DETROIT – The FDA’s vaccine advisory committee spoke at length about the ethics of what should happen to those that took the placebo in Pfizer’s vaccine trial.
Should they now be permitted to get the actual vaccine? It’s a question more complicated than you’d think.
Local 4 spoke about it with one of the trial participants who also is a member of the Local 4 family.
Local 4 assignment editor Matt Triplett said he’s ecstatic that Pfizer’s vaccine will soon be available for the first groups of high-priority Americans.
“Oh man, it’s amazing. It really is,” Triplett said. “I just talked to the clinic on the phone a couple of minutes ago. The phone’s ringing off the hook, everybody saying ‘Yay, we’re here!’”
As a trial participant, Triplett still doesn’t know if he received the actual vaccine or the placebo.
What to do with the brave volunteers from the clinical trials is a topic of much debate as letting the participants know whether or not they received the vaccine would limit researchers’ ability to gather long-term safety data.
But is it ethical to prevent those who got the placebo from getting the real vaccine once it’s authorized?
“If I already got it, great. If I didn’t get it, I’ll wait in line until my number is called,” Triplett said. “I didn’t do this to get a break.”
The FDA panel discussed an alternative called a Blind Crossover.
Essentially, everyone in the trial is vaccinated again with those who got the placebo the first time getting the vaccine and vice-versa.
“You don’t know personally, but they know so they know to monitor,” Triplett said. “By the time it’s all done, we all have it. They can look at it and say ‘OK, you have that many more people to look at.’ Me personally? I’d like to do it that way.”
Regardless of what happens, Triplett said he’s excited to see the light at the end of the tunnel.
“I want to be able to hug a friend I haven’t seen in six months and say ‘Hey, come on, we’re having a beer,’ give him a big bear hug, sit down, have a fire, go on a boat ride, enjoy life again,” Triplett said. “I think we deserve that.”
Volunteers in the Pfizer trial will continue to be monitored for two years, whether they choose to get the vaccine or not.
It doesn’t just impact Pfizer’s trial. If people in other trials withdraw after a different vaccine is authorized, it will make it more difficult to complete the studies on different vaccines.
Gov. Gretchen Whitmer said Thursday that the state is working on a distribution plan that will take effect the minute the vaccines arrive. She believes Michigan will start seeing doses within a few days and wants everyone to have the opportunity to get vaccinated.