Several local residents in a clinical trial that led to the first emergency-use authorization of a COVID-19 vaccine in the United States now plan to get the vaccination if they received a placebo for the study.
Mike Weimer, 68, and his wife Jeannette, 69, of Athens took part in a large-scale clinical trial of the coronavirus vaccine developed by Pfizer Inc., in collaboration with a German company, BioNTech, through the North Alabama Research Center in Athens. The Athens center and Medical-Affiliated Research Center in Huntsville are among clinical research sites in the U.S. that are involved in the Pfizer trial.
“We needed to help get a vaccine out there so we can resume our lives,” said Mike Weimer.
Neither he nor his wife had any reactions after receiving the two injections. “We’re assuming we got the placebo,” he said.
He said he and his wife were gratified to have been part of the clinical trial that provided justification for the Food and Drug Administration to authorize the emergency rollout of the Pfizer-BioNTech vaccine last month.
Injections in the Pfizer trial were given at the first two study visits, and four follow-up study visits are planned for participants over two years to monitor their health. Over the course of the study, they’re asked to track any side effects through a smartphone app.
In the double-blind study, neither the participants nor researchers know who is receiving the vaccine or the placebo. Now, Pfizer is offering all trial participants 16 years and older a “vaccine transition option,” which gives them the choice to learn whether they received the investigational vaccine or placebo and, for those who find out they received the placebo, to have the option of receiving the investigational vaccine while staying in the study.
According to the company, the vaccine doses for placebo recipients have been secured, and its aim is for participants who received the placebo to have the opportunity to receive their first dose of the investigational vaccine within the study by March 1 if they choose this option.
The company said the option is voluntary and participants can choose to remain “blinded.”
“If we’re in the placebo group, we’ll go ahead and get the vaccine,” Weimer said.
Brandy Owens, 44, of Trinity, also took part in the Pfizer-BioNTech study through the Athens research center.
“I was happy I could participate and help get (the vaccine) out there quickly,” said Owens, who also hoped she would be protecting others if she did receive the study vaccine. “I have several family members who are immunocompromised, and I was trying to protect them.”
She and six other family members, including her husband, Jason, ended up with the virus at the beginning of November.
“I was sick for three weeks,” with symptoms like shortness of breath, fatigue, coughing and a low-grade fever, Owens said.
The Pfizer-BioNTech vaccine was 95% effective in clinical trials, and about 22,000 people in the trial received the placebo.
Owens said she plans to get the two doses of vaccine at some point, though she doesn’t want to get them ahead of other people with serious health issues.
Dr. Jeanne Marrazzo, the director of UAB's Division of Infectious Diseases, cautioned last week during a news conference that a vaccine is “not a passport to a mask-free society.”
“We still don’t know how long the protection from the virus lasts,” she said. “I’m hopeful it will be at least a year.”
However, “you have to assume that even if you’re vaccinated, you might still be vulnerable,” Marrazzo said.