Almost 10 thousand places sold like hot cakes in a few hours, others arriving in the next few days. Vienna, the capital of Austria, inaugurated public vaccinations for children in the 5-11 age group on November 15: the 9 thousand seats available for administration, carried out in the Austria Center congress center, were sold out several hours in advance, while Mayor Michael Ludwing promises the opening of new ones slot quickly.
In the background, however, a not exactly secondary factor remains. Ema, the European drug agency, has yet to give its formal green light to administrations in that age group. How is it possible?
Because Vienna can “anticipate” the EMA verdict
The choice of capital is limited to simplifying and expanding a procedure already in use. Vaccinations of children under 11 years of age were already possible in the rest of Austria, according to the principle of “off label” use: the administration of a drug with different indications than those in its marketing authorization .
In general, it is a choice made by individual health professionals, who are fully responsible for the decisions to prescribe a “cleared” drug for other purposes. “In this case, however, it is different – explains Vincenzo Salvatore, lawyer of the Bonelli Erede law firm – The national authorities can authorize the use of the drug, so it is no longer the choice of the individual. And that’s what the Austrian drug agency did (Österreichische Agentur für Gesundheit und Ernährungssicherheit, ed) also giving the ok to the administration for children in the 5-11 year range. The Aifa, for example, preferred the final verdict of the EMA ».
But what are the criteria to justify the decision? A national agency, Salvatore explains, can authorize a drug without or pending further green light if it has a series of information. In the case of Austria, “the authorities already know that the drug was used elsewhere for that age group (in the US, ed) the information coming from Ema is positive and the government has decided to intervene promptly. Also because he is reasonably convinced that Ema’s ok is only a matter of time ».