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1 When will the Pfizer-Biontech vaccine be finally authorized?
The formal green light from the European Commission is expected tomorrow. On the same day, the drug regulatory agencies, Aifa for Italy, will receive the technical and information sheets on the product, translated into different languages. Aifa sent the Italian version to Ema last week. On the agency’s website, citizens can consult information and have clarifications.
2 Are additional authorization steps required?
No, the centralized procedure does not foresee a second step at the national level. The European body in recent months has worked in sync with the competent authorities in individual countries. The license for the new vaccine is valid not only in the EU states, but also in Iceland, Liechtenstein and Norway. The single price.
3 When is vaccination carried out in Italy?
December 27 is the agreed day for a simultaneous departure throughout the Union. The company has guaranteed that the start of distribution will be immediate. The trucks with the first quantities will leave the production site in Belgium to deliver the dose containers already at Christmas, escorted by the army to Spallanzani. Then we will proceed to deliver the quantities to the regions, in 220 hospitals. It will be a demonstrative vaccination for the 10 thousand health workers who have spontaneously booked. At least 300,000 weekly doses will arrive in the coming weeks. Throughout the year there will be 26 million doses.
5 Who will get the vaccine?
Initially to health workers and nursing home workers and guests, then to those over 80 years of age and then gradually moving to the younger age groups of 79 and up and the population with at least one chronic disease. Pfizer’s product has been licensed for use for more than 16 years.
6 How will you proceed?
Each vaccine, between the time of administration and informed consent, lasts about 30 minutes. The Pfizer product will be delivered in bottles of 5 doses each as a powder for dilution. The emergency commissioner has purchased anti-waste syringes that ensure the optimal amount of fluid is drawn from a single bottle. There will be a strict recording system: who gets the dose, when they get it, who gets the injection
7 Are there any side effects?
The Pfizer company described the side effects in a study published in the New England Medical Journal: In almost 40,000 patients (20,000 the control group), mild or moderate side effects such as pain at the injection site were documented. , malaise, asthenia, fever in 20% of patients, slightly more pronounced than those derived from the flu vaccine.
8 More serious adverse events?
Of the 270,000 people already vaccinated in Great Britain, 6 possible cases of allergic reaction have been identified, the majority moderate (source Ema). Aifa has organized a monitoring system to report adverse events.
December 22, 2020 (change December 22, 2020 | 07:45)
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