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Last Updated  1/11/2021

COVID-19 Vaccine

On Dec. 11, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the first COVID-19 vaccine. opens in a new tab The EUA allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S. An EUA is different than an FDA approval (licensure) of a vaccine. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits. If the benefit-risk assessment is favorable, the product is made available during the emergency.

In an emergency session on Dec. 12, Advisory Committee on Immunization Practices (ACIP) voted to recommend Americans receive the Pfizer-BioNTech COVID-19 vaccine, a key step that allows healthcare workers to begin administering the vaccine to people. ACIP’s interim recommendation covers people ages 16 years and older under the FDA EUA. Presentations from the Dec. 11 and Dec. 12 emergency sessions opens in a new tab are now available.

On Dec. 13, the ACIP’s Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020 opens in a new tab was published in the Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report (MMWR).

CDC Clinician Outreach and Communication Activity (COCA) – “What Every Clinician Should Know About COVID-19 Vaccine Safety” opens in a new tab. Webinar held Dec. 14.

On Dec. 18, the FDA issued its EUA for the Moderna COVID-19 vaccine opens in a new tab for individuals 18 years of age and older. The dosing regimen is two doses of 0.5 mL each, one month apart. As with the Pfizer vaccine, recipients and caretakers should be provided with a “Fact Sheet” opens in a new tab to help them understand the risks and benefits of the Moderna COVID-19 vaccine. There is a separate “Fact Sheet for Providers” opens in a new tab.

On Dec. 19, the ACIP met and voted on its interim recommendations for use of the Moderna COVID-19 vaccine. These recommendations were accepted by the Director of the CDC and published in MMWR on Dec. 20 opens in a new tab.

CDC COCA webinar “COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions” (Dec. 30) opens in a new tab. This presentation provides an overview of recommendations for use of COVID-19 vaccines in certain populations. Clinicians will learn more about the recent reports of anaphylaxis following vaccination, as well as CDC’s updated clinical considerations around contraindications and precautions to vaccination.

On Dec. 19, the CDC released initial information and resources to address “COVID-19 Vaccines and Severe Allergic Reactions”.  If you have a severe allergic reaction after getting the first shot, you should not get the second shot. “Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites opens in a new tab” provides detailed information and guidance.

CDC COCA webinar: “What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines” (Dec. 18) opens in a new tab. This presentation includes very helpful information about recommended medications and supplies for the management of anaphylaxis at COVID-19 vaccination sites.

CDC – “V-safe” After Vaccination Health Checker opens in a new tab. V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. V-safe will also remind you to get your second COVID-19 vaccine dose if you need one.

CDC – Post-Vaccine Considerations for Healthcare Personnel (Dec. 13) opens in a new tab. Systemic signs and symptoms such as fever, fatigue, headache, chills, myalgia and arthralgia can occur following COVID-19 vaccination. Early data from COVID-19 vaccine trials indicate that most systemic post-vaccination signs and symptoms are mild to moderate in severity, occur within the first three days of vaccination, resolve within one to two days of onset, and are more frequent and severe following the second dose and among younger persons compared to those who are older (>55 years). Cough, shortness of breath, rhinorrhea, sore throat, or loss of taste or smell are not consistent with post-vaccination symptoms, and instead may be symptoms of SARS-CoV-2 or another infection.

CDC – Post-Vaccine Considerations for Residents of Long-Term Care Facilities (Dec. 13) opens in a new tab. All symptomatic residents should be assessed; CDC provides a table of suggested approaches that should be tailored to fit the clinical and epidemiologic characteristics of the specific case.