IF YOU ARE FULLY VACCINATED

Find new guidance for fully vaccinated people. If you are not vaccinated, find a vaccine.

CDC has updated its guidance for people who are fully vaccinated. See Recommendations for Fully Vaccinated People.

IMPORTANT UPDATE FOR SCHOOLS

CDC recommends schools continue to use the current COVID-19 prevention strategies for the 2020-2021 school year. Learn more

Important update: Healthcare facilities

CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Learn more

Find the latest information:
Aquatics FAQs
Recommendations for Fully Vaccinated People
COVID-19 Homepage

UPDATE

Getting vaccinated prevents severe illness, hospitalizations, and death. Unvaccinated people should get vaccinated and continue masking until they are fully vaccinated. With the Delta variant, this is more urgent than ever. CDC has updated guidance for fully vaccinated people based on new evidence on the Delta variant.

UPDATE

Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the guidance for fully vaccinated people. CDC recommends universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Children should return to full-time in-person learning in the fall with layered prevention strategies in place.

FAQ: CDC Distribution of COVID-19 Assays

Updated July 15, 2021

At this time, CDC distributes the 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and the Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.

No, CDC does not manufacture either the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay for use by hospital, community, or commercial laboratories.
CDC provides both the 2019-nCoV Real-Time RT-PCR Diagnostic Panel and Flu SC2 Multiplex Assay for use in designated state, tribal, local, and territorial government-supported public health laboratories. For more information, check with your health department.
CDC encourages commercial manufacturers to use the CDC-published assay designs for the 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay to pursue their own Emergency Use Authorization (EUA). Laboratories also can use the published assay designs to create a laboratory-developed test (LDT).

No, CDC does not manufacture the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay for use by hospital, community, or commercial laboratories.
CDC provides the Flu SC2 Multiplex Assay for use in designated state, tribal, local, and territorial government-supported public health laboratories. For more information, check with your health department.
CDC encourages commercial manufacturers to use the CDC-published assay design to pursue their own Emergency Use Authorization (EUA). Laboratories also can use the published assay design to create a laboratory-developed test (LDT).

Yes, however, the manufacturer must pursue its own EUA.
CDC is offering developers the right of reference to both the 2019-nCoV Real-Time RT-PCR Diagnostic Panel and the Flu SC2 Multiplex Assay. The right of reference allows developers seeking EUA to use the performance data already submitted to FDA as part of the 2019-nCoV Real-Time RT-PCR Diagnostic Panelexternal icon (FDA submission number EUA200001) or CDC EUA request for the Flu SC2 Multiplex Assayexternal icon (FDA submission number EUA201781). This approach will help developers bring tests to the market more quickly.

Yes, however, the laboratory will need to manufacture the primers and probes or purchase them from a commercial vendor using the published designs for the 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay.
The laboratory will need to perform testing to meet all appropriate Clinical Laboratory Improvement Amendment (CLIA) regulations prior to reporting diagnostic results.
LDTs created using CDC’s design would not be authorized under the CDC 2019-nCoV Diagnostic Panel or Flu SC2 Multiplex Assay EUA.

CDC provides:
- Technical specifications for Flu SC2 Multiplex Assay primers and probes
- Right of reference to the performance data submitted to FDA as part of the CDC Flu SC2 Multiplex Assay EUA request
CDC does not provide:
- Quality control testing
- Positive controls – refer to the CDC Flu SC2 Multiplex Assay Instructions for Useexternal icon for additional information
- Validation panels
  - Exclusivity panels
  - Limit of Detection panels
- A CDC-manufactured kit to use for comparison or validation purposes

No license or agreement is necessary to use the CDC-published 2019-nCoV Real-Time RT-PCR Diagnostic Panel or the Flu SC2 Multiplex Assay primer and probe sequences. CDC has published these sequences to allow manufacturers and test developers to use this information for creation and/or distribution of their own test or components.
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel and the Flu SC2 Multiplex Assay use proprietary components from other companies. Developers of commercial tests will need to obtain licenses from the manufacturers of these proprietary components or qualify alternative materials to use in their test.