The drug, not authorized in Italy but imported from Brazil, appears to be offered off-label as a therapy for the prevention of Covid, as an alternative to authorized vaccines. “The use of the drug Parvulan in the prophylaxis of Sars-Cov-2 infection is not supported by the slightest evidence of efficacy and safety. The possible use of the drug in place of authorized vaccines therefore represents a potential health hazard”.
10 SET – Aifa intervenes on the use of Parvulan in the prophylaxis of Sars-Cov-2 infection. The drug, without MA in Italy, is legally registered and marketed in Brazil as an “adjuvant in the treatment of dermatological infections of viral, bacterial, fungal and protozoal origin, adjuvant in systemic and local infections. It has a regressive effect on solid neoplasms. treatment of erysipelas caused by Streptococcus pyogenes. Adjuvant in the treatment of acne “.
On the basis of the communications and requests received from patients, including those regarding the types of vaccines considered valid for the purpose of issuing the vaccine “Green Pass”, Aifa found that the medicine was used differently from that declared in the import request. : Parvulan would therefore be offered off indications (off label, therefore outside the constraints provided for in the aforementioned Ministerial Decree 11/2/97) as a therapy for the prevention of Covid, as an alternative to authorized vaccines.
The available documentation was subjected to the evaluation of the Technical Scientific Commission of Aifa (Cts) which, following examination of the preliminary investigation carried out in the session of last 12 July, expressed its opinion: “The Cts, having examined the investigation of the Offices , believes that the use of the drug Parvulan in the prophylaxis of Sars-COV-2 infection is not supported by the slightest evidence of efficacy and safety. It is also emphasized that even the rationale for this use is largely insufficient, so much so is It is true that the Commission had not considered it possible to authorize its use even in a clinical trial. The possible use of the drug as a substitute for authorized vaccines (for which solid efficacy and safety data are available) therefore represents a potential danger for people’s health due not only to the at least uncertain safety profile but also to the unjustified sense of protection that the treatment could generate despite the lack of documented efficacy “.
In light of these conclusions, AIFA with respect to the use of Parvulan, “considers it essential to draw the attention of all citizens to the risks associated with the use of unauthorized medicines for the prevention of Sars-CoV-2 infections (Covid- 19) “.
“We remind – Aifa underlines how the current national vaccination campaign provides for a reinforced control over the entire supply chain, to protect patients: the administration of vaccines, limited to those authorized in Italy for the prevention of Sars-Cov-2 infection , takes place exclusively at the official vaccination points, identified by each Region. The Agency therefore considers it necessary to invite all citizens to be wary of any alternative solution to official vaccines, or of any vaccine or medicine that has not been subjected to the necessary checks by of the authorities in charge, and which as such can represent a health risk as it lacks any guarantee with respect to the actual effectiveness in the prevention of Covid-19. A prudent attitude is more than ever necessary also in light of the persistence of the emergency. lastly, to reiterate how indispensable is the collaboration of all – private citizens, health professionals i, companies and associations – so that suspicious cases, such as the one reported here, are constantly reported to Aifa in order to implement all necessary measures to protect public health and the individual “.
September 10, 2021
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