Philippines FDA warns of counterfeit rabies vaccine
The Philippines Food and Drug Administration (FDA) together with Novartis Healthcare Philippines, Inc. have determined that there are illegally imported and unregistered Purified Chick Embryo Cell (Rabipur) Rabies Vaccine being offered for sale in vaccination clinics, drug establishments and outlets and internet websites.
A complaint sample of Rabipur Rabies Vaccine was collected at Tabuk City, the capital of pro of province of Kalinga. Upon verification of the complaint sample’s authenticity, it was confirmed to be counterfeit.
According to Acting Director General of the FDA, Dr. Kenneth Hartigan-Go, the rabies vaccine is administered to people who are at high risk of exposure to rabies or to someone who have been exposed to rabies. Vaccines are sensitive biological substances that can lose their potency and effectiveness if they are exposed to temperatures outside the temperature range of 2 to 8 degree Celsius.
“Proper handling and storage should be exercised to assure product’s safety, efficacy and quality. However, there is no assurance of safety, efficacy and quality of counterfeit vaccines,” Hatigan-Go adds in the FDA statement.
All drug establishments and outlets have been warned against importing, distributing and selling unregistered drug product.
Rabies is an acute viral infection that is transmitted to humans or other mammals usually through the saliva from a bite of an infected animal. It is also rarely contracted through breaks in the skin or contact with mucous membranes.
According to the Control of Communicable Diseases Manual, all mammals are susceptible to rabies. Raccoons, skunks, foxes, bats, dogs, coyotes and cats are the likely suspects. Other animals like otters and ferrets are also high risk. Mammals like rabbits, squirrels, rodents and opossums are rarely infected.
Animals with rabies can appear very aggressive, attacking for no reason. Some may act very tame. They may look like they are foaming at the mouth or drooling because they cannot swallow their saliva. Sometimes the animal may stagger (this can also be seen in distemper). Not long after this point they will die. Most animals can transmit rabies days before showing symptoms.
Initially, like in many diseases, the symptoms are non-specific; fever, headache and malaise. This may last several days. At the site of the bite there may be some pain and discomfort. Symptoms then progress to more severe: confusion, delirium, abnormal behavior and hallucinations.
More than 55 000 people die of rabies every year mostly (95%) in Asia and Africa.
Post-exposure prophylaxis (PEP) consists of:
- local treatment of the wound, initiated as soon as possible after exposure;
- a course of potent and effective rabies vaccine that meets WHO recommendations; and
- the administration of rabies immunoglobulin, if indicated.
Effective treatment soon after exposure to rabies can prevent the onset of symptoms and death.
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