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AT YOUR OWN RISK: FDA 'does not guarantee' safety, efficacy of Sinopharm vaccines for PSG use
AT YOUR OWN RISK: FDA 'does not guarantee' safety, efficacy of Sinopharm vaccines for PSG use
While it has granted the Compassionate Special Permit (CSP) to the Presidential Security Group (PSG) for the use of vaccines developed by Chinese pharmaceutical firm Sinopharm, the Food and Drug Administration (FDA) on Friday, Feb. 12, clarified that it “does not guarantee the safety and efficacy” of the said product.
“This is not a registered product and it does not undergo FDA verification,” said Director General Rolando Enrique Domingo in an online interview. “What we know is that it is registered in China but there is no application for registration here,” he added.
Given this, Domingo clarified that FDA “does guarantee the safety or the safety of this product” and that the person who applied for CSP or the person responsible for it will need to take “full responsibility for the product and its use.”
“The FDA does not guarantee the safety and efficacy of this product - that lies completely and solely on the shoulders of PSG Hospital,” Domingo stressed.
Domingo explained that the PSG Hospital, in a letter dated Jan. 18, initially wrote to FDA asking for CSP for the vaccine for PSG members. “We gave the requirements and the were able to comply,” he said. However, he stressed that such permit is only applicable for “future use” and “one-time importation.”
In requesting for the CSP, the PSG cited that this is crucial to protect President Duterte since close contact is needed - thus, social distancing may not be observed at all times.
“The health of the President is a national issue and we don’t want him getting sick and those around him, we decided to grant the CSP for PSG,” Domingo said.
Domingo said that the PSG Hospital requested 10,000 doses. “Apparently, there are more than 2,000 members of the PSG - including the soldiers that surround the President, some here in Manila and are in Davao,” he said.
Half of the requested amount, Domingo explained, will be used for the actual PSG and other half for “close contact” of PSG members - particularly their spouses. “What they asked is enough for 5,000 people,” he added.
The CSP is a special permit issued by the FDA. It grants an entity the privilege to avail of an unregistered drug, medical device, or food product. For COVID-19 vaccines, Domingo said that only “specialty groups, societies, or institutions” can apply for CSP.