performance to halt sales and distribution of various products purported to treat COVID. These include:

  • Organic Liposomal Vitamin C
  • Nanoemulsified D3K2
  • Immune Support Package (consisting of the company’s Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on)

The FDA also issued a warning letter to Riverstone LLC for promoting and selling a range of unauthorized COVID-19 treatments, including:

  • Flu Immune Drops
  • L-Lysine
  • Lysine Extra
  • Monolaurin

Testing updates

As of Dec. 28, 309 tests and sample collection devices have been granted EUAs by the FDA These include 235 molecular tests and sample collection devices, 63 antibody tests, and 11 antigen tests.

Additionally, the agency has given its seal of approval to 32 molecular authorizations that can be used with home-collected samples. This number includes one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

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