The COVID-19 pandemic has thrust the healthcare world into scenarios we’ve never before experienced—including the speed at which vaccines are being developed. The first two vaccines for COVID-19 were made available by the end of 2020, just one year after the first cases of the virus were reported. As soon as the data was available that met the requirements for emergency use authorization (EUA) by the Food and Drug Administration (FDA), authorization was granted and states began distribution.
The distribution of these highly anticipated vaccines is the latest “first” that we will witness as this pandemic plays out—one that is rife with complexities. “I can’t emphasize enough how complicated the logistics of this will be,” says Physician Advisor Kelly Moore, M.D., MPH, President of the Vaccine Advisor and Deputy Director of the Immunization Action Coalition.
As of press time, here’s what the experts are saying we might expect.
Prioritizing healthcare professionals
Two vaccines produced by Pfizer and Moderna were approved at the end of 2020 by the FDA under an EUA.
The approved vaccines were first available in small supplies. About 20 million doses were shipped by the end of 2020.
Pfizer projects that it can supply 100 million doses to the U.S. market by the end of March 2021. Public health advisory groups, including the National Academy of Medicine and the federal Advisory Committee on Immunization Practices, recommend that healthcare professionals be prioritized as the first in line to receive the earliest doses of the vaccine due to their risk for exposure to COVID-19.
Dr. Moore says those who work at long-term care facilities will be a particular focus. “There is careful planning taking place with long-term care facilities to ensure that these healthcare workers are highly prioritized,” she says.
State health departments are developing vaccine program plans that involve partnering with hospitals and health systems to set up clinics and administer the vaccine to all healthcare staff who work in patient care areas. The vaccines will become more widely available once these needs have been met.
Administrative challenges
Many aspects of this vaccine program won’t be typical. First, these are two-dose vaccines. People must have a second dose three to four weeks after their first dose to be fully protected. Dr. Moore says hospitals should prioritize the patient experience to ensure people come back for the second dose. “If people have a good experience, they’re well informed and their questions are answered, then they’re much more likely to come back for dose two.”
Another challenge is storage. The Moderna vaccine, distributed in 100-dose minimum shipments, can be stored in a regular freezer for up to six months or at refrigerated temperatures for 30 days. The Pfizer vaccine, distributed in 975-dose minimum shipments, requires storage on dry ice or in an ultra-low temperature freezer (which most hospitals don’t have) for up to six months, or just five days at refrigerated temperatures. The Pfizer product will be more easily used in urban, highly populated settings, while the Moderna vaccine will be easier to use when vaccinating in sparsely populated rural regions.
To solve the freezing issue, Pfizer designed its shipping boxes to double as storage containers. The box comes with enough dry ice to allow for 10 days of shipping time. Once opened, the dry ice can be replenished upon receipt and every five days after for a maximum storage time of 15 days in the Pfizer thermal shipper.
The frozen liquid concentrate comes in a five-dose vial, which can be kept in a refrigerator for up to five days. Once it’s diluted, each vial has to be used within six hours or be discarded—the vaccine doesn’t include preservatives.
Every dose has to be reported back to the state immunization registry within 24 hours of administration. “The data entry and reporting are more stringent than any routine vaccination program because we have to be sure people come back for dose two and because these vaccines are not interchangeable—if a patient starts the series with one brand they must complete the series with the same brand,” explains Dr. Moore.
Cost & access
Experts expect that health insurance companies will be billed for vaccine administration, and patients will not have out-of-pocket expenses. Those without health insurance will still be able to receive the vaccination; a federal program will be available to help people who can’t afford it.
“The most important thing is to get people vaccinated,” says Dr. Moore. “We don’t want any barriers to access.”
In addition, immunization providers should not have any upfront costs associated with the program. Hospitals will receive the vaccine and all ancillary supplies necessary to administer it at no cost. Hospital providers will place vaccine orders with their states, and the products and supplies will be shipped to them through the federal system.
One of the unknowns is when the vaccines will be made available to all people, but it will likely take several months. The first-available vaccines will come from the federal government by way of the state governments, pharmacy chains and the VA health system. As more vaccine becomes available, as indicated by public health officials, it will be more widely distributed.
“As long as we need the vaccine to help us fight this pandemic, the priority is, everyone who needs it gets it,” says Dr. Moore. The groups prioritized after healthcare workers are likely to include essential workers in critical non-healthcare occupations who need to be vaccinated because their jobs require them to have some exposure to others with COVID-19. Also in this tier are people who are considered high risk, including the elderly and the medically fragile.
States are working closely with hospitals and health systems in rural areas, including tribal lands, to make sure there will be equitable access to the vaccine. “Mobile clinics and special clinics will be set up in remote areas,” says Dr. Moore.
Efficacy & safety
The FDA requires the vaccine to perform at least as well as a typical influenza vaccine in order to be approved, but vaccines may not come as close to eliminating the risk of infection with the virus as some others do, such as the measles vaccine. Pfizer and Moderna interim analyses showed 95% and 94.5% effectiveness, respectively.
“We hope the vaccine will significantly reduce the risk of severe illness from COVID-19, especially the kind that requires hospitalization in older adults,” Dr. Moore says. But even when we begin using these vaccines, uncertainty remains about how well the vaccines will prevent asymptomatic infection and how long their protection will last. In addition, it will take months to vaccinate enough people to protect communities. So while it will be a critical tool in fighting this pandemic, wearing masks, practicing good hand hygiene and avoiding indoor crowds are behaviors that will continue to be essential in 2021.
Although the research and development process has been greatly accelerated, public health officials say corners have not been cut when it comes to safety. The vaccine clinical trials involved 30,000 to 44,000 volunteer participants. Even though the vaccines have initially been approved to be administered under the EUA, their manufacturers will go on to apply for full FDA licensure.
While the current clinical trials tell scientists a lot about the common side effects of the vaccines, the possibility of rare side effects won’t be fully determined until more of the population receives them. “Our knowledge at this point has limits, and we need to be honest about that,” says Dr. Moore.
The Centers for Disease Control and Prevention (CDC) has plans to enhance its existing vaccine safety monitoring system with an additional smartphone-based volunteer safety monitoring program for the earliest recipients, so officials can check in on how they’re doing and scientists can continue to learn.
For up-to-date information on the status of the vaccine and its distribution, visit HealthTrust’s vaccine resources.
Share Email COVID-19, FDA Update, Q1 2021
