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.
- Advisory Committee on Immunization Practices opens in a new tab (ACIP) – ACIP is composed of medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the U.S. The recommendations stand as public health guidance for safe use of vaccines and related biological products. On Dec. 1, the ACIP committee made recommendations opens in a new tab for prioritization of initial COVID-19 vaccines. “Phase 1a” will include 1) healthcare personnel and 2) residents of long-term care facilities. State governors will actually decide who gets the initial vaccines.
- CDC – COVID-19: Toolkit for Healthcare Providers (updated Nov.18) opens in a new tab. Guidance and planning documents include:
- Clinical Care Guidance for Healthcare Professionals about Coronavirus Disease 19 (COVID-19) opens in a new tab
- Considerations for Wearing Masks opens in a new tab
- COVID-19 Guidance for Shared or Congregate Housing opens in a new tab
- Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for Coronavirus Disease 2019 (COVID-19) opens in a new tab
- Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities opens in a new tab
- CDC – COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations opens in a new tab (Version 2.0; Oct. 29, 2020). Immunization with a safe and effective COVID-19 vaccine is a critical component of the U.S. strategy to reduce COVID-19-related illnesses, hospitalizations and deaths, and to help restore societal functioning. This interim playbook for state, territorial, tribal and local public health programs will be updated as new information (e.g., recommendations for pregnant women or pediatric populations) becomes available.
- FDA – Emergency Use Authorization (EUA) opens in a new tab (content current as of Dec. 1, 2020)
- FDA – Vaccine Facts. “The Path for a COVID19 Vaccine from research to Emergency Use Authorization” opens in a new tab (infographic)
- FDA – COVID-19 Vaccines opens in a new tab (content current as of Nov. 30, 2020). The FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Currently, there is no FDA-approved or authorized vaccine for the prevention of COVID-19.
- FDA – Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry opens in a new tab (current as of Nov. 18, 2020). This guidance provides sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with non-binding recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
- FDA – Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry opens in a new tab (June 30)FDA plays a critical role in protecting the U.S. from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. The purpose of this guidance is to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19.
- National Academy of Medicine (NAM) – “Framework for Equitable Allocation of COVID-19 Vaccine opens in a new tab” (Oct. 2)CDC and the National Institutes of Health (NIH) commissioned the nongovernmental NAM to convene experts and develop recommendations to inform national and local guidelines for equitable COVID-19 vaccine allocation, once vaccines become available. Through a transparent, iterative process, with public input throughout, NAM produced this consensus study. For the initial period when vaccine demand exceeds supply, the report recommends a four-phased approach opens in a new tab to allocation built on widely accepted foundational principles and guided by evidence to maximize societal benefit by reducing morbidity and mortality caused by the transmission of SARS-CoV-2.
- Network for Excellence in Health Innovation (NEHI) – Vaccine Summit Series:
- 1st Vaccine Summit (Aug. 27) – “Looming Challenges of COVID-19 Immunization: Communications and Messaging opens in a new tab”
- 2nd Vaccine Summit (Sept. 22) – “Looming Challenges of COVID-19 Immunization: Preparing the Immunization Infrastructure opens in a new tab”
- Premier – “Flu and COVID-19” – information and resources.