COVID-19 vaccines are advancing through development with unprecedented speed and several are in the final stages of clinical trials. To help members keep up with clinical development efforts, Vizient launched a COVID-19 vaccine resource center, offering insights, tools, and the latest information on the development of COVID-19 vaccines.
The vaccine resource center contains the latest supplier, distribution, and clinical information, including a vaccine development tracker. Updated weekly, the tracker charts the progress of several manufacturers’ vaccine candidates, including current phase, technology, dosage, and supporting notes. The resource center also includes a COVID-19 vaccine candidate clinical comparison document as well as links to other important information and education.
“With so many vaccines in development, the COVID-19 vaccine development tracker is designed to clear up some of the ambiguity and confusion about the various candidates,” says Azra Behlim, PharmD, MBA, senior director, pharmacy sourcing and program services. “The tracker focuses on the candidates that we think are going to be most relevant for the U.S. market.”
Behlim shared an overview of four vaccine candidates from the tracker that show promise for FDA approval:
- Pfizer—Currently in Phase 3, Pfizer is developing the vaccine with partner BioNTech/Acuitas Therapeutics. The company intends to file an emergency use authorization (EUA) with the Food and Drug Administration (FDA) during the third week of November when it surpasses a safety benchmark set by the FDA. The vaccine uses a base technology of messenger mRNA, a technology that had never been tested in large scale trials before 2020.
“There’s currently not a vaccine that has been developed using this technology. It’s been studied for a few years, but it has yet to produce a fully viable vaccine,” notes Behlim. “So, this is pretty exciting and groundbreaking.”
- Moderna—Pfizer’s data bodes well for Moderna’s vaccine candidate, which uses the same mRNA technology and is in Phase 3. Moderna plans to file an EUA application duringthe third week of November.
Both the Pfizer and Moderna candidates require two doses — 21 days apart for Pfizer’s and 28 days apart for Moderna’s. The biggest difference between the two vaccines is storage temperatures. Pfizer’s candidate requires a frozen temperature of negative 70 degrees Celsius, while Moderna’s requires a temperature of negative 20 degrees Celsius.
- Johnson & Johnson—This vaccine candidate, currently in Phase 3, will likely be a single dose regimen. The investigational vaccine uses a base technology of adenovirus. Adenovirus is a newer technology, but it has produced other vaccines currently on the market, such as the Ebola vaccine. “That means there’s a lot more safety data and other information on the adenovirus,” adds Behlim.
Another differentiator for the Johnson & Johnson candidate is the fact that it requires refrigeration storage rather than freezer storage. The manufacturer’s clinical trial is the largest of the COVID-19 vaccine clinical trials, with 60,000 patients enrolled worldwide. “They’re studying the vaccine in a lot more countries than the other manufacturers, which will give them a lot of good data from a diversity perspective,” notes Behlim.
- AstraZeneca—In conjunction with research from Oxford University, AstraZeneca’s candidate also is an adenovirus-based vaccine. It is similar to Johnson & Johnson’s candidate, but will be a two-dose series. The vaccine will likely be released in the United Kingdom during late December. The company is expected to pursue FDA approval shortly after that.
Vizient’s COVID-19 vaccine development tracker also includes vaccine candidates from Novavax, Sanofi Pasteur, and Merck, which are not as far along in development as the candidates from Pfizer, Moderna, Johnson & Johnson, and AstraZeneca.
What your organization should do to prepare
Vaccinating hundreds of millions of Americans will be a vast, complex effort. The first vaccine or vaccines will initially be on allocation and prioritized for high-risk groups and those who are part of a community’s critical infrastructure, such as health care workers and other first responders. But production and distribution will eventually scale up and hospitals will need to be prepared to receive and administer large quantities of vaccine. Complicating factors include cold storage requirements and the likelihood that initial vaccines will require two doses to be effective.
First, if your organization has not already done so, contact your state health department and enroll as a vaccine provider. “A lot of members don’t realize that you must be an enrolled provider in order to receive the vaccine,” comments Behlim.
Determine how many people your organization can realistically vaccinate and communicate these processes and expectations to employees. Stay up to date on current guidelines regarding prioritization of patients for vaccination and estimate the number of people you will vaccinate in each population based on local demographics.
“A lot of organizations are still thinking about these issues at too high a level. You need to understand the number of sites and personnel who will be involved in the administration of the vaccine to know how many doses you can realistically administer in a given day,” says Behlim. She adds that the two-dose vaccines will require patient education to ensure patients return for the second dose at the right interval.
If vaccines from multiple manufacturers are available, prepare now for the different dosing, storage, and volume scenarios. Think about how and where you’ll store your vaccine supply and designate freezer, refrigerator, or shelf space to isolate and control your COVID-19 vaccine supply.
“After three to four months, distribution and allocation of the vaccine is going to be different than it is initially,” says Behlim. “The situation will be fluid, so members need to set themselves up to understand and anticipate that dynamic.”
For the latest COVID-19 vaccine updates and the vaccine development tracker, visit Vizient’s Vaccine Resource Center.