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Cases of COVID-19 New Variants are rising. 

VACCINATION

There is no FDA-approved vaccine to prevent COVID-19; however, based on the available scientific information, the FDA issued an EMERGENCY USE AUTHORIZATION (EUA) for Pfizer-BioNTech COVID-19,  Moderna mRNA-1273 vaccines, and Janssen’s COVID-19 Vaccine.   The duration of this protection is still under investigation.

Authorized and Recommended Vaccines for the US

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19 recommended for people aged 16 years and older. The vaccine has been shown to prevent COVID-19 following two doses given three weeks apart. However, the duration of protection against COVID-19 is currently unknown.

ModernaTX, Inc., The mRNA-1273 Vaccine is an unapproved vaccine that may prevent COVID-19. It is recommended for people aged 18 years and older. The vaccine has been shown to prevent COVID-19 following two doses (28 days) 4 weeks apart. However, the duration of protection against COVID-19 is currently unknown.

Janssen’s COVID-19 vaccine

The known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. The FDA and CDC are confident that this vaccine continues to meet our safety, effectiveness, and quality standards. People with questions about which vaccine is suitable for them to discuss with their health care provider.

 

AFTER VACCINATION – Monitoring for Safety Will Continue

Keep your vaccination card! And Reports of adverse events to the vaccination using the link below.

Vaccine Adverse Event Reporting System

 

Do COVID-19 tests check for the delta and other variants?

There are no authorized COVID-19 antigen or molecular tests that specifically report the presence of the SARS-CoV-2 delta variant. Currently, COVID-19 tests are designed to check broadly for the SARS-CoV-2 virus, including the SARS-CoV-2 delta variant.

The FDA works closely with test developers to identify potential impacts of virus mutations on FDA authorized COVID-19 tests and help ensure minimal impact on test performance.

Many tests, including some home collection and at-home tests, require a prescription or order from a health care provider.

Prescription Tests – Health care providers can determine whether you need a test, ensure you get the most appropriate test, and know what the results mean.

Non-Prescription Tests – Some tests are available without a prescription. Home collection and at-home tests available without a prescription may be called “direct-to-consumer” (DTC) or “over-the-counter” (OTC).

If you want to be sure, the test you are buying is authorized by the FDA, visit our tables of molecular, antigen, and serology and adaptive immune response in vitro diagnostic emergency use authorizations (EUA) for more information.

Understanding Your Test Results

Generally, for diagnostic tests, a negative result means the test did not detect the SARS-CoV-2 virus, and a positive result means the test did detect the SARS-CoV-2 virus, and you are very likely to have COVID-19.

However, no test is perfect. There is always a chance that a test will return a false result. For diagnostic tests, a false negative means the test says you don’t have COVID-19, but you are infected, and a false positive means that the test says you have COVID-19, but you are not infected.

Because of this, even if you receive a negative result, you should keep practicing preventive measures, such as distancing, washing hands, and wearing masks. These measures help to reduce the risk of spreading COVID-19.

If you are sick, you should stay home and isolate yourself from others, even if you receive a negative test result. Talk with your health care provider to determine if you should be retested or for advice on managing your symptoms.

For serology tests, a negative result means the test did not detect antibodies to the virus that causes COVID-19. Conversely, a positive result means the test did detect antibodies to the virus that causes COVID-19 due to a recent or prior COVID-19 infection, and you have developed an adaptive immune response to the virus.

Key Terms

• SARS-CoV-2: the virus that causes COVID-19
• COVID-19: the illness caused by the SARS-CoV-2 virus
• Home Collection Test: sample is collected at home but analyzed in a laboratory
• Direct to Consumer (DTC) Test: home collection tests are available without a prescription, but the sample is analyzed in a laboratory
• At-home testing: consumer completes sample collection and testing at home
• Over the Counter (OTC) Test: consumer completes sample collection and testing at home, without a prescription
• Diagnostic test: shows if you have an active COVID-19 infection
• Molecular Test: a diagnostic test that detects genetic material from the virus
• Reverse Transcription Polymerase Chain Reaction (RT-PCR): one type of molecular diagnostic test
• Nucleic Acid Amplification Test (NAAT): one type of molecular diagnostic test
• Antigen Test: a diagnostic test that detects specific proteins from the virus
• Antibody (Serology) Test: detects antibodies that are made by your immune system in response to a threat, such as a specific virus; not used to diagnose active infection