Covid and unauthorized treatment in Italy. The Italian Medicines Agency (Aifa) raises the alarm for the use of a drug, the Parvulan, indicated for the treatment of Herpes Zoster, the so-called ‘shingles’, in the prophylaxis against Coronavirus. The drug is illegal in Italy because it is not authorized, but it is registered and marketed in Brazil. In our country, however, suspicious import requests have increased exponentially. Hence the discovery of the use in place of anti-Covid vaccines. “The use of the drug in the prophylaxis” of Sars-CoV-2 “is not supported by the minimal evidence of efficacy and safety” and “represents a potential danger to people’s health“, warns AIFA in an opinion from the Agency’s Technical Scientific Commission.
The investigations by AIFA arise after the Maritime, Air and Border Health Offices (Usmaf) of the Ministry of Health (also responsible for the supervision and verification of certain types of imports of medicines from abroad), reported suspicious requests import concerning the Parvulan. This drug – explains Aifa – containing Corynebacterium parvum is registered and marketed in Brazil as a stimulant of innate immunity, 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. Help in the treatment of erysipelas caused by Streptococcus pyogenes. Adjuvant in the treatment of acne “.
Aifa’s investigations were aimed at “ascertaining the reference framework and the admissibility of the import, due to both the considerable quantities requested, and the therapeutic indication reported in support of the import, namely the treatment of patients suffering from Herpes Zoster, a disease for which, currently, various medicines (and molecules) are authorized and marketed in Italy “.
“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 – the drug Agency reports – it was possible to detect a different use of the drug from that declared in the import request: Parvulan would appear to be offered out of indications (off label as a therapy for the prevention of Covid-19, as an alternative to authorized vaccines.
The Technical Scientific Commission (Cts) of Aifa therefore expressed its opinion, believing that “the use of the drug Parvulan in the prophylaxis of Sars-CoV-2 infection is not supported by even minimal evidence of efficacy and safety. moreover, that even the rationale for this use is largely insufficient, so much so that the Commission had not considered it possible to authorize its use even in the context of a clinical trial “.
And again: “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 to, in addition to the at least uncertain safety profile, also of the unjustified sense of protection that the treatment could generate in spite of the lack of documented efficacy “.
For this reason, the AIFA draws the attention of all citizens to the risks associated with taking unauthorized medicines for the prevention of infections from Covid-19. The Agency “therefore believes that it is right to ask 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 the competent authorities, and which as such may represent a health risk in as lacking any guarantee with respect to the actual effectiveness in the prevention of Covid-19 “, concludes Aifa, recalling the importance of the” collaboration of everyone – private citizens, health professionals, 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 “.