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September 10, 2021It can also be a health risk to use the

antiviral drug Parvulan

, containing Corynebacterium parvum and without marketing authorization in Italy, legally registered and marketed in Brazil, to combat Covid.



This is the alert released by AIFA and published on its portal. Stimulant of innate immunity, adjuvant in the treatment of dermatological infections of viral, bacterial, fungal and protozoal origin, adjuvant in systemic and local infections, the drug has a regressive effect on solid neoplasms, but is also an adjuvant in the treatment of acne.



Based on the communications and requests received from patients, "including - writes Aifa - those concerning the types of vaccines considered valid for the purpose of issuing the vaccine Green Pass, it was possible to detect a use of the medicine other than that declared in the import request: Parvulan would appear to be offered out of 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-19, as an alternative to authorized vaccines ". 



The Technical Scientific Commission of AIFA issued an opinion on the subject, in which it is emphasized that "the use of the drug Parvulan in the prophylaxis of Sars-Cov-2 infection" is not supported " from the

slightest evidence of efficacy and safety

".



It is also emphasized that" even the rationale for this use is largely insufficient, so much so that the Commission had not deemed it possible to authorize its use even in the context of a clinical trial. The possible

use of the drug to replace the authorized vaccines

(for which solid efficacy and safety data are available) therefore represents a potential danger to 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 in spite of the lack of documented efficacy. "



Vaccine control and patient protection

For this reason, the Medicines Agency 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. It should be remembered that the current national vaccination campaign provides for a strengthened control over the entire supply chain, to the protection of patients: the administration of vaccines, limited to those authorized in Italy for the prevention of SARS-COV-2, takes place exclusively at the official vaccination points, identified by each region.



Suspected adverse reactions to vaccines: 91 thousand out of 76 million doses

In the period December 27, 2020 - August 26, 2021, 91,360 reports of suspected adverse reactions were received out of a total of 76,509,846 doses of the anti-Covid vaccine administered (119 per 100 thousand doses), of which 86.1% referred to unrelated events. severe, such as injection site pain, fever, asthenia / tiredness, body aches. Aifa reports this in the Pharmacovigilance Report on anti-Covid vaccines. The data concern the reports of suspected adverse reactions for the 4 vaccines in use in the campaign.



In the age group between 12 and 19 years, as of 08/26/2021 838 reports of suspected adverse event were received out of a total of 3,798,938 doses of anti-Covid vaccine administered, with a reporting rate of 22 events adverse every 100,000 doses administered. The distribution by type of adverse events is not substantially different from that observed for all other age groups.