I suspect there’s a lot of “professional self interest” going on here, like if they admit a drug can be approved in 2 weeks if necessary then they’re going to be under intense pressure to turn around everything in two weeks in the future.
My guess is that he means that 4-6 weeks is how long it has taken to review other COVID-19 vaccine applications for EUA (which is what I think he means by “these applications”) and that the timeline is already accelerated vs the normal EUA process.
The bottleneck is probably the people with the relevant backgrounds doing the review. I would guess they are delaying everything else to prioritize this, but you still need competent humans to do the work.
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It looks like the data is not submitted all at once, so part of the delay is waiting for the rest of the data to come in. They are reviewing partial data before full results are in.
From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
That seems a little conspiracyish to me. It does seem pretty ridiculous that it’s taking this long to get these vaccines into arms. On the other hand, I don’t know what really goes into these kinds of approvals, and it makes sense that you’d want stricter review of pharmaceuticals for children, esp when kids are at an extremely low risk for COVID complications.
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I dont think its a conspiracy to assert that technocrats commonly overestimate the importance of their policies and procedures, to the detriment of the general public.
I mean, your claim that they’re deliberately sandbagging how long the process takes seems a bit much to me.
Kind of feels like you’re saying that scientists are too emotionally attached to the scientific method.
No I wouldn’t put it that way. “Sandbagging” is an unnecessarily pejorative term. I’m talking more about the natural incentives built into regulation and administrative processes. I have been close enough to some regulatory processes to see that they have a lot of slack in them. That’s the nature of the beast and I think its kind of unrealistic to expect a bunch of people that have behaved one way for years or decades to suddenly change their behavior. People just aren’t wired that way.
I would say that they likely have a habitual and instinctive faith in administrative timelines that probably don’t have that much to do with the scientific method.
I’m not sure I have the implications of this quite right, but FDA also changed their requirements for pediatric trials this summer:
Timing roughly works out for the additional participants added to the study needing 3 weeks + 2 months follow-up from mid-late July bringing us to mid-late October.
For drugs like oncology drugs the accelerated review and approval timelines are measured in multiple months. Not sure if it differs for vaccines in general, but based on the timelines I’m familiar with in oncology, 4-6 weeks is insanely fast.
They are approving a vaccine rollout for millions of children in the middle of the most contentious time for vaccines ever. 4-6 weeks seems light basically instant approval under these conditions.
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It feels wrong that adults in first world countries are getting third shots offered while children and many in the third-world haven’t had a chance to get their first.
It “feels” wrong?
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I’m not a parent, but the temptation to try to go off label if I had kids (aged 5-11) would be quite a bit greater once we enter the “data submitted to FDA and seems thoroughly unthreatening, number crunchers undergoing 1-2 month review” phase.
re: adult boosters, hasn’t the USA actually deployed <50% of its total doses to date? I remember media reports of a billion surplus doses. I’m a-OK with aggressively managing those to avoid any expiring, and sending them all over the world.
But we as individuals only have the option to take the booster or not take the booster. It’s clearly in the public interest for us to take the booster as soon as we are allowed to.
I know the Czech Republic does have more than enough to vaccinate at least some of its population more than once but one would think that approval for kids would’ve happened before we got to this point.
Plus, the rate of vaccination has decreased dramatically. We went from 100K+ per day at peak to 30-40K per day. This excludes weekends where there are fewer places open and fewer vaccinations.
The department’s Office for Civil Rights sent letters to education chiefs in Iowa, Oklahoma, South Carolina, Tennessee, and Utah. Those states have barred schools from requiring masks among all students and staff, a move that the department says could prevent some students from safely attending school.
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Meh. Every vaccine refused is two booster doses for the smart people. So if you get a booster this fall, thank a moron.
I am sympathetic to the worldwide dosing issue but given my real sphere of influence, I will still get the booster when offered if they seem plentiful locally.
just posting for the quots
The artist took to Twitter to explain that the cancellationsw were due to coronavirus writing, “I am pi–ed. Over half the band has f—ing covid (not me), and before u s— for brains bloggers and media trolls run your mouths, many of them, like me, have been vaccinated.”
Rock added, “I was gonna come and rock the house anyway, play acoustic, DJ or even just Juggle… Deez Nutz!! - or at least try to entertain u good folks. But seriously, s— is way out of my hands on this one. I am beyond upset and you real ones know I would never cancel if I absolutely didn’t have too. For this, I am sorry.”