Technically Speaking |
|
A Monthly Column by Deborah Wexler, MD |
|
|
|
|
|
IAC Executive Director Dr. Deborah Wexler writes
Technically Speaking, a column featured in each issue of
Vaccine Update for Healthcare Professionals,
the monthly e-newsletter from the Vaccine Education Center
(VEC) at the Children's Hospital of Philadelphia.
Technically Speaking columns cover practical topics in
immunization delivery such as vaccine administration
techniques, storage and handling, contraindications and
precautions, and scheduling. |
|
Subscribe to VEC's
Vaccine Update for Healthcare Professionals to stay up to date
on vaccine-related issues, including reviews of recently
published journal articles, media recaps, and announcements
about new resources and webinars. To subscribe, visit the
Vaccine Update Newsletter Sign-up Form |
|
The
archive of past Technically Speaking columns is also available through links on the right side of this web page. |
|
|
|
|
TECHNICALLY SPEAKING |
|
FDA issues EUA for Pfizer-BioNTech mRNA vaccine; CDC approves its use and provides clinical guidance |
|
Published December 2020 |
|
On December 11, the Food and Drug Administration (FDA) issued an
Emergency Use Authorization (EUA) to allow the Pfizer-BioNTech
COVID-19 vaccine to be distributed in the United States for use in
people 16 years of age and older. The Advisory Committee on
Immunization Practices (ACIP) met on December 1112 and voted to
recommend the use of Pfizer's mRNA vaccine in people 16 years of
age and older, and on December 13, CDC published
ACIP's Interim
Recommendation for Use of Pfizer-BioNTech COVID-19 VaccineU.S.,
December 2020
as a Morbidity and Mortality Weekly Report (MMWR) Early Release.
While MMWR publications should always be consulted for official
guidance, additional highlights of ACIP's clinical guidance
discussed at the committee's December 1112 meeting are provided
below:
- Administration The Pfizer-BioNTech COVID-19 vaccine is
administered intramuscularly as a 2-dose series separated by 21
days. Although the 21-day separation should be followed as closely
as possible, the standard 4-day grace period (allowing a 1720 day
interval between doses) is acceptable. If more than 21 days elapse
between doses, vaccine should be administered at the earliest
opportunity, but doses do not need to be repeated due to a longer
interval. Both doses are necessary for protection. COVID-19
vaccines are not interchangeable, and care should be taken to
ensure the same vaccine is used for both doses. However, if
different mRNA vaccines are inadvertently administered, no
additional doses of either vaccine are recommended at this time. A
minimum interval of 14 days should be maintained before or after
administration of this COVID-19 vaccine with any other type of
vaccine.
- People with a history of SARS-CoV-2 infection or exposure
People should be offered vaccine regardless of a prior history of
infection. However, if they are currently infected, vaccination
should be deferred until their recovery from acute illness. To
avoid exposure to healthcare personnel, vaccination should be
deferred for people with a known SARS-CoV-2 exposure until after
their quarantine period has ended, with the exception of those who
live in congregate settings (e.g., long-term care, correctional
facilities, homeless shelters). Vaccination should be deferred for
90 days following receipt of monoclonal antibodies or convalescent
plasma used as part of COVID-19 treatment.
- Special populations Unless otherwise contraindicated, people
with underlying medical conditions or who are immunocompromised may
receive COVID-19 vaccine. Pregnant or lactating women may choose to
be vaccinated after discussion with their healthcare provider to
assess their risk of infection, to make an informed decision.
Routine testing for pregnancy before vaccination is not
recommended.
- Patient vaccine counseling All patients should be counseled
about the importance of receiving both doses of vaccine, as well as
expected local and systemic post-vaccination symptoms.
- Interpretation of SARS-CoV-2 test results in a vaccinated person
Prior receipt of vaccine will not affect results of viral tests.
Vaccination could affect anti-spike antibody test results, but not
antibody tests based on nucleocapsid.
Several key resources from FDA and CDC are listed below. CDC is
updating COVID-19 information on its web pages frequently.
From FDA
From CDC
|
This page was updated on
December 22, 2020. |
This page was reviewed on
December 22, 2020 |
|
|
|
|
|
|
|