If authorized by the U.S. Food and Drug Administration, a COVID-19 vaccine could be available soon.
“Once authorized, the COVID vaccine will take a week or two to get to Samaritan,” said Chief Pharmacy Officer Daniel Rackham of Samaritan Health Services. “We expect to receive only a small amount at first and will follow specific federal directives for distribution.”
According to those requirements, the vaccine will be distributed in multiple phases beginning with health care workers, first responders and residents and staff of long-term care facilities. As more vaccine is produced and made available, additional tiers prioritize those at the highest risk for the disease and essential workers followed by the younger and healthier general public in the final phases of distribution.
Until you are vaccinated, you are not protected from the virus, which continues to spread and increase in our communities. Continue to follow Oregon Health Authority and Centers for Disease Control and Prevention guidelines on wearing face masks, washing your hands and physically distancing.
“The target goal by the FDA is for the vaccine to be effective at preventing COVID-19 in at least 50% of the population,” Rackham said. “If it’s able to do that, it does a lot to decrease transmission rate, which, over time, helps us develop herd immunity and get past this.”
How long that process takes is unpredictable.
“It depends on the vaccine’s effectiveness, how long it takes to vaccinate everyone in the community and how long the vaccine gives us immunity,” he said.
“We won’t know how long our immunity to the virus will be – whether we need to get it yearly like with the flu vaccine or less frequently – until we begin using the vaccine,” he said.
What is known is that the COVID-19 vaccine will require two doses.
“With this vaccine you’ll get one dose and then about a month later, you’ll need a second dose for it to be effective,” he said. “You will not be protected until that second dose.”
Samaritan is currently working with area health officials, including Oregon Health Authority, county public health agencies, Oregon State University and other entities, to coordinate COVID-19 vaccine distribution within our three-county service area in the most timely and efficient way possible.
“I feel confident that we will be ready to best support our community as soon as the vaccine arrives,” he said.
To understand safety, it is helpful to know the process a drug goes through before it gets to your local hospital or pharmacy, and the mechanisms in place to protect patients.
Before receiving FDA approval, all drugs, including vaccines, go through three phases of clinical trials with increasingly larger numbers of people, starting with dozens of people, then hundreds, and finally, tens of thousands of people.
“Safety and protection of human test subjects are concerns all along the way, but especially in the final trial, researchers must prove that the benefits of the drug outweigh any risks,” Rackham said.
There can be pauses along the way if problems arise, or trials can end completely if a vaccine is not effective or safe. However, if both effectiveness and safety are proven, the drug goes to the FDA for approval.
For a typical drug, this process can take years. However, the FDA can approve drugs more rapidly through an emergency-use authorization (EUA).
“Before the FDA can approve a vaccine through emergency use, there must be hard evidence that the vaccine is effective at safely preventing the disease in tens of thousands of people,” Rackham said. “In the case of COVID, the FDA has set 30,000 as the threshold.”
While the COVID-19 vaccine will likely receive an EUA, it does not mean any steps in the typical testing or approval process have been skipped, Rackham explained.
“Drug manufacturers could not normally afford to take such a chance as manufacturing a vaccine that has not yet been approved, but because of the billions of dollars of federal government support they received through Operation Warp Speed, they were manufacturing at the same time they were testing,” Rackham said. “All the usual steps in the drug approval process are there; they just occurred simultaneously in some cases.”
Added Safety Checks
Once FDA-approved, a drug doesn’t just automatically make it to your local hospital or pharmacy. Other scientific bodies also review it.
Nationwide, the CDC’s Advisory Committee on Immunization Practices reviews all vaccines in the U.S. before they go into public use. This group makes evidence-based recommendations on how to use the new vaccines to control disease.
“This advisory group is widely trusted among health care professionals, and they will make recommendations for the COVID vaccine,” he said.
“Additionally, all research in the United States is overseen by regional Institutional Review Boards affiliated with all major health care systems in the country. The goal of these bodies is the protection of human subjects,” Rackham said.
Serving under federal guidelines and tasked with an intensive review of research protocols and related materials, the Institutional Review Board – comprised of pharmacists, physicians, nurses, non-scientific members and general community members – monitors biomedical research involving humans.
“Before we will use a new drug to treat patients, the board verifies the integrity of the research data and that the drug’s benefits outweigh the risks,” Rackham said. “All drugs have some risk (the potential for adverse side-effects) but we carefully study the benefits-to-risk ratio to make sure it is a ratio that we feel comfortable with.”
There is one more safety mechanism – Samaritan’s Pharmacy and Therapeutics Committee, which critically evaluates drugs to determine those that should be placed on Samaritan’s preferred drug list, or formulary.
This group recently reviewed current treatments for COVID-19 in-use at Samaritan, such as remdesivir and convalescent plasma, two drugs that also received the FDA’s emergency-use authorization.
“We have some of the most brilliant people in their respected fields serving on our local committee,” Rackham said. “Their decisions determine treatment protocols within our hospital system – whether a vaccine should be used, when it should be used and with whom.”
Patient health and safety has always been the primary focus of care at Samaritan, and that continues even through the pandemic, Rackham said.
“I want to assure the public and our employees that all drugs in use in our system are thoroughly reviewed for safety and effectiveness before we use them in treatment. That will also be the case with the COVID vaccine,” Rackham said.
Watch the linked video on this page to learn more about the COVID-19 vaccine. Infectious Disease Specialist Adam Brady, MD, explains how the vaccine works, its safety profile and common concerns and about the virus and vaccine.
Learn how Samaritan is keeping patients safe during the pandemic at samhealth.org/Coronavirus.