Justifying illegality

President Duterte casually disclosed in a televised address on Dec. 26 that members of his close-in security detail had been secretly inoculated with the COVID-19 vaccine from Chinese pharmaceutical giant Sinopharm sans the required authorization and approval from the Food and Drug Administration (FDA). His exact words: “Sabihin ko sa iyo, marami na ang nagpa-injection dito sa Sinopharm. Halos lahat ng sundalo natusukan na. I have to be frank and I have to tell the truth. I will not foist a lie.”

The alarming revelation triggered a barrage of pointed criticism and brought to the fore grave concerns, not least of which was that the President himself, sworn to uphold and defend the law, appeared to be fine with government personnel in his very circle violating the Food and Drug Administration Act of 2009.

The FDA Act “prohibits the manufacture, importation, exportation, sale, distribution, transfer and non-consumer use of unregistered products.” The FDA has stressed that so far, no COVID-19 vaccine has been approved for local use, which means the vaccines from Sinopharm that were injected on the Presidential Security Group members purportedly as early as September last year were smuggled in, and their use an illegal act.

Only two vaccine makers have so far sought regulatory approval to sell and distribute their vaccines in the country under emergency use authorization: Pfizer-BioNTech, which has secured approval from the World Health Organization and is already being used in the United States and the United Kingdom, and AstraZeneca.

Sinopharm has yet to seek FDA approval, although the FDA said it is expected to do so “in the next few days.” This is the same Sinopharm that last year had the audacity to ask that the Philippines, through the Department of Science and Technology (DOST), either fund the conduct of the clinical trial for its COVID-19 vaccine, or merely recognize the emergency approval/authorization from China.

In effect, Sinopharm was asking the Philippine government to bypass its own regulatory processes and merely rely on the assurances of safety by the Chinese government, which, it bears pointing out, has a vested interest in pushing for Sinopharm vaccines, the company being state-owned. That glaringly irregular detail apparently escaped Malacañang mouthpiece Harry Roque, who, in trying to tamp down the uproar over the illegal use of the Sinopharm vaccine on the presidential guards, essentially parroted Sinopharm’s stance that the FDA’s evaluation was irrelevant. “Ang importante po ay mayroong EUA [emergency use authorization] iyan sa Tsina,” Roque declared.

Sinopharm, which continues to be hounded by trust issues due to lack of transparency on its test results, eventually dropped its plan to conduct clinical trials in the Philippines, saying in October last year that it had “changed its mind,” perhaps after the DOST turned down the proposal for the country to underwrite the clinical trials on grounds that the Philippines only funds trials under the WHO Solidarity Trial.

It goes without saying that the use of an unauthorized drug may have unnecessarily put the lives of the PSG men in danger. As FDA director-general Eric Domingo said, “Without the proper authorization, there is no guarantee on the safety, quality, and efficacy of said vaccine as the same has not undergone the required technical evaluation by the FDA.”

The clandestine use of the Sinopharm vaccine in the Philippines even came ahead of the Chinese government’s own approval of that particular vaccine for general use on its citizens, which came only at the end of last year after the company revealed an efficacy rate of 79.34 percent for its vaccine. That still trailed the over 90-percent efficacy rate of rival vaccines from Pfizer/BioNTech and Moderna, Inc.

So if Sinopharm is still barred for use here, who facilitated its illegal entry, and at such volumes that, according to Chinese-Filipino community leader Teresita Ang-See, over 100,000 Chinese nationals in the country, mostly Pogo workers, have also been inoculated with the vaccine?

Ang-See claimed the Sinopharm shots were “legitimate” and that they were coursed through “official channels.” But if the FDA, the health department, the Bureau of Customs, etc. have all said that no vaccine shipments have passed through or been authorized by their offices for use in the Philippines, which “official channels” are these? Even Philippine ambassador to China Chito Santa Romana professed ignorance about the provenance of the Sinopharm vaccines the PSG used. “I have no knowledge about it. We’re also curious to know but unfortunately we were not involved,” he said.

Curiouser and curiouser, indeed — and a mystery about which the public will continue to demand answers as long as the administration seems unembarrassed about providing only evasion, stonewalling, and justifications of illegality rather than plain talk and clarity.