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Technically Speaking
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December 2020
Technically Speaking
A Monthly Column by Deborah Wexler, MD
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 11–12 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 Vaccine—U.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 11–12 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 17–20 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

The archive of past Technically Speaking columns is also available through links on the right side of this web page.
 
This page was updated on December 22, 2020.
This page was reviewed on December 22, 2020
2020 ISSUES >> view all issues
DECEMBER 2020
FDA issues EUA for Pfizer-BioNTech mRNA vaccine; CDC approves its use and provides clinical guidance
NOVEMBER 2020
Prevent Shoulder Injuries Caused by Missing the Deltoid Muscle When Injecting Vaccines!
OCTOBER 2020
ACIP Updates Recommendations on the Use of MenACWY and MenB Vaccines
SEPTEMBER 2020
Is It 0.25 mL or 0.5 mL? What Is the Correct Dose of Injectable Flu Vaccine for Children Younger Than 3?
JULY 2020
Choosing Proper Needle Length for Vaccination of Children and Adults: What Should You Consider?
JUNE 2020
Preventing Preventable Vaccine Administration Errors in Your Medical Setting
MAY 2020
IAC Launches New MenB Vaccination Honor Roll Recognizing Colleges and Universities That Require or Recommend the Vaccine to Protect Their Students
APRIL 2020
Our Society Deserves Vaccination: Two New Educational Pieces from IAC Explain the Science Supporting Vaccines and the Value of the Vaccine Injury Compensation Program
MARCH 2020
Now Available to Order! IAC's Laminated Versions of CDC's 2020 Immunization Schedules
FEBRUARY 2020
Sign up for IAC Express—the Best Way to Stay Current with Weekly U.S. Immunization News, Information, and Resources
JANUARY 2020
CDC Releases 2020 Version of Its Vaccine Storage and Handling Toolkit
    >> view all issues
2019 ISSUES >> view all issues
DECEMBER 2019
ACIP Updates Its Pneumococcal Vaccine Recommendations for Adults Age 65 Years and Older
NOVEMBER 2019
ACIP Votes to Approve That Tdap and Td Vaccines May Now Be Used Interchangeably
OCTOBER 2019
CDC Updates Recommendations on the Use of HPV Vaccine
SEPTEMBER 2019
"Dear Colleague" Call-to-Action Letter from AAFP, AAP, ACHA, ACOG, APhA, SAHM, and IAC Stresses Importance of Implementing Immunization Visit at 16 Years of Age
AUGUST 2019
Newly Designed and Easy to Navigate—Visit Give2MenACWY.org to Enhance Your Efforts to Increase Rates for MenACWY Booster Doses and Other Adolescent Vaccinations
JULY 2019
ACIP Updates Its Guidance on the Use of HPV, PCV13, HepA, HPV, and MenB Vaccines at June 26–27 Meeting
JUNE 2019
Looking for New Tools and Resources to Help Increase Your Clinic's HPV Vaccination Rates? Here Are Some Great Ones!
MAY 2019
How to Protect Children, Adults, and Healthcare Personnel from Measles
APRIL 2019
Refresher! Use of Pneumococcal Vaccines in Infants and Children, as well as in Children with Health Conditions
MARCH 2019
With Measles "Breaking Out" All over the United States, Here Are Some Good Educational Resources
FEBRUARY 2019
Questions about Proper Vaccine Storage and Handling? CDC's Redesigned Toolkit Has Answers!
JANUARY 2019
Want to Avoid Vaccination Errors? These Print Materials and Slide Sets Will Help You!
    >> view all issues
 
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This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 1NH23IP922654) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.