COVID-19 Vaccine Arrives in Northeast Ohio

The much-anticipated approval of the Pfizer BioNTech COVID-19 vaccine by the U.S. Food and Drug Administration (FDA) launched a flurry of activity in Ohio and across the country as plans went into action to begin shipping out and putting into use 100 million doses of the new vaccine.  The Ohio Department of Health identified 10 sites around the state to receive the initial doses of vaccine and begin vaccinating according to guidelines by the Centers for Disease Control and Prevention. In Northeast Ohio, Cleveland Clinic and MetroHealth are the designated sites, along with Aultman Hospital in Stark County.  The first shipment of vaccine from Pfizer to Ohio was expected to include 9,750 doses, primarily for healthcare workers. An additional 88,725 vaccines will go to Walgreens and CVS for use in congregate care settings. Over the coming weeks, a few hundred thousand additional doses are expected to arrive from Pfizer as well as Moderna, which is anticipating approval for its vaccine after the FDA meets Dec. 17. Ohio’s Plan: Phase 1A Earlier this month, Gov. Mike DeWine announced that, in accordance with guidance from the Advisory Committee on Immunization Practices (ACIP), the state’s vaccination plan prioritizes healthcare workers who care for COVID-19 patients, individuals in congregate care settings, and EMS workers as those who will receive the vaccine in Phase 1A.  A variety of materials, including FAQs and information about the state’s phased approach to vaccination, is included on a web page dedicated to information on COVID-19 vaccination. Vaccine Details Hospital vaccination sites should have received a product information guide directly from the state health department containing detailed information on the Pfizer and Moderna vaccines and ancillary supply kits. The guide will be updated as additional vaccines are approved and made available.  Both the Pfizer and the Moderna vaccines require ultra-cold storage. For providers receiving Pfizer shipments, there are three storage options: 

1. Store in an ultra-low temperature freezer for up to six months.
2. Store in the Pfizer-provided thermal shipping packs by refilling with dry ice every five days for up to 30 days total. 
3. Refrigerate for five days at a temperature between 2°C and 8°C. 

For providers electing to store in the Pfizer shipping containers, the government will provide a dry ice supply kit within 24 hours of vaccine receipt to support storage. Providers will also receive a remote temperature monitoring device to continuously monitor temperatures. The federal government has contracted with Controlant to provide continuous monitoring. Monitoring devices will need to be returned along with the shipping container for reuse. For providers receiving the Moderna vaccine, there are two storage options: 

1. In a vaccine storage unit at temperatures of -25°C to -15°C.
2. Refrigerated at a temperature of 2°C to 8°C for up to 30 days.

The Pfizer vaccine is shipping directly, while the Moderna vaccine will be distributed through McKesson. Along with the vaccine, kits are being provided containing the necessary ancillary supplies. Each Pfizer kit will support 975 vaccinations and each Moderna kit will support 100. Both the Pfizer and Moderna vaccines require two doses, with the second dose of the Pfizer vaccine occurring after 21 days and of the Moderna vaccine after 28 days. Shipments for second doses will take place at a later time. The Pfizer and Moderna vaccines are just the first two of more that are likely to hit the market in 2021. A number of additional vaccines are in development, including several currently in Phase 3 trials from Johnson & Johnson, AstraZeneca and Novavax. A Role for All Providers While only a small number of facilities will be receiving these first doses, all providers can participate in the initiative by communicating regularly about the safety and efficacy of COVID-19 vaccines, emphasizing the following critical points:

• The COVID-19 vaccine development process included several steps comparable with those used to develop earlier vaccines, such as the flu or measles vaccine. 
• The FDA, as well as independent medical experts, are ensuring these vaccines are thoroughly and rigorously evaluated prior to authorizing their use.

The CDC has developed an FAQ about COVID-19 vaccination that addresses common questions. It is also critical to emphasize the importance of continuing to use all of the tools available to help stop the pandemic, including wearing masks, washing hands, and social distancing, especially during this holiday season and with the current nationwide surge in cases. Finally, The Center for Health Affairs echoes the sentiments shared by the American Hospital Association along with nurse and physician colleagues in their recent statement recognizing and expressing gratitude to all of the healthcare professionals in hospitals across the country – including right here in Northeast Ohio – for their brave and tireless work this year in the fight against COVID-19. And we encourage these healthcare heroes to get vaccinated when they have the opportunity and to share their trusted voices within their communities.  For more information about COVID-19 vaccine distribution, contact us.