If you know anything about vaccine licensing regulations, can you explain this paragraph to me?

[PuzzledObserver]

“A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested’: this temporary authorisation process exists to address the possibility that, in certain situations of public health need, the licensing authority may consider that the balance of risk and benefit to patients justifies the temporary supply of the relevant vaccine pending the issue of a product licence.”

www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines?fbclid=IwAR2es8yxia_YdLfGC_E32Zt9e0fGL1V5fVGeCvi6twJMZrCMcaUT11Cit1E

If the UK’s regulation authority thinks there is sufficient evidence of safety and efficacy, why don’t they just grant the licence straight away?

Medicinal products can be given in special circumstances before they have completed the marketing authorisation process if they are used for 'compassionate use', for example.
That would allow the UK to give the vaccine to the very vulnerable before it is fully licensed.

Currently the vaccine is following the full formal process for gaining marketing authorisation, but it may well be known before that process is over whether or not the vaccine is safe and effective, so it could be given under special conditions prior to formal authorisation.

most vaccines take years of testing to see if they're fully safe (as some side effects may come much later). But they may think the risk is worth it and start giving it to vulnerable people sooner.

I guess my confusion is, why don't they just issue the licence?

It's clear from what I quoted that the Regulator is not going to issue the emergency authorisation before it has received the trial data and had time to scrutinise it. After that, what else is there to be done before the licence can be issued.... and how long will that take? Do they (for example) have to wait at least two years after completion of the phase 3 trial, to allow time for side effects to emerge?

I guess my confusion is, why don't they just issue the licence?

Because licencing takes time and involves trials.

Licencing usually starts with drugs being licenced for adults but not children, but if there is a medical need a doctor can prescribe 'off licence'.

With something new like a vaccine for Covid the people who would benefit most are those who would/will do less well if they catch covid, but these people are vulnerable and a vaccine may not be suitable, it is possible there will be prescription on a case by case basis.

They’ve made it pretty clear they would only authorise it AFTER trials. What else is there? That’s what I don’t get.

They also say (elsewhere in the document) that the authorisation would include restrictions, many of which would be the same as the eventual licence that would be given. So it wouldn’t be willy nilly give it to everybody, it might be give it only to people who meet certain criteria, with the full rollout waiting for the full licensing process to complete.

They also say it is their strong preference to do it through the normal process anyway. The emergency authorisation may not even be used, but it’s one of the things that several people I’ve seen on social media have been stamping their feet about.

The UK is currently in the EU, so while we have the MHRA a license requires EMA approval. Once testing is approved they want to bypass the red tape and finish that bit later. This might be interesting for you: www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19.