8 January 2021

This document is an update of the guidance published on 21 March 2020 and contains new evidence and guidance, including the following:

• updated results from published studies on:
  
  • the epidemiology and extent of SARS-CoV-2 infection among residents and staff in long-term care facilities (LTCFs);
  • the effectiveness of infection prevention and control (IPC) precautions to prevent SARS-CoV-2 transmission in LTCFs;
  • the impact of IPC precautions on mental and physical health and well-being of older people, and in particular people with dementia or other mental health or neurological disorders;
• updated advice on IPC precautions to prevent the spread of SARS-CoV-2 and to protect health workers and caregivers of patients with suspected or confirmed COVID-19 in LTCFs;
• advice on early detection of and testing for SARS-CoV-2 among residents and staff in LTCFs;
• advice on policies for visitors to LTCFs and additional considerations on minimizing the mental and physical health impacts of restrictions and IPC precautions implemented in the context of COVID-19.

The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taking additional actions to ensure authorized tests remain accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. The FDA believes the risk that these mutations will impact overall testing accuracy is low.

“The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients,” said FDA Commissioner Stephen M. Hahn, M.D. “While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants. At this time, we believe the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain. The FDA will continue to keep health care providers and the public informed of any new information as it becomes available.”

The FDA has been monitoring SARS-CoV-2 viral mutations, and potential impact on testing, throughout the pandemic. The presence of SARS-CoV-2 genetic variants in a patient sample can potentially change the performance of a SARS-CoV-2 test. Tests that rely on the detection of multiple regions of the genome may be less impacted by genetic variation in the SARS-CoV-2 genome than tests that rely on detection of only a single region.

Three currently authorized molecular tests, MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit, may be impacted by genetic variants of SARS-CoV-2, but the impact does not appear to be significant. Importantly, the detection pattern that appears with the TaqPath and Linea diagnostic tests when certain genetic variants are present may help with early identification of new variants in patients to reduce further spread of infection. The recently identified B.1.1.7 variant has been associated with an increased risk of transmission, therefore early identification of this variant in patients may help reduce further spread of infection.

The FDA has reminded clinical laboratory staff and health care providers about the risk of false negative results with all laboratory tests, including molecular tests. Laboratories should expect some false results to occur even when very accurate SARS-CoV-2 tests are used. Today’s announcement also provides important information and recommendations for clinical laboratory staff and health care providers who use molecular tests for the detection of SARS-CoV-2.

The FDA will continue to communicate with the public as we have additional information to share. The FDA encourages stakeholders to report any adverse events or suspected adverse events experienced with molecular tests for detection of SARS-CoV-2. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel and clinical laboratory staff employed by facilities that are performing COVID-19 testing should follow the reporting requirements for authorized laboratories as specified in the test’s Emergency Use Authorization. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

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Summary

What is already known about this topic?

On December 11, 2020, the Food and Drug Administration issued an Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine.

What is added by this report?

On December 12, 2020, after an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.

What are the implications for public health practice?

The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP’s interim recommendation for allocating initial supplies of COVID-19 vaccines.

The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020

Summary

What is already known about this topic?

On December 18, 2020, the Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine.

What is added by this report?

On December 19, 2020, after a transparent, evidence-based review of available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19.

What are the implications for public health practice?

Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP’s interim recommendations for allocating initial supplies of COVID-19 vaccines.