The issue most debated during the meeting was whether to include people 16 and 17 years old in the emergency authorization. Several committee members said they wanted to exclude them because they are at less risk from the coronavirus and because less is known about how the vaccine might affect them.
The committee members didn’t get the chance to vote on that modification or any other.
Monto turned to the FDA’s Gruber for direction on how to proceed, and Gruber urged him to call for a vote on the question as originally drafted—whether the benefits of the vaccine outweigh the risks for people 16 and older.
“It is 5:30, and Arnold, we have a strategy,” Gruber said. “Provided that other committee members do no longer want to weigh in, I would like for the committee to really vote on this question as is.”
It was unclear how many members still might have wanted to weigh in, because no one asked them.
It was also unclear whether any members wanted to discuss other possible modifications to the authorization.
Monto proceeded to call the vote.
“The votes will be announced and then we will have an explanation of vote from those who wish to give an explanation of their vote,” he said.
One committee member, Dr. H. Cody Meissner, chief of the division of pediatric infectious disease at Tufts Children’s Hospital in Boston, tried again. Meissner said he didn’t want to vote against the emergency authorization just because he was uncomfortable including the 16- and 17-year-olds, and he asked if the committee could modify the wording if the question didn’t pass. He was shut down.
“I would recommend voting on this question as is for now because we have not heard from all the committee members,” Gruber said, with baffling logic.
Another member, Dr. Michael Kurilla of the National Institutes of Health, spoke up, asking if he could ask one last question.
“Only about the voting process,” Monto said.
After the votes were counted, members were not given the chance they had been promised to explain the thinking behind their votes.
Instead, Gruber delivered concluding remarks and Monto closed the meeting.
“And therefore our work for the day is done,” Monto said. “So thank you very much, good night, and see you soon.”
The following night, the FDA issued the emergency authorization. By Monday morning, Americans began receiving injections.
The advisory committee is scheduled to meet again tomorrow to consider another experimental coronavirus vaccine.