Oregon officials anticipate seeing the first shipments of the COVID-19 vaccine arrive in just a couple of weeks. The deliveries are expected to be enough to provide the first of a two-dose vaccination for just over 100,000 people.
The speed at which vaccines for COVID-19 have been developed and soon distributed has been unprecedented.
“In the past, it might have taken 10 years to get a vaccine. And oh my God, we have one in, what? Eight months? That’s amazing,” said Dr. Marianne Parshley, a board member of the Oregon Medical Association.
But still, drug companies are waiting on the U.S. Food and Drug Administration to grant emergency use authorization for the vaccines before they’re allowed to be administered. In the meantime, Oregon continues to prepare to get the vaccines into the arms of those who need it most.
How many vaccine doses are we getting and when?
The Oregon Health Authority (OHA) says it expects to get 35,100 doses of the Pfizer COVID-19 vaccine around Dec. 15 and then another 40,950 from Pfizer and 71,900 doses from drug-developer Moderna around Dec. 22.
Both vaccines require two doses to achieve the 95% effectiveness rate the developers are touting, and the doses have to be spaced out by three to four weeks, depending on the vaccine. This means that those early shipments of about 147,000 doses will serve as the first dose, and then additional shipments of an estimated 120,000 more at the end of the month will provide the second dose for those early recipients.
These first doses are enough to provide vaccine to Oregon’s health care workers — nurses, doctors and other support staff — who are in direct or indirect contact with COVID-19 patients
The vaccines are coming from the federal government, which says it will distribute them to states based on the adult population. Oregon has roughly 1.3% of adults in the U.S. and consequently should get 1.3% of the available vaccine.
“Think of it as the reverse of a funnel where at first it will be a fairly narrow amount of vaccine available. But as time goes by, and particularly if more vaccines are approved, that volume should widen out,” said OHA Director Patrick Allen. “By the time we’re out of prioritized groups, it should look a lot more like other vaccines that you get.”
Allen cautioned that during the pandemic, the promises made about deliveries and distribution of supplies have often been overstated and that he’s viewing the vaccine delivery numbers as “aspirational.”
Who gets the vaccine?
Understanding that there won’t be enough vaccine available for everyone for many months, Oregon is developing a phased hierarchy to determine who gets vaccinated first. The state is taking its cues from the Advisory Committee on Immunization Practices, which is part of the Centers for Disease Control and Prevention.
The groups are broken into three phases of vaccine availability. The specifics of who gets vaccinated and when are being finalized and will govern how these early vaccines are distributed. The priorities for the first shipments are:
· Front-line health care workers and support staff
· Emergency medical service providers
· Residents and workers in long term and communal care settings
Parshley says this makes sense from a standpoint serving the highest needs.
“(This is so) we can continue to treat people who are seriously ill with COVID and take care of the most vulnerable patients,” she said.
Health care providers in outpatient and non-front-line capacity would follow closely behind.
“We’re talking about a number of weeks and not months of difference between when the first people get this and last people in this group get this,” OHA senior health advisor Joe Sullivan told health care workers in a briefing this week.
He said if all goes smoothly, the state should have enough vaccine to cover all of the highest priority groups, including individuals at a higher risk of severe COVID-19 illness, by the end of March.
Does the plan account for health disparities for people of color when prioritizing distribution?
State officials say they are placing a high priority on equity and addressing traditional health disparities when deciding where to prioritize vaccines, but the details of how that will look have not been figured out.
In Oregon, the number of cases per thousand for Black, Indigenous and people of color is far higher than for the white population. Pacific Islanders have five times as many cases per thousand, Hispanic people have four times as many and Native Americans and African Americans have around three times the cases. Nationally these groups are nearly three times more likely to die of COVID-19 than are their white counterparts.
“We have a variety of ways to ensure there’s equitable distribution, both geographically and particularly focused on our communities of color who’ve seen unfair disproportionate impact from COVID-19,” said Rachael Banks, OHA’s head of public health.
Banks says the state is pulling together an advisory committee to help make decisions about distribution priority.
Does Oregon have a plan for the physical distribution COVID-19 vaccine?
Yes. The state currently is working on the logistics of how to get the vaccine to where it’s needed in the state. The first shipments will be sent to hospitals, which will administer the vaccine to frontline medical and support staff.
Oregon is also taking advantage of a federal program that is contracting with pharmacies such as Walgreens and CVS. The companies will receive vaccine doses from the state and then provide on-site vaccine clinics at long term care facilities across the state.
For populations of people that are more scattered and difficult to reach — such as people experiencing homelessness, migrant agriculture communities, and dispersed rural communities — the state is planning to contract with local EMS providers to deliver vaccines in the field.
More generally, the state is in the process of designating regional hubs for vaccine storage. Specialty storage is necessary because the Pfizer vaccine has to be stored at extremely cold temperatures to remain viable.
Is the state ready to store ultra-cold vaccines?
“That, I will tell you, is the biggest headache at OHA in trying to plan this rollout of these vaccines,” Sullivan told health care providers.
“It requires us to set up a cold chain, the ability to keep this vaccine protected and safe at a minus 70 C from the manufacturer, out to the place where it’s going to be provided,” he added in an interview with OPB.
OHA hasn’t finalized the list of hubs that have appropriate storage capabilities. But a few candidates seem obvious.
“Any large research institution…our institution, OSU, OHSU — we all have 80-below freezer farms,” said Andre Le Duc, Chief Resilience Officer at the University of Oregon.
The problem on campus is that a lot of that space is already being used for the UO’s testing program and other active research. Le Duc says the university is looking at how to compress everything and free up storage.
The UO is working with the state to get 15 smaller, more portable ultra-low temperature freezer units to send to remote areas that don’t have sufficient storage. Le Duc says they were able to get their order in before the supplies dwindled nationally and that the first five freezers have shipped.
Only the Pfizer vaccine needs to be stored at ultra-low temperatures. The Moderna vaccine and others in the development pipeline have much higher temperature storage requirements. OHA says part of the solution to the ultra-low temperature storage problem will be to reserve the Pfizer vaccine for the facilities that have the storage capabilities.
What are the benefits of having different kinds of vaccines?
When the pandemic broke out, dozens of companies and institutions turned their focus to creating a vaccine for COVID-19. It was unknown if any of the vaccines being developed would work, and the more shots on goal there were, the better the chance we’d have of finding success.
Now, nearly a year later, there are several vaccines that are showing great promise. They’ve gone through or are close to completing sufficient testing to apply for Emergency Use Authorization from the FDA. Two companies have applied and another small group is expected to apply within the next few months.
But even now, with so much early vaccine-development success, there’s still a great advantage in having several vaccines available. One is related to manufacturing: If several companies are making vaccines, the chance they’ll be able to make enough doses to inoculate a global population increases.
Also, these vaccines are seeking special emergency use approval before the full slate of vaccine trials required for full FDA approval is completed. That means developers don’t yet understand the intricacies of how well the vaccines will work.
“If you have four vaccine products that are showing good efficacy, and we find out that one of the vaccines doesn’t particularly work well in elderly populations, one of the other three might,” said OHSU’s Marcel Curlin.
Curlin is currently leading and seeking volunteers for a large research study for a potential COVID-19 vaccine from the drug-maker AstraZeneca.
“It’s important to have options going forward so that you can make choices,” he said.
When is federal emergency use authorization (EAU) expected to come through?
Both Pfizer and Moderna have applied for EAU for their vaccines. The FDA is expected to hold off on its decision until the scientific and human vaccine trial data is analyzed by the agency’s Vaccines and Related Biological Products Advisory Committee.
The committee will meet on Dec. 10 to evaluate the Pfizer vaccine. Moderna’s vaccine will be considered on Dec. 17.
AstraZeneca is expected to apply for a EUA soon. The company is already seeking similar approval in the United Kingdom.
Are the vaccines safe?
The FDA requires all vaccines to be extensively tested in three phases of human trials before approving them for wider use. Each trial seeks to answer different questions, with the first two focusing heavily on safety — specifically short-term side effects. During phase three testing, which can last several years, researchers are looking for longer-term safety concerns.
Development and testing of the COVID-19 vaccines have been sped up, but OHSU professor Mark Slifka says that doesn’t mean corners have been cut.
“They still have to do all the same steps in the Phase 1, Phase 2 and Phase 3 (trials) that you would for a typical vaccine. They just did it quicker because of great coordination. And the funding was right there and available,” he said. “It is as close as you can get to the real deal, but without having to wait two years.”
Because of the dire need for a COVID-19 vaccine, the FDA is considering emergency approval before the Phase 3 trials are completed. Officials won’t yet have full information about long-term effects of the vaccine, but the United States is experiencing a record number of COVID-19 deaths. The federal process is designed to determine if the vaccines are safe and effective enough that the immediate benefits of slowing an out-of-control pandemic outweigh the unknowns.
In addition to the federal process underway, Oregon has joined Washington, Nevada and California to conduct an independent safety review of the vaccines. Two physicians from Oregon are part of that working group, which will examine the data from the vaccine trials before recommending their use.
“All of these safety steps have to occur before (the) vaccine will go into an arm here in Oregon,” OHA’s Sullivan said.