Kaiser Permanente is recruiting at least 100 Oregonians to participate in one of the state’s first vaccine trials for the coronavirus.
Trials could begin as soon as next week for volunteers, who must receive health care through the Kaiser network to participate.
Britta Torgrimson-Ojerio, a nurse researcher at the Kaiser Permanente Center for Health Research, said volunteers are eager to enroll.
“We have already had an incredible response from our Kaiser membership,” she said, “which I think is a tribute to how much people believe in helping to find a vaccine that will help our community to get out of the social and economic turmoil we’re in in this pandemic.”
The center is one of three Kaiser sites around the country engaged in trials for the vaccine, which was developed by Pfizer and its German partner BioNTech. The companies, under a $2 billion contract with the Trump Administration, are part of what the White House calls Operation Warp Speed, an effort to dramatically decrease the amount of time to develop a working and distributable coronavirus vaccine.
The Pfizer vaccine is one of eight in the world that have entered phase three trials – the final stage before a drug can be administered to the public. Another trial for a vaccine developed by the company Moderna is underway in Medford.
Oregonians who participate in Kaiser’s trial will be part of a larger sampling of 1,400 participants in Oregon and California, and 30,000 participants worldwide. People with serious medical conditions, like cancer, will be screened out.
Participants will sign consent forms that are not liability waivers, Torgrimson-Ojerio said, and they are free to end their trial at any point.
“It’s really important for any research that has potential risk associated with it to closely work with participants and explain to them the potential harm and potential benefit,” she said.
Selected Oregonians will participate in what is called a double-blind trial. Half will receive the vaccine and half will receive a placebo. They will not know which they receive.
Participants will then log and report back to Kaiser about any side effects, which, much like the flu shot, may include coronavirus symptoms. They will also receive a “booster” vaccine weeks after the first injection.
Kaiser will collect data for two months and report it to Pfizer, and it will also continue monitoring participants through regular checkups and blood testing for two years.
Researchers will analyze the effectiveness by determining if coronavirus infections are more prevalent among people who received the vaccine or the placebo, Torgrimson-Ojerio said. Health care professionals must also be sure the side effects from the vaccine are manageable.
The U.S. Food and Drug Administration will ultimately decide if the vaccine is ready for the market.
Vaccines typically take years to complete before they are cleared for medical use. The rapid pace of coronavirus trials has drawn concern among scientists who fear that mounting political pressure may lead to botched results.
The United States has recorded more than 5.2 million coronavirus infections and 166,900 have died, according to a New York Times database.
“I truly believe we don’t want to rush through that process because the best way to get through this difficult time in this pandemic is to get a vaccine that works and works for a diverse community and population of people,” Torgrimson-Ojerio said.
This story has been updated to clarify that participants do not waive legal rights by participating in the trial, and that Kaiser will continue monitoring participants for two years.
-- Bryce Dole; bdole@oregonian.com; 541-660-9844; @DoleBryce