It will take more than two vaccine candidates to wipe out the pandemic. And while there are two vaccines for COVID-19 authorized for use in the United States, researchers are studying dozens more vaccine candidates through clinical trials.
In the United States, there are three more vaccine candidates about to begin or already going through Phase 3 trials, the longest and most comprehensive trial necessary before the Food and Drug Administration can review it for emergency use. One of these trials is coming to Spokane County.
The MultiCare Institute for Research is hoping to enroll about 300 local residents in the Novavax COVID-19 vaccine trial, based at the MultiCare clinic in Cheney. Dr. Jonathan Staben will lead the trial there and is looking for participants from the area to sign up.
Ideal candidates for the trial are those at highest risk for contracting COVID-19, Staben said, including those over the age of 65, those with underlying health conditions or those from communities that have been disproportionately affected by the pandemic.
Staben said he hopes to enroll all the participants in the trial based at the Cheney clinic by the end of January. He acknowledged that while there might not be immediate benefits to joining a trial when there are already two vaccines on the market, he said that he already has interest from community members who want to participate. With the slow rollout of COVID-19 vaccines and limited doses initially available, health officials currently estimate that the vaccines will likely not be widely available to anyone who wants them until this summer.
“You will get a two-thirds chance of getting a vaccine that we hope will be effective against COVID-19,” Staben said. “If you’re in that group and don’t have the availability to get the other vaccines for a while … this might be a good thing to consider.”
The trial will have a placebo group, and participants will have a two-thirds chance of receiving the vaccine candidate, while one third of the group will receive placebo. The trial is “blinded,” so candidates will not know what they are receiving. Staben and his team will take blood samples regularly and study those for antibodies.
In the first two months of the trial, participants will make more frequent visits to the Cheney MultiCare clinic, getting both doses of the vaccine candidate (or the placebo). Participants will be compensated for their participation.
To participate in the Novavax trial, participants must be over the age of 18 and cannot have a previous positive COVID-19 test. This will eliminate some Spokane County residents from participating, especially as disease activity is very high in the community. High community transmission also might speed the trial along faster.
“Typically what would happen once you have enough cases of COVID across the two study populations, the vaccinated and unvaccinated groups, you can analyze data and see how effective it is,” Staben said.
The trial will take about two years to complete as participants will be studied long after the candidate is submitted to the FDA for emergency use.
Staben said this is standard practice for vaccine trials, which he has experience working on since 2007, and he noted that even vaccines with emergency use authorization are still being studied well into 2021 and beyond.
“We have to have some mechanism of long-term monitoring for these vaccines,” he said, noting that even the vaccines available for use currently are still being studied. “All of these vaccine trials are still going on for safety monitoring even though we know the results.”
The Novavax vaccine uses different technology than the Pfizer and Moderna vaccines, but its administration is very similar. The Novavax vaccine is a subunit protein vaccine, which introduces the protein antigen, which cannot replicate or cause the virus but can produce an immune response. The result in initial phases of the Novavax vaccine trial has been a robust antibody response, but Phase 3 will help determine how widespread those immune responses are across a much broader sample size.
The Novavax vaccine also differs from Pfizer and Moderna candidates in how it is stored. It can be stored at normal refrigerator temperatures, Staben said, which could ease distribution and make this candidate easier to get to more rural parts of the United States and beyond if it’s eventually approved later in 2021. Before it can be approved, however, the trial must give a lot of shots, analyze and release its data and eventually, apply to the FDA for emergency use.
The trial will include 30,000 participants across 114 sites in the United States. The vaccine candidate is being studied through trials in other countries as well, and the United Kingdom is well into the Phase 3 trial of the candidate there. Much like the Moderna and Pfizer vaccine candidates, the Novavax candidate is a two-dose vaccine, taken 21 days apart.
While researchers can only speculate on how quickly participants will enroll and the trial can get moving, Staben said that by spring his team, along with hundreds nationwide, might have good data on whether the Novavax vaccine is working.
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