[gr2zr4]

This could be the fastes approval in the whole drugs' history considering that

The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application.

This time is interrupted by one or two ‘clock-stops’ during which the applicant prepares the answers to any questions raised by the CHMP. The maximum duration of a clock-stop depend on how long the applicant thinks it will take to respond, but must be agreed by the CHMP. The first clock-stop usually lasts 3 to 6 months and the second one 1 to 3 months.

Overall, the assessment of a new medicine usually lasts around a year.

https://www.ema.europa.eu/en/human-regulatory/marketing-auth...

[akiselev]

> This could be the fastes approval in the whole drugs' history considering that

Without a doubt. The closest competitors would be imatinib (3 years) and several other chemotherapy drugs (~5 years) meant to treat malignant tumors. The vast majority of the drugs approved this quickly, with the exception of the HepC treatment, treated diseases with a life expectancy of less than the time it took to approve the drugs so long term side effects was less of a concern.

[alexchamberlain]

Would those drugs be in use by the majority of the patients that need them before that though, as they'd be in the studies etc? Whereas this vaccine needs to be given to a large percentage of the population. How are flu vaccines regulated? They change yearly, correct?

[jfoster]

Do drug approvals even have much history? My impression was that the concept of drugs needing to be approved has been around for less than 100 years, but I guess it will vary from country to country.

[disgruntledphd2]

It's been around (for clinical trials and whatnot) since the late 50's in the US I believe.

I think it's been mandatory since thalidomide.