PROVIDENCE – With the news that COVID-19 vaccines will begin to be dispensed in just a few weeks, you may wonder whether you can still volunteer to participate in a vaccine trial – and if you should.
The answer to both questions is “Yes!” says Dr. Karen Tashima, an infectious diseases physician and director of clinical trials at The Immunology Center of The Miriam Hospital.
There are still plenty of trials going on. Six vaccines are in development, each using slightly different technology. Five of those are part of the government’s Operation Warp Speed. The drug-makers that have applied for emergency approval from the Food and Drug Administration are only the first to get to the point where their vaccine is ready for deployment.
“We need all of them because we need to know which ones are going to work, and if we have several that are FDA-approved, it will make it that much easier to get the vaccines to the public,” Tashima said.
She also pointed out that the manufacturers aren’t just supplying vaccines for the United States, but for other nations as well. Massive numbers of vaccines will be needed, and no one manufacturer could supply all of them.
At The Miriam, Tashima hopes they will soon be testing one of the modified protein-based vaccines. They already have more than 5,000 people in the volunteer registry. But Tashima says a bigger pool of volunteers is needed to enable researchers to test a wide variety of people from communities across the state – from women in their 20s to men over 80, along with different races and people with some preexisting conditions. Not every volunteer will qualify for the trial.
Tashima’s study at The Miriam will involve about 400 people. It will be conducted elsewhere as well. She said she hopes the study will begin in January. It’s a Phase 3 study, meaning that the vaccine has already gone through Phase 1 and 2 trials on smaller groups of people. Those phases look for vaccine reactions and side effects in a concentrated group.
Of the two vaccines that have been sent to the FDA for emergency approval, Tashima, who is also a professor of medicine at Brown University’s Warren Alpert Medical School, said “they look really effective early on.”