Please note: Information in this article is updated as of December 17, 2020. Due to the nature of the rapidly evolving COVID-19 pandemic and COVID-19 vaccines, this information may have changed since that date.
Arrival of the COVID-19 vaccines are bringing hope for change and a possible end to the COVID-19 pandemic. In order to bring about this change, health care professionals are urged to get the vaccine and to encourage others to do so (https://www.aha.org/press-releases/2020-12-15-aha-ama-and-ana-urge-health-care-professionals-take-covid-19-vaccine.) To combat this pandemic, we must obtain high rates of vaccination within the U.S population. As COVID-19 vaccines become more widely available, it is the job of health care and public health professionals to advocate for COVID-19 vaccine and to encourage the public to obtain this safe, effective vaccine.
On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) (https://www.fda.gov/emergency-prepared-
covid-19/pfizer-biontech-covid-19-vaccine) for a vaccine in the prevention of COVID-19 in individuals 16 years of age and older. This EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. effective immediately. This was a critical step in making COVID-19 vaccine available as quickly as possible. On November 30, 2020 ModernaTX submitted an EUA request to the FDA for their COVID-19 vaccine. The FDA has yet to issue an EUA for Moderna’s vaccine, however we anticipate that this will be coming in the next few days. Due to the fact that initial supply of the vaccine is limited, the Centers for Disease Control and Prevention (CDC) recommended that priority groups be established. On December 3, 2020, based on recommendations from the Advisory Committee on Immunization Practices (ACIP) (https://www.cdc.gov/vaccines/acip/), an independent panel of medical and public health experts, CDC recommended that COVID-19 vaccine be allocated to health care personnel and long-term care facility residents first. Read the entire Morbidity and Mortality Weekly Report (MMWR) here: https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w.
Although the COVID-19 vaccines were made more quickly than other vaccines, the safety of the vaccines were of utmost priority. No steps were omitted in the process of developing these safe, effective vaccines. Phase III trials for COVID-19 vaccines have been as large as those for other vaccines, including tens of thousands of participants. COVID-19 vaccines will be approved using the FDA’s EUA process, rather than the typical Biologics Licensing Application (BLA) process due to the emergency being faced as a result of the pandemic. The main difference between these processes is that under the EUA process the vaccine can be approved more quickly, however companies are required to continue monitoring trial participants, even after the EUA is issued, and submit subsequent findings to the FDA. For more information on the safety of COVID-19 vaccines, as well as additional frequently asked questions, visit the Children’s Hospital of Philadelphia’s COVID-19 Vaccines FAQ at https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid.
As the COVID-19 pandemic continues to change, CDC and the Michigan Department of Health and Human Services (MDHHS) are working diligently to keep health care providers and the public informed. For more information from CDC on Coronavirus Disease and Vaccines, visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html. In addition, MDHHS has created a website, www.michigan.gov/COVIDvaccine, to keep Michiganders up-to-date on COVID-19 resources, as well as information regarding the prioritization and distribution of COVID-19 vaccines. This website includes an interactive COVID-19 dashboard where health care providers and the public can track the number of providers enrolled in Michigan’s COVID Vaccination Program, the number of COVID-19 vaccines shipped, and the number of doses administered in Michigan. The vaccination data provided on this COVID-19 Vaccine Dashboard is from data reported to the Michigan Care Improvement Registry (MCIR). As part of the COVID Vaccination Program, providers are required to report COVID-19 vaccination data to MCIR.
Over 40,000 brave volunteers have stepped up to make COVID-19 vaccines a reality. Now it is time for health care professionals to roll up their sleeves and set the tone for promoting vaccine confidence and putting an end to COVID-19.