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Friday, April 26, 2024

Palace: PSG given donated drugs

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A palace spokesman on Tuesday defended the use of an unauthorized Chinese vaccine against COVID-19 that was given to some members of the Presidential Security Group (PSG), saying the government accepted them as “tokens” of small value.

Presidential spokesman Harry Roque said the law prohibiting public officials and workers from soliciting and accepting gifts or anything of monetary value was “not absolute.”

However, Roque did not say if the vaccines were legally brought in or passed through proper channels, since such products need government permits.

In his regular press briefing, Roque said no government funds were used to purchase the vaccines given to the PSG members.

“It was not paid for so it’s a donation, but that’s all that I know,” he said.

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“Let’s not take it the wrong way because that will result in the President’s good health and let’s close the issue at that,” he said.

Roque said the government remains committed to prioritizing the country’s health workers, the poor and vulnerable and essential workers for the immunization drive.

The Food and Drug Administration (FDA) has yet to approve any coronavirus vaccine for use in the country.

The Palace earlier said it was not against the law for someone to receive a vaccine as long as it was not commercially imported, distributed and sold in large amounts.

The Bureau of Customs (BOC) warned that government officials who took part in the importation of coronavirus vaccines without necessary permits from the FDA and passed through the BOC without the required import permitS may face administrative and civil charges.

In an interview over Super Radyo DZBB, BOC Assistant Commissioner Philip Vincent Maronilla admitted that the agency did not receive any formal communication on the importation of COVID-19 vaccines administered to the PSG.

President Duterte admitted that some members of his security team had received a coronavirus vaccine from the Chinese company Sinopharm — the first people in the country to be immunized against COVID-19—without the necessary regulatory approval.

He said importation of any products without the required permits or import permits is deemed to be smuggling.

“All COVID-19 vaccines that enter the country should secure the necessary permits from the FDA, which already said it has not given any go-ahead for such medicines,” he said.

Maronilla said they will look into their records to see if the vaccines were brought in for the use of the general public.

The BOC is now looking into the possibility that the vaccines were brought in through air freight given the logistical and transportation concerns of transporting vaccines. It is also possible that the vaccines were brought in by the military themselves, and no communication was given to the BOC.

FDA Director General Eric Comingo said his agency is investigating the inoculation of some military and Cabinet members with unauthorized COVID-19 vaccines.

In an interview on Super Radyo dzBB, Domingo said the regulatory enforcement unit has yet to submit a report.

“I really want to know the details of how it happened,” Domingo said in Filipino.

“Where did the vaccine come from? What is our assurance that it is a real vaccine and it was handled properly before being injected into soldiers?” he added.

Domingo said they will also ask the Philippine Army and the PSG for information on the personnel who received the unregistered vaccine.

He said he was not privy to who among the Cabinet members also received the unauthorized vaccine and said Health Secretary Francisco Duque III did not know either.

After the President’s revelation Saturday, the Armed Forces of the Philippines confirmed that members of the PSG were given shots of the unauthorized vaccine.

Domingo said Sinopharm has yet to contact the FDA to apply for emergency use authorization.

“Sinopharm has not yet approached the FDA. They have not yet applied for anything here in the Philippines and then they do not have a representative here in the Philippines,” he said.

Domingo added that the FDA will try to communicate with the Chinese manufacturer through the Chinese Embassy.

Domingo also said he finds it shocking that an unregulated vaccine has been reportedly used on military personnel and Cabinet members, saying this was unsafe.

Domingo said the process of acquiring the vaccine could have been made legal only if the manufacturer applied for a “compassionate use special permit,” which was given to potential COVID-19 medicine Remdesivir for a clinical trial in the Philippines.

The FDA said Philippine laws prohibit the manufacturing, importation, exportation, sale, distribution, and non-consumer use of unregistered products.

Violating manufacturers, importers, and distributors will be fined from P500,000 to P5 million.

Domingo added that even donated vaccines would still need clearances before they are brought into the country.

“The Department of Health does accept donations, like for food and drugs. But, usually if they are foreign donations, they go through the Bureau of Internal Health Cooperation,” Domingo said.

“Then, the BIHC of the DOH coordinates with the FDA to get the necessary clearances for them to be able to bring it into the country. In this case, I do not think there was any process that was done,” he said.

On Tuesday, Interior Secretary Eduardo Año said the vaccines administered to members of the PSG were probably donated, considering the sale and distribution of them are illegal.

Opposition senators protested the advanced vaccination of members of the PSG and the Cabinet.

Senators Francis Pangilinan, Risa Hontiveros and Leila de Lima questioned the priority given to these groups instead of those belonging to the most high-risk groups.

"I thought medical frontliners and our seniors and the most high-risk would be vaccinated first," Pangilinan said.

"Did Malacanang go ahead of the FDA in ensuring that the vaccine is safe?" he asked.

Did the government’s vaccination program prioritize those who had "pull" with the people in power, he asked.

Senator Risa Hontiveros said the government must answer all questions regarding the unauthorized vaccination of top officials and soldiers, 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,” she said.

“This is a major risk to the public’s health. Not only is it possible that the vaccine is unsafe, but it also might not even be effective in the first place. They might become confident, freely walking COVID superspreaders. They’ve put our soldiers at risk,”she added.

Hontiveros asked the National Task Force against COVID-19 (NTF) to provide a transparency report which she said is crucial for preventing a waste of funds or even corruption.

She added that it would also give peace of mind to the public whose fear of using vaccines remains high. The transparency report should “reflect the decisions of the NTF every step of the way,” she said.

She said the vaccination plan clearly says that the first step is to locally approve the vaccines, which was not done with Sinopharm.

On top of this, she said the government promised that it would vaccinate health care workers, who put their lives on the line everyday, first, which it also didn’t.

"What happened to the plan?” she asked.

De Lima also insisted that the government reveal which Cabinet members had taken the vaccine.

"Who are they? Why were these individuals prioritized? What vaccines were used? Under what deal? Who exactly gave the imprimatur to what is patently a transgression of law and public policy?" she said.

Senate Minority Leader Franklin Drilon questioned how the China-made vaccines were able to get past the Bureau of Customs.

Drilon pointed out that the administration of the unauthorized drug to some Cabinet members and the military clearly violates an FDA Circular entitled “Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for Covid-19.”

He also said the inoculation of some Cabinet members set a bad example and undermined the very purpose of the creation of the FDA.

“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 said.

Dr. Tony Leachon, former part of the inter-agency task force against COVID-19, said getting the vaccine from the black market could sabotage the government's vaccination program.

Leachon told ABS-CBN News in an interview that aside from the black market, some Filipinos are also planning to travel abroad because they have a higher chance of getting the vaccine there.

Leachon said some Filipino green card holders are keen on being inoculated in the United States where the vaccines are already being rolled out.

Others want to go to Singapore because the vaccines have arrived in Singapore and it's closer to the Philippines, he said.

Duque III earlier said the country would begin its inoculation program for high-risk individuals and poor families in March.

As of Monday, the Philippines has yet to approve the use and sale of any COVID-19 vaccine in the country.

This is not the first time the rich and the privileged secured COVID-19-related items ahead of those who need it more, Leachon said.

"It happened already during the first few months of the (COVID-19) laboratory testing," he said.

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