Originally Posted by teacozy
Glad to read that the data they are looking for to feel more confident could be available as soon as next month from the FDA according to that link.
95% efficacy with a sample size of over 60 thousand participants between the two vaccines is pretty remarkable (these were double-blind saline placebo trials to boot).
There were a number of concerns raised at this FDA committee meeting:
Dr. Luigi Notarangelo, a committee member who is a chief researcher at the National Institutes of Health, minced no words as he articulated several of the critiques.
Notarangelo said measures of vaccine effectiveness included in an FDA document the committee was asked to review have two problems.
“First of all, they really are biased — skewed towards mild disease,” he said. “Mild disease may not mean very much.”
“The other problem with those efficacy measures is that most of them are really subjective,” he said. “And I think that’s a major concern. I mean, we’re relying basically upon reporting from the subjects without any objective validation of what they’re reporting.”
“I think children at this point should not be considered for use of this vaccine until there is sufficient evidence” that it’s safe for them, “and what we’ve been presented today does not provide that,” Notarangelo said.
Without sufficient racial minority representation in the clinical trials, “the net effect will be that perhaps the white population might be protected, and we will only see cases of severe COVID among the Black [population], which would be a total disaster,” he added.
Dr. Hayley Altman-Gans, a professor of pediatrics at Stanford University Medical Center, painted a picture of the clinical trials as deeply flawed. She spoke of “hugely missed opportunities” and said, “We really need to be thinking about this differently.”
“I really feel like they haven’t gone far enough in terms of the safety outline” and “efficacy as well,” she said. What’s more, “nobody’s collecting as far as I can tell” certain important data.
“One of the things I have not heard much about during this conversation is infection,” said committee member Kathryn Holmes, a professor emerita at the University of Colorado School of Medicine. “I’d like to see how we could actually be measuring infection rather than just mild disease. … We should be looking to see what can prevent infection because that is the rubric which would prevent spread through the community most effectively and that is what would protect our elderly as well.”
Dr. Michael Kurilla, an expert on infectious diseases and a director of clinical innovation at the National Institutes of Health, said a standard the FDA has set for coronavirus vaccine authorization — 50% efficacy — doesn’t make sense in all situations. For health care workers and staff in long-term care facilities, a vaccine “that would take them merely from a mild infection to potentially an asymptomatic infection where they still might be infectious doesn’t seem like it’s something worthy” of an EUA, he said.
“The minimum has to be much, much higher in terms of having a general overall public health impact,” he said.
Lots of concerns being raised at that meeting.
Under the proposed FDA standard, “we could have a vaccine that seems to do well, meets the 50% test, and it’s effective at avoiding mild cases but actually does very little to address what we really care about, which is serious disease and death,” said Sheldon Toubman, a legal assistance attorney in New Haven, Connecticut, and the advisory committee’s consumer representative.
Toubman also challenged the FDA’s stated openness to granting an EUA based on two months of observations.
“There could be adverse effects we don’t know about, and so isn’t two months a little short?” he asked.
Toubman recommended that the FDA not grant EUA for coronavirus vaccines.
FDA officials rebutted some of the committee members’ concerns — saying, for example, that focusing on more severe cases would require enrolling an unrealistically large number of people in the clinical trials.
You were saying?