SAN DIEGO (KGTV) - As San Diegans receive vaccines from both Pfizer and Moderna, the two-year clinical trials for both companies are still underway.
As the vaccines are rolled out, trial participants may be anxious to find out if they received a placebo or the actual vaccine.
“Everything was just looking so dire I felt really helpless, and when I saw this, I thought this would be a way I could do something,” said Leslie Sullivan, who signed up to be part of the Moderna trial happening in San Diego. “This was my way to contribute.”
While Sullivan hasn’t been officially told if she received the placebo or vaccine in the double-blind study, she believes she got the vaccine.
“I do feel 99.999 percent positive that I got the real vaccine based on the reactions I had, particularly after the second dose,” she said. “After the second dose at the beginning of September, by that night, I had a 101 temperature, chills, and body aches that lasted for about 36 hours. I was fine after.”
Sullivan received an email from the Medical Center for Clinical Research Tuesday laying out what the next steps are for Moderna trial participants.
The email states, “The study has not ended, and we still need your contributions. As previously communicated, we have now re-designed the study to permit volunteers to know whether the mRNA-1273 vaccine or placebo was received and offer the mRNA-1273 vaccine to all who received placebo.”
According to the email sent to participants, those who would like to know whether they received the placebo or vaccine and want to receive the vaccine if they got the placebo are told to contact their study site to arrange a visit.
During the visit, participants are given a new Informed Consent Form that describes benefits, expectations, and risks if they continue to participate in the study.
A blood sample and nasopharyngeal swab will also be taken. The study doctor will then let the participant know if they received the placebo or vaccine, and they will receive the first dose of the vaccine. Participants are asked to return a month later for the second dose.
Participants may also receive a vaccination card as proof that they received the COVID-19 vaccine.
Scheduling visits should start on Wednesday, but because approximately 30,000 volunteers took part in the Moderna study, they cannot vaccinate everyone at once. The focus will first be on the most at-risk populations, according to the email.
Pfizer has laid out a similar plan. The media relations department for Pfizer sent the following statement to ABC 10News writing in part,
We have developed a Vaccine Transition Option so that all interested, eligible participants 16 years and older in the placebo group have the option to move into the vaccine group in the study. Participants should not have to choose between remaining in the study or receiving the investigational vaccine if it is available to them in their community.
The Vaccine Transition Option will be implemented in a phased approach, starting with those who would qualify for vaccination if they were not part of the clinical trial. At this time, the eligible groups are healthcare personnel and residents of long-term care facilities.
As additional groups are added, participants who fall into the new groups can choose to take the Vaccine Transition Option at that time. For all other participants, when they reach the 6 month mark after their second injection, they can choose to take the Vaccine Transition Option.
Please note that this move from the placebo group to the vaccine group is completely optional, and participants are encouraged to remain blinded throughout the full study duration.
As for Sullivan, she hopes to receive confirmation about which group she’s in soon but said no matter the outcome, she will remain in the study for the full duration.
“I will stay in the trial, it’s a two-year-long total trial. They’ll monitor antibodies and things over time,” Sullivan said. “I think clinical trials are vitally important, and it’s part of the process most people don’t think about and see.”