REVELATIONS that some soldiers and government officials were vaccinated against Covid-19 has sparked a firestorm, with Palace officials defending the act as regulators asserted “no violation was commited,” even though the Food and Drug Administration (FDA) reiterated it had not yet issued “any Emergency Use Authorization [EUA]” to any vaccine for Covid-19.
FDA Director Eric Domingo issued the reminder following reports that certain individuals have received vaccines against Covid-19 and reiterated its public advisory (FDA 2020-1395-00-A) counseling extreme caution in the purchase and use of vaccines claiming to be safe and effective against the virus.
“Rest assured that the FDA is observing utmost diligence in the regulation of vaccines. Vaccines will only be approved if there is a reasonable scientific evidence to show that benefit outweighs risk,” Domingo said on Monday.
Asked by the BusinessMirror if there was a violation after some soldiers, members of the Presidential Security Group, and government officials were given the Covid vaccine, Domingo replied: “Walang violation ang nagpabakuna [There was no violation].”
He added: “Ang bawal ay ang [What is prohibited is ] importing, distribution and dispensing of unregistered drugs.”
He said the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any unauthorized vaccine is prohibited —a point echoed separately by Presidential Spokesman Harry Roque, a lawyer.
The FDA said commission of such prohibited acts may lead to possible liabilities provided under the law.
“The FDA will coordinate with other agencies and take appropriate regulatory action involving any unauthorized vaccines,” the FDA added.
Meanwhile, the Department of Health (DOH) maintained that all vaccines should undergo the evaluation and regulatory process of Philippine regulatory and expert bodies.
“We also reiterate that the use of unregistered products poses harm to a person’s health and safety,” the DOH stressed.
This is why, the DOH said, only vaccines which have been approved and found to be safe should be administered.
On Monday, Malacañang said the use of unregistered vaccine by some members of the Cabinet and “soldiers” was not illegal.
In an online press briefing on Monday, Roque said an individual has the “personal choice” to use a vaccine, whether it is registered or not, but they are still bound by FDA regulations, when it comes to how they were able to access such imported item.
“The law does not prohibit people from injecting themselves unregistered [vaccine]. What is illegal is its distribution and selling,” Roque said.
Currently, FDA has yet to authorize any clinical trial or approve an EUA, which would have allowed the importation, distribution as well as administration of any Covid-19 vaccine.
In fact, FDA and concerned agencies have conducted several raids specifically meant to confiscate unregistered vaccine, which it discouraged the public from purchasing and using due to safety concerns.
But in the case of Sinopharm, Roque said, its vaccine is safe since its use was already approved in China and the United Arab Emirates (UAE).
Official confirmation
Roque confirmed Duterte’s remarks at his public address last Saturday that some soldiers were inoculated with the vaccine from Chinese drug maker Sinopharm.
The Palace official said the vaccine may likely be a donation from China.
“If it was able to pass through [the customs], it has to be in small quantities because if it is in commercial quantities, it will require a license [from FDA],” Roque said.
Defense Secretary Delfin Lorenzana clarified that only members of the Presidential Security Group (PSG) were given the vaccine.
This was confirmed by PSG Commander Jesus Durante, who said those inoculated were close-in security for the President.
“With the current pandemic, PSG needs to ensure that they are not themselves threat to the President’s health and safety,” Durante said in a statement.
Side effects
Durante said they were aware of the possible risk of using new vaccines.
The PSG roster includes members of the Armed Forces of the Philippines (AFP), Philippine National Police (PNP) and the Philippine Coast Guard (PCG).
In a radio interview, Interior Secretary Eduardo Año said some of those inoculated suffered side effects from the second dose.
Army chief admits
A top commander of the military has admitted that some soldiers have been vaccinated with a Chinese-manufactured anti-coronavirus medicine, an admission that the military spokesman refused to confirm, however.
The confirmation by Army chief Lt. Gen. Cirilito Sobejana that some military officers took anti-Covid shots stirred a controversy, given that the FDA is yet to approve any anti-Covid vaccine in the country.
“I know of some, but I could not just disclose the unit. I know personally that some in the ranks of the AFP have been vaccinated,” Sobejana said on radio station DWIZ.
His admission followed an earlier statement by Duterte that some members of the military have taken anti-coronavirus shots from Chinese-manufactured SinoPharm.
Military spokesman Major General Edgard Arevalo said the Armed Forces is not officially aware of any vaccination in the organization, although they are trying to verify it.
”The AFP is not aware of Covid-19 inoculation made to military personnel. We do not have an AFP Leadership-sanctioned vaccination. We are getting details,” he said in a statement.
Lacson laments Palace switch
Senator Panfilo Lacson lamented Monday Malacañang’s mishandling of the Covid vaccine supply deal with United States pharmaceutical companies to favor a Chinese supplier, which was seen to likely derail annual joint military exercises under the RP-US Visiting Forces Agreement (VFA).
Lacson warned that the President’s “No vaccines, no VFA!” threat was uncalled for.
He added that, “treating the Americans like a bunch of yokels might have sealed our fate to settle for China’s Sinovac in lieu of the US-made Pfizer-BioNTech and Moderna vaccines.”
Lacson aired his disappointment in a statement indicating his frustration that concerned Duterte administration officials could have handled the matter diplomatically, to avoid misperceptions they were “blackmailing” the US.
“Such a pronouncement from the President is at the very least, unfortunate,” Lacson rued. “I think there could be a more diplomatic or at least a better way of asking a longtime ally to help us avail of the vaccines for our people without sounding like we are blackmailing our way into it.”
The senator added: “What is more unfortunate is that we had a good chance to procure vaccines early from the US, but someone from our side dropped the ball, and has yet to be held accountable up to this day,” a reference to Health Secretary Francisco Duque III.
Not blackmail–Roque
Malacañang defended Duterte’s decision to require the US to provide the country access to its vaccine or it will risk losing the Visiting Forces Agreement (VFA).
Presidential spokesman Roque said the initiative only aims to ensure the country’s interest especially during the pandemic.
“What the President is saying, since we are friends [with the US], we should help one another. We need the vaccine, and they have it, so they should send some to us,” Roque said.
“They need our territory for their Visiting Forces Agreement, so we will give them [access] to it,” he added.
Last Saturday, Duterte said in his public address that if the US government will not provide the government at least 20 million doses of vaccine, then he will bar their military personnel from entering the country under the VFA.
Roque said the condition is not considered as blackmail and is the government exercising its independent foreign policy.
‘Overpriced vaccine’
Meanwhile, a senator has added to the controversy with revelations that some vaccines being imported by the Duterte administration seem “overpriced.”
Senator Imee Marcos asked officials involved in the deal to explain “why [the Philippines] will pay more than double what rich countries have negotiated to buy the same vaccine against Covid-19.”
Marcos earlier pushed for an Asean initiative to lobby global pharmaceutical firms to waive their intellectual-property rights on vaccine patents, “so that vaccines can be produced locally and sold at a cheaper price in poorer countries, adding that “computed that at $5 per dose, 30 million doses will cost the Philippine government $150 million or almost P7.2 billion, which could buy more than 69 million doses for the EU.”
With two doses required, Marcos computed that “15 million Filipinos can be vaccinated at the same cost that can cover about 34.5 million Europeans.”
She noted that Belgium’s Budget Secretary Eva De Bleeker had earlier disclosed that EU member-states will buy the AstraZeneca vaccine for only 1.78 euro or about 105 pesos per dose which, Marcos computed, “is 2.3 times less than what the Philippines will be paying the British-Swedish pharmaceutical firm.”
She noted that the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) will sign this week an agreement with AstraZeneca to buy 30 million doses of its vaccine at $5 or about P240 per dose, as soon as the UK health ministry authorizes its use.
At the same time, she recalled statements by AstraZeneca’s CEO Pascal Soriot and its research partner Oxford University “to provide the vaccine on a not-for-profit basis for the duration of the pandemic across the world, and in perpetuity to low- and middle-income countries.”
Marcos cited reports the United States will be buying the AstraZeneca vaccine at $4 per dose, at which rate five Americans can be immunized for every four Filipinos.
She stressed that “the pricing issue must be addressed by the IATF, lest the government be suspected of profiteering amid tight funding for vaccines.” With Claudeth Mocon-Ciriaco
Image credits: Malacanang Presidential Photographers Division via AP