‘Secret, VIP Vaccination’ Assailed; Entry Of Sinopharm Vaccines To Be Probed; Janssen Allowed To Conduct Clinical Trials

It’s been a month since members of the Presidential Security Group (PSG) were vaccinated against coronavirus disease 2019 (COVID-19), Defense Secretary Delfin Lorenzana bared on Tuesday, Dec. 29.

According to Lorenzana, there had been “no adverse effect reported” among those inoculated. “I have no problem. The vaccine has been approved, tried and found to be effective in the country of origin.”  But Lorenzana said he did not know where the vaccines came from.

The inoculation was disclosed only last Saturday, Dec. 26, by President Duterte himself. The Chief Executive said almost all soldiers had received the vaccines from the Chinese pharmaceutical firm Sinopharm.

Even if Malacañang does not see anything illegal with it, many are asking why the Food and Drug Administration (FDA) was bypassed before the vaccines from was administered to at least one Cabinet member and the soldiers.

The Department of Health (DOH) said the people involved in the inoculation of military personnel with unregistered COVID-19 vaccine may be held liable for violating FDA Act of 2009.

The law provides that it is unlawful to sell, supply or distribute a product that is not registered with the FDA, DOH Undersecretary Maria Rosario Vergeire noted in a press briefing on Tuesday.

FDA director general Eric Domingo said he ordered an investigation to determine the “details” surrounding the vaccination of the military personnel.

Domingo said they have to establish the vaccines used, who administered and brought the vaccine, among other information.

He reiterated that the Sinopharm vaccine has not been approved by FDA so they could not guarantee its safety and efficacy.

“We advised the public not to let yourself be vaccinated against COVID-19 yet.  There is no registered vaccines here that have passed the evaluation of our experts and FDA,” he added.

Domingo stressed even donated vaccines, food or medicines should be coursed through the DOH, which will then coordinate with FDA.

“We don’t know who made the decision (to use Sinopharm).  I don’t think it’s the President. I asked (DOH) Secretary Francisco Duque III, he was also surprised.  There was no consultation with DOH or FDA,” he said.

He also advised those vaccinated to see a doctor if they experience “adverse event reaction” or side effects of the vaccination.

“We have this protocol that they have to immediately consult with their doctors or they can go to hospitals and these hospitals would know how to manage that,” Domingo added.

BOC investigation

The Bureau of Customs (BOC) is also conducting an investigation into the entry of the Sinopharm vaccines.

BOC spokesman Philip Vincent Maronilla said vaccines must be approved by the FDA before they could be used in the country.

Asked whether the vaccines were smuggle, Maronilla could not say yet. He said there had been no communication from the FDA to the BOC with regard to the vaccines.

Officials who were proven to have used the vaccines even without the approval of the FDA could be held administratively and criminally liable and for violation of the Customs Modernization Act, Maronilla pointed out.

Maronilla said they will also "find out" where the PSG and the military have gotten the vaccines.

Senate Minority Leader Franklin Drilon also warned that any distribution and inoculation of vaccines without proper authorization from the FDA is illegal and punishable by law.

The senator also wondered how the China-made vaccines were able to get past the BOC.

Drilon said the inoculation of the officials “set a bad example” and “undermined the very purpose of the creation of the FDA which is to “protect and promote the right to health of the Filipino people” and to ensure the “purity, safety, efficacy and quality of drugs and vaccines in the country.”

“What was done completely dismissed the well-entrenched public safety and health protocols. It further undermined the regulatory authority of the FDA with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products,” Drilon added.

Drilon underscored the FDA Law or Republic Act (RA) No. 3720, as amended by RA 9711, prohibits the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded or any health product which, although requiring registration, is not registered with the FDA pursuant to this Act.”

Section 21 of the same law provides that no person shall manufacture, sell, offer for the sale or transfer any new drug, unless an application filed containing full reports of investigations to show that such drug is safe, efficacious and of good quality for use based on clinical studies, prior to manufacture, sale, importation, exportation, distribution or transfer thereof.

Drilon said the administration of the unauthorized vaccine clearly violates FDA Circular No. 2020-036 or the “Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19.”

The circular, which applies both to “pharmaceutical industry and government entities such as national procurer or health program implementors,” requires that an application for the issuance of an emergency use authorization be filed and obtained from the FDA.

The EUA is an authorization issued for unregistered drugs and vaccines in a public health emergency, upon demonstration of safety, effectiveness and quality. The FDA made clear that it has not given any EUA to any vaccine for COVID-19.

Drilon said any person who violates any of the provisions of Section 11 of RA 3720, as amended, faces a penalty of imprisonment ranging from one to 10 years or a fine of not less P50 thousand but not more half a million, or both.

The manufacturer, importer or distributor faces stiffer penalties of five to 10 years imprisonment and a fine of P500 thousand to P5 million, he added.

An exception is if the pharmaceutical company and national procurer or health program implementer obtain the EUA under the FDA Circular, he noted.

Sen. Risa Hontiveros said the government must answer all questions regarding the unauthorized vaccination, saying a black market for COVID-19 vaccines “should not be tolerated in any way.”

“This was unsafe and illegal. These vaccines were clearly smuggled through a black market, and even worse, seem to be sanctioned by the government. Did the people pay for this illegal vaccination?” Hontiveros asked. "What is the story behind this 'secret vaccination'? Who is the initiator and who is the supplier? If President Duterte did not order AFP (Armed Forces of the Philippines) members to inject unauthorized and unsure vaccines from China, who in Malacanang is the promoter of this illegal and irresponsible action?”

She said the government should be transparent about the deal and the decision to have the soldiers vaccinated.

“If the vaccine is unsafe, who will be held accountable? There are major life-threatening consequences in any lapse in this mass vaccination program,” Hontiveros said, adding those behind the vaccination must be held accountable.

Blatant disregard

The Coalition for People's Right to Health (CPRH), for its part,  said the vaccination of government personnel even without FDA approval exposed blatant disregard for regulatory processes and the people's right to health.

The CPRH condemned what happened and said existing laws must be respected. “Once again, the people's health is sacrificed for the convenience and privilege of a few.”

CPRH called on the health agencies and independent groups to denounce and investigate this “mockery” of regulatory processes and institutional mandate.

“Wider testing and vaccination must be for the good of all, not VIPs and cronies. These incidents betray the reality that health leaders have not been in charge of what is truly a public health crisis,” the group said.

“As health workers and advocates, we must not and cannot accept this. We must stand for the people's right to health, especially for those made vulnerable by a chronically neglected health system,” it added.

Dr. Anthony Leachon, a former member of the National Task Force Against COVID-19, said it is alarming when “government agencies are doing things on their own.”

“What we need is an all-of-government and whole-of-society approach. Everyone must be on the same page. Full transparency on matters like this which involves public welfare and safety. It claims that most of the soldiers were already vaccinated. What if there’s a significant side effect?” Leachon said.

“The AFP will be sidelined and potentially paralyzed. Soldiers are also a ‘vulnerable population’ in clinical trials, and they can’t readily say no if their commanders order them to get vaccinated. There’s no such thing as an informed consent when you’re dealing with a vulnerable sector,” he emphasized.

No Duterte approval

PSG commander Brig. Gen. Jesus Durante III cleared Duterte of any liability following the vaccination of the President’s close-in security personnel.

Durante said in a television interview that the President was surprised when they informed him about it.

Durante maintained only a few of his members were inoculated – the reason why they did not think of consulting the DOH. “This is not a massive vaccination…we acquired purposely for the use of the close-in personnel of the President,” he said.

“We know the implications,” he added.

Durante belied claims that the vaccination could not be done without the nod of Duterte as commander-in-chief.  “I told him that, be rest assured that those who were inoculated will be safe and definitely,  we did it for the President himself.”

“That was the time when there were already vaccines coming out… so we researched (about it)…what vaccine to acquire for the unit alone,” he said.

“We are in the state of war, as war against COVID-19. War compels us to survive as what we are now doing in this pandemic. As such, PSG exploits all means in order to deliver its mandate as what is highly expected of them by the Filipino people,” Durante said.

 Mere ‘token’

Presidential spokesman Harry Roque expressed belief  that the PSG did not violate any law.

Roque described the vaccines as a “token” and PSG’s acceptance was not a violation of RA 3019 or the Anti-Graft and Corrupt Practices Act.

“I am a lawyer.  (That law) is not absolute.  The tokens are allowed especially during Christmas season,” Roque said.

He added that no public funds were spent for these vaccines.

Interior and Local Government Secretary Eduardo Año said private citizens are free to use  unregistered COVID-19 vaccines if the medicines are donated to them.

The department chief said it is not unlawful to have unauthorized vaccines for as long as it administered to the recipients with consent.

Ano said it is up to the recipients if the want to be inoculated with the vaccine and be ready to face the consequences or side effects.

“If they are able to get it from their relatives, I don't see anything that is against the law,” Ano said in an interview over ABS-CBN News Channel.

Ano appealed to critics not to complicate matters as only a “handful” of PSG troops who are part of Duterte's close-in security and a Cabinet official received COVID-19 vaccines.

He stressed frontline healthcare workers will get the vaccines first once they are available and approved by the FDA.

Janssen gets approval

Meanwhile, Belgium’s Janssen Pharmaceutical Inc. becomes the first company to conduct clinical trials for its COVID-19 vaccine in the Philippines.

Domingo said the agency had approved on Monday, Dec. 28, Janssen’s application to hold Phase 3 clinical trials in the country.

“Maybe, they will be able to start their clinical trial after the New Year,” he said.

Janssen, owned by Johnson & Johnson, is among the three pharmaceutical firms with pending applications to do clinical trials in the Philippines.

The others are Sinovac  and Clover Biopharmaceuticals of China.

Domingo noted that Sinovac had made some changes in “protocol or research design”” so their documents “were given back to the reviewers.”

On the other hand, the FDA is waiting for Clover to complete their documentary requirements.

He added the next step would be would be for the Vaccine Expert Panel of the Department of Science and Technology to assign an area where the trial will take place.

There will be preliminary preparations and the recruitment of participants in the trials will start in the next few weeks.

The official also said that so far, only US pharmaceutical Pfizer Inc. had applied for EAU to be able to supply the country with its candidate vaccine.

Pfizer’s application was submitted online last Dec. 23.

“We already downloaded and submitted their documents to the evaluators and we hope to complete the preliminary evaluation  within two weeks,” Domingo bared.

After this, Pfizer’s application will be evaluated both on the regulatory side for the quality of the vaccine and clinical side for its efficacy and safety. – With Michael Punongbayan, Cecille Suerte Felipe, Emmanuel Tupas