As we move into December, each day is met with new information about the forthcoming COVID-19 vaccines: from promising news from the clinical trials for the Pfizer and BioNTech, Moderna, and AstraZeneca vaccines to Pfizer and Moderna’s requests for an Emergency Use Authorizations, and the news that WV is expected to begin receiving COVID-19 vaccine around December 10-12th.
The rollout of the first COVID-19 vaccines is both exciting and daunting, but there is a great deal that we can do in preparation for this rollout. Below are some resources that may be helpful to you as we prepare for the distribution of the first vaccine.
ACIP Meetings in Preparation for COVID-19 Vaccine
The Advisory Committee on Immunization Practices (ACIP) met on November 23 to hear the latest on the Evidence to Recommendation framework and vaccine allocation. A summary and slides from the meeting are available online.
ACIP will meet next after Vaccines and Related Biological Products Advisory Committee (VRBPAC) has met (VRBPAC is planning to meet on December 10; see meeting information below) to either recommended that FDA authorize or approve a COVID-19 vaccine.
Emergency Use Authorization
Data and information needed to support the issuance of an Emergency Use Authorization (EUA) by FDA have been outlined in guidance from FDA entitled “Emergency Use Authorization for Vaccines to Prevent COVID-19 (released October 2020)”. The guidance also discusses FDA’s current thinking regarding the circumstances under which the issuance of an EUA would be appropriate, including the safety and efficacy data to support an EUA
To request an EUA request for an investigational COVID-19 vaccine, the following information must be submitted to FDA:
- Chemistry, manufacturing, and controls information (CMC)
- Nonclinical data and information
- Clinical data and information
- Administrative and regulatory information
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines that are intended for use in the prevention of human diseases, and, as required, any other products for which FDA has regulatory responsibility.
VRBPAC will convene open sessions on COVID-19 vaccines with meeting materials available on FDA’s website. Sessions include general discussion of the development, authorization, and/or licensure of vaccines to prevent COVID-19. FDA expects to convene an open session of FDA’s VRBPAC prior to the issuance of any EUA for a COVID-19 vaccine, to discuss whether the available data support authorization of an EUA for the specific vaccine under review.
The Vaccines and Related Biological Products Advisory Committee meeting scheduled for December 10, 2020 from 9am-6pm, can be viewed here.
View the WV Project ECHO on COVID-19 Response
November 19, 2020
This webinar features Dr. Lisa Costello, Dr. Kara Willenburg, Dr. Christopher Martin, and Dr. Meera Mehta with presentations on COVID-19 Vaccine Planning.
COVID -19 Vaccine Resources
FDA COVID-19 Vaccine Development and Review Process Resources
- Vaccine Development 101
- Emergency Use Authorization for Vaccines Explained
- The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization
COVID-19 Development and Distribution
- COVID-19 Vaccine Training Module for Healthcare Providers
- Operation Warp Speed
- 10 Things Healthcare Professional Need to Know about
- S. Covid-19 Vaccination Plans
- S. Food & Drug Administration: COVID-19 Vaccine Webpage
- Understanding the Pharmacy Partnership for Long-Term Care Program
Mass Vaccination Clinics
- Mass Clinic Guidance
- Considerations for Planning Curbside/Drive-Through Vaccination Clinics
- CDC Vaccine Storage and Handling Toolkit
COVID-19 Vaccine Resources
- Different COVID-19 Vaccines
- Understanding COVID-19 mRNA Vaccines
- Ensuring COVID-19 Vaccines Work
- Facts about COVID-19 Vaccines
- How CDC Is Making COVID-19 Vaccine Recommendations
- Vaccine Education and Training for Healthcare Professionals
- COVID-19 Vaccination Resources
- Provider Resources for COVID-19 Vaccine Conversations with Patients
- Answering Patients’ Questions about COVID-19 Vaccine
- Questions and Answers about COVID-19 Vaccines
AMA Announces Vaccine-Specific CPT Codes for Coronavirus Immunization
The American Medical Association (AMA) has published an update to the Current Procedural Terminology (CPT®) code set that includes new vaccine-specific codes to report immunizations for the novel coronavirus (SARS-CoV-2).
Working closely with the Centers for Disease Control and Prevention, the CPT Editorial Panel has approved a unique CPT code for each of two coronavirus vaccines as well as administration codes unique to each such vaccine. The new CPT codes clinically distinguish each coronavirus vaccine for better tracking, reporting and analysis that supports data-driven planning and allocation. Importantly, these CPT codes are available prior to the public availability of the vaccines to facilitate updating of health care electronic systems across the U.S.
About the WV Immunization Network (WIN)
The WV Immunization Network (WIN) is a statewide coalition of over 400 members from the public and private sectors who are focused on improving immunization rates and protecting West Virginians from vaccine-preventable diseases. The Center for Rural Health Development serves as the lead agency for WIN.