Influenza Update: FDA Authorizes Diagnostic Test for COVID-19 and Flu

A universal flu vaccine is also another step closer, according to researchers at Mount Sinai.

The US Food and Drug Administration (FDA) granted their authorization for a diagnostic home test based on patient samples that detects both the novel coronavirus (COVID-19) and influenza A and B infection, the agency announced Friday.

The test comes from Quest Diagnostics and is meant for prescription use for individuals suspected of a respiratory viral infection consistent with COVID-19 symptoms, they added. The appropriate usage for home collection is to be determined by patient’s health care provider, they continued, and at such a time the patient can collect a home sample and ship the sample to a Quest Diagnostics lab for analysis. Instructions for this are included in the kit, the FDA said.

“With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans,” FDA Commissioner Stephen M. Hahn, MD, said in the statement. “With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

Through the week ending Nov. 28, the U.S. Centers for Disease and Prevention (CDC) reports that seasonal flu activity remains "lower than usual for this time of year.” Surveillance this flu seasonal should be interpreted with caution, they warned, in the wake of the ongoing COVID-19 pandemic, though.

Investigators at the CDC noted that the flu vaccine is the first step in preventing the flu and can offer some protection against poor pregnancy outcomes. In addition, a study published in The Lancet Infectious Diseases suggested that having the flu during pregnancy was associated with an increased risk for pregnancy loss and reduced birthweight.

A meta-analysis published in Infection examined the different interventions used to vaccinate health care workers against influenza, finding that mandatory vaccination policies were an effective measure in achieving high overall vaccination covers, the study authors said.

“In clinics where policies are infeasible, multifaceted campaigns comprising on-site vaccination, vaccination stands and educational and promotional campaigns as well as incentives should be implemented,” the study authors wrote, adding that the lessons they learned from studying flu vaccine policies could be implemented in future COVID-19 vaccination campaigns.

Authors from the Tulane University School of Medicine in New Orleans published an article in the Journal of the National Medical Association explaining barriers to “twindemic” vaccination for COVID-19 and the flu.

They noted that African Americans in particular experience a low vaccination uptake due to a variety of factors such as distrust of orthodox medicine, safety concerns, and barriers in the environment to vaccine access. As such, there may be low uptake of a COVID-19 vaccine when one is available—a disease that has disproportionately affected African Americans and other minorities.

“Robust educational campaigns, policy initiatives, and novel approaches to influenza immunization must be considered for the African American community to build trust in the health benefits of the influenza vaccination and, ultimately, to trust in the health benefits of potential SARS-CoV2 vaccines, when available for the general public,” the authors said.

In other flu news:

  • Researchers from Mount Sinai say they are one more step closer to a universal flu vaccine, finding strong results in early stage human clinical trials. “An influenza virus vaccine that results in broad immunity would likely protect against any emerging influenza virus subtype or strain and would significantly enhance our pandemic preparedness, avoiding future problems with influenza pandemics as we see them now with COVID-19” Florian Krammer, PhD, corresponding author of the study, said in a statement. The paper was published in Nature Medicine.

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