Below is the added language; clinical guidance has been underlined.
Updated recommendations on intervals between the first and second dose
Language has been added to clarify doses inadvertently administered earlier than the grace period should not be repeated.
Language has also been added that states “The second dose should be administered as close to the recommended interval as possible.However, if it is not feasible to adhere to the recommended interval, the second does of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose.There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window.If the second dose is administered beyond these intervals, there is no need to restart the series.”
Updated recommendations on interchangeability of vaccine products
mRNA COVID-19 vaccines are not interchangeable. Language has been added to provide suggested strategies to help ensure patients receive the second dose with the appropriate product and interval between doses including:
“Providing COVID-19 vaccination record cards to vaccine recipients, asking recipients to bring their card to their appointment for the second dose, and encouraging recipients to make a backup copy (e.g., by taking a picture of the card on their phone).
Recording each recipient’s vaccination in the immunization information system (IIS).
Recording vaccine administration information in the patient’s medical record.
Making an appointment for the second dose before the vaccine recipient leaves, to increase the likelihood that patients will present at the same vaccination site for the second dose.
Using the above strategies, every effort should be made to determine which vaccine product was received as the first dose, in order to ensure completion of the vaccine series with the same product.In exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimal interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time.
Updated language on vaccination of persons with a history of SARS-CoV-2 infection
Updated language includes:
“Data from clinical trials indicate that mRNA COVID-19 vaccines can safely be given to persons with evidence of a prior SARS-CoV-2 infection.”
“Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection for the purposes of vaccine decision-making is not recommended.”
“While there is no recommended minimum interval between infection and vaccination,current evidencesuggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity.Thus,while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, may increase with time following initial infection.”
New vaccination recommendations with a history of dermal fillers
Added language states “Infrequently, persons ho have received dermal fillers may develop selling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine. This appears to be temporary and can resolve with medical treatment, including corticosteroid therapy.mRNA COVID-19 vaccines may be administered to persons who have received injectable dermal fillers who have no contraindications to vaccination. No additional precautions are needed.However, these persons should be advised to contact their healthcare provider for evaluation if they develop swelling at or near the site of dermal filler following vaccination.”
Additional resources on vaccine excipients (Appendix B)
“The language added in Appendix B is “As of January 21, 2021, mRNA COVID-19 vaccines are the only currently available vaccines in the United States that contain PEG, though several vaccines contain polysorbate (more information can be found inCDC’s vaccine excipient summary).”
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