Updates to the Interim Clinical Considerations for Covid Vaccines

Dear Immunization Partners,

The CDC (Centers for Disease Control and Prevention) has updated the Interim Clinical Considerations as of December 23, 2021.  We are sending you a summary of those updates.

Updated information about a second formulation of Pfizer-BioNTech Covid-19 Vaccine that is authorized for use in persons age 12 years and older.

There are two formulations of Pfizer-BioNTech that are FDA-approved for use in persons aged 16 years and older and FDA-authorized for use in persons aged 12 through 15 years:

•A formulation supplied in a multiple dose vial with a purple cap and label with a purple border, and which must be dilutedprior to use. It uses phosphate buffered saline (PBS). Each diluted 0.3 mL dose contains 30 µg of modified mRNA.

•A formulation supplied in a multiple dose vial with a gray cap and label with a gray border, and which that does not require dilution prior to use. It uses tromethamine (Tris) buffer. Each 0.3 mL dose contains 30 µg of modified mRNA.  Be sure to note the difference in storage and handling and preparation with this formulation.

Updated information on vaccinating people during quarantine after a known SARS-CoV-2 exposure or during COVID-19 outbreaks.

•COVID-19 vaccines are not recommended for post-exposure prophylaxis to prevent SARS-CoV-2 infection, however:

•to avoid missed opportunities for vaccination, vaccination during quarantine could be considered during outreach and contact tracing activities or at the time of post-exposure SARS-CoV-2 testing in certain circumstances. Examples might include when people:

•are likely to have repeated SARS-CoV-2 exposures because they are unable to effectively quarantine (e.g., residing in a congregate or crowded setting or during outbreaks in their community), or,

•will have limited access to vaccination after their quarantine period has ended, or,

•are unlikely to otherwise seek vaccination after their quarantine period has ended.

•In such situations, the person recommended for quarantine can receive vaccination as long as:

•they do not have symptoms consistent with COVID-19, and,

•appropriate infection prevention and control procedures are employed during vaccination. Furthermore, unvaccinated people who are being tested for SARS-CoV-2 may be candidates for same-day vaccination if they do not have symptoms consistent with COVID-19.

People should be counseled that COVID-19 vaccines are effective, especially at preventing serious COVID-19 illnesses. However, they should also be informed that vaccination may not prevent SARS-CoV-2 infection until 2 weeks after the primary series is completed, i.e., will not prevent them from getting COVID-19 from the current exposure but should help protect them from infection after future exposures. In addition, SARS-CoV-2 viral testing may be necessary to differentiate between common post-vaccination symptoms and symptoms of SARS-CoV-2 infection:

•Persons who develop signs and symptoms not associated with the COVID-19 vaccination (e.g., cough, shortness of breath, runny nose, sore throat, loss of taste or smell) should isolate and be evaluated for SARS-CoV-2 infection as soon as possible.

•Persons who develop signs and symptoms that could be from either COVID-19 vaccination or SARS-CoV-2 infection (e.g., fever, fatigue, headache, myalgia) without typical COVID-19 symptoms described above, and are clinically stable, should isolate and, if symptoms do not improve by two days post-vaccination, be evaluated for SARS-CoV-2 infection.

Update to alert providers of possible false positive Rapid Plasma Reagin (RPR; non-treponemal) test results in some people after COVID-19 vaccines.

-FDA has reported that falsely reactive Rapid Plasma Reagin (RPR: non-treponemal) can occur with certain RPR tests for at least five months following COVID-19 vaccination in some people. Treponemal testing for syphilis such as Treponema pallidum particle agglutination (TP-PA) and treponemal immunoassays do not appear to be impacted by this issue.

Updated information on vaccine administration errors and deviations.

-Vaccine Administration errors and deviations has been updated to include the Pfizer BioNTech Covid-19 Vaccine with the gray cap.

Thank you for all you do to protect Michiganders from Vaccine-preventable diseases.

The MDHHS Immunization Nurse Education Team.