FDA current COVID-19 updates, actions and advice

17-Mar-2021 - Last updated on 17-Mar-2021 at 16:33 GMT

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Related tags Fda COVID-19 Coronavirus Testing Regulation

As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.

The phenomenon of "vaccine euphoria" has taken hold in the US, with patients receiving their first or second shots gleefully sharing images on Facebook, Instagram and other social media platforms. Still, because the virus is not over, the US Food and Drug Administration (FDA) continues to act as a resource for medical professionals working on tests, treatments and vaccines.

COVID test program guidance

With schools, offices, communities and other entities interested in screening and testing for COVID-19, the FDA has provided a range of resources to help test developers streamline the emergency use authorization (EUA) process, and to help organizations set up effective, efficient testing programs.

The agency has issued a new supplemental template for test developers seeking EUAs for tests used to screen with serial testing which involves testing the same individual multiple times within a few days. The process can increase the chances of detecting asymptomatic infection, which does not always show with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission.

The new template applies to the development of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This includes tests conducted in any location, including in a laboratory, at the point-of-care (POC), or even places such as a person’s home or certain non-traditional sites such as offices, sporting venues, airports, schools, etc.

The FDA also issued a fact sheet which outlines considerations for selecting a test for use in a screening testing program. The fact sheet is intended to help schools, workplaces, communities and other locations as they working to select a test for screening, and to help them understand the difference between tests used for diagnosis of suspected COVID-19 compared to those used for screening asymptomatic individuals.

At-home test EUAs

The FDA continues to issue EUAs for various COVID-19 screening and testing products. Its recent EUAs include approval for two tests designed for at-home use.

The Quidel QuickVue At-Home COVID-19 Test is an antigen test that certain individuals can use to rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. It is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult, and it is intended for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

The agency also issued an EUA for the Cue COVID-19 Test for Home and OTC Use, a molecular nucleic acid amplification test (NAAT) intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.

Fake FDA approval documents, COVID-19 products

The agency continues to deal with unscrupulous companies purporting to offer the public products that prevent, treat and cure COVID-19; to date, no such product has received FDA approval. In addition, the agency has sent warning letters to firms unlawfully issuing “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers)—while the certificates appear to bear the look of an official document, the FDA does not issue any such certificates, which can give the false impression of agency approval.

Additionally, the FDA has issued warnings to manufacturers of unauthorized COVID-19 products:

Ageless Global was written up by the FDA and Federal Trade Commission for selling “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray,” none of which have received the thumbs up from the federal government.
KDunn and Associates (dba HealthQuilt) was cited for not complying with federal laws and regulations, including laws and regulations to protect people participating in clinical trials, during the clinical investigation of an investigational drug to treat, cure and prevent COVID-19.
CAMA Wellness Center/IodoRios Company received a warning for selling a hand-wipe product they claimed that could prevent or treat COVID-19.
Cannafyl received a citation for selling unapproved CBD-containing products, including “Balance CBD Drops,” “Relief CBD Drops,” “Relax CBD Drops” and “Relief CBD Salve,” which the company claimed could mitigate, prevent, treat, diagnose or cure COVID-19 in people.
Ravenscroft Apothecary (dba DBA Ravenscroft Escentials) received a warning for “AIR PURIFY AROMAMIST,” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST” and “ROSE FREQUENCY TONGUE TINCTURE,” products they claimed could mitigate, prevent, treat, diagnose or cure COVID-19 in people.