Italian Medicines Agency Agenzia Italiana del Farmaco

BioNTech/Pfizer vaccine authorised Answers to frequently asked questions on AIFA’s website - BioNTech/Pfizer vaccine authorised Answers to frequently asked questions on AIFA’s website

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BioNTech/Pfizer vaccine authorised Answers to frequently asked questions on AIFA’s website

The Italian Medicines Agency authorises the marketing of COVID-19 Comirnaty vaccine, developed by BioNTech and Pfizer. “I believe that today is an exceptional day”, said President Palù. “After only ten months following the publication of the genome sequences of the virus, we have a vaccine against COVID-19 with a very high efficacy, around 95%, and another 5-6 are in the pipeline”.

“AIFA's decision is not just an acknowledgement of the European approval”, said Director General Magrini. “In addition to authorising the marketing and reimbursement of the vaccine by the NHS for all, AIFA has planned an information and communication campaign on COVID-19 vaccines, starting with a series of answers to frequently asked questions which are already available on AIFA's website”.

“Comirnaty has been approved for the entire population aged 16 years of age and older”, added Director General Magrini. “It has no absolute contraindications, and no special precautions are required for specific subpopulations such as the elderly, immunocompromised people or subjects with coagulation disorders and at risk of bleeding. There are also no contraindications for pregnant or breast-feeding women”.

“27 December will be the European Vaccination Day, a symbolic event that will make us feel part of a wider community within a global pandemic, and that inaugurates the mass vaccination campaign that will take place across Europe”, concluded Director General Magrini.

The FAQ document is available here:

https://www.aifa.gov.it/comirnaty

To watch again the press conference:

https://youtu.be/TKlyg47KPgA


Published on: 22 December 2020

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