French-made Covid nasal spray suspended due to lack of safety data
A French company has been ordered to halt sales and recall a nasal spray that it claimed eliminated Covid after the national health regulator said there was no data demonstrating its performance or safety.
The French company Pharma & Beauty had announced that its spray would be available for purchase in pharmacies from March 1st. The company claimed its "Spray Nasal COV-Defense", also called "spray nasal Biokami", which is made from ionized water, gets rid of about 99 percent of the viral load in 30 seconds.
But the national medicines agency, the Agence nationale de sécurité du médicament (ANSM), said it had not received any clinical validation demonstrating the performance and safety of the spray - a basic requirement for marketing the product.
#COVID19 Suspension de la commercialisation du « spray nasal COV-Defense » ou « spray nasal Biokami » qui assurerait l'inactivation du virus
🔹Nous n’avons reçu aucune donnée de validation clinique démontrant la performance et la sécurité d’utilisation
👉https://t.co/6hAdEWMhgr pic.twitter.com/3tqpqtFnSH
— ANSM (@ansm) February 23, 2021
"In the absence of such requirements and pending further information, the marketing, distribution, advertising and use of the spray is suspended until they are brought into compliance with the regulations," the agency said in a statement.
Scientists warn that above all, a spray like this would at best serve as an extra barrier for the virus, much like masks, but nothing more.
"It might work in the moment you use it, but it won't have a residual effect," professor Bernard La Scola of IHU Méditerranée hospital told France Info.
The company has also been ordered to recall any sprays that may have already been distributed, and inform all people who may have obtained it.
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The French company Pharma & Beauty had announced that its spray would be available for purchase in pharmacies from March 1st. The company claimed its "Spray Nasal COV-Defense", also called "spray nasal Biokami", which is made from ionized water, gets rid of about 99 percent of the viral load in 30 seconds.
But the national medicines agency, the Agence nationale de sécurité du médicament (ANSM), said it had not received any clinical validation demonstrating the performance and safety of the spray - a basic requirement for marketing the product.
#COVID19 Suspension de la commercialisation du « spray nasal COV-Defense » ou « spray nasal Biokami » qui assurerait l'inactivation du virus
— ANSM (@ansm) February 23, 2021
🔹Nous n’avons reçu aucune donnée de validation clinique démontrant la performance et la sécurité d’utilisation
👉https://t.co/6hAdEWMhgr pic.twitter.com/3tqpqtFnSH
"In the absence of such requirements and pending further information, the marketing, distribution, advertising and use of the spray is suspended until they are brought into compliance with the regulations," the agency said in a statement.
Scientists warn that above all, a spray like this would at best serve as an extra barrier for the virus, much like masks, but nothing more.
"It might work in the moment you use it, but it won't have a residual effect," professor Bernard La Scola of IHU Méditerranée hospital told France Info.
The company has also been ordered to recall any sprays that may have already been distributed, and inform all people who may have obtained it.
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