By Teddy Cambosa
The Food and Drug Administration (FDA) in the Philippines has recently warned the public about a fake vaccine, purposely labeling itself to be from Pfizer.
According to the FDA advisory, the COVID-19 vaccine is identified as “BNT162b2”, initially detected in Mexico last February 2021 and was recently confirmed as falsified to the WHO by the manufacturer. It has a lot of 783201 and an expiry date of August 24.
“The FDA strongly advises the public to be vigilant on the circulation of this falsified COVID-19 vaccine since this poses a serious risk to global public health and further increases the burden on vulnerable populations and health systems,” FDA stated in a press statement.
They added, “A falsified vaccine deliberately or fraudulently misrepresents identity, composition, or source, and upon confirmation with the genuine manufacturer, it was confirmed that this vaccine was not manufactured by them, batch number and expiry date were falsified, and glass vials and labels were different from the authentic COVID-19 vaccine BNT162b2 vials.”
Meanwhile, FDA also clarified on the use of the drug Leronlimab that while it has been given a Compassionate Special Permit (CSP) for COVID-19 patients, it is still not approved by the FDA for treatment of COVID-19.
Leronlimab is an investigational product which is still undergoing clinical trials for the treatment of Cancer and Human Immunodeficiency Virus (HIV). Now, it is also being investigated for use in the treatment of COVID-19.
It is clarified that a CSP is a special permit granted to physicians or hospitals to use investigational drugs or drugs which are not yet registered or in the process of registration here in the Philippines for the treatment of seriously ill patients. A CSP can only be requested by physicians in charge or by the institution where patients are being treated, who takes full responsibility for the use and dispensing of the requested drug product.
However, while a CSP grants access to investigational drugs, such as Leronlimab, the permit is not intended to replace the prescribed drug registration process which involves a systematic evaluation of evidence-based data. It must be stressed that an approved CSP is not a Certificate of Product Registration (CPR) or an Emergency Use Authorization (EUA), hence it is not an assurance of the product quality, safety, and efficacy.
Teddy Cambosa is a graduating BS Biology student and a former campus journalist at Batangas State University. He is also currently writing for MARKETECH APAC, a small APAC-focused marketing news site.