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Anonymous ID: 5427c1 Aug. 23, 2021, 6:14 p.m. No.14441021   🗄️.is 🔗kun

>>14441009

 

Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 12 years and older.

 

Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Comirnaty does not contain the virus itself and cannot cause COVID-19.

Anonymous ID: 5427c1 Aug. 23, 2021, 6:15 p.m. No.14441027   🗄️.is 🔗kun   >>1036

Conditional marketing authorisation

 

The approval of a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.

 

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation#use-during-covid-19-pandemic-section

Anonymous ID: 5427c1 Aug. 23, 2021, 6:16 p.m. No.14441036   🗄️.is 🔗kun

>>14441027

>https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation#use-during-covid-19-pandemic-section

 

During the COVID-19 pandemic, the conditional marketing authorisation procedure is being used to expedite the approval of safe and effective COVID-19 treatments and vaccines in the EU.

This is in line with EU legislation which foresees that conditional marketing authorisation is used as the fast-track authorisation during public health emergencies to speed up approval and save lives.

It allows regulators to grant a marketing authorisation as soon as sufficient data becomes available to demonstrate that the medicine's benefits outweigh its risks, with robust safeguards and controls in place post-authorisation.

In a public health emergency, it can also be combined with a rolling review of data during the development of a promising medicine, to further expedite the evaluation.

Conditional marketing authorisation is the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.