Philippines targets manufacturers of counterfeit rabies vaccines
The Philippines Food and Drug Administration (FDA) has issued a closure notice for a company allegedly responsible for producing counterfeit rabies vaccines.
Filipino media outlet ABS-CBN reported yesterday, February 3, that the FDA had temporarily closed Geramil Trading, which is suspected of distributing a fake version of the Verorab vaccine.
The news followed a World Health Organization (WHO) medical product alert for a falsified rabies vaccine circulating in the Philippines, issued Thursday, January 31.
Verorab, manufactured by French pharmaceutical company Sanofi Pasteur, is administered for both pre-exposure vaccination and post-exposure prophylaxis.
The counterfeits first came to the attention of Filipino authorities late last year. In December, the Philippines Food and Drug Administration (FDA) issued a public health warning concerning falsified versions of the vaccine.
According to WHO, a further batch of the counterfeits have since emerged. “Investigations are ongoing and laboratory analysis is underway to better assess the potential risk to public health”, a WHO statement said.
There are two counterfeit versions of Verorab in circulation, with batch numbers NIE135 and HI1833, according to the alert. Both contain powder in a vial, while one contains solvent in a syringe and the other in an ampoule.
Geramil is accused of distributing batch HI1833, the ABS-CBN report said.
Eric Domingo, Health Undersecretary, reportedly told ABS-CBN that the company faces administrative and criminal charges.
The Medical City, a Filipino healthcare network primarily based in Manila, acknowledged that it had administered the counterfeit vaccine to patients earlier this year, but said it had since co-operated with the FDA and the Department of Health in reporting and testing the counterfeit batch.
In a statement sent to LSIPR, the hospital said that “there is no reason to believe that the culprit vaccines contain harmful substance or that it has caused any reported case of rabies”.
“At the administrative level, our institution is doing its duty as a corporate citizen to contain this public health concern”, the statement added.
There were no adverse reactions to the fake vaccines reported at the time of the issuing of the WHO alert. According to the WHO statement, Sanofi Pasteur confirmed to the authorities that it did not manufacture the vaccines in the relevant batch numbers.
WHO urged anyone in possession of the vaccines not to use them, and if they already had, to seek urgent medical attention. The organisation requested that national health authorities notify them if these or any other falsified vaccines were found to be in circulation in their jurisdiction.
In a statement sent to LSIPR, Sanofi Pasteur said it had alerted the FDA to the counterfeit vaccine on December 12.
“Our vaccines are manufactured in compliance with Good Manufacturing Practices requirements and fully comply with international and Philippine FDA standards”, the statement said.
The Sanofi spokesperson added that since the discovery of the counterfeit product, the company has cooperated with the FDA to help stop the sale of it to hospitals and pharmacies “that may unknowingly procure it”.
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