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Post-Covid Vaccine Assessment

The U.S. Food and Drug Administration (FDA) is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests shouldn’t be used to analyze a person’s level of immunity or protection from COVID-19 at any time, and particularly after the person received a COVID-19 vaccination.

While a positive antibody test result could be used to help identify people who might have had prior SARS-CoV-2 infection, more research is required in people who have received a COVID-19 vaccination. Currently authorized SARS-CoV-2 antibody tests have not been analyzed to evaluate the level of protection provided by an immune response to COVID-19 vaccination.

If antibody test results are interpreted incorrectly, there is a potential risk that people might take fewer precautions against SARS-CoV-2 exposure. Taking fewer steps to protect against SARS-CoV-2 could increase their risk of SARS-CoV-2 infection and might result in the increased spread of SARS-CoV-2.

The Food and Drug Administration (FDA) is offering additional information and suggestions to the public and health care providers about the use of antibody tests in people who received a COVID-19 vaccination.

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Common Side Effects of a COVID-19 Vaccine

COVID-19 vaccination will help defend you from getting COVID-19. You might have some side effects, which are common signs that your body is building protection. These side effects might affect your ability to do everyday activities, but they should go away in a few days. Some people do not experience side effects.

On the arm where you got the vaccine administered:

  •    Pain
  •    Redness
  •    Swelling

Throughout the rest of your body:

  •    Tiredness
  •    Headache
  •    Muscle pain
  •    Chills
  •    Fever
  •    Nausea

New Vaccine Post-Introduction Evaluation (PIE) Tool

This post-introduction evaluation (PIE) tool offers a standardized method for assessing the impact of the introduction of a vaccine on the existing immunization system in a country. The post-introduction evaluation (PIE) tool is designed for immunization managers in countries that have introduced a new or underused vaccine. The World Health Organization (WHO) recommends that all countries which have introduced a new vaccine conduct a post-introduction evaluation (PIE).

Conducting a post-introduction evaluation (PIE) is not a new concept, and there are various instances of assessments of Hepatitis B (Hep B) and Haemophilus influenzae type B (I-lib) vaccine introductions-those experiences have been incorporated into this tool. The purpose of the current tool is to offer a systematic method of performing the assessment that is comparable across countries, to facilitate the sharing of experiences.

Numerous world health organizations (WHO) and United Nations Children's Fund (UNICEF) guidelines and operational manuals have been consulted in the preparation of the tool, which is suitable for assessment of all new vaccines but will need revision for each country's individual circumstances, and for the different vaccine formulations and presentations.

This manual consists of an overview of the post-introduction evaluation (PIE), a description of what needs to be evaluated and what the evaluator should be looking for, and an explanation of how to synthesize the data and present the results.


Positive Covid-19 Antibody Test

A positive test simply means you have COVID-19 antibodies in your blood, which shows past infection with the virus. It is possible to have a positive test result even if you never had any symptoms of COVID-19. False-positive test results could happen. It might be that the test detected antibodies to a coronavirus closely associated with the COVID-19 virus or that the test quality was flawed.


Negative Covid-19 Antibody Test

A negative test simply means that you have no COVID-19 antibodies, so you probably were not infected with the COVID-19 virus in the past. Because it takes time for antibodies to develop, false-negative test results could occur if the blood sample is collected too soon after your infection began. In some cases, the test might be flawed.


Recommendations for People Who Had or Might Have a SARS-CoV-2 Antibody Test


  •    Be aware that SARS-CoV-2 antibody tests help health care providers identify whether someone has antibodies to SARS-CoV-2, the virus that causes COVID-19, denoting a prior infection with the virus.
    Although, more research is required to understand the meaning of a positive or negative antibody test, beyond the presence or absence of antibodies, including in people who received a COVID-19 vaccination, for those who have been exposed and have SARS-CoV-2 antibodies, and for those who are not fully vaccinated.
  •    If you have not been vaccinated - Be aware that a positive result from an antibody test does not mean you have a certain amount of immunity or protection from SARS-CoV-2 infection.
    If you have a positive test result on a SARS-CoV-2 antibody test, it means that it is possible you were earlier infected with the SARS-CoV-2 virus. Speak with your health care provider about the meaning of your SARS-CoV-2 antibody test results.
  •    If you received a COVID-19 vaccination - Continue to follow the centers for disease control and prevention (CDCs) recommendations for fully vaccinated people.
    Be aware that if you have a positive test result on a SARS-CoV-2 antibody test, it is possible you were earlier infected with SARS-CoV-2. A COVID-19 vaccination might also cause a positive antibody test result for some but not all antibody tests.
    You should not interpret the results of your SARS-CoV-2 antibody test as an indication of a certain level of immunity or protection from SARS-CoV-2 infection. Speak to your health care provider or your state and local health departments if you have questions about whether an antibody test is right for you.

Recommendations for Health Care Providers

At this time, don’t interpret the results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests as an indication of a certain level of immunity or protection from SARS-CoV-2 infection after the person has received a COVID-19 vaccination.

While a positive antibody test could indicate an immune response has happened (seroconversion), and failure to detect such a response might suggest a lack of immune response, more research is required.

Currently authorized SARS-CoV-2 antibody tests are not validated to assess certain immunity or protection from SARS-CoV-2 infection. SARS-CoV-2 antibody tests should be ordered only by health care providers who are knowledgeable about the use and limitations of the test.

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Be aware that vaccines trigger antibodies to certain viral protein targets. For instance, currently authorized COVID-19 mRNA vaccines to induce antibodies to the spike protein and not to nucleocapsid proteins that are likely detected only after natural infections.

Thus, COVID-19 vaccinated people who have not had previous natural infection will receive a negative antibody test result if the antibody test doesn’t detect the antibodies induced by the COVID-19 vaccine.

If you are considering antibody testing in vaccinated individuals, follow the Centers for Disease Control and Prevention’s (CDCs) guidelines for antibody testing.


Possible Risks of Incorrectly Using SARS-CoV-2 Antibody Test Results

Antibodies are proteins formed by your body’s immune system soon after you have been infected or vaccinated. The SARS-CoV-2 antibody or serology tests look for antibodies in a blood sample to decide if an individual has had a prior infection with the virus that causes COVID-19. These types of tests can’t be used to diagnose a current infection.

Test results from currently authorized SARS-CoV-2 antibody tests should not be used to assess a person’s level of immunity or protection from COVID-19. If the results of the antibody test are interpreted as an indication of a certain level of immunity or protection from SARS-CoV-2 infection, there is a possible risk that people might take fewer precautions against SARS-CoV-2 exposure.

Taking fewer precautions against SARS-CoV-2 exposure could increase their risk of infection and might result in increased spread of SARS-CoV-2.


Food and Drug Administration (FDA) Actions

The Food and Drug Administration (FDA) will continue to monitor the use of authorized SARS-CoV-2 antibody tests for purposes other than identifying people with an immune response to SARS-CoV-2 from a recent or previous infection.

The Food and Drug Administration (FDA) offered updated information about SARS-CoV-2 antibody tests and will continue to keep health care providers and the public informed if new additional information becomes available.


Reporting Problems

If you think you had a problem with a SARS-CoV-2 antibody test, the food and drug administration (FDA) encourages you to report the problem through the Med-Watch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the food and drug administrations (FDAs) user facility reporting requirements should follow the reporting procedures established by their facilities.




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