MANILA, Philippines – The Food and Drug Administration (FDA) has warned the public against purchasing COVID-19 vaccines supposedly sold online.
Dr. Oscar Gutierrez, FDA Field Regulatory Operations Deputy Director, said COVID-19 vaccines currently in use are only issued with emergency use authorization (EUA) in the country and are not commercially sold.
An EUA is issued for unregistered vaccines during a public health emergency and is not a certificate of product registration or a marketing authorization, he stressed.
“I am sure that vaccines sold online are falsified and fake vaccines. They should not be patronized by anybody. Otherwise, they are only giving their money to the criminals,” Gutierrez said during a virtual press briefing.
The FDA official also said that legitimate and approved COVID-19 vaccines are not available online.
To date, there are only four COVID-19 vaccines that were granted with emergency use authorization by the Philippine government. These are Pfizer-BioNTech, AstraZeneca, Sinovac’s CoronaVac, and Gamaleya’s Sputnik V.
Gutierrez warned that fake COVID-19 vaccines are contaminated with hazardous substances which may lead to severe diseases, toxicity, or death.
Fake vaccines are likewise ineffective, giving a false sense of protection, he added.
According to the FDA, spotting fake COVID-19 vaccines can be difficult and a laboratory test is the only way to identify the difference between a fake and an authentic vaccine.
The public, however, can take note of the following ways to spot fake COVID-19 vaccines:
- Counterfeit vaccines are not correctly labeled or not labeled at all
- It has an out-of-date or missing expiry date
- It does not contain information on how to store the medicine
- In terms of packaging, fake vaccines’ packaging looks poorly constructed or appears to have been altered
- There are spelling or grammatical errors on the packaging or instructions
- In terms of the vials, counterfeit vaccines may have dirty or scratched bottles
- The cap (plastic/aluminum) is dent or broken
- The rubber seal is already punctured
- For products that need to be diluted, the color changes or solution becomes cloudy; there are foreign matters inside the vial
The FDA said it has tasked regulatory inspectors to monitor reports of fake vaccines.
To ensure that no counterfeit COVID-19 vaccine gets into the country’s supply chain, the agency said it has collaborated with the World Health Organization, the International Police Organization, and other international groups.
Those found selling fake vaccines will face penalties under the Food and Drug Administration Act of 2009, the FDA said.
“They are actually violating the RA 9711 or the FDA Act of 2009 specifically provisions po on prohibition which states that no vaccine should be imported, manufactured, sold, transported, advertised, offered for sale which is not registered with the FDA,” Gutierrez said.
The agency also called on the public to report to the FDA individuals offering or selling COVID-19 vaccines online. – RRD (with details from Correspondent Aiko Miguel)