As probably everyone knows, the vaccines available in the US (Moderna, Pfizer, and Johnson and Johnson) are all approved under an Emergency Use Authorization, not full approval. And fairly obviously, the companies that make all of those vaccines would like to have full approval, and are going through whatever the steps are to make that happen. Does anyone know when that is expected to happen?
It’s a very relevant question because full approval would remove some of the current resistance to use of the vaccine. It might not make all that great of a difference on the individual level, but many institutions have already stated policies that they will require vaccination once it’s fully approved, but do not yet require vaccination right now. And of course, I’d like to see that as soon as possible.
Matt Yglesias made a good point recently in an article that the FDA, like many agencies, is somewhat susceptible to lobbying and pressure from drug manufacturers, and that in this case, the various vaccine manufacturers are not really putting that much pressure on the FDA to speed up full approval.
Right now the vaccines are all supply constrained, so while full approval might be nice to have, it won’t meaningfully expand their market. They can already trivially sell every dose they can manage to make, and that’s not likely to change any time soon. They can’t really raise the price for PR reasons. So just let the process happen. They’re currently investing their institutional bandwidth in getting Delta/etc. variant boosters approved. Because that might actually result in a bigger market/higher prices.
I share your desire to see meaningful mandates put in place, and the fact that no one in a position to do something about it seems to treat full approval as an urgent problem is frustrating and dismaying.
Is that still the case? I would have thought that we’ve close to saturated the set of people who are inclined to ever get the vaccine. In the early days of the vaccine, you could find someone willing to take every dose you could make, and you needed appointments rationed by age, occupation, and health groups, but now I’m seeing all sorts of places advertising walk-up vaccinations. Surely the constraint now is on demand, and full approval would increase that demand.
Maybe in the US, but worldwide this isn’t the case. Many countries, even developed western countries that can afford to pay full price, are nowhere close to having vaccinated everyone who wants to be vaccinated.
Ah, true. I hadn’t considered that, but of course to the drug company, a sale anywhere in the world is still a sale. It’s good to hear that the anti-vaxers are having at least one positive effect: They’re giving up their place in line to others who actually have the sense to want it.
Looks like most likely a couple of months away for Pfizer, which applied in May. Moderna is right behind them, having applied in June.
On 16 July, FDA accepted Pfizer’s application “under priority review”—meaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but last week an FDA official told CNN that the decision is likely to come within 2 months. “The review … has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date,” an FDA press officer confirmed to Science in a statement.
Are there any countries not following the model of vaccines first being authorized then — depending on whether further requirements are met — being approved or disapproved?
The fact that eventual approval is being taken as a given shows something is wrong.
Well, it’s not guaranteed: If it were, then they would already be approved. But the vaccines have now been administered to a very large number of patients, with extremely high effectiveness, at extremely high statistical significance, and with serious side effects being very rare even by the most scaremongering of estimates. It would, at this point, be quite surprising if they’re not fully approved, and even more surprising if none of them are fully approved.
…New Zealand went through our standard approval protocol before we started vaccinating: we didn’t use emergency use protocols. Pfizer-BioNTech was approved on the 3rd of February 2021, and we have purchased enough to provide everyone in NZ double doses, as well as many of our Pacific neighbours. Janssen was approved on the 7th of July (but we are continuing to use Pfizer) .
The problem is that the approval process appears to exist almost entirely separate from the rest of reality. Having a slow and deliberate process for determining drugs are safe makes sense when the rest of the world is moving in a slow and deliberate way. For most diseases and treatments, a given delay causes some constant increase in the number of people who suffer without the treatment, and you have to balance that against the risk of approving a treatment that causes more problems than it solves.
For a novel pandemic disease, every delay causes exponentially more suffering. The process should not be the same because the risks of delay are not the same.
New Zealand managed very effective containment prior to vaccination, so there’s a good argument that normal protocols were sensible. A few months delay in New Zealand didn’t result in lots of excess deaths in New Zealand. But that was never the case in the US (mostly because we didn’t even try to actually contain things). When the disease isn’t raging, go through normal channels. When it is, you gotta speed it up!
…I’m not exactly sure why you felt the need to tell me this. I never argued against emergency use authorization. Just explaining that some countries didn’t have to use it.
If that were the case for a new untested cancer treatment, you would have a point. But at this stage, full approval of COVID is almost a given because the testing has been done, and is almost irrelevant because of supply constraints and emergency approval.
The fact that America has a separate approval process, rather than just accepting Aus/NZ approvals, and that the American approval process has run slower than other countries, isn’t evidence that something is wrong. That’s like saying that high-school graduation of some kids at 16 and some at 17 is evidence that something is wrong.
He also said that he doesn’t know, and it’s not appropriate to pressure the FDA, which needs to do its thing in its regular way.
But i agree that given the enormous size of the “experiment” we’ve done under the EUA, and the small number of problems that have surfaced, it would be astonishing if none of the vaccines get full approval.