BY IME SORNITO
ILOILO City – The Department of Health (DOH) has issued an advisory urging local government units (LGUs) in Western Visayas, healthcare professionals, and the public to remain vigilant and refrain from using an unregistered anti-rabies vaccine.
The advisory specifically warns against the purchase and use of the purified chick embryo cell culture rabies vaccine called VaxiRab N (with Batch No. Vial RV40015; Batch No. Ampule CH223004).
“This product is unregistered, and its use poses a serious risk to public health. We advise all healthcare professionals and the general public to be cautious and avoid any supplies of this product,” DOH Region 6 stated in its advisory, which was posted on its official Facebook page.
It also reminded LGUs to “monitor and prevent the distribution or purchase of this unregistered product” in their localities.
Rabies is a viral disease primarily transmitted through the bite of an infected animal, often dogs. The virus affects the central nervous system, ultimately leading to brain inflammation and, if untreated, death.
Symptoms may include fever, headaches, and discomfort at the site of the bite, progressing to severe neurological symptoms such as paralysis, hallucinations, and agitation.
Rabies can be prevented by vaccinating pets, avoiding contact with stray or wild animals, and seeking prompt medical attention after potential exposure.
Proper vaccination of pets and immediate administration of post-exposure prophylaxis (PEP) can save lives.
The DOH warning followed the discovery of questionable samples of the VaxiRab N vaccine at the Rural Health Unit (RHU) of Oton, Iloilo. This came after RHU-Oton submitted an incident report to DOH-6 due to concerns raised about the vaccine they had been using.
According to the incident report, RHU-Oton began administering a new batch of VaxiRab N on July 12, 2024. However, discrepancies were soon observed compared to previous batches of the vaccine.
These were the discrepancies:
* Packaging – The labels had noticeable differences in font style and printing quality.
* Diluent Volume – The diluent included in the kit was only 0.5-0.8 ml, deviating from the standard 1.0 ml.
* Vaccine Powder – The vaccine powder had a talcum-like consistency and was difficult to dissolve.
* Vaccine Characteristics – The reconstituted vaccine lacked the typical itchy or sticky sensation associated with previous batches.
RHU-Oton raised concerns about the potential impact on public health, particularly the risk of reduced protection against rabies due to the atypical characteristics of the vaccine.
As a result, the affected batches were immediately quarantined, and a report was submitted to the DOH.
Upon receiving the report, DOH-6 promptly collected samples from RHU-Oton and sent them to the Food and Drug Administration (FDA) for verification.
On September 25, 2024, Director IV Maria Cecilia Matienzo of the FDA’s Center for Drug Regulation and Research, certified that the anti-rabies vaccine, manufactured by Zydus Lifesciences Limited, was illegally diverted and intended for the Indian market.
In response, the FDA ordered DOH-6 and RHU-Oton to conduct an inventory and seize the violative drug product./PN
