It has emergency approval. The CDC decided the result of waiting for a full approval would likely cost more than allowing it early.
Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines.
Agreed, but it was given a temporary emergency approval due to the pandemic. We need long term data on technologies before we immunize hundreds of millions of people with it.
That is incorrect. They are available for emergency use authorization. The FDA doesn’t designate that status[0].
Only Pfizer, IIRC, has even submitted a request for approval, and that was just last month. Minimally FDA approval takes ˜6 months, but it could also take several years.
As mentioned above, the vaccines being offered in the US are unlike any other that have been approved previously for use in the general population. I don’t think other vaccines (except the Ebola vaccine for specifically J&J) are reasonable analogues.
It's the same thing with flu vaccines, mind you. They only get a few months testing before entering mass use
The speed of access for these vaccines is that they started mass production while testing was ongoing, rather than waiting until after testing to start production
It wasn't rushed, the science was ready to go early last year and all they did was accelerate the first trial phases, the Phase 3 trials went quickly because infections were so widespread.
That there are multiple candidate vaccines targeting the spike protein without using the virus directly is strong evidence that the science was ready (using mRNA, viral vector and other technologies).
Are you arguing that it's the norm to go from we want to develop a vaccine against this new disease to here's a vaccine ready for trials within months is the general norm?
Regardless of the massive speedup and exceptions given by the FDA, you don't agree that the lab part of the development was slightly (understatement) faster than usual?
All the vaccines available in the US have completed the FDA approval process, which was allowed to proceed to later stages before an earlier stage was complete, to accelerate development. The length of time passed from last trial until approval was roughly the same as for most other vaccines, from what I recall.
The technology behind this vaccine has been actively worked on for over a decade. Yes, these vaccines have been sent to market faster than normal, but they certainly have not been "rushed".
The documentation required for approval was submitted by the pharma companies a long time ago. Many experts, including some previous FDA commissioners have stated these vaccines should have been approved by now given the data submitted. The current FDA commissioner has said it will take until January, without explaining why it's taking them so long.
The vaccines were NOT approved by Fast Track or Breakthrough Therapy pathways.
The vaccines were approved through Emergency Use Authorization. Since no Covid vaccine had ever been produced before, the manufacturers and FDA had to come to an agreement on trial design, data needs and minimum thresholds.
I read they have a few SARS vaccines, but non that have gone through human trials yet.
Side not: I'm always concerned when we're put in a situation like this where we're pressured to put out a vaccine quickly because it opens the door for a less than optimal solution to become a mainstay. For example since it's an emergency you may put forward a solution, have it go through human trials, find some side effect, but given the current circumstance say that it's "good enough" and give it the green light of approval. Now I understand that in such an urgent circumstance that this may be justified, but after the urgency is over it's my understanding that this solution that may or may not be approved under regular circumstances will remain approved.
Did you mean that you were waiting for the regular use authorization rather than the emergency use authorization? OK, that's expected early next month:
You might want to make your reservation early, since I hear a lot of people claiming that they're waiting for that. Of course it's the very same vaccine that's available today; it's just a matter of going over the paperwork to make sure all of the i's are dotted and t's crossed.
The faster approvals were because of prioritisation of the government's during a pandemic and nearly flawless execution of Pfizer.
But doing something faster doesn't mean it's new. In many cases it means you made your existing processes more efficient. Not changed them.
You are also changing your point. You said Biontech did almost nothing and compared it to a iphone app, lol. They could have chosen someone else and there aren't many that failed approvals. ( Except if you count Russia). But as mentioned, Pfizer was the best choice.
The largest difference in making it faster was an in-place term that allowed simultaneous clinical trials, which was unique and funded by the government due to extra costs and risks for pharma. This was not due to Pfizer and shouldn't be attributed to them as you are trying too.
Without that regulation it would have taken multiple years like before.
The government's also quickened feedback from months to weeks, which was an additional efficiency improvement.
If you're "in the know", you sure are forgetting the most important "details" for cutting the duration till approval vs. the past.
In the context of this article, it's important to note that the first authorized vaccine was not funded by the program.
The other US approved vaccine is a live viral carrier that has only been used fairly recently in experimental treatments (I think maybe an Ebola vaccine using it got approved recently?).
Then where are all the other mRNA vaccines? If it is a tech change rather than a regulatory exception there should be a whole bunch of other vaccines coming out by now, they've had long enough.
COVID appeared in March, they had the vaccine in clinical trials by April. The technical aspects aren't a factor here - the time taken to develop a vaccine is basically instant.
Exactly. This is a new type of vaccine that was rushed through testing being deployed widely for a disease that kills less than 1% of people who get it.
Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines.
edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
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