Summary List Placement11:00 AM: Moderna pitches plan to immunize placebo volunteers without ‘jumping the line’
Moderna has a plan to offer trial volunteers who received placebo shots the actual vaccine, while side-stepping some of the key ethical concerns.
What to do with ongoing placebo-controlled trials during the pandemic has become a top conundrum facing vaccine developers like Pfizer and Moderna. On one hand, researchers want to keep following the placebo group to have high-quality, long-term data to see how these shots work. But ethicists also wonder if studies can, or should, withhold an effective vaccine from volunteers.
Moderna’s proposal is to ask participants whether or not they want to know if they got the real vaccine or a placebo. They can choose to remain blinded and in the study, or they can decide to know which arm they were in. Placebo participants who choose to become unblinded are then offered the real vaccine from clinical trial stocks, if they want it. All of those participants would be followed for long-term data.
Tal Zaks, Moderna’s chief medical officer, said this would not take doses away from priority groups. Instead, placebo recipients would get doses already produced for the sole purpose of clinical trial use that can’t be dispatched to the general public.
“None of our vaccine trial participants would be ‘jumping the line’ ahead of others, because we have clinical trial supplies available that would in fact expire and go to waste if we don’t use them,” Zaks told the panel.
Dr. Lindsey Baden, an infectious-disease expert at Brigham and Women’s Hospital, also spoke as part of Moderna’s presentation as one of the study’s investigators.
Baden said there have been a “substantial” number of volunteers dropping out of the trial in the last week since Pfizer’s vaccine secured an emergency OK last Friday.
“This dropout undermines the data integrity and what can be learned,” Baden said. “We must be proactive to ensure that the best choice is for our participants to remain in the study.”
Giving placebo recipients the chance to be vaccinated is important, because Zaks said many of the volunteers are at higher risk of infection and also have risk factors for severe disease.
A 54-year-old man with diabetes who got placebo shots in Moderna’s trial ultimately died from COVID-19, Zaks said, highlighting the risk in not immunizing these volunteers.
9:50 AM: FDA and CDC are investigating allergic reactions to Pfizer’s vaccine, but have no answers or recommendations yet
Dr. Stanley Perlman, a University of Iowa immunologist, asked about possible explanations for allergic reactions to COVID-19 vaccines, after two healthcare workers in the UK, and then two more in Alaska, had anaphylactic reactions after receiving Pfizer’s vaccine.
Pfizer’s vaccine ingredients don’t seem to be anything highly allergenic, and at least one of the healthcare workers had no history of allergies, leaving experts (like Perlman) puzzled as to what’s going on.
“At this point we and CDC are continuing to investigate cases and consider data,” said Doran Fink, an FDA vaccine expert. “At this point, we don’t have enough information to make definitive recommendations one way or another, and as we continue to investigate and evaluate the data we will consider whether additional recommendations need to be made.”
9:00 AM: Panel kicks off, releasing key voting question
We are off and running for a marathon meeting expected to wrap up at 5:15 p.m.
On Tuesday, the FDA released the most detailed results yet from Moderna’s late-stage study in preparation for this meeting. The agency’s summary showed the two-dose vaccine to be overwhelmingly protective at preventing symptomatic COVID-19 with no major safety concerns.
All in all, it’s a very similar profile to Pfizer’s vaccine, which was authorized last Friday, and we compared what we know about each shot here.
It’s poised to be a long but important day. The panel’s recommendation on whether or not to OK Moderna’s vaccine is seen as the last remaining barrier to an FDA authorization decision.
Here’s the agenda for the day:
9:00 a.m. — Introductions
9:30 a.m. — FDA deputy director Doran Fink outlines emergency use authorization
10:05 a.m. — Stanford researcher Steven Goodman discusses the possible options for ongoing placebo-controlled vaccine trials, given COVID-19 shots are now being rolled out
10:45 a.m. — Moderna chief medical officer Tal Zaks and senior vice president Jacqueline Miller present the biotech’s vaccine data
12:00 p.m. — Public comment
1:00 p.m. — Zaks and Miller answer questions from committee members
2:00 p.m. — FDA medical officer Rachel Zhang presents the agency’s perspective on the vaccine data
3:10 p.m. — Committee discusses, ultimately votes, and adjourns