FDA clueless on arrival of Sinopharm vaccines
No evaluation has been done on the safety, efficacy and quality of the Sinopharm vaccine given to President Duterte Monday night, the Food and Drug Administration (FDA) said yesterday.
FDA director general Eric Domingo also admitted not knowing that Sinopharm vaccines had already arrived in the country until one was given to the President on Monday night.
“As of early March, we asked them to report and they told us that the vaccines have not arrived. I don’t have the full information when and how many (doses) arrived,” Domingo said.
He said that while Sinopharm was not evaluated yet because it has not applied
for emergency use authorization (EUA), the jab is covered by compassionate special permit (CSP) issued to Presidential Security Group (PSG) Hospital last February.
“When we give CSP, it’s very clear that we have no assurance of its safety, efficacy and quality because they were not evaluated by the FDA,” Domingo said. He added that PSG Hospital will have to take “full responsibility” for the consequences of Sinopharm inoculations.
Earlier, Domingo said three companies sent separate letters of intent to apply for EUA but none have submitted the needed requirements, “so there is no Sinopharm application to evaluate at this point.”
Domingo also stated that FDA is facing a “blank wall” in its probe on the illegal vaccination of PSG personnel with Sinopharm jabs last year as the PSG is still not cooperating with their request for information.
“Until now, we have no lead in the investigation. We wanted to know who received the vaccines so we can monitor them,” Domingo said.
No violation
Malacañang said President Duterte did not violate any law when he had himself inoculated with the Sinopharm vaccine without FDA approval.
“The President did not commit anything illegal because (Sinopharm) has been issued compassionate use for use of the PSG Hospital and the vaccine used by the President is not smuggled because it was part of the ones donated by the Chinese government,” presidential spokesman Harry Roque Jr. said.
In March, Roque said the President would wait until the FDA issues an EUA for Sinopharm. But the delay prompted Duterte, upon consultation with his doctors, to take the Sinopharm jab already.
Health Secretary Francisco Duque III also defended the inoculation, saying that having the public witness the President’s vaccination will increase confidence in the jabs.
“It only means that the President believes that our vaccines are safe and effective,” Duque said.
Chief presidential legal adviser Salvador Panelo also got a Sinopharm jab yesterday morning inside the Malacañang compound.
Mockery
Militant group Bagong Alyansang Makabayan (Bayan) slammed President Duterte and Duque for “making a mockery” of the vaccine approval process.
“It has become one questionable act after another. Our regulatory processes bent in favor of those in power. This is just a sample of what we find wrong in the entire pandemic response. There are so many exceptions for VIP and people in power, while there are so many restrictions imposed on ordinary people. It is hardly science-based and reveals how chaotic the pandemic response has been,” Bayan secretarygeneral Renato Reyes said.