The drug, approved in Brazil (not in Italy), was the subject of a parliamentary question in July 2020. For AIFA, even minimal evidence of efficacy and safety is lacking
In Italy, requests for imports of Parvulan, a drug not on the market, have increased. What is it about?
a medicine based on Streptomyces, a bacteria that is harmless to humans. Legally registered and marketed in Brazil (but not in Italy, nor in other countries), it is believed to have an immunostimulating action. The leaflet of the Brazilian product reads: 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. In Italy it has been talked about for some time: in July 2020, Forza Italia senator Enrico Aimi presented a parliamentary question to evaluate the proposal made to the Medicines Agency (Aifa) by Professor Beniamino Palmieri of the University of Modena and Reggio Emilia, according to which – pending the arrival of vaccines – Parvulan could have protected people from contagion. Today, more than a year later and in the middle of the countryside with effective and safe vaccines, Aifa has launched an alarm on the clandestine importation of the product, which is ordered for the treatment of Herpes Zoster. In reality – writes Aifa in the press release – used to replace the anti-Covid vaccine.
Can it really protect against infection?
The answer no, the experts have no doubts. The use of the drug in the prophylaxis of Sars-CoV-2 not supported by the minimal evidence of efficacy and safety and a potential danger to people’s health, the opinion of the Agency of the drug. The Streptomyces a bacterium similar to the one that causes diphtheria, but “good” – he explains Gianni Sava, professor at the University of Trieste, former director of the Italian Society of Pharmacology (Sif) -. The problem is that we don’t know if Parvulan produces immunity, because no human studies have been done, only in vitro. In the 1970s it was studied as a possible immunomodulator in the treatment of tumors, but then the hypothesis was abandoned.
What are the risks of using this medicine yourself?
As mentioned, the non-toxic molecule per se (in Italy there is a product with similar characteristics, lysozyme). But there is no scientifically valid evidence that can protect against Covid. Not only that – continues Sava -. Any interactions with other medications are not known, so a person taking Parvulan may experience side effects. Also, if you take too high a dose, as is the case with ivermectin (a pesticide) in the United States, there are health risks. unreasonable to use molecules whose effectiveness is unknown when we have highly protective vaccines.
Have studies been done on Parvulan as a prophylaxis against the coronavirus?
No, the scientific technical commission of Aifa believes that the rationale for this use is largely insufficient. In fact, in the face of Professor Palmieri’s proposal, the Commission had not considered it possible to authorize its use even in the context of a clinical trial. In addition to having no supporting scientific studies – confirms Sava -, we know of this drug, only through anecdotal writings and therefore relating to individual patients, the effectiveness in the treatment of some infections, not in the prevention of the same. At the moment there is no drug that can replace the vaccine – warns the pharmacologist Silvio Garattini, founder and president of the Mario Negri Institute -, except for monoclonal antibodies which, however, have a limited action over time, unlike vaccination which gives long-term coverage.
September 11, 2021 (change September 11, 2021 | 09:47)
© Time.News