Inside This Issue: FDA grants Emergency Use Authorization for first COVID-19 vaccine, recommendations for allocating initial COVID-19 vaccine supplies, goals and ethical principles for vaccine allocation, COVID-19 in New England, and other COVID-19 news.
FDA Grants Emergency Use Authorization for First COVID-19 Vaccine
On December 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine to prevent COVID-19 – the disease caused by the SARS-CoV-2 virus – in persons aged 16 years and older. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed across the United States.
The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA genetic material that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” noted FDA Commissioner Dr. Stephen Hahn. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts,” as well as extensive evaluation within FDA to ensure the vaccine met the agency’s standards for safety, effectiveness, and manufacturing quality.
On December 12, an advisory panel on the U.S. Centers for Disease Control and Prevention (CDC) also voted to endorse the use of the Pfizer-BioNTech vaccine. Within hours, CDC Director Dr. Robert Redfield signed off on the recommendations, clearing the way for distribution of the vaccine to sites across the country. “As COVID-19 cases continue to surge throughout the U.S., CDC’s recommendation comes at a critical time,” Dr. Redfield stated. “Initial COVID-19 vaccination is set to start as early as Monday [December 14], and this is the next step in our efforts to protect Americans, reduce the impact of the COVID-19 pandemic, and help restore some normalcy to our lives and our country.”
Recommendations and Guidelines
CDC Issues Recommendation for Allocating Initial COVID-19 Vaccine Supplies
Early this month, CDC’s Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation, adopted by the CDC director, to provide guidance to federal, state, and local jurisdictions on allocation of the initial doses of COVID-19 vaccine. In particular, ACIP recommends that initial vaccine doses be offered to two groups: 1) health care personnel and 2) residents of long-term care facilities (LTCFs). In this context, CDC defines LTCF residents as adults who reside in facilities that provide a range of services, including medical and personal care, to persons who are unable to live independently.
“In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles,” according to CDC. As of December 1, approximately 245,000 COVID-19 cases and 858 COVID-19-associated deaths had been reported among U.S. health care personnel. “Early protection of health care personnel is critical to preserve capacity to care for patients with COVID-19 or other illnesses.”
Approximately 21 million U.S. health care personnel work in settings such as hospitals, LTCFs, outpatient clinics, home health care, public health clinical services, emergency medical services, and pharmacies. Since demand for COVID-19 vaccine is expected to exceed the available supply during the early months of vaccination, “Jurisdictions might consider first offering vaccine to health care personnel whose duties require proximity (within 6 feet) to other persons,” CDC notes.
In addition, “LTCF residents, because of their age, high rates of underlying medical conditions, and congregate living situation, are at high risk for infection and severe illness from COVID-19,” CDC notes. “As of November 15, 2020, approximately 500,000 COVID-19 cases and 70,000 associated deaths had been reported among residents of skilled nursing facilities, a subset of LTCFs serving residents with more complex medical needs.” An estimated 3 million adults live in LTCFs across the United States. “Depending upon the number of initial vaccine doses available, jurisdictions might consider first offering vaccination to residents and health care personnel in skilled nursing facilities because of high medical acuity and COVID-19-associated mortality among residents in these settings,” according to CDC.
“The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization,” CDC notes. These updates may include recommendations concerning specific vaccines, as well as guidance on allocation of limited vaccine supplies to other population groups. CDC published interim guidance specifically for the Pfizer-BioNTech vaccine on December 13.
Goals and Ethical Principles Guiding the Allocation of COVID-19 Vaccines
In addition to its specific guidance regarding allocation of the initial supplies of COVID-19 vaccine, CDC has published an easy-to-read summary of the public health goals and ethical principles underlying its recommendations. In particular, the ACIP recommends that, when vaccine supplies are limited, determining which groups should receive vaccines should be based on:
- decreasing death and serious disease as much as possible;
- preserving functioning of society;
- reducing the extra burden COVID-19 is having on people already facing disparities; and
- increasing the chance for everyone to enjoy health and well-being.
In addition, ACIP has identified the following ethical principles to further inform decision-making:
- Maximizing benefits and minimizing harms – This involves respecting and caring for people using the best available data to promote public health and minimize death and severe illness.
- Mitigating health inequities – This involves reducing health disparities in the burden of COVID-19 disease and death, and making sure that everyone has the opportunity to be as healthy as possible.
- Promoting justice – This involves treating affected groups, populations, and communities fairly, as well as removing unfair, unjust, and avoidable barriers to COVID-19 vaccination.
- Promoting transparency – This involves making decisions that are clear, understandable, and open for review, as well as allowing and seeking public participation in the creation and review of the decision processes.
On its webpage, How CDC Is Making COVID-19 Vaccine Recommendations, the agency summarizes these goals and principles and provides links to ACIP’s current guidance. In addition to the English version, this page has been translated into Chinese, Spanish, and Vietnamese. CDC has also published the full version of ACIP’s ethical principles for allocating initial supplies of COVID-19.
Vaccine Distribution in New England
Estimates of Initial COVID-19 Vaccine Distribution and Priority Populations in New England
Following FDA’s recent issuing of an EUA for the Pfizer-BioNTech vaccine and in anticipation of similar action on a second vaccine – mRNA-1273 – developed by Moderna Inc., several news outlets, including The Washington Post, have compiled state-by-state timelines of expected COVID-19 vaccine distribution through the end of 2020. The Kaiser Family Foundation has also recently published estimates on the “initial priority population for COVID-19 vaccination” by state. This priority population, which includes health care workers and nursing facility residents is based on CDC’s recommendations for vaccination priority (discussed earlier in this issue) published on December 11.
Since In Brief focuses particularly on New England, we have summarized below information on estimated initial vaccine distribution and priority populations in the six-state region. In addition, we have provided links to each state’s vaccination distribution pages.
Connecticut is expected to receive about 32,000 doses in the first set of Pfizer-BioNTech vaccines. If the Moderna vaccine is approved soon, the state could receive a total of 160,000 doses before the end of 2020 – enough to vaccinate 4.6% of the state population. Connecticut has about 197,200 health care workers with direct patient contact and 19,600 nursing facility residents. More information about vaccine distribution in Connecticut is available here.
Maine is expected to receive about 13,000 doses in the first set of Pfizer-BioNTech vaccines. If the Moderna vaccine is approved soon, the state could receive a total of 58,000 doses before year’s end – enough to vaccinate 4.3% of the state population. Maine has about 75,000 health care workers with direct patient contact and 5,800 nursing facility residents. More information about vaccine distribution in Maine is available here.
Massachusetts is expected to receive about 60,000 doses in the first set of Pfizer-BioNTech vaccines. If the Moderna vaccine is approved soon, the state could receive a total of 360,000 doses before year’s end – enough to vaccinate 5.2% of the state population. Massachusetts has about 390,300 health care workers with direct patient contact and 34,400 nursing facility residents. More information about vaccine distribution in Massachusetts is available here.
New Hampshire is expected to receive about 13,000 doses in the first set of Pfizer-BioNTech vaccines. If the Moderna vaccine is approved soon, the state could receive a total of 50,000 doses before year’s end – enough to vaccinate 3.7% of the state population. New Hampshire has about 75,400 health care workers with direct patient contact and 6,400 nursing facility residents. More information about vaccine distribution in New Hampshire is available here.
Rhode Island is expected to receive about 10,000 doses in the first set of Pfizer-BioNTech vaccines. If the Moderna vaccine is approved soon, the state could receive a total of 39,000 doses before year’s end – enough to vaccinate 3.7% of the state population. Rhode Island has about 58,400 health care workers with direct patient contact and 7,600 nursing facility residents. More information about vaccine distribution in Rhode Island is available here.
Vermont is expected to receive about 5,800 doses in the first set of Pfizer-BioNTech vaccines. If the Moderna vaccine is approved soon, the state could receive a total of 30,000 doses before year’s end – enough to vaccinate 4.8% of the state population. Vermont has about 33,000 health care workers with direct patient contact and 2,400 nursing facility residents. More information about vaccine distribution in Vermont is available here.
Other COVID-19 News
Recent COVID-19 Recommendations and Reports from CDC
CDC is providing extensive coverage of COVID-19-related research in its Morbidity and Mortality Weekly Report (MMWR) and the agency’s website. The MMWR resources are aggregated on a page devoted to studies about COVID-19, and summarized in a weekly podcast. For your convenience, we have grouped a selection of CDC’s recently published reports and other information on COVID-19 into several subtopics below.
Guidelines and Recommendations
- The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine – United States, 2020
- The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine – United States, 2020
- The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine – United States, December 2020
- Summary of Guidance for Public Health Strategies to Address High Levels of Community Transmission of SARS-CoV-2 and Related Deaths, December 2020
- Options to Reduce Quarantine for Contacts of Persons with SARS-CoV-2 Infection Using Symptom Monitoring and Diagnostic Testing
Prevention and Pandemic Response
- Implementing Mitigation Strategies in Early Care and Education Settings for Prevention of SARS-CoV-2 Transmission – Eight States, September-October 2020
- Implementation of Hospital Practices Supportive of Breastfeeding in the Context of COVID-19 – United States, July 15-August 20, 2020
- Trends in County-Level COVID-19 Incidence in Counties With and Without a Mask Mandate – Kansas, June 1-August 23, 2020
- Racial and Ethnic Differences in Parental Attitudes and Concerns About School Reopening During the COVID-19 Pandemic – United States, July 2020
- Characterization of COVID-19 in Assisted Living Facilities – 39 States, October 2020
- COVID-19-Stats: COVID-19 Incidence, by Urban-Rural Classification – United States, January 22-October 31, 2020
- COVID-19 Mortality Among American Indian and Alaska Native Persons – 14 States, January-June 2020
- Disproportionate Incidence of COVID-19 Infection, Hospitalizations, and Deaths Among Persons Identifying as Hispanic or Latino – Denver, Colorado March-October 2020
- Multidisciplinary Community-Based Investigation of a COVID-19 Outbreak Among Marshallese and Hispanic/Latino Communities – Benton and Washington Counties, Arkansas, March 2020-June 2020
- COVID-19 Outbreak Associated with a 10-Day Motorcycle Rally in a Neighboring State – Minnesota, August-September 2020
- COVID-19 Outbreak – New York City, February 29-June 1, 2020
Health Risks, Outcomes, and Related Issues
- Trends in U.S. Emergency Department Visits Related to Suspected or Confirmed Child Abuse and Neglect Among Children and Adolescents Aged <18 Years Before and During the COVID-19 Pandemic – United States, January 2019-September 2020
- Increase in Hospital-Acquired Carbapenem-Resistant Acinetobacter baumannii Infection and Colonization in an Acute Care Hospital During a Surge in COVID-19 Admissions – New Jersey, February-July 2020
- Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network – 12 States, April-August 2020