The Manager's report back on a Vaccine Task Force

OVERVIEW In May 2020, the U.S. Department of Health and Human Services launched Operation Warp Speed (OWS), a partnership of multiple government agencies, to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and other countermeasures.

Investment by OWS in pharmaceutical and biotech companies has thus far resulted in the development of a number of vaccines, two of which were the focus of recent hearings regarding emergency authorization use (EAU) by the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (Advisory Committee). The Advisory Committee held hearings on the Pfizer (and partner BioNTec) vaccine on December 10, and granted emergency authorization the next day.

Distribution of the Pfizer/BioNTec vaccine began immediately, with hospitals across the nation receiving the first batch of the vaccine on Monday, December 14. The Moderna vaccine was the discussion of an EAU meeting on December 17, and EAU was granted the next day.

Consistent with vaccine rollout plans in other U.S. communities, the City of Cambridge, Cambridge Public Health Department (CPHD), hospitals, community health centers, pharmacies, long-term care facilities, and first responders will be at the forefront of administering, distributing, communicating, and monitoring the new vaccine(s) to residents.

ROLE OF FEDERAL AND STATE GOVERNMENT IN VACCINE ADMINISTRATION

As with the COVID-19 response itself, CPHD’s vaccine “rollout” efforts cannot be developed and deployed successfully by operating on its own and must, at a minimum, follow guidance from the federal government and Commonwealth of Massachusetts. The current administration in Washington has placed the full burden of vaccine distribution on states, and without providing additional funding as of yet. On December 9, Governor Baker announced a three-phase approach and timeline for vaccine distribution in the Commonwealth, though details regarding municipal allocation and distribution protocol and support were not provided.

When the Biden Administration takes office on January 20, there is likely to be more robust guidance and support for states, as well as additional federal funding.

Federal Government Guidance

On October 29, the Centers for Disease Control and Prevention (CDC) released the COVID-19 Vaccination Program Interim Play Book for Jurisdiction Operations (Play Book), federal guidance on a vaccine distribution program for states, territories, and local and tribal public health departments. The Play Book offers a three-phased process regarding vaccine distribution: Phase 1: Potentially limited supply of COVID-19 vaccine doses available. Efforts will focus on reaching initial critical populations, with the goal of maximizing vaccine acceptance and public health protection while minimizing waste and inefficiency.

Key updates:

The United States is currently in Phase 1.

On December 1, the CDC officially adopted the Advisory Committee on Immunization

Practices (ACIP) recommendations for vaccination distribution to highest priority populations: 21 million health-care workers and 3 million residents/staff of long-term care facilities. Phase 2: Vaccine production will continue, making it more widely available to the larger population. Objectives include: 1. Provide widespread access to, and coverage of, the vaccine throughout the country. 2. Ensure high uptake in populations at greatest risk for severe outcomes, including death, from COVID-19. Phase 3: Vaccines become universally available and part of routine vaccination programs.

Commonwealth of Massachusetts

In Massachusetts, the COVID-19 Vaccination Program (MCVP) is responsible for developing and implementing a vaccine distribution plan. The COVID-19 Vaccine Advisory Group, announced by Governor Baker on October 7, was established to provide counsel to the MCVP. The Advisory Group is comprised of medical professionals, public health experts, elected officials, community leaders, and infectious disease specialists.

On October 16, Governor Baker announced an interim COVID-19 Vaccination Plan, which

closely aligns with the CDC’s aforementioned three-phased approach to vaccine availability, distribution, and monitoring. Key components of Governor Baker’s plan:

Critical populations

Provider recruitment and enrollment Storage and handling Second dose reminders

Program communications

Safety monitoring

Program monitoring

On December 9, Governor Baker announced the state’s vaccine distribution program with the following details:

Phase One (December 2020–February 2021). Priority populations for the first phase include: Clinical and non-clinical health care workers doing direct and COVID-facing care Long-term care facilities, rest homes and assisted living facilities

Police, Fire and Emergency Medical Services

Congregate care settings (including shelters and corrections) Home-based health care workers Health care workers doing non-COVID facing care Phase One update: The first vaccines, manufactured by Moderna and Pfizer, will require two doses administered three to four weeks apart. While all delivery dates and quantities are subject to change due to ongoing federal approval and allocation, the Baker Administration plans to receive and distribute over 2 million doses to priority population groups by the end of March.

Phase Two (February 2021–April 2021). Priority populations in the second phase include: Individuals with two or more comorbidities (e.g., cancer, heart disease, obesity) that put them at increased risk for COVID-19 complications. Early education, K–12, transit, grocery, utility, food and agriculture, sanitation, public works and public health workers Adults 65+ Individuals with one comorbidity Phase Three (Starting April 2021). In this final phase, the vaccine will be available to the general public.

The Governor announced that the first round of COVID-19 vaccine shipments to Massachusetts is set to begin around December 15. The state’s first shipment of 59,475 doses of the Pfizer vaccine was ordered from the federal government on Friday, Dec. 4 and will be delivered directly to 21 hospitals across eight counties, as well as to the Massachusetts Department of Public Health immunization laboratory. Doses will then be redistributed for access to 74 hospitals across all 14 counties for frontline medical workers.

The next 40,000 doses of Pfizer vaccine will be allocated to the Federal Pharmacy Program to begin vaccinating staff and residents of skilled nursing facilities, rest homes, and assisted living residences.

CAMBRIDGE RESPONSE