EUA can be applied to many different product categories including diagnostics (basically every single PCR and antigen test in the US up to very recently was initially released under EUA), therapeutics (for example the FDA granted an EUA on chloroquine for threatment of COVID), other medical devices (for example PPE) and vaccines.
The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent.
There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it.
In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.
This flow chart is not quite accurate, or at least is misleading. There is more to a distinction between EUA and full FDA approval than where manufacturing happens. The FDA's own website[0] says:
> The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate.
In general, COVID vaccines have been far more extensively studied than any other vaccine has ever been.
There is a problem - with every single possible authorized medicine - that there may be long-term longitudinal issues that are uncovered, especially when the entire world is the population study.
You've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved).
Said another way, what was the extra steps that needed to happen between EUA & full approval?
> Technically the same thing but legally different and therefore has a different liability profile.
AFAIK, any different liability profile between an EUA and approved product is moot in the case of COVID vaccines, because they are out of both normal liability regimes and standard vaccine liability regimes and covered by the PREP Act pandemic countermeasures regime which does not make a distinction.
For what it’s worth, the vaccines have been released under Emergency Use Authorization, not the normal approval process. The EUA still requires safety data etc.. but isn’t as rigorous as the full process. Here’s a decent write up:
https://theconversation.com/what-are-emergency-use-authoriza...
You've moved the goal post (again) but I'll address yet another false claim. Nothing was "violated". The vaccines were rigorously tested.
> An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks.
> It is the job of the FDA to ensure medical products meet rigorous safety and efficacy standards, a process that can take years for what’s called “full approval.” Though that timeline is condensed when an EUA is granted, the FDA still upholds its strict standards.
Read the whole page, carefully. Both are fully approved. I do not understand how you can conclude that the word "approved" is an error when both vaccines were upgraded from EUA to fully approved, in the words of the FDA themselves.
Interesting. So they couldn't use them yet in the EU. Then the export matter would possibly be separate? (There are millions of AZ vaccines in Ohio and Maryland waiting to become the 4th approved vaccine in the US, but are stuck in FDA EUA paperwork.)
I believe the crux of the issue and the reason for the push to approval is contained in this section:
> Finally, it may affect the potential for vaccine mandates: “It is unlikely these vaccines will be mandated while an EUA is in place. Remember that currently these vaccines are still considered experimental.”
While still under EUA, an increasing number of educational and other institutions have already mandated vaccines, but debates over the legality of these actions has hinged on the distinction between authorisation and approval.
The clinical trials are actually the same (statistical power) as previous vaccine trials. They've simply enrolled more people faster and had a higher infection rate to evaluate safety and efficacy. It is likely in the next month that Pfizer will get a standard (non Emergency Use) Authorization.
The reason for EUA was that so many people were dying that some more limited (<1yr clinical safety) data was accepted. Now that many of the original subjects are falling past 1yr post inoculation (and variants have been evaluated) a full authorization in eminent. Previously, people worried that once one vaccine was authorized other EUA (NovaVax, AZ/ChadOx, etc) wouldn't happened, has also been resolved since the FDA realizes people want choice.
They ordered one slightly later than the UK and the US (let's ignore Israel which is basically a large scale trial). The main difference: the EU used normal certification processes, just sped them up considerably. The UK and US used emergncy certification.
The volumes the EU ordered initially were absolutely sufficient with 4+ doses per EU inhabitant. Manufacturing capacities were sufficient for that as well. It all started to go south as soon as memeber states looked for scape goats why vaccination happened so slowly. First the manufacturers, then the EU, then the federal government (where applicable). It is a last-mile distribution issue if you will now, not a manufacturing one.
0) From a clinical perspective this is data we are generating on an on going basis. Analytically this is a largely a function of the characteristics of the affinity, specificity of the capture molecule used to capture the target (viral particle). As you point out EUA gives opportunities to launch sooner... But it's still critical to validate technogies both internally and externally probably to a greater extent than the de minimus EUA reqs
1) great question. Our approach is novel which allows us to tap into new supply chains that are inherently more scalable (think semi-conductor Fab) but the trade off is execution risk.
See the section "What are the main differences between the EU's Conditional Marketing Authorisation and the Emergency Use Authorisation issued by some other countries?", onwards.
It explains amongst other things that a Conditional Marketing Authorisation (CMA) is a real, controlled and robust, authorisation of the vaccine; this is unlike the Emergency Use Authorisation (EUA), which is really an authorisation of the use of an unauthorised vaccine.
A CMA requires data on safety and efficacy, showing the benefits outweigh the risks. An EUA has no such requirement.
I'm less familiar with EU liability laws. In the US the FDA differentiates an EUA version and the regular FDA approved version. The difference may only be the label, but Pfizer would be foolish to distribute a version with liability attached when they could distribute a version without liability attached.
Are you familiar enough with EU drug liability laws to speak to whether Pfizer has any liability?
I hate having these autistic fine detail discussions in this context because people assume I'm anti-vax. I will state here again I believe the vaccines are safe enough and effective enough to justify use.
> Only you can't get it anywhere and BioNTech is considered legally distinct
Which is interesting for some very esoteric legal reasons, but even to the extent that a formulation only allowed for non-investigatory use under an EUA rather than normal approval might approximately be said to be “experimental” (which is a fairly weak argument itself), the Pfizer-BioNTech COVID-19 Vaccine, which is an identical formulation to the fully-approved Cominarty, but legally distinct because packaging is legally significant in drugs and biologics, would still not be “experimental”.
The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent.
I found this article to be a better summary of the differences between EUA and BLA (https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the...). I think you are right - the diagram from the OP is somewhat misleading.
There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it.
In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.
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