COVID-19 variant updates | Pediatric disease modeling for long COVID

Public health emergency response and other updates from FDA since our last MCMi email include:

• January 10, 2023: FDA Roundup including an update on new drug approvals that will improve the lives of patients and consumers
• January 10, 2023: Pediatric disease modeling for long COVID (new MCMi Extramural Research project page) 
• January 6, 2023: FDA Roundup including a warning letter to a company for selling unapproved and misbranded products as drugs for use in treating or preventing COVID-19
• January 6, 2022: FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld (updated)
• January 5, 2023: FDA BAA Questions & Answers (new page)
• January 4, 2023: COVID-19 Test Basics (updated Consumer Update)

Quick links: COVID-19 updates from FDA, FDA Mpox Response 

Emerging COVID-19 variants, like XBB, XBB.1 and XBB 1.5 are currently the predominantly circulating variants in the U.S., leading to a moderate increase in cases, but no evidence of increased severity at this time. There is no clear or compelling evidence that repeated vaccination with COVID-19 vaccines makes people more susceptible to the XBB, XBB.1 or XBB 1.5 variants. Well-designed clinical trial evidence demonstrated that the updated COVID-19 vaccines given as boosters elicited superior neutralizing antibody response compared to the original (monovalent) boosters, and are therefore expected to provide notable efficacy against symptomatic and severe disease from the BA.4/BA.5 variants.

Additionally, based on what is known about their viral neutralizing ability (Neutralization against BA.2.75.2, BQ.1.1, and XBB from mRNA Bivalent Booster | NEJM), it is very likely that the current bivalent COVID-19 vaccines provide at least some protection against the XBB, XBB.1 and XBB 1.5 variants. Most importantly, multiple studies have shown that staying up to date on vaccination provides the best protection against severe COVID-19, which can lead to hospitalization or death.

The most recent studies (here and here) about the effectiveness of the COVID-19 vaccines show that the vaccines continue to provide a benefit, particularly in older individuals. (January 4, 2023)

People infected with SARS-CoV-2 (the virus that causes COVID-19) typically recover within a few days or weeks. However some individuals have long-term effects that persist for multiple weeks, months, or even years; this is known as post-COVID conditions (PCC) or long COVID. In such cases, people experience both obvious and subtle long-term health consequences after recovering from the active infection.

While PCC occurs more frequently in people who have had severe COVID-19 illness, individuals experiencing these health consequences are not limited those who were the sickest. These effects manifest in patients across the full spectrum of COVID-19 severity and ages, including children.

In an MCMi Regulatory Science program extramural research project, Children’s Hospital Los Angeles and partners are studying how early inflammatory and tissue responses can predict long-term health consequences of COVID-19 in children.

EUA revocations

FDA revoked the EUA for these tests for the reasons noted in the revocation letter: 

• January 3, 2023: HDPCR SARS-CoV-2 Assay (PDF) (ChromaCode, Inc.)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

COVID-19 in vitro diagnostic (test) EUAs

As of January 10, 2023, 442 tests and sample collection devices are authorized by FDA under EUAs. These include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 43 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,197 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics  

BAA: Don't delay! 
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. For consideration in FY 2023, white papers are due by 5:00 p.m. EST, January 23, 2023. Also see: MCM-related research areas of interest and FDA BAA Questions & Answers

It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)

COVID-19 at-home tests
Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date. Bookmark our new guide: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.