FDA warns public vs fake COVID-19 vaccines sold online

Robie de Guzman   •   March 31, 2021   •   286

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  • It has an out-of-date or missing expiry date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)

FDA issues advisory on sale of unregistered drug Lianhua Qingwen Jiaonang

Robie de Guzman   •   April 19, 2021

 

MANILA, Philippines – The Food and Drug Administration (FDA) has advised the public against the sale and distribution of unregistered drug Lianhua Qingwen Jiaonang with Chinese characters.

In its advisory, the FDA said there is still an “incessant sale and distribution” of the product, which were verified as unregistered.

 “As per continuing surveillance, there is still an incessant sale and distribution even through social media platforms, such as Facebook, of Lianhuan Qingwen Jiaonang with Chinese characters, which were verified as unregistered by the FDA,” the agency said.

The FDA added that only the Lianhuan Qingwen Jiaonang with English text and details provided in the advisory was issued with a certificate of product registration and approved to be sold/marketed in the Philippines.

“The agency cannot guarantee the quality and safety of the product with the Chinese text due to these have not undergone evaluation by the FDA and these came from unlicensed sources or establishments. The consumption of such violative product may pose potential danger or injury if administered,” it said.

Lianhuan Qingwen Jiaonang is a traditional Chinese drug that some people believe can cure COVID-19, but health experts said this drug should only be taken with a doctor’s prescription.

“All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product, otherwise regulatory actions and sanctions shall be strictly pursued,” the FDA said.

Under the country’s Food and Drug Administration Act of 2009, the manufacture, importation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from the FDA is prohibited.

Second hospital given compassionate permit on ivermectin use vs COVID-19 – FDA

Robie de Guzman   •   April 16, 2021

MANILA, Philippines – Another hospital has been granted with compassionate special permit (CSP) to use anti-parasitic drug ivermectin to treat patients with COVID-19, the Food and Drug Administration (FDA) said Friday.

“Two hospitals na actually na nag-apply sa atin ang nabigyan ng CSP,” FDA director-general Eric Domingo said in an interview with ANC.

Domingo, however, did not specify the names of these hospitals.

The FDA earlier said that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

The agency also emphasized that a compassionate use permit is different from a certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise reiterated that only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will use ivermectin to treat COVID-19 patients are required to report to the FDA on a monthly basis, he said.

The FDA earlier said that the distribution and promotion of ivermectin as a COVID-19 treatment remains prohibited in the country.

Ivermectin is registered in the Philippines for veterinary use to prevent heartworm disease and treat internal and external parasites in certain species.

The agency also stressed that the ivermectin products registered for human use in the country were in topical formulations under prescription use only. – RRD (with details from Correspondent Aiko Miguel)

FDA recommends continued use of AstraZeneca COVID-19 vax in PH

Robie de Guzman   •   April 15, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) on Thursday recommended to the Department of Health (DOH) the continued use of AstraZeneca COVID-19 vaccine in the country’s vaccination drive.

In a Palace briefing, FDA director-general Eric Domingo said the World Health Organization (WHO), Philippine Vaccine Experts Panel, and the adverse events committee were “unanimous” in saying that the benefits of using AstraZeneca vaccine outweigh the risks.

“Sumulat ako kanina kay [Health] Secretary [Francisco] Duque para sabihin sa kanya, reiterate the benefit outweighs risk and we should continue using the vaccine,” he said.

“Tamang-tama nama, padating pa lang yung next vaccine natin, siguro mga two or three weeks, so yung mga nabigyan dati, matutuloy naman yung kanilang second dose,” he added.

The development came after the FDA and DOH temporarily suspended the use of AstraZeneca vaccine to persons below 60 years old following reports in other countries of “very rare” blood clotting possibly linked to the vaccine.

“Dito sa atin wala pang nakita yung adverse events committee natin na similar cases. Pero sa Europa, at saka sa ibang parte ng mundo, nakita na very rare naman ito,” Domingo said.

The FDA chief earlier said that a new set of guidelines on the use of AstraZeneca vaccine will be issued this week for those who will be giving the vaccine “so they can properly advise those who will be getting the vaccine in terms of what symptoms to watch out for.”

“Kasi kailangan lang paalalahan yung mga nagbabakuna, of course, that there’s the possibility of this rare side effect at kung ano ang gagawin kung sakaling merong makita na mga sintomas, at guidelines lang po ng ating mga vaccinators kung sino ang pwede at hidi pwedeng bigyan ng bakuna,” he said.

 

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