“Get your vaccines from DOH-FDA authorized facilities,” says FDA official
MANILA – Dr. Oscar G. Gutierrez, Jr., Food and Drug Administration’s deputy director general for field operations called on the general public to get their vaccines from facilities authorized by the Department of Health and the FDA.
Speaking at the weekly Wednesday Roundtable @ Lido, Dr. Gutierrez, a veteran of FDA operations from 1986, said there are no authorized vaccines being sold online.
“While we receive reports of clandestine vaccination sites, they have yet to catch people in the illicit business red-handed,” Dr. Gutierrez said.
Dr. Beaver Tamesis, president of the Pharmaceutical and Healthcare Association of the Philippines (PHAP) said during his practice, he had patients who claimed to have been inoculated as early as October 2020.
Asked if his patients may have received their jabs abroad, Dr. Tamesis said it was difficult to leave the country at that time.
“You must remember it is still difficult to travel within the country,” Dr. Tamesis said.
Meanwhile, GS1 Philippines Chair Jesus Varela said as early as September, he was offered vaccines by friends who received their jabs. He said he opted not to join the bandwagon as he has no way of tracing the origins of the preparation.
Dr. Gutierrez added the Philippines remains a vaccine importer. He said the whole-of-government approach with the partnership between and among the Departments of Health, Finance, Trade and Industry and the Bureau of Customs with a sole negotiator for the government.
“Secretary Carlito Galvez, Jr. is the only authorized person to negotiate with vaccine manufacturers,” he said. The government remains solid and there’s a very strong possibility counterfeits would reach the country and that the government takes charge from the procurement until post market surveillance where patients are observed, along with a reporting system where those inoculated could report the vaccine’s effects.
Dr. Tamesis said there are unauthorized distributors who use recycled vaccine vials and present them as original vaccines. However, Dr. Gutierrez said health facilities from clinics to hospitals are required to dispose their vaccine vials in the presence of FDA officials.
“Sputnik V’s vials breaks upon use so there’s no change it could be recycled,” Dr. Gutierrez added.
Asked of the current available vaccines in the Philippines, Dr. Gutierrez said Pfizer, Sinovac, Sputnik V, AstraZeneca and Bharat Biotech have received Emergency Use Authorization.
Asked of Sinophram’s entry into the Philippines where the Presidential Security Group where its personnel have been inoculated, Dr. Gutierrez said it was under Compassionate Special Permit (CSP) where the Health officials from the PSG requested permission to import the said vaccines.
President Rodrigo Duterte was inoculated with Sinopharm vaccine last Monday by no less than Health Secretary Francisco T. Duque III in Malacañang.
Dr. Gutierrez said the PSG Health officials are responsible in monitoring the Sinopharm vaccine’s effects on those inoculated.
After successful trials and peer review, vaccines may be given Certificate of Product Registration which means it could be sold to the general public.
It will be recalled the FDA said no COVID-19 vaccines are available on line and that no COVID-19 vaccines are sold in any pharmacy of drug outlets.
“Any vaccine being advertised on websites are not legitimate. Only COVID-19 vaccines with Emergency Use Authorization and those purchased by and through the Philippine Government are allowed,” the FDA advisory added.
GS1’s Jess Varela said the government needs to watch because substandard vaccines and other products are getting into Third World countries like the Philippines.
He expressed fears with the coming mass production of vaccines, there may be instances when counterfeit vaccines get into the legitimate market without the necessary safeguards provided by strict standards using barcodes.
“These codes include the products origins, contents and other basic information that need to be known by consumers. Most pharmaceutical companies are into the GS1 program,” Mr. Varela said. However, the FDA suspended its implementation in the Philippines some years ago.
Dr. Gutierrez said most small and medium scale industries cannot cope with the stringent measures to which Mr. Varela said the use of GS1 application will assure everyone of safe, effective, and dependable products, be they pharmaceutical or other consumer items.
Dr. Tamesis meanwhile said the Philippine drug industry was worth P270 billion in 2019 although it dipped by 11% last year due to the pandemic.
“People are too afraid to visit hospitals, but I tell you, the only part of the hospital that are fully utilized are for COVID-19 cases. Non-COVID cases are at a low 40% and hospitals are suffering. They need to revisit their plans and programs and find out the role they place, realign expenses and assure their patients of uninterrupted supply of medicines,” Dr. Tamesis added.
FDA Deputy Director General Oscar G. Gutierrez, Jr, PHAP President Dr. Beaver Tamesis and GS1 Philippines' Chair Jesus Varela. (Screen grabs from Wednesday Roundtable @ Lito/Melo M. Acuna)