JOHNYTHEDEVIL: tady mas rozdil mezi EUA a CMA. EMA udelala CMA, ne EUA.
Press corner | European Commissionhttps://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390Tady mas summary toho procesu v ruznych zemich. povsimni si, ze jediny rozdil je v dobe sledovani, ktera byla 2 misto 6 mesicu. No a 6 mesicu uz uplynulo.
Summary of COVID-19 vaccine approval processes in the UK, EU, and the US
While UK, EU and US have also expedited the COVID-19 vaccine approval process, regulatory authorities in these countries have made no compromise on quality, efficacy & safety standards [6, 21]. A key
difference between the expedited procedures (emergency use authorization/temporary use authorization/conditional marketing authorization) used for COVID-19 vaccines and standard licencing procedures
is the length of study participants’ follow-up to evaluate the duration of protection and if there were any rare adverse events down the road.
The average follow-up period used for COVID-19 vaccine procedures is 2 months, but standard licencing procedures require 6 months [22]. It is important to note that COVID-19 vaccines,
SINOPHARM in China, and Sputnik V in Russia have been approved for use even before the completion of phase 3 trials.Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research | Journal of Pharmaceutical Policy and Practice | Full Texthttps://joppp.biomedcentral.com/articles/10.1186/s40545-021-00400-0