‘Some Cabinet, PSG men have received vaccine’

MANILA, Philippines — Interior Secretary Eduardo Año confirmed yesterday that several Cabinet members and soldiers belonging to the Presidential Security Group (PSG) have received COVID-19 vaccines.

Año said he knew some of the Cabinet members and PSG personnel who have been inoculated, but he did not name them. He said the vaccine was administered under emergency use authorization.

EUA is a mechanism that allows the use of medical countermeasures, including vaccines, during public health emergencies. The Food and Drug Administration (FDA), which issues the EUA, has not given it to any COVID vaccine so far.

President Duterte announced last Saturday night that a number of people in the Philippines, among them soldiers, have been given the vaccine developed by Chinese firm Sinopharm. The company has not yet applied for an EUA in the Philippines for its vaccine.

Philippine Army spokesman Demy Zagala confirmed that Army soldiers were among those vaccinated. He said the inoculation appeared to have been cleared with the President.

Duterte fueled speculation that he himself had received the Chinese vaccine, when he asked last Saturday if he could also get the Pfizer vaccine after a previous inoculation. Malacañang said yesterday that Duterte had not yet received any COVID vaccine.

The Department of Health (DOH) last Saturday confirmed that US pharmaceutical giant Pfizer had applied before Christmas for an EUA. The FDA has yet to grant it.

“It’s confidential. You cannot divulge (the names of vaccine makers) because I might be violating his privacy but I know some from the Cabinet and from the PSG (who have been inoculated) and that has EUA,” Año told TeleRadyo.

There is nothing illegal with getting unregistered vaccines, Malacañang maintained yesterday, as it defended the inoculation of some soldiers even before a vaccine has been authorized for use in the Philippines.

Last Saturday, Duterte said “almost all” soldiers have been inoculated even if the FDA has not approved any vaccine for use.

“The law does not prohibit getting vaccines that are not yet registered. What it prohibits are distribution and sale,” presidential spokesman Harry Roque said at a press briefing.

“Do not deprive our soldiers of protection. Let us accept the fact that our soldiers are important and the ones looking after our safety should be safe from COVID so they can perform their duties,” he added.

Roque said the vaccine doses given to soldiers were “donated” but could not say who provided them. He claimed the inoculation was not mandatory.

“This (decision to be vaccinated) must have been made by the soldiers and probably by their commanders. It won’t reach soldiers without the go-signal of commanders. And I understand, this is voluntary,” he said.

Roque could not say whether Dutere has been inoculated with a COVID-19 vaccine.

“I do not know if he has been vaccinated. Moreover, I don’t think the President will allow any vaccine to enter his system unless he has considered it. But as I said, I cannot confirm nor deny and I must say, as far as I know, he has not been vaccinated,” he said.

The PSG confirmed that some of its members have received COVID-19 vaccines.

“With the current pandemic, PSG needs to ensure that they are not themselves (a) threat to the President’s health and safety. As such the PSG administered COVID-19 vaccine to its personnel performing close-in security operations to the President,” PSG chief Brig. Gen. Jesus Durante III said in a statement.

“National security imposes the protection of the President being the commander-in-chief from all forms of threat, especially COVID-19, in order to preserve the stability of our nation. It is PSG’s primordial task to ensure that we have a healthy President serving our fellow Filipinos every day,” he added.

Durante, however, clarified that his unit cannot speak in behalf of the vaccine and its effectiveness.

Año said that Duterte has not yet received the vaccine after his doctors advised against it.

Durante said the President is still waiting for the perfect or appropriate vaccine.

Vice President Leni Robredo has not yet received a vaccine against the coronavirus, her spokesman said yesterday.

“She has neither been vaccinated nor has an offer to do so been made,” lawyer Barry Gutierrez said in a statement.

Justice Secretary Menardo Guevarra yesterday denied that he was among Cabinet officials inoculated with the COVID vaccine.

Año meanwhile confirmed that several members of the military who had taken the vaccines have experienced side effects after receiving their second dose.

“We heard that it seems that upon receiving the second dose, they have sore throats for a day or two and after that, it was gone. That’s maybe the only side effect. They said they were OK,” Año added.

Senate President Vicente Sotto III saw nothing wrong with PSG members and others from the uniformed services being inoculated with vaccines from China that apparently had no clearance from the FDA.

“I don’t think there’s anything wrong about that. There is no law that says you cannot take any medicine or vaccine that FDA has not approved,” Sotto said.

“Last I recall, there is even no law vs. suicide. So what’s the fuss?” he said.

Sotto believes the vaccines were donated and were “administered for free.”

He said those criticizing the move may complain if the government paid for the vaccines. “They should complain to the donor why they wanted them (PSG) inoculated first.”

Senate Minority Leader Franklin Drilon, however, warned the government that the move could affect public confidence in the vaccination program and did not adhere to well-established scientific protocols.

“Public confidence is critical to the successful inoculation of our people. Confidence is developed by adhering to a science-based process and the opinion of our vaccine expert panel,” Drilon said.

“The inoculation using vaccines not approved by our FDA will not contribute to the need to develop public confidence that the government program will succeed,” he said.

Sen. Francis Pangilinan said the reported vaccinations showed the administration’s reckless and haphazard vaccination plan.

Defense Secretary Delfin Lorenzana clarified that the President was referring to PSG members when he said some soldiers have been inoculated.

“I think the President meant the PSG, not AFP (Armed Forces of the Philippines),” he said after the military also issued a clarification.

AFP spokesman Maj. Gen. Edgard Arevalo, after initially clarifying that the AFP is not aware of any COVID-19 inoculation made to military personnel, later confirmed that members of the PSG were the first from the AFP vaccinated, owing to the nature of their job.

“As the unit primarily tasked to protect and secure the highest official of the land, the PSG will have to ensure that the President is safe from all threats – including COVID-19,” he said.

Arevalo noted that “because the safety of the President equates to national well-being, that security posture should necessarily include protecting the commander-in-chief from contracting the deadly virus from those he is constantly exposed to, like the members of his security detail.”

He, however, emphasized that the AFP is not privy to the arrangements on how the vaccines were obtained, though “we have taken cognizance of the fact that the members of the PSG under Brig. Gen. Jesus Durante have taken a bold step to try the vaccine to protect the President.”

No harm Sinopharm?

Food and Drug Administration director general Eric Domingo noted in a text message that Sinopharm has not filed any application with the agency.

Domingo gave assurance that FDA has been investigating reports of underground vaccination against COVID-19 in Binondo, Manila but no one has been arrested so far.

He added that the public should report any individuals offering to have them immunized against the disease because no vaccine manufacturer has been licensed to market or supply vaccines.

Domingo, however, said the Department of Health (DOH) or the government has the option to apply with FDA for emergency use authorization if they intend to import such vaccines. This option is not available to the private sector.

For the DOH, all vaccines against COVID should undergo evaluation process of regulatory and expert bodies before they can be used in the Philippines.

According to DOH, using “unregistered products poses harm to a person’s health and safety.”

“This is why only vaccines which have been approved and found to be safe should be administered. The administration of approved vaccines is also accompanied by strict monitoring of all vaccine recipients in order to ensure proper management of possible effects,” the DOH said.

Domingo said that it may take two to three weeks for the FDA to complete the evaluation of the documents submitted by US pharmaceutial firm Pfizer as part of its application for EUA.

As of date, the FDA has not issued any EUA to any vaccine for COVID-19.

“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,” he added.

Under the FDA Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement or sponsorship of any unauthorized vaccine is prohibited.

“Rest assured that the FDA is observing utmost diligence in the regulation of vaccines. Vaccines will only be approved if there is reasonable scientific evidence to show that benefit outweighs risk,” he added.

Philippine National Police chief Gen. Debold Sinas yesterday said that the police are investigating the reported sale of COVID-19 vaccines in the black market amid reports of Filipinos being inoculated despite the absence of approval from regulators. — Alexis Romero, Sheila Crisostomo, Michael Punongbayan, Neil Jayson Servallos, Evelyn Macairan, Paolo Romero