Operation Warp Speed, the White House COVID-19 initiative, has preliminary plans to only ship half of all vaccines available each week. The other half will be held in storage and be released just before the second dose is due for those vaccinated the first time.
Five percent of all produced COVID-19 vaccine will be held back for emergencies and states will have the option of trading vials within the government’s ordering system to get the kind they want.
Two vaccines have been approved or are in the final phases of the Food and Drug Administration (FDA) emergency authorization process, with Pfizer-BioNTech collaboration and the other by Moderna.
How Will Vaccines Be Shipped?
The vaccines are shipped in glass vials– five-dose vials for Pfizer and 10-dose vials for Moderna. The Pfizer vaccine must be stored at minus 94 degrees or below; Moderna‘s at minus 4 degrees.
Because of the ultracold storage requirements of the Pfizer vaccine, it is being stored either at Pfizer production facilities or what are known as “freezer farms.”
Pfizer started shipping its vaccine using UPS and FedEx as its main distributors. Moderna’s vaccine distribution is being coordinated by McKesson, the nation’s largest medical supply distributor.
Within 24 hours of the first vaccine being authorized by the FDA, it was shipped to all 50 states and outlying U.S. territories.
How Many Vaccines Are There?
As previously mentioned, of the total doses of the vaccine manufactured, 5% of each lot will be held back as a safety factor. “The vendor is going to keep it in case we have a truck that goes down, we have vaccine that gets lost, a natural disaster hits or the power goes out,” says retired Lt. Gen. Paul Ostrowski, formerly director of the Army Acquisition Corps and Director of Supply, Production, and Distribution for Operation Warp Speed.
With each lot of the vaccine, it will be split in half, half to ship out and half to remain stored. The Pfizer and the Moderna vaccines both require two doses, given 21 and 28 days apart, respectively. Operation Warp Speed wants to ensure there are always vaccines available for the second dose.
“When we’re at about the 18th or 19th day, we’re going to move that product from Pfizer’s location to the actual administration sites so that everybody that received their first dose has their second dose,” Ostrowski said.
The initial shipments are being divided up between the 50 states, the District of Columbia, and six U.S. territories, with some also going to the departments of Defense and State, the Veterans Health Administration, the Bureau of Prisons, and the Indian Health Service.
What Is the Delivery Schedule?
After the initial doses have been shipped, the system will begin regular deliveries. Each week, whatever vaccine the authorized manufacturers have made will be divided. Half will be stored and the other half shipped out. Each Thursday, Operation Warp Speed will ask vaccine producers how many vaccines they have made during the week. On Friday, staff will meet and decide how many doses can be allocated.
States will put in their orders on Saturday and deliveries will happen on Monday morning. Vaccine shipments will get what Ostrowski called “white glove” service.
“These packages are monitored in terms of temperature and also tracking. We’ll know where they are at all times,” Ostrowski said.Article, USA Today, December 8, 2020
For the Pfizer vaccine, each package must be signed for by the receiving pharmacy, hospital, or clinic. The temperature controls will be inspected to make sure it has been held at the correct temperature during transit and the vials counted to make sure they are all there.
UPS, FedEx, and McKesson all have 24-hour hotlines if there are delivery troubles. In addition, Operation Warp Speed will have staff available 24/7, he said. There are two operations centers, one in Washington and one in Atlanta, both with 24-hour hotlines.
How Does OWS Track Doses?
Operation Warp Speed created a software system called Tiberius that allows states and local jurisdictions to order and track vaccines. It records all allocations of COVID-19 vaccines to states, territories, cities, and federal entities. It works in conjunction with the Centers for Disease Control and Prevention’s Vaccine Tracking System, known as VTrckS, which has been distributing vaccines for children for a decade. The systems also will allow networks to know who got their first shot and which manufacturer it was and when they should get their second dose.
According to Ostrowski, these systems will store as little personal information as possible to protect privacy. They won’t include Social Security numbers or driver’s license numbers. “The only number that it would ask for is a date of birth,” he said.
Lower-tech systems also will be in place. Each dose of vaccine will come with a card that tells the recipient which vaccine they got and when they should come back for their second dose. They will also be encouraged to take a picture of the card with their phone in case they lose it.
How Can States Trade Vaccines?
Tiberius, the vaccine tracking system, will also include an exchange system where states can trade vaccines among them. This is important because the initial allocations are based only on how much vaccine is available and the population of a state.
For example, a state may have limited ultracold storage capacity, so might prefer to trade it’s allotment of Pfizer vaccine for the Moderna’s since its cold requirements are less. Another state with dozens of hospitals might be fine with a higher proportion of Pfizer vaccine.
Jurisdictions could use the exchange to more appropriately portion out vaccine where it’s needed. The federal government doesn’t want to be involved in making those trades and want to keep it a jurisdiction decision.
A few weeks ago, county health officials shared a plan on who would get the vaccine first, the plan is organized into three phases, created by the federal Advisory Committee on Immunization Prevention. The first phase has three parts, 1A, 1B, and 1C.
Who Gets the COVID-19 Vaccine First?
Health care workers, group 1A, will be the first to receive the COVID-19 vaccine, followed by long-term care facility residents and employees. Essential workers, group 1B, will follow. This group includes those who work in food and agriculture, education, transportation, firefighters, police officers, and correctional officers. In the final part of Phase 1, the county will prioritize vaccinating adults with underlying medical conditions and those who are over the age of 65.
Once all three groups of Phase 1 are satisfied, vaccine doses will be available for children and adults under the age of 30. The vaccine will also be available for critical workers who were not previously included in Phase 1.
Phase 3 will include everyone of all ages in the U.S.
The Centers for Disease Control and Prevention estimates by June 2021, everyone who would like to get vaccinated will be able to do so.
The Pfizer vaccine, which has a 95% effectiveness rate, will be administered with two shots in the arm and may have side effects like fatigue, swelling, some pain, irritation, or headache. Some patients who have taken the vaccine reported chills and low-grade fever, according to former FDA chief Dr. Margaret Hamburg.
Long Term Facilities Opt for Federal Vaccine Program
The Pfizer-BioNTech vaccine sparked confusion nationwide as it became clear most long-term care facilities and nursing homes were not taking part in the initial immunizations, despite the CDC’s decision weeks ago to include residents in the first phase of distribution because the majority of long-term care facilities opted to take part in a federal program that uses pharmacy chains, including CVS, Walgreens, and others, to facilitate vaccination of staff and residents.
The Federal Pharmacy Partnership for Long-term Care program launched Dec. 21 for jurisdictions that opted to use the Pfizer-BioNtech vaccine for more than 1,100 vaccination clinics at long-term care facilities across the country.
Another round was scheduled for Dec. 28 for jurisdictions that opted to use Moderna’s COVID-19 vaccine. It does not have the ultracold storage requirements of the Pfizer vaccine, which makes it easier to use in areas without access to specialized equipment. This will include selected long-term care facility sites in Florida, Ohio, Connecticut, and West Virginia, with others receiving doses as state leaders coordinate with pharmacies, the Department of Health and Human Service said in a statement.
Gen. Gustave Perna, Chief Operating Officer for the federal government’s Operation Warp Speed, said planning to get vaccine to America’s more than 70,000 long-term health facilities and nursing homes was “incredibly difficult.”
The longer lead time for the facilities was necessary given the complexity, HHS Secretary Alex Azar said during the same briefing. The extra time was required in part to allow facilities to prepare so vaccinations can be done efficiently and with as few visits as possible, “so we’re not going back and forth,” Perna said.
Proper Signatures for Elderly Patients Proves Difficult in Vaccination Process
One issue is getting the necessary permissions signed for residents who may not be able to sign for themselves, he said. “You have to make sure that all the patients have a signed contract which means sometimes you have to reach out to several layers of family to get the final approval,” Perna said.
Many nursing homes are still struggling with that requirement, said Kathleen Heren, Rhode Island’s long-term care ombudsman. The CDC allowed nursing homes to get verbal permission from residents, she said, but the pharmacies that will do the vaccinations have mailed out written permission forms for residents to sign.
“We’re still working on how we’re going to get people vaccinated who do not have someone to sign for them, or for those with dementia,” said Heren, adding that homes were hoping to get clarification from the state Department of Health. In CVS’s case, those were printed forms in triplicate, said Dr. Richard Feifer, chief medical officer at Genesis HealthCare, which runs more than 325 short- and long-term care facilities in 24 states.
Understanding the Pharmacy Partnership for Long-Term Care Programs
The CDC is partnering with CVS, Walgreens, and Managed Health Care Associates, Inc. (MHA– see pharmacies participating through MHA below) to offer on-site COVID-19 vaccination services for residents of nursing homes and assisted living facilities.
The Pharmacy Partnership for Long-term Care (LTC) Program will facilitate safe vaccination of this critical patient population while reducing the burden on LTC facilities (LTCF) and health departments. At no cost to facilities, the program provides end-to-end management of the COVID-19 vaccination process, including cold chain management, on-site vaccinations, and fulfillment of reporting requirements.
LTCF staff who have not received the COVID-19 vaccine can also be vaccinated as part of the program. This program is being implemented in close coordination with jurisdictions; LTCFs; federal partners, including the Centers for Medicare and Medicaid Services (CMS); and professional organizations, including American Health Care Association (AHCA) and Leading Age, which include members across both nursing homes and assisted living facilities.
CVS, Walgreens, and select pharmacies that are part of the MHA network will provide critical vaccination services to LTCFs.
Participating MHA pharmacies include:
- Absolute Pharmacy (in Ohio)
- Community Pharmacy (in Iowa and Nebraska)
- Consonus Pharmacy (in Oregon and Nevada)
- HealthDirect/Kinney Drugs (in New York and Vermont)
- Pharmscript (in Indiana, Illinois, New York, Ohio, and Texas)
- Senior Care Pharmacy (in Alabama)
- Thrifty Drug Stores (in Minnesota and North Dakota)
Program Planning and Implementation
In November 2020, LTCFs had the opportunity to sign up for the program and select a pharmacy partner. Sign up for the program has since closed. The CDC has worked with jurisdictions to match facilities with their requested pharmacy partner.
In some instances, the CDC and jurisdictions reassigned pharmacy partners to facilities to account for logistics and program needs. Pharmacy partners have started reaching out to participating LTCFs they were matched with to coordinate vaccination efforts.
As part of this program, which is free of charge to facilities, the pharmacy will:
- Schedule and coordinate on-site clinic date(s) directly with each facility
- Order vaccines and associated supplies (e.g., syringes, needles, personal protective equipment)
- Ensure cold chain management for vaccine
- Provide on-site administration of vaccines to all residents and any staff not already vaccinated
- Report required vaccination data to the local, state/territorial, and federal jurisdictions within 72 hours of administering each dose
- Adhere to all applicable CMS COVID-19 testing requirements for LTCF staff
Vaccination clinics cannot begin at facilities until after a jurisdiction sends the CDC a request to activate the program. Jurisdictions will consider various factors when making the decision to activate the LTCF program, including:
- The goals and desired impacts of their immunization program
- The priority groups for vaccination
- Vaccine supply (the allocation of doses a jurisdiction has available and the amount required for the LTCF program)
The CDC expects the program services to continue on-site at participating facilities for approximately two months from the date of the first vaccination clinic. After the initial phase of vaccinations, facilities may continue working with the federal pharmacy partner it was matched with or shift to another pharmacy provider that is enrolled with the jurisdiction to provide ongoing COVID-19 vaccination.
These are just a few of the initial details we’ve learned regarding how the vaccine will move around the nation as distribution begins. As with most complicated distribution processes, we anticipate there could be changes, especially if issues with fulfilling shipments arise.